Beconase AQ eent

Generic Name: Beclomethasone Dipropionate eent
Class: Corticosteroids
VA Class: NT200
Molecular Formula: C₂₈H₃₇ClO₇
CAS Number: 5534-09-8

Introduction

Synthetic corticosteroid.^a

Uses for Beconase AQ

Seasonal and Perennial Rhinitis

Symptomatic treatment of seasonal or perennial rhinitis.¹⁰³

Generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing (including morning sneezing attacks), and nasal and pharyngeal itching.^a

Generally does not relieve signs and symptoms of conjunctivitis or those involving the lower respiratory tract (e.g., coughing), although improvement in ophthalmic and respiratory manifestations may occur.^a

Relieves symptoms in both allergic and nonallergic rhinitis, although intranasal route appears to provide greater relief in allergic rhinitis.^a

Continuous concomitant therapies (e.g., oral or orally inhaled corticosteroids, bronchodilators, antihistamines, decongestants) may be required for optimum symptomatic relief, especially in patients with concurrent asthmatic conditions.^a

Symptomatic relief is usually evident within several days of initiating continuous intranasal therapy; however, up to 2 weeks may be required for optimum effectiveness.^a

Nasal Polyposis

Used principally to prevent nasal polyp recurrence after surgical removal.^a

May delay need for subsequent surgery, but should not preclude polypectomy when polyp size prevents adequate penetration of drug into nasal passages.^a

May reduce polyp size and the degree of nasal obstruction, but apparently does not alter underlying disease; manifestations usually recur when the drug is discontinued.^a

Periodically monitor patients receiving prolonged intranasal corticosteroid therapy with rhinoscopic examinations, since risk for atrophic rhinitis is increased.^a

Beconase AQ Dosage and Administration

Administration

Intranasal Inhalation

Administer by nasal inhalation only using a metered-dose nasal spray pump.^{103 104 a}

Prime spray pump prior to initial use (6 actuations or until a fine spray appears) and after ≥7days of non-use (until a fine spray appears).¹⁰⁴

Shake spray pump well immediately prior to use.¹⁰⁴

Avoid contact with the eyes.¹⁰⁴

Blow nose to clear nasal passages prior to administration.¹⁰⁴ Adequate penetration of the drug may require a topical nasal vasoconstrictor in patients with blocked nasal passages during the first 2–3 days of therapy.¹⁰³

For each inhalation, support the base of the spray bottle with the thumb and place the middle finger and forefinger on the white collar of the bottle.¹⁰⁴ Tilt the head slightly forward, keep the bottle upright, and insert the nasal applicator into one nostril while holding the other nostril closed.¹⁰⁴

Spray the drug into one nostril by pressing down firmly on the white collar of the bottle and concurrently inhaling gently through the nose, then exhale through the mouth.¹⁰⁴

Repeat procedure for the other nostril.¹⁰⁴

To clean nasal applicator, remove dust cap and safety clip and press applicator collar gently upward to free applicator.¹⁰⁴ Wash dust cap and nasal applicator in cold water, then dry and replace applicator, safety clip, and dust cap.¹⁰⁴

To unblock nasal applicator, remove dust cap, unscrew complete pump mechanism, and soak in warm water for a few minutes.¹⁰⁴ Rinse with cold water, dry, replace on bottle, and reprime the pump.¹⁰⁴

Dosage

Available as beclomethasone dipropionate monohydrate; dosage expressed in terms of the anhydrous salt.¹⁰³

After initial priming, each actuation of the nasal aqueous suspension spray pump delivers a 100-mg dose of beclomethasone dipropionate suspension equivalent to 42 mcg of anhydrous beclomethasone dipropionate.¹⁰³ Each 25-g spray bottle delivers 180 metered doses, after which the correct amount of drug in each spray cannot be assured.^{103 104} Discard the bottle after 180 sprays have been used.^{103 104}

Adjust dosage according to individual requirements and response.^a

Therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate.¹⁰³

Use of topical nasal decongestants or oral antihistamines may be necessary until the effects of intranasal beclomethasone dipropionate are fully manifested.¹⁰³

Symptomatic relief is usually evident within several days of continuous therapy; however, up to 2 weeks may be required for relief in some patients.¹⁰³

Do not continue therapy beyond 3 weeks in the absence of substantial symptomatic improvement.¹⁰³

Pediatric Patients

Seasonal Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Adults

Seasonal Rhinitis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dose: 168–336 mcg/day).¹⁰³

Prescribing Limits

No evidence that higher than recommended dosages or increased frequency of administration is beneficial.¹⁰³

Exceeding the maximum recommended daily dosage may only increase the risk of adverse systemic effects (e.g., HPA-axis suppression, Cushing’s syndrome) and should be avoided.¹⁰³

Pediatric Patients

Seasonal Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adults

Seasonal Rhinitis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Cautions for Beconase AQ

Contraindications

• 
  

  Known hypersensitivity to beclomethasone or any ingredient in the formulation.¹⁰³

  
  


• 
  

  Do not use in the presence of untreated localized nasal mucosa infections.¹⁰³

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Patients being switched from prolonged systemic corticosteroids to intranasal therapy should be monitored carefully since corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, and/or severe symptomatic exacerbation of asthma or other clinical conditions may occur.¹⁰³

In patients being switched to intranasal therapy, systemic corticosteroid dosage should be tapered and patients carefully monitored during dosage reduction.¹⁰³

Systemic Corticosteroid Effects

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may cause systemic corticosteroid effects (e.g., menstrual irregularities, acneiform lesions, cataracts, cushingoid features).¹⁰³

Avoid larger than recommended dosages; potential for systemic effects increases with excessive dosage.¹⁰³

If systemic effects occur, therapy with the drug should gradually be withdrawn (tapered).¹⁰³

