Tuesday, October 25, 2016

belatacept


Generic Name: belatacept (bel AT a sept)

Brand Names: Nulojix


What is belatacept?

Belacept lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a kidney. This is because the immune system treats the new organ as an invader.


Belatacept is used in combination with other medications to prevent organ rejection after a kidney transplant.


Belatacept may also be used for purposes not listed in this medication guide.


What is the most important information I should know about belatacept?


You should not use belatacept if you have received a liver transplant. Before you start treatment with belatacept, your doctor will perform tests to make sure you are immune to Epstein-Barr virus (EBV-positive). Your risk of serious infection is higher if you have never been exposed to EBV. Treatment with belatacept may increase your risk of developing certain life-threatening conditions, including serious infections, cancer, or transplant failure. Talk with your doctor about the risks and benefits of using this medication. Serious infections that have occurred in people using belatacept include tuberculosis, a severe brain infection, or a virus that can cause failure of a transplanted kidney.

Call your doctor right away if you have signs of infection such as: fever, night sweats, swollen glands, flu symptoms, change in your mental state, problems with speech or walking, decreased vision, tenderness of your transplanted kidney, a new skin lesion, a mole that has changed in size or color, pain or burning when you urinate, blood in your urine, or urinating less than usual or not at all.


You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.

What should I discuss with my healthcare provider before taking belatacept?


You should not use belatacept if you have received a liver transplant.

Before you start treatment with belatacept, your doctor will perform tests to make sure you are immune to Epstein-Barr virus (EBV-positive). Your risk of serious infection is higher if you have never been exposed to EBV.


Talk with your doctor about the risks and benefits of using this medication. Also tell your doctor about all of your medical conditions.


Belatacept can lower blood cells that help your body fight infections. This can make it easier for you to develop serious bacterial, fungal, or viral infections. Serious infections that have occurred in people using belatacept include tuberculosis, a severe brain infection, or a virus that can cause failure of a transplanted kidney. Belatacept may cause your body to produce too much of a certain type of white blood cells. This can lead to serious and sometimes fatal conditions, including cancer. Your risk is further increased if you have cytomegalovirus (CMV), or if you have never been exposed to the Epstein-Barr virus. Belatacept may also cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly. FDA pregnancy category C. It is not known whether belatacept will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

If you are pregnant, or if you are a man and your sexual partner is pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of belatacept on the baby.


It is not known whether belatacept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using belatacept.

How should I take belatacept?


Belatacept is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Belatacept must be given slowly, and the IV infusion can take up at least 30 minutes to complete.


Belatacept is usually given just before your kidney transplant, and again 5 days later, followed by once every 2 to 4 weeks. Follow your doctor's dosing instructions very carefully.


You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly. Do not miss any follow up visits to your doctor for blood or urine tests.

See also: Belatacept dosage (in more detail)

What happens if I miss a dose?


Call your doctor for instructions if you miss an appointment for your belatacept injection.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking belatacept?


Do not receive a "live" vaccine while using belatacept. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.


Avoid exposure to sunlight or tanning beds. Belatacept can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Belatacept side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with belatacept. Call your doctor right away if you have signs of infection such as:



  • fever, night sweats, tired feeling;




  • cough, sore throat, swollen glands;




  • flu symptoms, weight loss;




  • confusion, change in your mental state;




  • problems with thinking or memory;




  • problems with speech or walking,




  • decreased vision;




  • stomach pain, vomiting, diarrhea;




  • tenderness on the side where you received the transplanted kidney;




  • a new bump or lesion on your skin, or a mole that has changed in size or color; or




  • blood in your urine, pain or burning when you urinate, urinating less than usual or not at all.




Call your doctor at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;




  • wheezing, chest tightness, trouble breathing;




  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);




  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);




  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).



Less serious side effects may include:



  • nausea, constipation;




  • headache, back pain, joint pain;




  • cold symptoms such as runny or stuffy nose, sneezing




  • sleep problems (insomnia); or




  • swelling in your hands or feet.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Belatacept Dosing Information


Usual Adult Dose for Rejection Prophylaxis:

Initial dose: 10 mg/kg, intravenously, once daily, on day 1 (day of transplant, prior to implantation) and day 5, and at the end of weeks 2, 4, 8, and 12.

Maintenance dose: 5 mg/kg, intravenously, at the end of week 16 and every 4 weeks (plus or minus 3 days) thereafter.


What other drugs will affect belatacept?


There may be other drugs that can interact with belatacept. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More belatacept resources


  • Belatacept Side Effects (in more detail)
  • Belatacept Dosage
  • Belatacept Use in Pregnancy & Breastfeeding
  • Belatacept Drug Interactions
  • Belatacept Support Group
  • 0 Reviews for Belatacept - Add your own review/rating


  • belatacept Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Belatacept Professional Patient Advice (Wolters Kluwer)

  • Belatacept MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nulojix Prescribing Information (FDA)

  • Nulojix Consumer Overview



Compare belatacept with other medications


  • Rejection Prophylaxis


Where can I get more information?


  • Your pharmacist can provide more information about belatacept.

See also: belatacept side effects (in more detail)


Miscellaneous ophthalmic agents


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

The ophthalmic preparation categorized under miscellaneous ophthalmic agents is an antimydriatic agent, which decreases the size of the pupil. It is available as a solution and instilled into the eyes to decrease the size of the pupil after eye examinations or procedures (prior to which mydriatic agents are used to dilate the pupil, in order to examine the eye).

See also

Medical conditions associated with miscellaneous ophthalmic agents:

  • Eye Dryness/Redness

Drug List:

Bellamine S


Generic Name: Belladonna Alkaloids/Ergotamine/Phenobarbital (bell-a-DON-a/er-GOT-a-meen/fee-noe-BAR-bih-tal)
Brand Name: Examples include Bellamine S and Bellaspas


Bellamine S is used for:

Treating menopausal symptoms (eg, hot flashes, sweating, restlessness, trouble sleeping), certain heart problems (eg, fast or irregular heartbeat), certain stomach problems (eg, nervous stomach), and recurring, throbbing headaches. It may also be used for other conditions as determined by your doctor.


Bellamine S is an anticholinergic, barbiturate, and ergot combination. It works by affecting certain chemicals in the nervous system.


