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Wednesday, 25 July 2012

Cefaclor

Class: Second Generation Cephalosporins
VA Class: AM116
CAS Number: 53994-73-3

Introduction

Antibacterial; β-lactam antibiotic; second generation cephalosporin.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ^a

Uses for Cefaclor

Acute Otitis Media (AOM)

Treatment of AOM caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, or S. pyogenes (group A β-hemolytic streptococci).¹⁶⁷ (See Haemophilus influenzae Infections under Cautions.)

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).¹²⁴ ¹³⁵ ¹⁵² ¹⁵³ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;¹⁰¹ ¹⁰² ¹⁰⁶ ¹⁴⁴ oral cephalosporins and oral macrolides considered alternatives.¹⁰¹ ¹⁰² ¹⁰⁶ ¹⁴⁴ Amoxicillin sometimes used instead of penicillin V, especially for young children.¹⁰¹ ¹⁴⁴

Respiratory Tract Infections

Treatment of lower respiratory tract infections, including pneumonia, caused by susceptible H. influenzae, S. pneumoniae, or S. pyogenes (group A β-hemolytic streptococci).¹⁶⁷ (See Haemophilus influenzae Infections under Cautions.)

Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible H. influenzae (β-lactamase negative strains only), Moraxella catarrhalis (including β-lactamase producing strains), or S. pneumoniae.¹⁶⁸ ¹⁶⁹ (See Haemophilus influenzae Infections under Cautions.)

Treatment of secondary bacterial infections of acute bronchitis caused by susceptible H. influenzae (β-lactamase negative strains only) or M. catarrhalis (including β-lactamase producing strains).¹⁶⁸ ¹⁶⁹ (See Haemophilus influenzae Infections under Cautions.)

Skin and Skin Structure Infections

Uncomplicated skin and skin structure infections caused by susceptible Staphylococcus aureus (oxacillin-susceptible strains only)¹³⁶ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ or S. pyogenes.¹³⁶ ¹⁶⁷

Urinary Tract Infections (UTIs)

Treatment of UTIs (including pyelonephritis and cystitis) caused by susceptible Escherichia coli, Proteus mirabilis, Klebsiella, or coagulase-negative staphylococci.¹⁶⁷

Cefaclor Dosage and Administration

Administration

Oral Administration

Administer orally.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Conventional capsules or oral suspension: Administer without regard to meals.¹⁶⁷

Extended-release tablets: Administer with meals or within 1 hour of eating.¹⁶⁸ ¹⁶⁹ Should not be cut, crushed, or chewed.¹⁶⁸ ¹⁶⁹

Dosage

Available as cefaclor monohydrate; dosage expressed in terms of anhydrous cefaclor.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Pediatric Patients

General Pediatric Dosage

Oral

Children ≥1 month of age: AAP recommends 20–40 mg/kg daily in 2 or 3 equally divided doses for treatment of mild or moderate infections.¹⁰¹ AAP states the drug is inappropriate for treatment of severe infections.¹⁰¹

Acute Otitis Media (AOM)

Oral

Children ≥1 month of age: 40 mg/kg daily in divided doses every 8 or 12 hours (as capsules or oral suspension).¹⁶⁷

Pharyngitis and Tonsillitis

Oral

Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 or 12 hours for 10 days (as capsules or oral suspension).¹⁶⁷ For more severe infections or those caused by less-susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).¹⁶⁷

Respiratory Tract Infections

Oral

Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension) for lower respiratory tract infections.¹⁶⁷ For more severe infections or those caused by less-susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).¹⁶⁷

Skin and Skin Structure Infections

Oral

Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).¹⁶⁷ For more severe infections or those caused by less susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).¹⁶⁷

Urinary Tract Infections (UTIs)

Oral

Adults

Acute Otitis Media (AOM)

Oral

250 mg every 8 hours (as capsules or oral suspension).¹⁶⁷ For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).¹⁶⁷

Pharyngitis and Tonsillitis

Oral

250 mg every 8 hours (as capsules or oral suspension).¹⁶⁷ For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).¹⁶⁷

375 mg every 12 hours for 10 days (as extended-release tablets).¹⁶⁸ ¹⁶⁹

Respiratory Tract Infections

Lower Respiratory Tract Infections

Oral

250 mg every 8 hours (as capsules or oral suspension).¹⁶⁷ For more severe infections (e.g., pneumonia) or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).¹⁶⁷

Acute Bacterial Exacerbations of Chronic Bronchitis

Oral

500 mg every 12 hours for 7 days (as extended-release tablets).¹⁶⁸ ¹⁶⁹

Secondary Bacterial Infections of Acute Bronchitis

Oral

500 mg every 12 hours for 7 days (as extended-release tablets).¹⁶⁸ ¹⁶⁹

Skin and Skin Structure Infections

Oral

250 mg every 8 hours (as capsules or oral suspension).¹⁶⁷ For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).¹⁶⁷