Immunosuppression

Although risk with intranasal use is unknown, consider the possibility that corticosteroid-induced immunosuppression could occur.^a Avoid exposure to varicella and measles in previously unexposed patients and those who have not been properly immunized.¹⁰³

If exposure to varicella or measles occurs in such individuals, administration of varicella zoster immune globulin (VZIG) or immune globulin, respectively, may be indicated.¹⁰³ If varicella develops, treatment with an antiviral agent may be considered.¹⁰³

Sensitivity Reactions

Immediate or delayed hypersensitivity reactions, including anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, wheezing, and bronchospasm, have occurred rarely.¹⁰³

General Precautions

Nasopharyngeal Effects

Persistent nasopharyngeal irritation may require discontinuance of beclomethasone therapy.¹⁰³

Rarely, nasal septal perforations.¹⁰³

Rarely, localized candidal infections of the nose and/or pharynx.¹⁰³ Treat suspected infection with appropriate local therapy;¹⁰³ may require discontinuance of beclomethasone therapy.¹⁰³

Avoid use until healing occurs in patients with recurrent epistaxis, recent nasal septal ulcers, nasal surgery, or nasal trauma.¹⁰³

Ophthalmic Effects

Increased intraocular pressure (IOP), glaucoma, cataracts, and conjunctivitis have been reported rarely.¹⁰³

Hypothalamic-Pituitary-Adrenal Axis Suppression

Avoid higher than recommended dosages since suppression of hypothalamic-pituitary-adrenal (HPA) function may occur.¹⁰³

Reductions in plasma cortisol concentrations have occurred when intranasal and orally inhaled beclomethasone dipropionate were used concomitantly.^a

Cases of growth suppression also have been reported.¹⁰³ (See Pediatric Use under Cautions.)

Infection

Use cautiously, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex infections.¹⁰³

Nasal Polyposis

Treatment with beclomethasone should be considered adjunctive to surgical removal and/or use of other drugs that will permit effective penetration of the drug into the nose; polyps may recur after any treatment.¹⁰³

Nasal Mucosal Changes

During long-term intranasal therapy (several months or longer), periodically examine nasal passages for mucosal changes.¹⁰³

Specific Populations

Pregnancy

Category C.¹⁰³

Lactation

Other corticosteroids known to be distributed into milk.¹⁰³ Caution if used in nursing women.¹⁰³

Corticosteroids may cause adverse effects (e.g., growth suppression) in nursing infants if distributed into milk.^a

Pediatric Use

May be a useful therapeutic alternative to oral corticosteroids in children ≥6 years of age with seasonal or perennial allergic rhinitis, since intranasal administration is associated with a decreased risk of adverse systemic effects.^a

Intranasal corticosteroids, including beclomethasone, may reduce growth velocity in pediatric patients; use lowest effective dosage and monitor growth routinely.¹⁰³ In a placebo-controlled, 1-year study, approximately 50% of beclomethasone dipropionate-treated children were below the 10th percentile for growth velocity.¹⁰³

Safety and efficacy not established in children <6 years of age.¹⁰³

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether such patients respond differently than younger adults; select dosage with caution due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in geriatric patients.¹⁰³

Common Adverse Effects

Mild nasopharyngeal irritation, sneezing attacks, headache, nausea, lightheadedness, nasal stuffiness, nosebleeds, rhinorrhea, tearing eyes.¹⁰³

Beconase AQ Pharmacokinetics

Absorption

Bioavailability

Most of an intranasal dose is swallowed.^{103 105}

Systemic bioavailability (as active metabolite) is 44% (43% from swallowed portion, 1% from nasal mucosa).^{103 105}

Distribution

Extent

Moderate distribution, more extensive for active metabolite.^{103 105} Beclomethasone dipropionate and its metabolites are not stored in tissues.¹⁰³

Not known whether beclomethasone crosses the placenta or is distributed into milk; other corticosteroids are distributed into milk.^{a 103}

Plasma Protein Binding

Approximately 87%.¹⁰³

Elimination

Metabolism

Beclomethasone dipropionate is a weakly active prodrug, rapidly hydrolyzed to highly active beclomethasone-17-monopropionate (B-17-MP) by esterase enzymes found in most tissues.^{a 103 105}

Elimination Route

Excreted mainly as metabolites in feces (60%) and in urine (12%) following oral administration.¹⁰³

Half-life

Not determined following intranasal administration.^a Terminal half-life averages 0.5 hours (beclomethasone dipropionate) and 2.7 hours (active metabolite) following IV administration.¹⁰³

Stability

Storage

Nasal Suspension

15–30°C.¹⁰³

Discard the nasal pump spray after 180 sprays.^{103 104}

ActionsActions

• 
  

  Potent glucocorticoid and weak mineralocorticoid effects.^a

  
  


• 
  

  Topical anti-inflammatory potency of beclomethasone dipropionate is about 5000 times greater than hydrocortisone; 500 times greater than beclomethasone, betamethasone, or dexamethasone; and about 5 times greater than fluocinolone or the acetonides of fluocinolone or triamcinolone, as measured by vasoconstrictor assay.^a Beclomethasone dipropionate is 6–7 times more potent as a glucocorticoid than hydrocortisone when administered orally or subcutaneously.^a

  
  


• 
  

  Local anti-inflammatory and vasoconstrictor effects following topical application to the nasal mucosa.^{a 103}

  
  


• 
  

  Reduces number of mediator cells (basophil leukocytes and mast cells) at the epithelial level, number of eosinophils, sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity.^a

  
  


• 
  

  May inhibit capillary dilation and permeability, stabilize lysosomal membranes and prevent proteolytic enzyme release.^a

  
  


• 
  

  Adrenal suppression has not been observed when beclomethasone dipropionate inhalation aerosol (no longer commercially available in the US) was administered in clinical trials,¹⁰³ but decreases in nocturnal cortisol secretion have been reported with usual dosages of beclomethasone oral inhalation in children.¹⁰³ (See Hypothalamic-Pituitary-Adrenal Axis Suppression under Cautions.)