Do NOT use Bellamine S if:


  • you are allergic to any ingredient in Bellamine S

  • you have previously experienced restlessness or excitement after taking phenobarbital

  • you have glaucoma; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); a blockage of the stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or heart problems with severe bleeding

  • you have blood vessel problems (eg, peripheral vascular disease), heart blood vessel problems, high blood pressure, liver or kidney problems, or a severe infection (eg, sepsis)

  • you have a history of the blood disorder porphyria

  • you have a history of alcohol or substance abuse or dependence or may be at risk for an addiction

  • you are taking an azole antifungal (eg, voriconazole), delavirdine, efavirenz, an HIV protease inhibitor (eg, ritonavir), a ketolide antibiotic (eg, telithromycin), a macrolide antibiotic (eg, erythromycin), a selective 5-HT agonists (eg, sumatriptan), or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Bellamine S:


Some medical conditions may interact with Bellamine S. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have nerve problems, prostate problems, heart problems (eg, fast or irregular heartbeat, heart failure), hiatal hernia, diarrhea, a fever, risk factors for glaucoma, gallbladder problems, lung or breathing problems, an overactive thyroid, difficulty urinating, or an ulcer

  • if you have a history of depression, anxiety, stroke, or trouble sleeping, or you have had suicidal thoughts or behaviors

  • if you have been very ill or severely weakened

  • if you regularly consume alcohol or you smoke

Some MEDICINES MAY INTERACT with Bellamine S. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Amantadine, antihistamines (eg, diphenhydramine), beta-blockers (eg, propranolol), fluoxetine, fluvoxamine, haloperidol, monoamine oxidase (MAO) inhibitors (eg, phenelzine), nefazodone, phenothiazines (eg, thioridazine), quinine, quinolone antibiotics (eg, ciprofloxacin), saquinavir, stiripentol, sympathomimetics (eg, pseudoephedrine), tricyclic antidepressants (eg, amitriptyline), valproic acid, zileuton, or other anticholinergics (eg, scopolamine) because they may increase the risk of Bellamine S's side effects

  • Azole antifungals (eg, voriconazole), delavirdine, efavirenz, HIV protease inhibitors (eg, ritonavir), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin), or selective 5-HT agonists (eg, sumatriptan) because the risk of severe side effects, including irregular heartbeat or decreased oxygen to the extremities (eg, hands, feet), may be increased

  • Sodium oxybate (GHB) because the risk of its side effects may be increased by Bellamine S

  • Anticoagulants (eg, warfarin), clozapine, corticosteroids (eg, hydrocortisone), doxycycline, erlotinib, estrogens (eg, estradiol), griseofulvin, hydantoins (eg, phenytoin), imatinib, metronidazole, oral contraceptives (eg, birth control pills), quinidine, or theophylline because their effectiveness may be decreased by Bellamine S

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bellamine S may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Bellamine S:


Use Bellamine S as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Bellamine S by mouth with or without food.

  • Eating grapefruit or drinking grapefruit juice may affect the amount of Bellamine S in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.

  • If you miss a dose of Bellamine S, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Bellamine S.



Important safety information:


  • Bellamine S may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Bellamine S with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Bellamine S; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.

  • Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Use of nicotine may increase the risk of severe side effects with Bellamine S. Talk to your doctor before using Bellamine S if you smoke or use any other kind of nicotine.

  • Serious and sometimes life-threatening decreases in the blood supply to the extremities (eg, hands, feet) or brain may occur if Bellamine S is taken with certain other medicines, including HIV protease inhibitors (eg, ritonavir) or macrolide antibiotics (eg, erythromycin). Do not use Bellamine S if you are also taking these other medicines. Inform your doctor of all the medicines that you are taking.

  • Bellamine S may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

  • Tell your doctor or dentist that you take Bellamine S before you receive any medical or dental care, emergency care, or surgery.

  • Use Bellamine S with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.

  • Bellamine S should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Bellamine S. To prevent pregnancy, use an extra form of birth control (eg, condoms).

  • PREGNANCY and BREAST-FEEDING: Do not use Bellamine S if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Bellamine S is found in breast milk. Do not breast-feed while taking Bellamine S.

When used for long periods of time or at high doses, Bellamine S may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Bellamine S stops working well. Do not take more than prescribed. Discuss any questions or concerns with your doctor or pharmacist.


Some people who use Bellamine S for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Bellamine S suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.



Possible side effects of Bellamine S:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Bloated feeling; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; excessive daytime drowsiness ("hangover effect"); feeling of a whirling motion; headache; lightheadedness; nausea; nervousness; tired feeling; trouble sleeping.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; blue color of the fingers or toes; chest pain or tightness; cold or pale fingers or toes; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; leg cramps or weakness; loss of coordination; loss of taste; memory loss; mental or mood changes; muscle pain; numbness or tingling of the hands, feet, or skin; pounding in the chest; ringing in the ears; seizures; severe headache; severe or persistent trouble sleeping; trouble urinating; unusual weakness; very slow breathing; vision changes; vomiting.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Bellamine S side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include change in size of pupil; deep sleep; hot, dry skin; loss of consciousness; severe dry mouth; severe or persistent headache or nausea; slowed or fast breathing; trouble swallowing; vomiting.


Proper storage of Bellamine S:

Store Bellamine S at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bellamine S out of the reach of children and away from pets.


General information:


  • If you have any questions about Bellamine S, please talk with your doctor, pharmacist, or other health care provider.

  • Bellamine S is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Bellamine S. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Bellamine S resources


  • Bellamine S Side Effects (in more detail)
  • Bellamine S Use in Pregnancy & Breastfeeding
  • Drug Images
  • Bellamine S Drug Interactions
  • Bellamine S Support Group
  • 0 Reviews for Bellamine S - Add your own review/rating


  • Bel-Phen-Ergot Concise Consumer Information (Cerner Multum)



Compare Bellamine S with other medications


  • Hot Flashes
  • Menopausal Disorders
  • Perimenopausal Symptoms
  • Postmenopausal Symptoms

Betoptic S


Generic Name: betaxolol (Ophthalmic route)

be-TAX-oh-lol

Commonly used brand name(s)

In the U.S.


  • Betoptic S

Available Dosage Forms:


  • Solution

  • Suspension

Therapeutic Class: Antiglaucoma


Pharmacologic Class: Beta-Adrenergic Blocker, Cardioselective


Uses For Betoptic S


Betaxolol is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called ocular (eye) hypertension. This medicine is a beta-blocker .


This medicine is available only with your doctor's prescription .