375 mg every 12 hours for 7–10 days (as extended-release tablets).¹⁶⁸ ¹⁶⁹

Urinary Tract Infections (UTIs)

Oral

250 mg every 8 hours (as capsules or suspension).¹⁶⁷ For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).¹⁶⁷

Prescribing Limits

Pediatric Patients

Maximum 1 g daily.¹⁶⁷

Special Populations

Renal Impairment

No dosage adjustments required.¹⁶⁷

Close clinical observation and appropriate laboratory tests recommended in those with moderate or severe renal impairment.¹⁶⁷ Use with caution in patients with markedly impaired renal function.¹⁶⁷

Geriatric Patients

No age-related dosage adjustments required.¹⁶⁸ ¹⁶⁹

Cautions for Cefaclor

Contraindications

Known hypersensitivity to cefaclor, any other cephalosporin, or any ingredient in the formulation.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ Careful observation of the patient is essential.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ Institute appropriate therapy if superinfection occurs.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Treatment with anti-infectives may permit overgrowth of Clostridium difficile.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefaclor, and may range in severity from mild diarrhea to fatal colitis.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued. Some mild cases may respond to discontinuance alone.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Haemophilus influenza Infections

β-lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.¹⁶⁷ This should be considered when treating infections that may involve these strains (e.g., respiratory tract infections, AOM).¹⁶⁷

Efficacy of extended-release tablets in the treatment of bronchitis known, suspected, or potentially caused by β-lactamase-producing H. influenzae has not been established.¹⁶⁸ ¹⁶⁹

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions such as anaphylaxis, angioedema, serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

If an allergic reaction occurs, discontinue cefaclor and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Cross-hypersensitivity

Partial cross-hypersensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ^a

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ^a Cautious use recommended in individuals hypersensitive to penicillins:¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ^a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

History of GI Disease

Use cephalosporins with caution in patients with a history of GI disease, particularly colitis.¹⁶⁷ (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Specific Populations

Pregnancy

Category B.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Lactation

Distributed into milk; use with caution.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Pediatric Use

Safety and efficacy of capsules and oral suspension not established in infants <1 month of age.¹⁶⁷

Safety and efficacy of extended-release tablets not established in children <16 years of age.¹⁶⁸ ¹⁶⁹

Geriatric Use

Safety and efficacy in geriatric adults similar to that in younger adults.¹⁶⁸ ¹⁶⁹

Renal Impairment

Decreased clearance.¹⁶⁷

No dosage adjustment required for patients with renal impairment.¹⁶⁷ Close clinical observation and appropriate laboratory tests recommended in those with moderate or severe renal impairment.¹⁶⁷ Use with caution in patients with markedly impaired renal function.¹⁶⁷

Common Adverse Effects

Diarrhea, genital pruritus or vaginitis, headache, nausea, vomiting, rash.¹²³ ¹²⁵ ¹²⁷ ¹²⁹ ¹³⁰ ¹³² ¹⁵³ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Interactions for Cefaclor

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Antacids (aluminum- or magnesium-containing)	Decreased absorption of cefaclor extended-release tablets ¹⁶⁸ ¹⁶⁹	Administer cefaclor extended-release tablets at least 1 hour before aluminum- or magnesium-containing antacids¹⁶⁸ ¹⁶⁹
Anticoagulants, oral	Possible enhanced warfarin effects¹⁶⁷ ¹⁶⁸ ¹⁶⁹
Histamine H₂-receptor antagonists	No effect on rate or extent of absorption of cefaclor extended-release tablets¹⁶⁸ ¹⁶⁹
Probenecid	Decreased renal excretion of cefaclor¹⁶⁷ ¹⁶⁸ ¹⁶⁹
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution¹⁶⁷ ¹⁶⁸ ¹⁶⁹	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)^a

Cefaclor Pharmacokinetics

Absorption

Bioavailability

Well absorbed from GI tract following oral administration.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ Peak plasma concentrations attained within 0.5–1 hour with conventional preparations¹⁶⁷ and 1.5–2.7 hours with extended-release tablets.¹⁶⁸ ¹⁶⁹

Food

Peak serum concentrations are lower and attained later when cefaclor capsules are administrated with food, but total amount of drug absorbed is unchanged.¹⁶⁷ ¹⁰⁷ ¹⁰⁸

When extended-release tablets are administered with food, the extent of absorption and peak plasma concentrations of the drug are increased.¹⁶⁸ ¹⁶⁹