  
  

Advice to Patients

• 
  

  Importance of giving patient a copy of the manufacturer’s patient instructions.^{103 104}

  
  


• 
  

  Importance of instructing patient about proper techniques for assembly and priming of nasal spray pump and for administration and storage of the nasal solution.^{103 104}

  
  


• 
  

  Importance of shaking nasal spray well prior to each use.¹⁰⁴

  
  


• 
  

  Importance of discarding container after 180 actuations or once the expiration date on the label is reached.^{103 104}

  
  


• 
  

  Avoid spraying into eyes.¹⁰⁴

  
  


• 
  

  Importance of advising patient that effects are not immediate; full benefit may require ≤2 weeks of continuous use.¹⁰³

  
  


• 
  

  Importance of using at regular intervals as directed.¹⁰³

  
  


• 
  

  Importance of not continuing therapy for longer than 3 weeks in the absence of substantial symptomatic improvement.¹⁰³

  
  


• 
  

  Importance of informing clinician if symptoms fail to improve or worsen or if sneezing or nasal irritation occurs.¹⁰³

  
  


• 
  

  Importance of not increasing dosage unless directed by a clinician.¹⁰³

  
  


• 
  

  Importance of using concomitant nasal vasoconstrictor and/or oral antihistamines for 1–2 weeks if needed until the effects of beclomethasone are optimal.¹⁰³

  
  


• 
  

  Importance of avoiding exposure to chickenpox or measles if receiving immunosuppressive doses of corticosteroids; if exposed, notify a clinician.¹⁰³

  
  


• 
  

  Importance of patients with severe allergies avoiding exposure to allergens during intranasal beclomethasone dipropionate therapy to prevent the occurrence of severe allergic symptoms in the eyes and/or lower respiratory tract.^a

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹⁰³

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰³

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰³ (See Cautions.)

  
  

Preparations

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

Beclomethasone dipropionate inhalation aerosols containing chlorofluorocarbon (CFC) propellants are no longer marketed in the US.

Beclomethasone Dipropionate (Monohydrate)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Suspension	equivalent to Beclomethasone Dipropionate 42 mcg/metered dose	Beconase AQ Nasal Spray (with benzalkonium chloride and phenylethyl alcohol)	GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Qvar 40MCG/ACT Aerosol (IVAX PHARMACEUTICALS INC.): 7/$91.86 or 21/$258.52

Qvar 80MCG/ACT Aerosol (IVAX PHARMACEUTICALS INC.): 7/$109.99 or 21/$309.97

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, 1959-2011, Selected Revisions October 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Schering. Vancenase (beclomethasone dipropionate) Pockethaler nasal inhaler prescribing information. In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999(Suppl A):A292-4.

101. Schering. Vancenase (beclomethasone dipropionate) AQ 84 mcg double strength prescribing information. Kenilworth, NJ. 1996 Jun.

102. Schering. Vancenase (beclomethasone dipropionate) nasal inhaler prescribing information (dated 1997 Apr). In: Physicians' desk reference. 54th ed. Montvale, NJ: Medical Economics Company Inc; 2000:2844-5.

103. GlaxoSmithKline. Beconase AQ (beclomethasone dipropionate monohydrate) nasal spray prescribing information. Research Triangle Park, NC; 2005 Apr.

104. GlaxoSmithKline. Beconase AQ (beclomethasone dipropionate monohydrate) nasal spray patient instructions for use. Research Triangle Park, NC; 2005 Apr.

105. Daley-Yates PT, Price AC, Sisson JR et al. Beclomethasone dipropionate: absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man. Br J Clin Pharmacol. 2001; 51:400-9. [PubMed 11421996]

a. AHFS drug information 2005. McEvoy GK, ed. Beclomethasone dipropionate. Bethesda, MD: American Society of Health-System Pharmacists; 2005:2676-80.

c. Anon. FDA publishes final rule on chlorofluorocarbons in metered dose inhalers. FDA talk paper. Rockville, MD: Food and Drug Administration; 2005 Mar 31.

More Beconase AQ eent resources

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

Compare Beconase AQ eent with other medications

• Hay Fever
• Nasal Polyps
• Nasal Polyps, Prevention

belimumab Intravenous

be-LIM-ue-mab

Commonly used brand name(s)

In the U.S.

• Benlysta

Available Dosage Forms:

• Powder for Solution

Pharmacologic Class: Monoclonal Antibody

Uses For belimumab

Belimumab injection is used to treat systemic lupus erythematosus (SLE or lupus) in adults who are also receiving other therapy. It is a monoclonal antibody that changes the immune system to help control lupus symptoms.

belimumab is to be administered only by or under the immediate supervision of your doctor.

Before Using belimumab

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 belimumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to belimumab 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 have not been performed on the relationship of age to the effects of belimumab injection in children. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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. 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 belimumab. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or


• Mental illness, history of—Use with caution. May make these conditions worse.

• Infection or


• Weak immune system (eg, history of cancer or steroid use)—May decrease your body's ability to fight infection.

Proper Use of belimumab

A nurse or other trained health professional will give you belimumab. belimumab is given through a needle placed in one of your veins.

belimumab must be given slowly, so the needle will remain in place for at least one hour. You may also receive medicines to help prevent possible allergic reactions to the injection.

belimumab comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using belimumab

It is very important that your doctor check your progress at regular visits to make sure that belimumab is working properly. Blood tests may be needed to check for unwanted effects.

You should not receive belimumab if you are also using cyclophosphamide (Cytoxan®).