Before Using Betoptic S


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of betaxolol in children .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of betaxolol in the elderly .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Albuterol

  • Amiodarone

  • Arformoterol

  • Bambuterol

  • Bitolterol

  • Broxaterol

  • Clenbuterol

  • Clonidine

  • Colterol

  • Diltiazem

  • Disopyramide

  • Dronedarone

  • Fenoldopam

  • Fenoterol

  • Formoterol

  • Hexoprenaline

  • Indacaterol

  • Isoetharine

  • Levalbuterol

  • Metaproterenol

  • Pirbuterol

  • Procaterol

  • Reproterol

  • Rimiterol

  • Ritodrine

  • Salmeterol

  • Terbutaline

  • Tretoquinol

  • Tulobuterol

  • Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acarbose

  • Aceclofenac

  • Acemetacin

  • Acetohexamide

  • Alclofenac

  • Alfuzosin

  • Amlodipine

  • Apazone

  • Arbutamine

  • Benfluorex

  • Benoxaprofen

  • Bromfenac

  • Bufexamac

  • Bunazosin

  • Carprofen

  • Chlorpropamide

  • Clometacin

  • Clonixin

  • Dexketoprofen

  • Diclofenac

  • Diflunisal

  • Digoxin

  • Dipyrone

  • Doxazosin

  • Droxicam

  • Etodolac

  • Etofenamate

  • Felbinac

  • Felodipine

  • Fenbufen

  • Fenoprofen

  • Fentiazac

  • Floctafenine

  • Flufenamic Acid

  • Flurbiprofen

  • Gliclazide

  • Glimepiride

  • Glipizide

  • Gliquidone

  • Glyburide

  • Guar Gum

  • Ibuprofen

  • Indomethacin

  • Indoprofen

  • Insulin

  • Insulin Aspart, Recombinant

  • Insulin Glulisine

  • Insulin Lispro, Recombinant

  • Isoxicam

  • Ketoprofen

  • Ketorolac

  • Lacidipine

  • Lercanidipine

  • Lornoxicam

  • Manidipine

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Metformin

  • Mibefradil

  • Miglitol

  • Moxisylyte

  • Nabumetone

  • Naproxen

  • Nicardipine

  • Nifedipine

  • Niflumic Acid

  • Nilvadipine

  • Nimesulide

  • Nimodipine

  • Nisoldipine

  • Nitrendipine

  • Oxaprozin

  • Oxyphenbutazone

  • Phenoxybenzamine

  • Phentolamine

  • Phenylbutazone

  • Pirazolac

  • Piroxicam

  • Pirprofen

  • Pranidipine

  • Prazosin

  • Propyphenazone

  • Proquazone

  • Repaglinide

  • St John's Wort

  • Sulindac

  • Suprofen

  • Tamsulosin

  • Tenidap

  • Tenoxicam

  • Terazosin

  • Tiaprofenic Acid

  • Tolazamide

  • Tolbutamide

  • Tolmetin

  • Trimazosin

  • Troglitazone

  • Urapidil

  • Zomepirac

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Blood vessel disease (especially blood vessels in the brain) or

  • Stroke, history of—Use with caution. This medicine may worsen these conditions .

  • Bradycardia (slow heartbeat) or

  • Heart block or

  • Heart failure—Should not use in patients with these conditions .

  • Diabetes or

  • Hyperthyroidism (overactive thyroid) or

  • Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

  • Lung disease (e.g., asthma, bronchitis, emphysema)—Use with caution. May cause difficulty with breathing in patients with this condition .

  • Myasthenia gravis—May worsen symptoms of this condition, such as muscle weakness .

Proper Use of Betoptic S


Shake the medicine well just before each use .


To use the eye drops (solution):


  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.

  • Immediately after using the medicine, wash your hands to remove any medicine that may be on them.

  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines .

If your doctor ordered two different eye medicines to be used together, wait at least 10 minutes before using the second medicine. This will help prevent the second medicine from “washing out” the first one .


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For ophthalmic solution dosage form (eye drops):
    • For glaucoma or ocular hypertension:
      • Adults and children—One drop in the affected eye(s) two times a day .



Missed Dose


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Betoptic S


It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .


If itching, redness, swelling, or other signs of eye or eyelid irritation occur, stop using this medicine and check with your doctor. These signs may mean that you are allergic to this medicine .


Betaxolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .


This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .


Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .


Betoptic S Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Pain in the eye

Rare
  • Blistering, peeling, or loosening of skin

  • blue lips, fingernails, or skin

  • blurred vision

  • change in color vision

  • chest pain or discomfort

  • chills

  • cough

  • crusting of eyelashes

  • decreased urine output

  • decreased vision

  • diarrhea

  • different size pupils of the eyes

  • difficulty in breathing, chewing, swallowing, or talking

  • difficulty seeing at night

  • dilated neck veins

  • double vision

  • drainage from eyes

  • drooping eyelids

  • extreme fatigue

  • fast, slow, or irregular heartbeat

  • feeling of having something in the eye

  • hives

  • increased sensitivity of eyes to sunlight

  • irregular, fast or slow, or shallow breathing

  • irritation or inflammation of eye

  • itching, dryness of eyes

  • itching skin

  • joint or muscle pain

  • lightheadedness, dizziness, or fainting

  • muscle weakness

  • noisy breathing

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • severe tiredness

  • shortness of breath

  • skin rash

  • sore throat

  • sores, ulcers, or white spots in mouth or on lips

  • sweating

  • swelling of eyelids

  • swelling of face, fingers, feet, or lower legs

  • tearing

  • thickened mucous from lungs

  • tightness in chest

  • troubled breathing

  • unusual tiredness or weakness

  • weight gain

  • wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Rare
  • Bad, unusual, or unpleasant (after) taste

  • change in sense of smell

  • change in taste

  • discouragement

  • feeling of constant movement of self or surroundings

  • feeling sad or empty

  • hair loss

  • headaches

  • irritability

  • lack of appetite

  • loss of interest or pleasure

  • redness, swelling, or soreness of tongue

  • sensation of spinning

  • sleeplessness

  • tiredness

  • trouble concentrating

  • trouble sleeping

  • unable to sleep

  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Betoptic S side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Betoptic S resources


  • Betoptic S Side Effects (in more detail)
  • Betoptic S Use in Pregnancy & Breastfeeding
  • Betoptic S Drug Interactions
  • 0 Reviews for Betoptic S - Add your own review/rating


  • Betoptic S Prescribing Information (FDA)

  • Betoptic S Concise Consumer Information (Cerner Multum)

  • Betoptic S eent Monograph (AHFS DI)

  • Betoptic Prescribing Information (FDA)



Compare Betoptic S with other medications


  • Glaucoma, Open Angle
  • Intraocular Hypertension

Gynodian Depot




Gynodian Depot may be available in the countries listed below.