Distribution

Extent

Cephalosporins are widely distributed into tissues and fluids.^a

Distributed into milk in low concentrations.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Plasma Protein Binding

25%.^a

Elimination

Metabolism

Not appreciably metabolized.^a

Elimination Route

Excreted unchanged in urine.¹⁶⁷ About 60–85% is excreted unchanged in urine within 8 hours; majority is excreted during the first 2 hours.¹⁶⁷

Half-life

0.6–1 hour in adults with normal renal function.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Special Populations

Renal impairment decreases clearance of cefaclor.¹⁶⁷ Serum half-life is 2.3–2.8 hours in anuric patients.¹⁶⁷

Stability

Storage

Oral

Capsules

15–30°C; protect from moisture.¹⁶⁷

For Suspension

15–30°C.¹⁶⁷ After reconstitution, store suspension in tight container in the refrigerator; discard after 14 days.¹⁶⁷

Extended-release Tablets

15–30°C.¹⁶⁸ ¹⁶⁹

Actions and SpectrumActions

Second generation cephalosporin active against some gram-negative bacteria that generally are resistant to first generation cephalosporins, but has a narrower spectrum of activity than third generation cephalosporins.^a Less active against gram-negative bacteria than some other second generation cephalosporins.^a

Usually bactericidal.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ^a

In vitro spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and a few anaerobic bacteria; inactive against fungi and viruses.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ^a

Gram-positive aerobes: active in vitro and in clinical infections against staphylococci (including coagulase-positive, coagulase-negative, and penicillinase producing strains), Streptococcus pneumoniae, and S. pyogenes (group A β-hemolytic streptococci).¹⁶⁷ ¹⁶⁸ ¹⁶⁹ Enterococci (e.g., Enterococcus faecalis) and oxacillin-resistant (methicillin-resistant) staphylococci are resistant.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ^a

Gram-negative aerobes: active in vitro and in clinical infections against H. influenzae (except BLNAR strains), Moraxella catarrhalis (including β-lactamase producing strains), Escherichia coli, Klebsiella, and Proteus mirabilis.¹⁶⁷ ¹⁶⁸ ¹⁶⁹ Also active in vitro against H. parainfluenzae, Citrobacter diversus, and Neisseria gonorrhoeae. Inactive against Acinetobacter, Enterobacter, Morganella morganii, Proteus vulgaris, Providencia, Pseudomonas, and Serratia.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Anaerobes: active in vitro against Bacteroides (excluding B. fragilis), Peptococcus niger, Peptostreptococcus, and Propionibacterium acnes.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Advice to Patients

Importance of completing full course of therapy.¹⁶⁷

Importance of taking cefaclor extended-release tablets at least 1 hour before antacids containing aluminum or magnesium.¹⁶⁸ ¹⁶⁹

Importance of taking cefaclor extended-release tablets with meals or within 1 hour of eating.¹⁶⁸ ¹⁶⁹

Importance of taking cefaclor extended-release tablets at least 1 hour before antacids containing aluminum or magnesium.¹⁶⁸ ¹⁶⁹

Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

Importance of discontinuing cefaclor and informing clinician if an allergic reaction occurs.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.¹⁶⁷ ¹⁶⁸ ¹⁶⁹

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

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cefaclor
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	equivalent to anhydrous cefaclor 250 mg*	Cefaclor Capsules	Ranbaxy
		equivalent to anhydrous cefaclor 500 mg*	Cefaclor Capsules	Ranbaxy
	For suspension	equivalent to anhydrous cefaclor 125 mg/5 mL*	Cefaclor for Suspension	Ranbaxy
		equivalent to anhydrous cefaclor 187 mg/5 mL*	Cefaclor for Suspension	Ranbaxy
		equivalent to anhydrous cefaclor 250 mg/5 mL*	Cefaclor for Suspension	Ranbaxy
		equivalent to anhydrous cefaclor 375 mg/5 mL*	Cefaclor for Suspension	Ranbaxy
	Tablets, extended-release	equivalent to anhydrous cefaclor 500 mg	Cefaclor Extended-Release Tablets (with propylene glycol)	Teva

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.