Tell your doctor if you are pregnant or if you plan to become pregnant. Women who could potentially get pregnant while receiving belimumab must use an effective form of birth control during therapy and for at least 4 months after the last dose. If you become pregnant while receiving belimumab, your doctor may want you to join a registry for pregnant patients.

belimumab may increase your risk of developing infections. Avoid being near people who are sick while you are receiving belimumab. Wash your hands often. Tell your doctor if you have any kind of infection before you receive the medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you have blurred vision; a cough that won't go away; fever, chills, or flu-like symptoms, such as a runny or stuffy nose; a headache; night sweats; or weight loss. These may be signs that you have an infection.

Belimumab may cause an infustion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have a headache; itching; dizziness, fainting, or lightheadedness; nausea; muscle or joint pain; or a rash.

belimumab may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest pain; hives; itching; a rash; swelling of the face, tongue, and throat; or trouble breathing after you receive the medicine.

belimumab may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

While you are being treated with belimumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Belimumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

belimumab 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 or nurse immediately if any of the following side effects occur:

More common

• Bladder pain


• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the site of injection


• bloody or cloudy urine


• body aches or pain


• chest congestion


• chills


• cough


• cough-producing mucus


• diarrhea


• difficult, burning, or painful urination


• difficulty with breathing or swallowing


• dizziness


• ear congestion


• facial swelling


• fever


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• hives


• itching, pain, redness, swelling, tenderness, or warmth on the skin


• joint pain


• loss of appetite


• lower back or side pain


• muscle aches and pains


• nasal congestion


• nausea or vomiting


• pain or tenderness around the eyes and cheekbones


• reddening of the skin, especially around the ears


• swelling of the eyes, face, or inside of the nose


• shivering


• shortness of breath or troubled breathing


• skin rash


• sneezing


• sore throat


• stuffy or runny nose


• sweating


• tightness in the chest


• trouble sleeping


• unusual tiredness or weakness


• wheezing

Less common

• Black, tarry stools


• fast heartbeat


• hoarseness


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


• swollen glands


• tender, swollen glands in the neck


• unusual bleeding or bruising


• voice changes

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:

More common

• Arm or leg pain


• sleeplessness


• unable to sleep

Less common

• Abdominal or stomach pain


• depression


• fear or nervousness


• headache, severe and throbbing


• weakness

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: belimumab Intravenous 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 belimumab Intravenous resources

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

Compare belimumab Intravenous with other medications

• Systemic Lupus Erythematosus

Azathioprin beta

Azathioprin beta may be available in the countries listed below.

Ingredient matches for Azathioprin beta

Azathioprine

Azathioprine is reported as an ingredient of Azathioprin beta in the following countries:

• Germany

International Drug Name Search

Gadoxetic Acid

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

V08CA10

CAS registry number (Chemical Abstracts Service)

0135326-11-3

Chemical Formula

C23-H30-Gd-N3-O11

Molecular Weight

681

Therapeutic Categories

Contrast medium

Diagnostic agent

Chemical Names

Dihydrogen [N-[(2S)-2-]bis(carboxymethyl)amino]-3-(p-ethoxyphenyl)propyl]-N-[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]gadolinate(2-) (WHO)

Dihydrogen [N-{(2S)-2-[bis(carboxymethyl)amino]-3-(4-ethoxyphenyl)propyl}-N-{2-[bis(carboxymethyl)amino]ethyl}glycinato(5-)]gadolinat(2-) (IUPAC)

Gadolinium ethoxybenyldiethylenetriaminepentaacetic acid

Foreign Names

• Acidum gadoxeticum (Latin)
• Gadoxetsäure (German)
• Acide gadoxetique (French)
• Acido gadoxetico (Spanish)

Generic Names

• Gd-EOB-DTPA (IS)
• Gadoxetate Disodium (OS: USAN)
• Eovist (IS)
• SHL-569B (IS)
• ZK-139834 (IS)

Brand Names

• Eovist
  Bayer, United States



• Primovist
  Bayer, Austria; Bayer, Switzerland; Bayer, Germany; Bayer, Spain; Bayer, United Kingdom; Bayer, Hungary; Bayer, Italy; Bayer, Latvia; Bayer, Sweden; Bayer Animal Health, Luxembourg; Bayer Schering, Australia; Bayer Schering, Finland; Bayer Schering Pharma, Norway; Schering, Czech Republic; Schering, Estonia; Schering, Lithuania; Schering, Malta; Schering, Poland; Schering, Slovenia



• Primovist EOB
  Bayer Yakuhin, Japan

International Drug Name Search

Glossary

IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

bronchodilator, theophylline Oral, Parenteral

Class Name: bronchodilator, theophylline (Oral route, Parenteral route)

thee-OF-i-lin

Uses For This Medicine

Aminophylline, oxtriphylline, and theophylline are used to treat and/or prevent the symptoms of bronchial asthma, chronic bronchitis , and emphysema. These medicines relieve cough, wheezing, shortness of breath, and troubled breathing. They work by opening up the bronchial tubes (air passages of the lungs) and increasing the flow of air through them.

Aminophylline and theophylline may also be used for other conditions as determined by your doctor.

The oral liquid, tablet, and capsule dosage forms of these medicines may be used for treatment of the acute attack or for chronic long-term treatment. The enteric-coated and extended-release dosage forms are usually used only for chronic treatment. Sometimes, aminophylline suppositories may be used but they are generally not recommended because of possible poor absorption.

These medicines are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, aminophylline and theophylline are used in certain patients with the following medical condition:

• Apnea (breathing problem) in newborns

Importance of Diet

Make certain your health care professional knows if you are on any special diet, such as a high-protein, low-carbohydrate or a low-protein, high-carbohydrate diet.

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Very young children and newborn infants require a lower dose than older children. If the amount of theophylline in the blood is too high, side effects are more likely to occur. Your doctor may want to take blood samples to determine whether a dose change is needed.

Geriatric

Patients older than 60 years of age are likely to require a lower dose than younger adults. If the amount of theophylline is too high, side effects are more likely to occur. Your doctor may want to take blood samples to determine whether a dose change is needed.