Ingredient matches for Gynodian Depot



Estradiol

Estradiol is reported as an ingredient of Gynodian Depot in the following countries:


  • Slovenia

Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Gynodian Depot in the following countries:


  • Austria

  • Colombia

  • Germany

  • Italy

  • Peru

  • Switzerland

Dehydroepiandrosterone

Prasterone enantate (a derivative of Prasterone) is reported as an ingredient of Gynodian Depot in the following countries:


  • Austria

  • Colombia

  • Germany

  • Italy

  • Peru

  • Slovenia

  • Switzerland

International Drug Name Search

Baby Anbesol


Generic Name: benzocaine (Oral route, Oromucosal route)

BEN-zoe-kane

Commonly used brand name(s)

In the U.S.


  • Anbesol

  • Babee Teething

  • Benzodent

  • Benz-O-Sthetic

  • Bi-Zets/Benzo-Troches

  • Dentemp's

  • Dent-O-Kain/20

  • Detane

  • Gumsol

  • HAD

  • Hurricaine

  • Hurricane Spray Kit

  • Kank-A Soft Brush

  • Larynex

  • Miradyne-3

  • Mycinette

  • Orabase-B

  • Oracaine

  • Ora film

  • Orajel

  • OraMagic Plus

  • Orasol

  • Red Cross Canker Sore

  • Thorets

  • Trocaine

  • Zetts

  • Zilactin

  • Zilactin-B

In Canada


  • Anbesol Extra Strength

  • Anbesol Liquid

  • Baby Anbesol

  • Baby Orajel

  • Baby Orajel Liquid

  • Maximum Strength Orajel Pm

  • Orajel Extra Strength

Available Dosage Forms:


  • Liquid

  • Gel/Jelly

  • Solution

  • Lozenge/Troche

  • Film

  • Lotion

  • Ointment

  • Powder for Suspension

  • Cream

  • Tablet, Disintegrating

  • Swab

  • Spray

  • Gum

  • Paste

Therapeutic Class: Anesthetic, Local


Chemical Class: Amino Ester


Uses For Baby Anbesol


Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.


This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.


Before Using Baby Anbesol


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.


Geriatric


No information is available on the relationship of age to the effects of benzocaine in geriatric patients.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Infection in or around your mouth or

  • Large sores in or around your mouth—The chance of side effects may be increased.

Proper Use of benzocaine

This section provides information on the proper use of a number of products that contain benzocaine. It may not be specific to Baby Anbesol. Please read with care.


Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.


This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.


Do not use this medicine for more than 2 days without checking first with your doctor.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (lozenges):
    • For sore throat and mouth pain:
      • Adults, teenagers, and children 5 years of age and older—One lozenge, dissolved slowly in the mouth every 2 hours as needed.

      • Children younger than 5 years of age—Use is not recommended.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Baby Anbesol


If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.


Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.


Baby Anbesol Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Incidence not known
  • Headache

  • high fever

  • nausea

  • vomiting

  • worsening of pain, redness, swelling, or irritation in or around the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Baby Anbesol side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Baby Anbesol resources


  • Baby Anbesol Side Effects (in more detail)
  • Baby Anbesol Use in Pregnancy & Breastfeeding
  • Baby Anbesol Support Group
  • 0 Reviews for Baby Anbesol - Add your own review/rating


Compare Baby Anbesol with other medications


  • Oral and Dental Conditions

Monday, October 24, 2016

Lennon - Colchicine




Lennon - Colchicine may be available in the countries listed below.


Ingredient matches for Lennon - Colchicine



Colchicine

Colchicine is reported as an ingredient of Lennon - Colchicine in the following countries:


  • South Africa

International Drug Name Search

Sodium Bicarbonate Braun




Sodium Bicarbonate Braun may be available in the countries listed below.


Ingredient matches for Sodium Bicarbonate Braun



Sodium Bicarbonate

Sodium Bicarbonate is reported as an ingredient of Sodium Bicarbonate Braun in the following countries:


  • Estonia

  • Lithuania

International Drug Name Search

Belladonna Alkaloids/Phenobarbital


Pronunciation: bell-a-DON-a/fee-noe-BAR-bih-tal
Generic Name: Belladonna Alkaloids/Phenobarbital
Brand Name: Examples include Donnatal and Hyosophen


Belladonna Alkaloids/Phenobarbital is used for:

Treating irritable bowel syndrome and intestinal inflammation in combination with other medicines. It may also be used along with other medicines to treat intestinal ulcers. It may also be used for other conditions as determined by your doctor.


Belladonna Alkaloids/Phenobarbital is an anticholinergic and barbiturate combination. It works by decreasing the motion of the muscles in the stomach and intestine and providing mild sedation.


Do NOT use Belladonna Alkaloids/Phenobarbital if:


  • you are allergic to any ingredient in Belladonna Alkaloids/Phenobarbital

  • you have previously experienced restlessness or excitement after taking phenobarbital

  • you have glaucoma; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); a blockage of the stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or heart problems with severe bleeding

  • you have a history of the blood disorder porphyria

  • you have a history of alcohol or substance abuse or dependence or may be at risk for an addiction

  • you are taking methoxyflurane, sodium oxybate (GHB), or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.