Cefaclor 125MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 150/$24.99 or 450/$53.98

Cefaclor 125MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 75/$16.99 or 225/$34.97

Cefaclor 250MG Capsules (WEST-WARD): 30/$60.99 or 90/$165.97

Cefaclor 250MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 150/$34.99 or 450/$84.97

Cefaclor 250MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 75/$22.99 or 225/$47.98

Cefaclor 375MG/5ML Suspension (RANBAXY PHARMACEUTICALS): 100/$34.99 or 300/$84.97

Cefaclor 500MG Capsules (RANBAXY PHARMACEUTICALS): 30/$87.99 or 90/$249.98

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 March 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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140. Paradise JL. Treatment guidelines for otitis media: the need for breadth and flexibility. Pediatr Infect Dis J. 1995; 14:429-35. [IDIS 348106] [PubMed 7638033]

141. Berman S. Otitis media in children. N Engl J Med. 1995; 332:1560-5. [IDIS 348227] [PubMed 7739711]

142. The Otitis Media Guideline Panel. Managing otitis media with effusion in young children. Pediatrics. 1994; 94:766-73. [IDIS 337882] [PubMed 7936917]

143. Klein JO. Selection of oral antimicrobial agents for otitis media and pharyngitis. Infect Dis Clin Pract. 1995; 4(Suppl 2):S88-94.

144. Bisno AL, Gerber MA, Gwaltney JM et al et al. Diagnosis and management of group A streptococcal pharyngitis: a practice guideline. Clin Infect Dis. 1997; 25:574-83. [PubMed 9314443]

145. Klein JO. Management of streptococcal pharyngitis. Pediatr Infect Dis J. 1994; 13:572-5. [IDIS 331902] [PubMed 8078757]

146. Pichichero ME, Cohen R. Shortened course of antibiotic therapy for acute otitis media, sinusitis and tonsillopharyngitis. Pediatr Infect Dis J. 1997; 16:680-95. [IDIS 390075] [PubMed 9239773]

147. Tack KJ, Henry DC, Gooch WM et al et al. Five-day cefdinir treatment for streptococcal pharyngitis. Antimicrob Agents Chemother. 1998; 42:1073-5. [IDIS 404900] [PubMed 9593129]

148. Pichichero ME. Cephalosporins are superior to penicillin for treatment of streptococcal tonsillopharyngitis: is the difference worth it? Pediatr Infect Dis. 1993; 12:268-74.

149. Aujard Y, Boucot I, Brahimi N et al. Comparative efficacy and safety of four-day cefuroxime axetil and ten-day penicillin treatment of group A beta-hemolytic streptococcal pharyngitis in children. Pediatr Infect Dis J. 1995; 14:295-300. [IDIS 345876] [PubMed 7603811]

150. Mehra S, Van Moerkerke M, Welck J et al. Short course therapy with cefuroxime axetil for group A streptococcal tonsillopharyngitis in children. Pediatr Infect Dis J. 1998; 17:452-7. [IDIS 408830] [PubMed 9655533]

151. Milatovic D. Evaluation of cefadroxil, penicillin and erythromycin in the treatment of streptococcal tonsillopharyngitis. Pediatr Infect Dis J. 1991; 10:S61-3. [PubMed 1945599]

152. Esposito S, De Ritis G, D’Errico G et al. Clinical comparison of cefaclor twice daily versus amoxicillin-clavulanate or erythromycin three times daily in the treatment of patients with streptococcal pharyngitis. Clin Ther. 1998; 20:72-9. [IDIS 402071] [PubMed 9522105]

153. Derriennic M, Voi M, Thoren LM et al. Cefaclor AF in the treatment of streptococcal pharyngitis/tonsillitis. Postgrad Med J. 1992; 68(Suppl 3):S43-6. [PubMed 1287618]

154. Paradise JL. Short-course antimicrobial treatment for acute otitis media: not best for infants and young children. JAMA. 1997; 278:1640-2. [IDIS 396934] [PubMed 9388072]

155. Adam D, Hostalek U, Troster K. 5-day cefixime therapy for bacterial pharyngitis and/or tonsillitis: comparison with 10-day penicillin V therapy. Infection. 1995; 23(Supp 2):S83-6. [PubMed 8537138]

156. Lowery N, Kearns GL, Young RA et al. Serum sickness-like reactions associated with cefprozil therapy. J Pediatr. 1994; 125:325-8. [IDIS 335503] [PubMed 8040786]

157. Grouhi M, Hummel D, Roifman CM. Anaphylactic reaction to oral cefaclor in a child. Pediatrics. 1999; 103:50-1.

158. Beghetti M, Wilson GJ, Bohn D et al. Hypersensitivity myocarditis caused by an allergic reaction to cefaclor. J Pediatr. 1998; 132:172-3. [IDIS 401043] [PubMed 9470025]

159. Dowell SF, Marcy SM, Phillips WR et al. Otitis media—principles of judicious use of antimicrobial agents. Pediatrics. 1998; 101:165-71.

160. Stool SE, Berg AO, Berman S et al for the Otitis Media Guideline Panel. Otitis media with effusion in young children. Clinical Practice Guideline. Number 12. AHCPR Publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Resources. July 1994.