Pregnancy

Aminophylline, oxtriphylline, and theophylline are frequently used to treat asthma in pregnant women. Although there are no studies on birth defects in humans, problems have not been reported. Some studies in animals have shown that aminophylline, oxtriphylline, and theophylline can cause birth defects when given in doses many times the human dose.

Because your ability to clear theophylline from your body may decrease later in pregnancy, your doctor may want to take blood samples during your pregnancy to measure the amount of medicine in the blood. This will help your doctor decide whether the dose of this medicine should be changed.

Theophylline crosses the placenta. Use of aminophylline, oxtriphylline, or theophylline during pregnancy may cause unwanted effects such as fast heartbeat, irritability, jitteriness, or vomiting in the newborn infant if the amount of medicine in your blood is too high.

Breast Feeding

Theophylline passes into the breast milk and may cause irritability in nursing babies of mothers taking aminophylline, oxtriphylline, or theophylline.

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Convulsions (seizures)—Aminophylline, oxtriphylline, or theophylline may make this condition worse.

• Heart failure or


• Liver disease or


• Underactive thyroid—The effects of aminophylline, oxtriphylline, or theophylline may be increased.

Proper Use of This Medicine

For patients taking this medicine by mouth:

• If you are taking the capsule, tablet, liquid, or extended-release (not including the once-a-day capsule or tablet) form of this medicine, it works best when taken with a glass of water on an empty stomach (either 30 minutes to 1 hour before meals or 2 hours after meals). In some cases your doctor may want you to take this medicine with meals or right after meals to lessen stomach upset. If you have any questions about how you should be taking this medicine, check with your doctor.


• If you are taking the once-a-day capsule or tablet form of this medicine, some products are to be taken each morning after fasting overnight and at least 1 hour before eating. However, other products are to be taken in the morning or evening with or without food. Be sure you understand exactly how to take the medicine prescribed for you. Try to take the medicine about the same time each day.


• There are several different forms of aminophylline, oxtriphylline, and theophylline capsules and tablets. If you are taking:
  
  • Enteric-coated or delayed-release tablets—Swallow the tablets whole. Do not crush, break, or chew before swallowing.
  
  
  • Extended-release capsules—Swallow the capsule whole. Do not crush, break, or chew before swallowing. Do not open the capsule and sprinkle the beads onto food unless told to do so by your health care professional.
  
  
  • Extended-release tablets—Swallow the tablets whole. Do not break (unless tablet is scored for breaking), crush, or chew before swallowing.
  
  

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

In order for this medicine to help your medical problem, it must be taken every day in regularly spaced doses as ordered by your doctor. This is necessary to keep a constant amount of this medicine in the blood. To help keep the amount constant, do not miss any doses.

Dosing

The dose medicines in this class 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 these medicines. 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.

After you begin taking aminophylline, oxtriphylline, or theophylline, it is very important that your doctor check the level of medicine in your blood at regular intervals to find out if your dose needs to be changed.

Do not change your dose of aminophylline, oxtriphylline, or theophylline unless your doctor tells you to do so.

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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits, especially for the first few weeks after you begin using this medicine. A blood test may be taken to help your doctor decide whether the dose of this medicine should be changed.

Do not change brands or dosage forms of this medicine without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.

A change in your usual behavior or physical well-being may affect the way this medicine works in your body. Check with your doctor if you:

• have a fever of 102 °F or higher for at least 24 hours or higher than 100 °F for longer than 24 hours.


• start or stop smoking.


• start or stop taking another medicine.


• change your diet for a long time.

This medicine may add to the central nervous system (CNS) stimulant effects of caffeine-containing foods or beverages such as chocolate, cocoa, tea, coffee, and cola drinks. Avoid eating or drinking large amounts of these foods or beverages while using this medicine. If you have questions about this, check with your doctor.

Before you have myocardial perfusion studies (a medical test that shows how well blood is flowing to your heart), tell the medical doctor in charge that you are taking this medicine. The results of the test may be affected by this medicine.

Side Effects of This Medicine

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 as soon as possible if any of the following side effects occur:

Less common

• Heartburn and/or vomiting

Rare

• Hives, skin rash, or sloughing of skin (with aminophylline only)

Symptoms of toxicity

• Abdominal pain, continuing or severe


• confusion or change in behavior


• convulsions (seizures)


• dark or bloody vomit


• diarrhea


• dizziness or lightheadedness


• fast and/or irregular heartbeat


• nervousness or restlessness, continuing


• trembling, continuing

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:

Less common

• Headache


• fast heartbeat


• increased urination


• nausea


• nervousness


• trembling


• trouble in sleeping

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

The information contained in the Thomson Healthcare (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 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 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 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 HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Cefa-Drops

Dosage Form: FOR ANIMAL USE ONLY
Cefa-Drops®

Cefadroxil for Oral Suspension, USP

NADA 140-684, Approved by FDA

Cefa-Drops Description

Cefa-Drops (cefadroxil) contain a semi-synthetic cephalosporin antibiotic intended for oral administration. Cefa-Drops has an orange-pineapple flavor.

Cefadroxil is a member of a group of semi-synthetic derivatives of cephalosporin C, found among the metabolic products of the fungus Cephalosporium acremonium. The cephalosporins are structurally related to the penicillins in that both contain a 4-member beta-lactam ring. Cefadroxil is a 7-amino cephalosporanic acid substituted at the 7 position to form a molecule designated chemically as (6R, 7R)-7- [(R)-2-amino-2-(p-hydroxyphenyl)acetamido]- 3-methyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2- ene-2-carboxylic acid monohydrate:

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CAUTION

The enclosed dose dropper in Cefa Drops contains natural rubber latex which may cause allergic reactions.

INDICATIONS

Cefa-Drops (cefadroxil) are indicated for the treatment of the following conditions:

Dogs: Genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli, Proteus mirabilis and Staphylococcus aureus.

Skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections and abscesses caused by susceptible strains of Staphylococcus aureus.

Cats: Skin and soft tissue infections including abscesses, wound infections, cellulitis and dermatitis caused by susceptible strains of Pasteurella multocida, Staphylococcus aureus, Staphylococcus epidermidis and Streptococcus spp.

DOSAGE

Dogs: Cefa-Drops, 50 mg, should be administered orally at a dosage of 10 mg/lb of body weight twice daily. Dogs with skin or soft tissue infections should be treated for a minimum of three days. Genitourinary tract infections should be treated for a minimum of seven days with cefadroxil. Maximum duration of therapy should not exceed 30 days.

Cats: Cefa-Drops, 50 mg, should be administered orally at a dosage of 10 mg/lb of body weight once daily. Maximum duration of therapy should not exceed 21 days.

In both species, drug treatment should continue for at least 48 hours after the animal is afebrile or asymptomatic. If no response is observed after three days of treatment, therapy should be discontinued and the case should be re-evaluated.

TO PREPARE SUSPENSION

Tap bottle lightly to loosen powder. For 15 mL bottle, add 10.4 mL of water in two portions. For 50 mL bottle, add 34 mL of water in two portions. Shake well after each addition. After mixing, store in refrigerator. Shake well before use. Discard unused portion after 14 days.

Droppers supplied with Cefa-Drops are calibrated in mL increments. When mixed as directed, each mL contains cefadroxil monohydrate equivalent to 50 mg cefadroxil.

Contraindications

Cefa-Drops should not be administered to dogs or cats with a known allergy to cephalosporins. In penicillin-allergic animals, Cefa-Drops should be used with caution.

Warnings

For use in dogs and cats only. Do not use in animals intended for human consumption. Safety for use in pregnant female dogs and cats or in breeding males has not been determined (see Animal Safety).

Adverse Reactions

Occasional nausea and vomiting have been reported following cefadroxil therapy. Administration with food appears to decrease nausea. Diarrhea and lethargy have been occasionally reported.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet (MSDS) or for technical assistance, call 1-866-638-2226.

Cefa-Drops - Clinical Pharmacology

ACTION

Cefadroxil, like other beta-lactam antibiotics, is a bactericidal agent that causes death of bacterial cells through a diversity of biological and biochemical effects on the cell wall. The spectrum of antibacterial activity includes many gram-negative organisms since cefadroxil, like other cephalosporins, has the ability to penetrate the outer envelope of gram-negative bacilli, thereby gaining access to cell wall target sites. Cefadroxil is generally not broken down by penicillinases such as those produced by penicillin-resistant staphylococci, although cephalosporinases have been identified that can inactivate the molecule.

MICROBIOLOGY

The effectiveness of Cefa-Drops in skin and soft tissue infections caused by Staphylooccus aureus, (including penicillin-resistant strains) and in urinary tract infections caused by Staphylococcus aureus, Escherichia coli and Proteus mirabilis, has been demonstrated clinically in the dog. In cats, the effectiveness of cefadroxil in skin and soft tissue infections caused by susceptible pathogens such as Pasteurella multocida, Staphylococcus aureus, Staphylococcus epidermidis and Streptococcus spp. has also been demonstrated. In addition, cefadroxil has a broad spectrum of activity against both gram-positive and gram-negative human isolates. Although the clinical significance of in vitro data is unknown in the target species, the following human isolates are generally susceptible to cefadroxil at the indicated concentrations1.

		Minimum Inhibitory Concentration (mcg/mL)
Organism	No. of Isolates	Range	MIC90*
Streptococcus pyogenes	(24)	0.063-0.125	0.11
Streptococcus agalactiae	(27)	0.25-1	0.92
Streptococcus pneumoniae	(29)	0.5-2	1.2
Staphylococcus aureus, penicillin sensitive	(16)	2-16	3.2
Staphylococcus aureus, penicillin resistant	(63)	1-32	6.2
Staphylococcus epidermidis	(28)	0.125-4	2.13
Escherichia coli	(59)	4->125	16.0
Proteus mirabilis	(62)	4->125	15.6
Klebsiella pneumoniae	(61)	4-16	7.85
Salmonella spp.	(22)	4-8	7.19
Shigella spp.	(12)	2-8	6.98
Pasteurella multocida	(2)		1.4

*Concentration at which 90% of the isolates are susceptible.

The susceptibility of organisms to cefadroxil should be determined using the cephalosporin class disc, 30mcg. Specimens for susceptibility testing should be collected prior to the initiation of antibiotic therapy.

PHARMACOKINETICS

Cefadroxil is stable in gastric acid and only moderately bound to serum proteins (approximately 20%). Cefadroxil is well absorbed from the gastrointestinal tract even when administered with food. The drug is excreted largely unchanged by the kidney. In humans, high concentrations of cefadroxil activity are found in urine within three hours after oral dosage2. The concurrent administration of probenecid retards the elimination rate.

In dogs, oral administration of cefadroxil at a dosage of 10 mg/lb results in mean peak serum concentrations averaging 18.6 mcg/mL within 1 to 2 hours after treatment3. The serum half-life (T½) following oral administration is approximately 2 hours. Over 50%of an orally administered dose is excreted unchanged in the urine of dogs within 24 hours. Serum concentration time profiles in dogs following oral administration are illustrated graphically in Figure 1.

Figure 1: Cefadroxil Serum Concentration Curves in Dogs3

In cats, oral administration of cefadroxil at a dosage of 10 mg/lb results in mean peak serum concentrations of 17.4 mcg/mL within 1 to 2 hours after treatment. The serum half-life (T½) following oral administration to cats is 2½ to 3 hours. Serum concentration time profiles in cats following oral administration are illustrated graphically in Figure 2.