Before using Belladonna Alkaloids/Phenobarbital:


Some medical conditions may interact with Belladonna Alkaloids/Phenobarbital. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have nerve problems, prostate problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, diarrhea, fever, risk factors for glaucoma, kidney or liver problems, gallbladder problems, lung or breathing problems, an overactive thyroid, high blood pressure, difficulty urinating, or ulcer

  • if you have depression, pain, a history of suicidal thoughts or attempts, or are in shock

  • if you have been very ill or severely weakened

  • if you regularly consume alcohol

Some MEDICINES MAY INTERACT with Belladonna Alkaloids/Phenobarbital. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, thioridazine), quinine, stiripentol, tricyclic antidepressants (eg, amitriptyline), valproic acid, or other anticholinergics (eg, scopolamine) because they may increase the risk of Belladonna Alkaloids/Phenobarbital's side effects

  • Methoxyflurane orsodium oxybate (GHB) because the risk of their side effects may be increased by Belladonna Alkaloids/Phenobarbital

  • Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin, doxycycline, erlotinib, estrogens (eg, estradiol), imatinib, metronidazole, quinidine, steroidal contraceptives (eg, birth control pills), theophylline, or voriconazole because their effectiveness may be decreased by Belladonna Alkaloids/Phenobarbital

  • Halothane because Belladonna Alkaloids/Phenobarbital may mask the symptoms of halothane toxicity.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Belladonna Alkaloids/Phenobarbital may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Belladonna Alkaloids/Phenobarbital:


Use Belladonna Alkaloids/Phenobarbital as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Belladonna Alkaloids/Phenobarbital by mouth with or without food.

  • If you miss a dose of Belladonna Alkaloids/Phenobarbital, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Belladonna Alkaloids/Phenobarbital.



Important safety information:


  • Belladonna Alkaloids/Phenobarbital may cause dizziness, drowsiness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Belladonna Alkaloids/Phenobarbital with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Belladonna Alkaloids/Phenobarbital; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.

  • Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.

  • Belladonna Alkaloids/Phenobarbital may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

  • Use Belladonna Alkaloids/Phenobarbital with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.

  • Belladonna Alkaloids/Phenobarbital should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Belladonna Alkaloids/Phenobarbital. To prevent pregnancy, use an extra form of birth control (eg, condoms).

  • PREGNANCY and BREAST-FEEDING: Belladonna Alkaloids/Phenobarbital has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Belladonna Alkaloids/Phenobarbital while you are pregnant. Belladonna Alkaloids/Phenobarbital is found in breast milk. If you are or will be breast-feeding while you use Belladonna Alkaloids/Phenobarbital, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Belladonna Alkaloids/Phenobarbital may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Belladonna Alkaloids/Phenobarbital stops working well. Do not take more than prescribed.


Some people who use Belladonna Alkaloids/Phenobarbital for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Belladonna Alkaloids/Phenobarbital suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.



Possible side effects of Belladonna Alkaloids/Phenobarbital:


All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Bloated feeling; blurred vision; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; excessive daytime drowsiness ("hangover effect"); feeling of a whirling motion; headache; lightheadedness; nausea; nervousness; tired feeling; trouble sleeping.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; loss of coordination; loss of taste; memory loss; muscle pain; pounding in the chest; severe or persistent trouble sleeping; trouble urinating; unusual weakness; very slow breathing; vision changes; vomiting.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include change in size of pupil; deep sleep; hot, dry skin; loss of consciousness; severe dry mouth; severe or persistent headache or nausea; slowed or fast breathing; trouble swallowing; vomiting.


Proper storage of Belladonna Alkaloids/Phenobarbital:

Store Belladonna Alkaloids/Phenobarbital at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Belladonna Alkaloids/Phenobarbital out of the reach of children and away from pets.


General information:


  • If you have any questions about Belladonna Alkaloids/Phenobarbital, please talk with your doctor, pharmacist, or other health care provider.

  • Belladonna Alkaloids/Phenobarbital is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Belladonna Alkaloids/Phenobarbital. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Belladonna Alkaloids/Phenobarbital resources


  • Belladonna Alkaloids/Phenobarbital Dosage
  • Belladonna Alkaloids/Phenobarbital Use in Pregnancy & Breastfeeding
  • Drug Images
  • Belladonna Alkaloids/Phenobarbital Drug Interactions
  • Belladonna Alkaloids/Phenobarbital Support Group
  • 11 Reviews for Belladonna Alkaloids/Phenobarbital - Add your own review/rating


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  • Duodenal Ulcer
  • Enterocolitis
  • Irritable Bowel Syndrome

Friday, October 21, 2016

Bromfed DM



brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

Dosage Form: syrup
BROMFED® DM COUGH SYRUP

(Brompheniramine Maleate 2 mg,

Pseudoephedrine Hydrochloride 30 mg,

and Dextromethorphan Hydrobromide 10 mg)

Rx only



Bromfed DM Description


Bromfed® DM Cough Syrup is a clear, light pink syrup with a butterscotch flavor.


Each 5 mL (1 teaspoonful) contains:


Brompheniramine Maleate, USP     . . . . . . . .  2 mg


Pseudoephedrine Hydrochloride, USP . . . . . 30 mg


Dextromethorphan Hydrobromide, USP  . . . 10 mg


Alcohol 0.95% v/v


In a palatable, aromatic vehicle.


Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0.


C16H19BrN2•C4H4O4          M.W. 435.31




Brompheniramine Maleate, USP

(±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)

C10H15NO•HCl                    M.W. 201.69




Pseudoephedrine Hydrochloride, USP

(+)-Pseudoephedrine hydrochloride

C18H25NO•HBr•H2O          M.W. 370.32




Dextromethorphan Hydrobromide, USP

3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate

Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.



Bromfed DM - Clinical Pharmacology


Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.


Pseudoephedrine acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.


Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.



Indications and Usage for Bromfed DM


For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.



Contraindications


Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see Drug Interactions).


Antihistamines should not be used to treat lower respiratory tract conditions including asthma.



Warnings


Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.


Antihistamines may diminish mental alertness. In the young child, they may produce excitation.



Precautions



General


Because of its antihistamine component, Bromfed® DM Cough Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Bromfed® DM Cough Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.



Information for Patients


Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.



Drug Interactions


Monoamine oxidase (MAO) inhibitors

Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Bromfed® DM Cough Syrup and MAO inhibitors should be avoided (see CONTRAINDICATIONS).


Central nervous system (CNS) depressants

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).


Antihypertensive drugs

Sympathomimetic may reduce the effects of antihypertensive drugs.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Animal studies of Bromfed® DM Cough Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.



Pregnancy


Teratogenic Effects

Pregnancy Category C


Animal reproduction studies have not been conducted with Bromfed® DM Cough Syrup. It is also not known whether Bromfed® DM Cough Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.


Reproduction studies of brompheniramine maleate (a component of Bromfed® DM Cough Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.



Nursing Mothers


Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromfed® DM Cough Syrup is contraindicated in nursing mothers.



Pediatric Use


Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).



Adverse Reactions


The most frequent adverse reactions to Bromfed® DM Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:


Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.


Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation.


CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.