161. Perry BP, Zieno SA, Yonkers AJ. Outcome-oriented managed care comparing efficacies of cefaclor and amoxicillin in acute and recurrent acute otitis media. Ear Nose Throat J. 1995; 74:840-4. [PubMed 8556984]

162. Adderson EE. Preventing otitis media: medical approaches. Pediatr Ann. 1998; 27:101-7. [PubMed 9523298]

163. Klein JO. Protecting the therapeutic advantage of antimicrobial agents used for otitis media. Pediatr Infect Dis J. 1998; 17:571-5. [IDIS 408841] [PubMed 9655563]

164. Dowell SF, Marcy SM, Phillips WR et al. Otitis media—principles of judicious use of antimicrobial agents. Pediatrics. 1998; 101:165-71.

165. American Academy of Pediatrics and American Academy of Family Physicians Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics. 2004: 113:1451-65.

166. American Academy of Pediatrics, American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, and American Academy of Pediatrics Subcommittee on Otitis Media with Effusion. Otitis media with effusion. Pediatrics. 2004: 113:1412-29.

167. Ranbaxy. Cefaclor capsules USP and cefaclor for oral suspension USP prescribing information. Princeton, NJ; 2000 Jan.

168. Teva. Cefaclor extended-release tablets USP prescribing information. Sellersville, PA; 2002 May.

169. Ivax. Cefaclor extended-release tablets USP prescribing information. Miami, FL; 2003 Jan.

a. AHFS Drug Information. McEvoy GK, ed. Cephalosporins General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2003: 125-39.

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cefaclor Prescribing Information (FDA)

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Bladder Infection
Bronchitis
Kidney Infections
Otitis Media
Pneumonia
Sinusitis
Skin and Structure Infection
Skin Infection
Tonsillitis/Pharyngitis
Upper Respiratory Tract Infection
Urinary Tract Infection

Monday, 23 July 2012

FML

fluorometholone

Dosage Form: ophthalmic suspension
FML®

(fluorometholone ophthalmic suspension, USP) 0.1%

Sterile

DESCRIPTION

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name:

Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.

Structural Formula:

Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust the pH. FML® suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.

CLINICAL PHARMACOLOGY

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of documented steroid-responders, fluorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. The ultimate magnitude of the rise was equivalent for both drugs.

INDICATIONS AND USAGE

FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

CONTRAINDICATIONS

FML® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. FML® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

Corticosteroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.

PRECAUTIONS

General:

The initial prescription and renewal of the medication order beyond 20 milliliters of FML® suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

Information for Patients:

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

The preservative in FML® suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling FML® suspension to insert soft contact lenses.

Carcinogenesis, mutagenesis, impairment of fertility:

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

Pregnancy:

Teratogenic effects. Pregnancy Category C: Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in infants below the age of 2 years have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.

Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS).

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of FML® suspension. Other adverse events reported with the use of FML® suspension include: allergic reactions, visual disturbance (blurry vision), and taste perversion.

DOSAGE AND ADMINISTRATION

Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

The dosing of FML® suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

HOW SUPPLIED

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

     5mL in 10mL bottle NDC 11980-211-05

   10mL in 15mL bottle NDC 11980-211-10

   15mL in 15mL bottle NDC 11980-211-15

Note: Store between 2° and 25°C (36° - 77°F); protect from freezing. Shake well before using.

Rx Only

Revised June 2003

ALLERGAN

NDC 11980-211-15

Rx Only

FML®

(fluorometholone

ophthalmic suspension,

USP) 0.1%

15 mL sterile

ALLERGAN

NDC 11980-211-15 Rx Only

FML®

(fluorometholone

ophthalmic suspension,

USP) 0.1%

15 mL sterile

FML
fluorometholone suspension/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	11980-211
Route of Administration	OPHTHALMIC	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride
edetate disodium
polysorbate 80
polyvinyl alcohol
water
sodium chloride
sodium phosphate, dibasic
sodium phosphate, monobasic
sodium hydroxide

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	11980-211-05	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
1		5 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (11980-211-05)
2	11980-211-10	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
2		10 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (11980-211-10)
3	11980-211-15	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
3		15 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (11980-211-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016851	02/01/1972

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Allergan, Inc.		362898611	MANUFACTURE

Revised: 10/2010Allergan, Inc.

More FML resources

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FML Dosage
FML Use in Pregnancy & Breastfeeding
FML Drug Interactions
0 Reviews for FML - Add your own review/rating

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Eye Dryness/Redness
Eye Redness/Itching
Eyelash Hypotrichosis

Saturday, 14 July 2012

Varibar Thin oral and rectal

Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)

Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen

What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

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

What is the most important information I should know about barium sulfate?

You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?