Figure 2: Cefadroxil Serum Concentration Curves in Cats

ANIMAL SAFETY

In subacute studies, dogs administered 100, 200 or 400 mg/kg/day for 13 weeks showed no consistent or distinct treatment-related histopathologic changes. In chronic toxicity studies, dogs receiving doses as high as 600 mg/kg/day for six months showed no discernible treatment-related effects, with the exception of emesis in dogs receiving a 400 mg/kg/day dose at one time. No distinct or consistent meaningful drug-related changes in the hematologic, coagulation or urinalysis test results or in histologic examination of tissues were observed when compared to controls.

No teratogenic or antifertility effects were seen in reproductive studies done in mice and rats receiving dosages as high as nine times the maximum recommended canine dosage.

In cats, oral administration of cefadroxil at a dosage of 240 mg/kg/day divided into two equal doses (ten times the recommended daily dosage) for 21 consecutive days produced no clinical chemistry, pathological or other signs of toxicity other than reduced food consumption, vomiting and diarrhea.

STORAGE

Store at 20 - 25°C (68 - 77°F), excursions permitted between 15 - 30°C (59 - 86°F).

How is Cefa-Drops Supplied

Cefa-Drops (Cefadroxil for Oral Suspension, USP) equivalent to:

NDC 0010-4700-01 – 750 mg cefadroxil per 15 mL dropper bottle

NDC 0010-4700-02 – 2500 mg cefadroxil per 50 mL dropper bottle

REFERENCES

1. Leitner, F., et al: “Comparative antibacterial spectrum of cefadroxil.” J. Antimicrob. Chemother. 10, Suppl. B, 1 (1982).

2. Harstein, A.L., et al: “Comparison of pharmacological and antimicrobial properties of cefadroxil and cephalexin.” Antimicrob. Agents Chemother. 12, 93 (1977).

3. Gingerich, D. A.: “Clinical pharmacology of the cephalosporins and their present use in veterinary medicine.” College of Veterinary Medicine Review, Mississippi State University, 2, 93 (1982).

© 2010 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

Cefa-Drops is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.

Made in India

Manufactured for:

Boehringer Ingelheim Vetmedica, Inc.

St. Joseph, MO 64506 U.S.A.

D4230B 11660 P1503133

ML LABEL

ML CARTON

ML LABEL

ML CARTON

Cefa-Drops  cefadroxil for oral suspension  suspension

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0010-4700 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFADROXIL (CEFADROXIL) CEFADROXIL 50 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0010-4700-01 10.4 mL In 1 BOTTLE None 2 0010-4700-02 34 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140684	07/20/1988

Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)

Revised: 12/2010Boehringer Ingelheim Vetmedica, Inc.

Fenazon-Koffein

Fenazon-Koffein may be available in the countries listed below.

Ingredient matches for Fenazon-Koffein

Caffeine

Caffeine is reported as an ingredient of Fenazon-Koffein in the following countries:

• Norway

Phenazone

Phenazone is reported as an ingredient of Fenazon-Koffein in the following countries:

• Norway

International Drug Name Search

Butisol Sodium

Generic Name: butabarbital (byoo ta BAR bi tal)

Brand Names: Butisol Sodium

What is Butisol Sodium (butabarbital)?

Butabarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Butabarbital slows the activity of your brain and nervous system.

Butabarbital is used short-term to treat insomnia, or as a sedative before surgery.

Butabarbital may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Butisol Sodium (butabarbital)?

Butabarbital may cause a severe allergic reaction. Stop taking butabarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Take butabarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking butabarbital and talk with your doctor about another treatment for your sleep disorder.

Do not use butabarbital without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Butabarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking butabarbital. Butabarbital may be habit-forming and should be used only by the person it was prescribed for. Butabarbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking Butisol Sodium (butabarbital)?

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking butabarbital and talk with your doctor about another treatment for your sleep disorder.

Do not take this medication if you are allergic to butabarbital, aspirin, or any kind of yellow dye (coloring in food or medicines).

Before taking butabarbital, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  severe asthma, chronic obstructive pulmonary disorder (COPD), or other breathing disorder;

  
  


• liver disease;


• 
  

  anemia (lack of red blood cells);

  
  


• 
  

  a history of depression, mental illness, or suicide attempt; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

If you have any of these conditions, you may not be able to use butabarbital, or you may need a dosage adjustment or special tests during treatment.

Butabarbital may be habit-forming and should be used only by the person it was prescribed for. Butabarbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use butabarbital without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Butabarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking butabarbital. Butabarbital can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Butisol Sodium (butabarbital)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take butabarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine. Take this medicine with a full glass of water. Do not mix butabarbital oral liquid with any type of fruit juice.

Measure the liquid form of butabarbital with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are taking this medicine to treat insomnia, take it only at bedtime. Call your doctor if your insomnia symptoms do not improve within 7 to 10 days of taking butabarbital.

Do not change your dose of butabarbital without your doctor's advice. Do not use butabarbital for longer than 2 weeks to treat insomnia, unless your doctor has told you to. You may have withdrawal symptoms (such as anxiety, insomnia, or feeling irritable) when you stop using butabarbital after using it over a long period of time. Do not stop using butabarbital suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store butabarbital at room temperature away from moisture and heat.

Keep track of how many pills have been used from each new bottle of this medicine. Butabarbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Skip the missed dose and wait until your next regularly scheduled time to take the medicine. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of butabarbital can be fatal.

Symptoms of a butabarbital overdose may include slow or shallow breathing, blurred vision, extreme drowsiness, feeling light-headed, or fainting.

What should I avoid while taking Butisol Sodium (butabarbital)?

Butabarbital can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by butabarbital. Tell your doctor if you need to use any of these other medicines while you are taking butabarbital. Avoid drinking alcohol. It can increase some of the side effects of butabarbital.

Butisol Sodium (butabarbital) side effects

Butabarbital may cause a severe allergic reaction. Stop taking butabarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  feeling like you might pass out;

  
  


• 
  

  a fever or a sore throat;

  
  


• 
  

  sores in your mouth;

  
  


• 
  

  easy bruising or bleeding; or

  
  


• 
  

  trouble breathing or swallowing.