G.U. System: Urinary frequency, difficult urination.


G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.


Respiratory System: Tightness of chest and wheezing, shortness of breath.


Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.



Overdosage



Signs and Symptoms


Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.



Toxic Doses


Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.



Treatment


Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.



Bromfed DM Dosage and Administration


Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.


Do not exceed 6 doses during a 24-hour period.



How is Bromfed DM Supplied


Bromfed® DM Cough Syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:


15 mL (Professional Sample-Not For Resale)

4 fl oz (118 mL)

1 Pint (473 mL)



RECOMMENDED STORAGE


Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature].


KEEP TIGHTLY CLOSED


Dispense in a tight, light-resistant container as defined in the USP.



Rx Only


Product No.: 8837


BROMFED® is a registered trademark of Wockhardt.


Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054


Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053


A50-8837-16

REV. 02-10



PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label


WOCKHARDT


NDC 60432-837-04


BROMFED® DM

COUGH SYRUP

Alcohol 0.95% v/v


DO NOT USE IF INNER FOIL SEAL PRINTED

"SEALED FOR YOUR PROTECTION" IS

BROKEN OR MISSING.


Rx Only


NET: 4 fl oz (118 mL)










BROMFED  DM
brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide  syrup










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)60432-837
Route of AdministrationORALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (Brompheniramine)Brompheniramine2 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine)Pseudoephedrine30 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan)Dextromethorphan10 mg  in 5 mL






















Inactive Ingredients
Ingredient NameStrength
glycerin 
propylene glycol 
sodium benzoate 
anhydrous citric acid 
alcohol 
methylparaben 
raw sugar 
FD&C Red No. 40 
water 


















Product Characteristics
ColorPINK (Light Pink)Score    
ShapeSize
FlavorBUTTERSCOTCHImprint Code
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
160432-837-1515 mL In 1 BOTTLE, PLASTICNone
260432-837-04118 mL In 1 BOTTLE, PLASTICNone
360432-837-16473 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08881108/21/2009


Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)
Revised: 06/2010Morton Grove Pharmaceuticals, Inc.

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  • Cough and Nasal Congestion

Irbesartan


Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: 2 - Butyl - 3 - [[2′(1H - tetrazol - 5 - yl)[1,1′ - biphenyl] - 4 - yl]methyl] - 1,3 - diazaspiro[4.4]non - 1 - en - 4 - one
Molecular Formula: C25H28N6O3S•½C4H4 O4
CAS Number: 138402-11-6
Brands: Avapro, Avalide



  • May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 26 71 72 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)




  • If pregnancy is detected, discontinue the drug as soon as possible.1 26 72




Introduction

Angiotensin II receptor (AT1) antagonist.1 2 4 5 6 21 22 23


Uses for Irbesartan


Hypertension


Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 4 5 6 14 15 16 17 18 20 21 22 23


One of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.60


Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.60


Diabetic Nephropathy


Management of diabetic nephropathy manifested by elevated Scr and proteinuria (urinary protein excretion >300 mg daily) in patients with type 2 diabetes mellitus and hypertension.1


A first-line agent in the treatment of diabetic nephropathy in such patients.37 39


CHF


A second-line agent in the treatment of CHF; should be used only in those intolerant of ACE inhibitors.25 38 41


Irbesartan Dosage and Administration


General


Hypertension



  • Irbesartan in fixed combination with hydrochlorothiazide tablets can be used for initial treatment of hypertension in patients who are likely to need multiple drugs to achieve their BP goals.26 Consider potential benefits and risks of initiating therapy with the fixed combination of irbesartan and hydrochlorothiazide.26



Administration


Oral Administration


Administer orally once daily without regard to meals.1 21


Dosage


Adults


Hypertension

Monotherapy

Oral

Initially, 150 mg once daily in adults without intravascular volume depletion.1 Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.60 In adults with depletion of intravascular volume, the usual initial dosage is 75 mg once daily.1 24


Usual dosage: 150–300 mg once daily; no additional therapeutic benefit with higher dosages or with twice-daily dosing.1


Combination Therapy

Oral

If BP is not adequately controlled by monotherapy with irbesartan or hydrochlorothiazide, can switch to fixed-combination tablets (irbesartan 150 mg and 12.5 mg hydrochlorothiazide; then irbesartan 300 mg and hydrochlorothiazide 12.5 mg), administered once daily.26 Can increase dosage to irbesartan 300 mg and hydrochlorothiazide 25 mg daily, if needed, to control BP.26


In patients receiving fixed-combination tablets as initial therapy, the usual starting dosage is irbesartan 150 mg and hydrochlorothiazide 12.5 mg once daily.26 May increase dosage after 1–2 weeks of therapy to a maximum of irbesartan 300 mg and hydrochlorothiazide 25 mg once daily.26


Diabetic Nephropathy

Oral

Initial dosage of 75 mg once daily used in clinical trial.1 Increase dosage to target maintenance dosage of 300 mg once daily.1 No data available on effects of lower dosages.1


Special Populations


Hepatic Impairment


No initial dosage adjustments necessary.1 26


Renal Impairment


No initial dosage adjustments necessary.1 26


Irbesartan/hydrochlorothiazide fixed combination not recommended in patients with severe renal impairment.26


Geriatric Patients


No initial dosage adjustments necessary.1 26


Volume- and/or Salt-depleted Patients


Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy using lower initial dosage (75 mg once daily).1 24 26 Fixed-combination tablets containing irbesartan and hydrochlorothiazide are not recommended as initial therapy in patients with intravascular volume depletion.26


Cautions for Irbesartan


Contraindications



  • Known hypersensitivity to irbesartan or any ingredient in the formulation.1 26



Warnings/Precautions


Warnings


Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when drugs that act directly on the renin-angiotensin system (e.g., angiotensin II receptor antagonists, ACE inhibitors) are used during the second and third trimesters of pregnancy.1 26 (See Boxed Warning.) ACE inhibitors also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.71 72


Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.71 72


Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.1 72 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.13


Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis).1 26 (See Volume- and/or Salt-depleted Patients under Dosage and Administration.)


Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).1 26


Malignancies

In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.120 121 123 126 However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.126 127 128 129 Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.126


Sensitivity Reactions


Anaphylactoid reactions and/or angioedema possible;1 26 not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.73


General Precautions


Renal Effects

Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe CHF.1 26


Increases in BUN and Scr possible in patients with unilateral or bilateral renal artery stenosis.1 26


Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.26


Specific Populations


Pregnancy

Category D.26 (See Boxed Warning.)


Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 26 Discontinue nursing or the drug.1 26


Pediatric Use

Dosages of up to 4.5 mg/kg once daily did not appear to effectively lower BP in pediatric patients 6–16 years of age.1 Not studied in children <6 years of age.1


Safety and efficacy of the fixed-combination preparation containing irbesartan and hydrochlorothiazide not established.26


Geriatric Use

No substantial differences in safety or efficacy of irbesartan monotherapy or fixed-combination containing irbesartan and hydrochlorothiazide relative to younger adults, but increased sensitivity cannot be ruled out.1 26


Renal Impairment

Use with caution.1


Deterioration of renal function may occur.1 26 (See Renal Effects under Cautions.)


Use of irbesartan in fixed combination with hydrochlorothiazide is not recommended in patients with severe renal impairment.26


Blacks

BP reduction may be smaller in black patients compared with nonblack patients; use in combination with a diuretic.1 26 60 69 70


Common Adverse Effects


Diarrhea, dyspepsia/heartburn, fatigue; also, dizziness, orthostatic dizziness, and orthostatic hypotension in patients with diabetic nephropathy.1


Interactions for Irbesartan


Metabolized principally by CYP2C9.1 26 Does not substantially induce or inhibit CYP1A1, 1A2, 2A6, 2B6, 2D6, 2E1, or 3A4.1 26


Drugs Affecting Hepatic Microsomal Enzymes


Potential pharmacokinetic interaction (decreased irbesartan metabolism) with CYP2C9 inhibitors.1 26


Specific Drugs
























Drug



Interaction



Comments



Digoxin



Pharmacologic and/or pharmacokinetic interactions unlikely1 26



Hydrochlorothiazide



Pharmacokinetic interactions unlikely1 26


Additive hypotensive effects1 26



Nifedipine



Decreased irbesartan metabolism in vitro; alteration of irbesartan pharmacokinetics not observed in vivo1 26



NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors



Possible deterioration of renal function in geriatric, volume-depleted, or renally impaired patients1


Possible reduced antihypertensive effects1



Monitor renal function periodically1



Tolbutamide



Possible decreased irbesartan metabolism26



Warfarin



Pharmacologic and/or pharmacokinetic interaction unlikely1 26


Irbesartan Pharmacokinetics


Absorption


Bioavailability


Peak plasma concentration generally achieved 1.5–2 hours after oral dose.1 Absolute bioavailability is about 60–80%.1 26


Onset


Antihypertensive effect evident within 2 weeks, with maximum BP reduction after 2–4 weeks.1 26


Food


Food does not affect bioavailability.1 26


Distribution


Extent


Crosses the placenta and is distributed in the fetus in animals.1 26


Crosses the blood-brain barrier poorly, if at all, in animals.1 15


Distributed into milk in rats; not known whether distributed into human milk.1 26


Plasma Protein Binding


90% (principally albumin and α1-acid glycoprotein).1 26


Elimination


Metabolism


Undergoes hepatic metabolism by glucuronide conjugation and oxidation (principally by CYP2C9) to inactive metabolites.1 26


Elimination Route


Eliminated in urine and feces (via bile).1 26


Half-life


Terminal elimination half-life: 11–15 hours.1


Special Populations


Not removed by hemodialysis.1 26 Pharmacokinetics not substantially altered by hemodialysis or renal impairment.1 26


Stability


Storage


Oral


Tablets

15–30°C.1 26


Actions



  • Blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.1 21 22 23 26




  • Does not interfere with response to bradykinins and substance P.1 5 6 21




  • Does not share the ACE inhibitor common adverse effect of dry cough.1 5 6 20 21 26



Advice to Patients



  • Risks of use during pregnancy.1 26




  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 26




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 26




  • Importance of informing patients of other important precautionary information.1 26 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.























Irbesartan

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



75 mg



Avapro



Bristol-Myers Squibb, (also promoted by Sanofi-Synthelabo)



150 mg



Avapro



Bristol-Myers Squibb, (also promoted by Sanofi-Synthelabo)



300 mg



Avapro



Bristol-Myers Squibb, (also promoted by Sanofi-Synthelabo)























Irbesartan Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



150 mg with Hydrochlorothiazide 12.5 mg



Avalide



Bristol-Myers Squibb, (also promoted by Sanofi-Synthelabo)



300 mg with Hydrochlorothiazide 12.5 mg



Avalide



Bristol-Myers Squibb, (also promoted by Sanofi-Synthelabo)



300 mg with Hydrochlorothiazide 25 mg



Avalide



Bristol-Myers Squibb, (also promoted by Sanofi-Synthelabo)


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Avalide 150-12.5MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$111.99 or 90/$320.98


Avalide 300-12.5MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$122.99 or 90/$352.96


Avalide 300-25MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$122.95 or 90/$345.09


Avapro 150MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$92.99 or 90/$247.98


Avapro 300MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$111.99 or 90/$299.96


Avapro 75MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$87.99 or 90/$232.96



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



1. Bristol-Myers Squibb Company. Avapro (irbesartan) tablets prescribing information. New York, NY; 2011 Apr.



2. van den Meiracker AH, Admiraal PJJ, Janssen JA et al. Hemodynamic and biochemical effects of the AT1 receptor antagonist irbesartan in hypertension. Hypertension. 1995; 25:22-9. [PubMed 7843749]



3. Ellis ML, Patterson JH. A new class of antihypertensive therapy: angiotensin II receptor antagonists. Pharmacotherapy. 1996; 16:849-60. [IDIS 374571] [PubMed 8888079]



4. Bauer JH, Reams GP. The angiotensin II type 1 receptor antagonists: a new class of antihypertensive drugs. Arch Intern Med. 1995; 155:1361-8. [IDIS 350333] [PubMed 7794084]



5. Burnier M, Buclin T, Biollaz J et al. Pharmacokinetic-pharmacodynamic relationships of three angiotensin II receptor antagonists in normal volunteers. Kidney Int. 1996; 49(Suppl 55):S-24–S-29.