You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:

asthma, eczema, or allergies;

a blockage in your stomach or intestines;

cystic fibrosis;

a colostomy;

rectal cancer;

heart disease or high blood pressure;

Hirschsprung's disease (a disorder of the intestines);

a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);

a recent history of surgery on your esophagus, stomach, or intestines;

a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;

if you have recently had a rectal biopsy;

if you have ever choked on food by accidentally inhaling it into your lungs;

if you are allergic to simethicone (Gas-X, Phazyme, and others); or

if you are allergic to latex rubber.

It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.

How should I use barium sulfate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.

What happens if I overdose?

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

Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.

What should I avoid before or after using barium sulfate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Barium sulfate side effects

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 a serious side effect such as:

severe stomach pain;

severe cramping, diarrhea, or constipation;

sweating;

ringing in your ears;

confusion, fast heart rate; or

pale skin, weakness.

Less serious side effects may include:

mild stomach cramps;

nausea, vomiting;

loose stools or mild constipation.

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.

What other drugs will affect barium sulfate?

There may be other drugs that can interact with barium sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Varibar Thin resources

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

Compare Varibar Thin with other medications

Computed Tomography

Where can I get more information?

Your doctor or pharmacist can provide more information about barium sulfate.

See also: Varibar Thin side effects (in more detail)

Thursday, 12 July 2012

cabazitaxel

Generic Name: cabazitaxel (ka BAZ i TAX el)

Brand Names: Jevtana

What is cabazitaxel?

Cabazitaxel is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body (metastatic).

Cabazitaxel is usually given after other cancer medicines have been tried without successful treatment.

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

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

Do not use cabazitaxel if you are pregnant. It could harm the unborn baby. You should not use this medication if you are allergic to cabazitaxel, or if you have liver disease, low white blood cell counts, or an allergy to any medicine that contains polysorbate 80. You should not breast-feed while you are receiving cabazitaxel.

Before you receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.

Cabazitaxel is used together with prednisone, and you may also be given other medications to help prevent certain side effects. Use all medications as directed by your doctor.

To make sure cabazitaxel is helping your condition and not causing harmful effects, your blood will need to be tested often.

What should I discuss with my health care provider before receiving cabazitaxel?

You should not use this medication if you are allergic to cabazitaxel, or if you have:

liver disease;

low white blood cell counts; or

an allergy to any medicine that contains polysorbate 80.

To make sure you can safely receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.

FDA pregnancy category D. Do not use cabazitaxel if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether cabazitaxel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving cabazitaxel. Serious side effects may be more likely in older adults receiving cabazitaxel.

How is cabazitaxel given?

Cabazitaxel is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Cabazitaxel must be given slowly, and the IV infusion can take about 1 hour to complete.

Cabazitaxel is usually given once every 3 weeks. You will most likely take prednisone by mouth every day throughout your cabazitaxel treatment. Follow your doctor's dosing instructions very carefully.

Do not stop taking prednisone without your doctor's advice, or you could have unpleasant side effects caused by cabazitaxel. Tell your doctor if you have missed any doses or have stopped taking prednisone for any reason.

About 30 minutes before you receive cabazitaxel, you may be given other medications to help prevent certain side effects.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Your doctor may tell you to check your temperature at home throughout your treatment with cabazitaxel.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while receiving cabazitaxel, which can lead to a serious electrolyte imbalance.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while receiving cabazitaxel?

Avoid taking an herbal supplement containing St. John's wort while you are being treated with cabazitaxel.

Cabazitaxel side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, red skin rash; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, cough, chills, muscle aches, flu symptoms, sores in your mouth and throat, rapid and shallow breathing, fainting;

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

severe or ongoing diarrhea;

trouble breathing;

feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

swelling or rapid weight gain; or

blood in your urine, pain or burning when you urinate.

Less serious side effects may include:

nausea, vomiting, stomach pain;

constipation, mild diarrhea;

weakness, tired feeling;

joint pain, back pain;

numbness, burning pain, or tingly feeling en your hands or feet;

changes in your sense of taste; or

hair loss.

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.

Cabazitaxel Dosing Information

Usual Adult Dose for Prostate Cancer:

Initial dose: 25 mg/m2 IV every 3 weeks in combination with prednisone 10 mg orally once daily.

What other drugs will affect cabazitaxel?