  
  

Less serious side effects may be more likely to occur, such as:

• 
  

  drowsiness or dizziness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  excitement (especially in children or older adults);

  
  


• 
  

  joint or muscle pain;

  
  


• 
  

  nausea, vomiting, upset stomach, constipation; or

  
  


• 
  

  nightmares or increased dreaming.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Butisol Sodium (butabarbital)?

The following drugs can interact with butabarbital. Tell your doctor if you are using any of these:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  seizure medication;

  
  


• 
  

  metronidazole (Flagyl);

  
  


• 
  

  theophylline (Theo-Dur, Theochron, Theolair, Slo-Bid, others);

  
  


• 
  

  rifampin (Rifadin, Rifamate, Rimactane);

  
  


• 
  

  a beta-blocker such as metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others;

  
  


• 
  

  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  
  


• 
  

  a calcium channel blocker such as felodipine (Plendil) or verapamil (Calan, Covera); or

  
  


• 
  

  steroids such as prednisone (Orasone, Deltasone), prednisolone (Prelone, Delta Cortef), methylprednisolone (Medrol), and others.

  
  

This list is not complete and there may be other drugs that can interact with butabarbital. 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 Butisol Sodium resources

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

• Butisol Sodium Advanced Consumer (Micromedex) - Includes Dosage Information


• Butisol Sodium MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Butisol Sodium with other medications

• Insomnia
• Sedation

Where can I get more information?

• Your pharmacist can provide more information about butabarbital.

See also: Butisol Sodium side effects (in more detail)

Simvafar

Simvafar may be available in the countries listed below.

Ingredient matches for Simvafar

Simvastatin

Simvastatin is reported as an ingredient of Simvafar in the following countries:

• Vietnam

International Drug Name Search

PediaCare Long-Acting Cough Freezer Pops

Pronunciation: DEX-troe-meth-OR-fan
Generic Name: Dextromethorphan
Brand Name: PediaCare Long-Acting Cough

PediaCare Long-Acting Cough Freezer Pops are used for:

Temporarily relieving cough due to the common cold, hay fever, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.

PediaCare Long-Acting Cough Freezer Pops are a cough suppressant. It works in the cough center of the brain to reduce a dry or nonproductive cough.

Do NOT use PediaCare Long-Acting Cough Freezer Pops if:

• you are allergic to any ingredient in PediaCare Long-Acting Cough Freezer Pops


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using PediaCare Long-Acting Cough Freezer Pops:

Some medical conditions may interact with PediaCare Long-Acting Cough Freezer Pops. Tell your health care provider 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 a history of chronic cough, asthma, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), or if cough occurs with a large amount of mucus

Some MEDICINES MAY INTERACT with PediaCare Long-Acting Cough Freezer Pops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Furazolidone or MAO inhibitors (eg, phenelzine) because the risk of serious side effects, such as severe low blood pressure, fever, severe muscle problems, and possibly death, may be increased by PediaCare Long-Acting Cough Freezer Pops

This may not be a complete list of all interactions that may occur. Ask your health care provider if PediaCare Long-Acting Cough Freezer Pops 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 PediaCare Long-Acting Cough Freezer Pops:

Use PediaCare Long-Acting Cough Freezer Pops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• PediaCare Long-Acting Cough Freezer Pops may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• To use, cut off the top of the freezer pop sleeve and push freezer pop up from the bottom. PediaCare Long-Acting Cough Freezer Pops may be eaten frozen or the contents of 1 unfrozen sleeve may be poured into a cup or glass to drink. Immediately throw away any unused portion of the opened medicine.


• If you miss a dose of PediaCare Long-Acting Cough Freezer Pops and you are taking it regularly, 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 PediaCare Long-Acting Cough Freezer Pops.

Important safety information:

• PediaCare Long-Acting Cough Freezer Pops may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to PediaCare Long-Acting Cough Freezer Pops. Using PediaCare Long-Acting Cough Freezer Pops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your doctor. A persistent cough could be a sign of a serious condition.


• PediaCare Long-Acting Cough Freezer Pops contains dextromethorphan. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dextromethorphan. If it does or if you are not sure, contact your doctor or pharmacist.


• Diabetes patients - Some brands of PediaCare Long-Acting Cough Freezer Pops may contain sugar and affect your blood sugar level. Read the label carefully before using PediaCare Long-Acting Cough Freezer Pops.


• PediaCare Long-Acting Cough Freezer Pops are not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if PediaCare Long-Acting Cough Freezer Pops can cause harm to the fetus. If you become pregnant while taking PediaCare Long-Acting Cough Freezer Pops, discuss with your doctor the benefits and risks of using PediaCare Long-Acting Cough Freezer Pops during pregnancy. It is unknown if PediaCare Long-Acting Cough Freezer Pops are excreted in breast milk. Do not breast-feed while taking PediaCare Long-Acting Cough Freezer Pops.

Possible side effects of PediaCare Long-Acting Cough Freezer Pops:

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:

Dizziness; drowsiness; stomach upset.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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: PediaCare Long-Acting Cough 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 confusion; excitement; hallucinations; slowed breathing.

Proper storage of PediaCare Long-Acting Cough Freezer Pops:

Store PediaCare Long-Acting Cough Freezer Pops at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep PediaCare Long-Acting Cough Freezer Pops out of the reach of children and away from pets.

General information:

• If you have any questions about PediaCare Long-Acting Cough Freezer Pops, please talk with your doctor, pharmacist, or other health care provider.


• PediaCare Long-Acting Cough Freezer Pops are 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 PediaCare Long-Acting Cough Freezer Pops. 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 PediaCare Long-Acting Cough resources

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

Compare PediaCare Long-Acting Cough with other medications

• Cough