6. Velasquez MT. Angiotensin II receptor blockers: a new class of hypertensive drugs. Arch Fam Med. 1996; 5:351-356. [PubMed 8640326]



7. Anon. Valsartan for hypertension. Med Lett Drugs Ther. 1997; 39:43-4. [PubMed 9137296]



8. Pitt B, Segal R, Martinez FA et al for the ELITE study investigators. Randomized trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet. 1997; 349:747-52. [IDIS 381678] [PubMed 9074572]



9. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]



10. Anon. Drugs for hypertension. Med Lett Drugs Ther. 1995; 37:45-50. [PubMed 7760767]



11. Joint National Committee on Detection, Evaluation, and Treatment of High Blod Pressure. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]



12. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]



13. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.



14. Pool JL, Guthrie RM, Littlejohn T et al. The antihypertensive effects of irbesartan in patients with mild-to-moderate hypertension. Am J Hypertens. 1996; 9:152A.



15. Fogari R, Zanchetti A, Moran S et al et al. Once-daily irbesartan provides full 24-hour ambulatory blood pressure control. J Hypertens. 1997; 15(Suppl 4):S113.



16. Stumpe KO, Haworth D, Höglund C et al et al. Comparison of the angiotensin II receptor antagonist, irbesartan, and atenolol for the treatment of hypertension. J Hypertens. 1997; 15(Suppl 4):S115.



17. Larochelle P, Flack JM, Hannah S et al et al. Irbesartan versus enalapril in severe hypertension. Am J Hypertens. 1997; 10:131A.



18. Mimran A, Ruilope L, Kerwin L et al et al. Comparison of the angiotensin II receptor antagonist, irbesartan, with the full dose range of enalapril for the treatment of hypertension. J Hypertens. 1997; 15(Suppl 4):S117.



19. Cazaubon C, Gougat J, Bousquet F et al. Pharmacological characterization of SR 47436, a new nonpeptide AT1 subtype angiotensin II receptor antagonist. J Pharmacol Exp Ther. 1993; 265: 826-34. [PubMed 8496828]



20. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The sixth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Arch Intern Med. 1997; 157:2413-46. [IDIS 395691] [PubMed 9385294]



21. Anon. Irbesartan for hypertension. Med Lett Drugs Ther. 1998; 40:18-9. [PubMed 9465857]



22. Kossler-Taub K, Littlejohn T, Elliott W et al. Comparative efficacy of two angiotensin II receptor antagonists, irbesartan and losartan, in mild-to-moderate hypertension. Am J Hypertens. 1998; 11:445-53. [PubMed 9607383]



23. Larochelle P, Flack JM, Marbury TC et al. Effects and tolerability of irbesartan versus enalapril in patients with severe hypertension. Am J Cardiol. 1997; 80:1613-5. [IDIS 399095] [PubMed 9416950]



24. Bristol-Myers Squibb Company. Princeton, NJ: Personal communication.



25. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9-38A.



26. Bristol-Myers Squibb Company. Avalide (irbesartan-hydrochlorothiazide) tablets prescribing information. Princeton, NJ; 2008 Nov.



27. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]



28. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]



29. Merck & Co, Inc. Results of second heart-failure study with Cozaar presented at American Heart Association scientific sessions. West Point, PA; 1999 Nov 10. Press release from Yahoo web site.



30. Food and Drug Administration. Avapro (irbesartan) and Avalide (irbesartan/hydrochlorothiazide) tablets [May 9, 2000: Bristol-Myers Squibb]. MedWatch drug labeling changes. Rockville, MD; May 2000. From FDA website.



31. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]



32. Hansson L, Zanchetti A, Carruthers SG et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. Lancet. 1998; 351:1755-62. [IDIS 409003] [PubMed 9635947]



33. Pitt B, Segal R, Martinez FA et al. Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet. 1997; 349:747-52. [IDIS 381678] [PubMed 9074572]



34. American Diabetes Association. Clinical Practice Recommendations 2001. Position Statement. Diabetic nephropathy. Diabetes Care. 2001; 24(Suppl 1):S69-72.



35. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2001; 24(Suppl 1):S33-43.



36. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25:134-47. [IDIS 479088] [PubMed 11772914]



37. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002; 25(Suppl 1):S33-43.



38. Hunt SA, Baker DW, Chin MH et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). 2001. From ACC website. Accessed July 25, 2002.



39. American Diabetes Association. Clinical Practice Recommendations 2002. Position Statement. Diabetic nephropathy. Diabetes Care. 2002; 25(Suppl 1):S85-9.



40. Cohn JN, Tognoni G, for the Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med. 2001; 345:1667-75. [IDIS 473009] [PubMed 11759645]



41. Novartis. Diovan (valsartan) tablets prescribing information. East Hanover, NJ; 2002 Jul.



42. Williams CL, Hayman LL, Daniels SR et al. Cardiovascular health in childhood: a statement for health professional from the Committee on Atherosclerosis, Hypertension, and Obesity in the Young (AHOY) of the Council on Cardiovascular Disease in the Young, American Heart Association. Circulation. 2002; 106:143-60. [PubMed 12093785]



43. Lewis EJ, Hunsicker LG, Clarke WR et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001; 345:851-60. [IDIS 469606] [PubMed 11565517]



44. Blankfield RP. Angiotensin-receptor blockers, type 2 diabetes, and renoprotection. N Engl J Med. 2002: 346;705. Letter.



45. Lewis EJ. Angiotensin-receptor blockers, type 2 diabetes, and renoprotection. N Engl J Med. 2002: 346;706. Letter.



46. Williams MA, Fleg JL, Ades PA et al. Secondary prevention of coronary heart disease in the elderly (with emphasis on patients ≥ 75 years of age). An American Heart Association Scientific Statement from the Council on Clinical Cardiology Subcommittee on Exercise, Cardiac rehabilitation, and Prevention. Circulation. 2002; 105:1735-43. [PubMed 11940556]



47. Brenner BM, Cooper ME, de Zeeuw D et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001; 345:861-9. [IDIS 469607] [PubMed 11565518]



48. Parving HH, Lehnert H, Bröchner-Mortensen J et al. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med. 2001; 345:870-6. [IDIS 469608] [PubMed 11565519]



49. Remuzzi G. Slowing the progression of diabetic nephropathy. N Engl J Med. 1993; 329:1496-7. [PubMed 8413463]



50. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)



51. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]



52. Viberti G, Mogensen CE, Groop LC et al. Effect of captopril on progression to clinical proteinuria in patients with insulin-dependent diabetes mellitus and microalbuminuria. JAMA. 1994; 271:275-9. [IDIS 324307] [PubMed 8295285]



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