Many drugs can interact with cabazitaxel. Below is just a partial list. Tell your doctor if you are using:

conivaptan (Vaprisol);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

aprepitant (Emend);

cimetidine (Tagamet);

cyclosporine (Gengraf, Neoral, Sandimmune);

haloperidol (Haldol);

lidocaine (Xylocaine);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl), norfloxacin (Noroxin), telithromycin (Ketek), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

antifungal medication such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

an antidepressant such as nefazodone, desipramine (Norpramin), or sertraline (Zoloft);

heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

This list is not complete and there are many other drugs that can interact with cabazitaxel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More cabazitaxel resources

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

cabazitaxel Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Cabazitaxel Professional Patient Advice (Wolters Kluwer)

Cabazitaxel MedFacts Consumer Leaflet (Wolters Kluwer)

Cabazitaxel Monograph (AHFS DI)

Jevtana Prescribing Information (FDA)

Jevtana Consumer Overview

Compare cabazitaxel with other medications

Prostate Cancer

Where can I get more information?

Your doctor or pharmacist can provide more information about cabazitaxel.

See also: cabazitaxel side effects (in more detail)

Migraine Medications

Definition of Migraine:

Migraine headaches are a type of headache that some people get repeatedly over time. Migraines are different from other headaches because they occur with symptoms such as nausea, vomiting, or sensitivity to light.

Some people who get migraines have warning symptoms, called an aura, before the actual headache begins. Most people, however, do not have such warning symptoms.

Drugs associated with Migraine

The following drugs and medications are in some way related to, or used in the treatment of Migraine. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Migraine

Migraine Prevention (39 drugs)

Trochleitis (0 drugs)

Learn more about Migraine

Micromedex Care Notes:

Acute Headache
Cluster Headache
Migraine Headache

Medical Encyclopedia:

Migraine

Harvard Health Guide:

Symptoms and treatment for Migraine

Drug List:

Alsuma

Amerge

Amrix-Extended-Release-Capsules

Anacin-Advanced-Headache-Formula

Comfort-Pac-With-Cyclobenzaprine

Excedrin-Extra-Strength

Goody-S-Extra-Strength-Headache-Powders-Powder-Packet

Goodys-Extra-Strength

Goodys-Headache-Powders

Imitrex

Imitrex-Nasal-Oral-Nasal

Imitrex-Statdose-Refill-Injection

Laniroif

Levacet

Maxalt

Maxalt-Mlt-Orally-Disintegrating-Tablets

Methergine

Migergot-Suppositories

Zomig-Zmt-Disintegrating-Tablets

Wednesday, 11 July 2012

Zanaflex Capsule

Generic Name: tizanidine (Oral route)

tye-ZAN-i-deen

Commonly used brand name(s)

In the U.S.

Comfort Pac w/Tizanidine

Zanaflex

Zanaflex Capsule

Available Dosage Forms:

Capsule

Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Uses For Zanaflex Capsule

Tizanidine is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or certain injuries to the spine. Tizanidine does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Tizanidine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine's side effects.

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

Before Using Zanaflex Capsule

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tizanidine in children with use in other age groups.

Geriatric

Studies in older adults show that tizanidine stays in the body a little longer than it does in younger adults. Your doctor will consider this when deciding on your dose.

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. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ciprofloxacin

Fluvoxamine

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.

Acyclovir

Amiodarone

Cimetidine

Desogestrel

Dienogest

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Famotidine

Levonorgestrel

Medroxyprogesterone Acetate

Mestranol

Mexiletine

Norelgestromin

Norethindrone

Norfloxacin

Norgestimate

Norgestrel

Ofloxacin

Propafenone

Rofecoxib

Ticlopidine

Vemurafenib

Verapamil

Zileuton

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.

Fosphenytoin

Lisinopril

Phenytoin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of tizanidine

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

When you take the different dosage forms (tablets, capsules, capsule contents sprinkled over applesauce) of tizanidine with food, it effects the amount of the medicine absorbed into your blood differently. Follow your doctor's instructions for when to take this medicine and whether or not you should take it with food.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

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 (capsules and tablets):
- For muscle relaxation:
  - Adults—The dose is 8 milligrams (mg) every six to eight hours as needed. No more than 36 mg should be taken within a twenty-four-hour period.
  - Children—Use and dose must be determined by your doctor.

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.

Precautions While Using Zanaflex Capsule

Your doctor should check your progress at regular visits, especially during the first few weeks of treatment with this medicine. During this time the amount of medicine you are taking may have to be changed often to meet your individual needs.

Do not suddenly stop taking this medicine. Unwanted effects may occur if the medicine is stopped suddenly. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using tizanidine.

This medicine may cause dizziness, drowsiness, lightheadedness, clumsiness or unsteadiness, or vision problems in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.

Tizanidine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

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

More common

Chest pain or discomfort

fever

loss of appetite

lower back or side pain

nausea and/or vomiting

nervousness

pain or burning while urinating

painful or difficult urination

sores on the skin

tingling, burning, or prickling sensations

unusual tiredness

yellow eyes or skin

Less common

Black, tarry stools

bloody vomit

blurred vision

chills or sore throat

coldness

convulsions (seizures)

cough or hoarseness

dark urine

dry, puffy skin

eye pain

fainting

influenza (flu)-like symptoms

irregular heartbeat

kidney stones

persistent anorexia

pruritus

right upper quadrant tenderness

seeing things that are not there

shortness of breath

slow or irregular heartbeat

unusual tiredness or weakness

weight gain

Incidence not known

Continuing vomiting

general feeling of tiredness or weakness

headache

light-colored stools

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

change in consciousness

chest pain or discomfort

confusion

decreased awareness or responsiveness

difficult or troubled breathing

dizziness, faintness or lightheadedness when getting up from a lying position

irregular, fast or slow, or shallow breathing

lightheadedness, dizziness or fainting

loss of consciousness

pale or blue lips, fingernails, or skin

severe sleepiness

shortness of breath

sleepiness or unusual drowsiness

slow or irregular heartbeat

sweating

unusual tiredness or weakness

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

Anxiety

back pain

constipation

depression

diarrhea

difficulty in speaking

dizziness or lightheadedness, especially when getting up from a lying or sitting position

drowsiness

dry mouth

heartburn

increased sweating

increased muscle spasms or tone

muscle weakness

pain or burning in throat

runny nose

skin rash

sleepiness

stomach pain

uncontrolled movements of the body

Less common

Difficulty swallowing

dry skin

general feeling of discomfort or illness

increased need to urinate

joint or muscle pain or stiffness

loss of hair

migraine headache

mood changes

neck pain

passing urine more often

shivering

swelling of feet or lower legs

swollen area that feels warm and tender

trembling or shaking

trouble sleeping

unusual feeling of well-being

unusual tiredness or weakness

weight loss

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: Zanaflex Capsule 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 Zanaflex Capsule resources

Zanaflex Capsule Side Effects (in more detail)
Zanaflex Capsule Use in Pregnancy & Breastfeeding
Drug Images
Zanaflex Capsule Drug Interactions
Zanaflex Capsule Support Group
73 Reviews for Zanaflex Capsule - Add your own review/rating

Compare Zanaflex Capsule with other medications

Cluster Headaches
Muscle Spasm

Tuesday, 10 July 2012

Zofran Tablets

Pronunciation: on-DAN-se-tron
Generic Name: Ondansetron
Brand Name: Zofran

Zofran is used for:

Preventing nausea and vomiting associated with cancer chemotherapy, radiation treatment, or surgery. It may also be used for other conditions as determined by your doctor.

Zofran is a serotonin 5-HT₃ receptor blocker. It works by blocking a chemical thought to be a cause of nausea and vomiting in certain situations (eg, chemotherapy).

Do NOT use Zofran if:

you are allergic to any ingredient in Zofran

you are taking apomorphine

you have a certain type of irregular heartbeat (congenital long QT syndrome)

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

Before using Zofran:

Some medical conditions may interact with Zofran. 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 had an allergic reaction to another serotonin 5-HT₃ receptor blocker (eg, dolasetron, granisetron)

if you have liver problems, heart problems (eg, congestive heart failure, slow or irregular heartbeat, QT prolongation), or electrolyte problems (eg, low potassium or magnesium levels)

if you take medicines that may affect your heartbeat. Check with your doctor if you are unsure if any of your medicines may affect your heartbeat

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

Apomorphine because the risk of its side effects may be increased by Zofran

Antineoplastic agents (eg, cyclophosphamide) or tramadol because their effectiveness may be decreased by Zofran.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zofran 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 Zofran:

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

Take Zofran by mouth with or without food.

To prevent or reduce the possibility of nausea or vomiting, continue taking Zofran for the entire time recommended by your doctor even if you do not notice any nausea.

If you miss a dose of Zofran, 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 Zofran.

Important safety information:

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

Zofran should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zofran while you are pregnant. It is not known if Zofran is found in breast milk. If you are or will be breast-feeding while you use Zofran, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zofran:

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:

Constipation; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.

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, throat, or tongue; wheezing; unusual hoarseness); chest or jaw pain, numbness of an arm or leg, or sudden severe headache or vomiting; fainting; fast, slow, or irregular heartbeat; fever; seizures; severe or persistent dizziness; skin tingling or numbness; stomach pain; trouble urinating; uncontrolled muscle movements; vision changes or loss.

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: Zofran 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 fainting; severe dizziness; slowed/irregular heartbeat; sudden, temporary blindness.

Proper storage of Zofran:

Store Zofran between 36 and 86 degrees F (2 and 30 degrees C) in a tightly closed container. Protect from heat, moisture, and light. Do not store in the bathroom. Keep Zofran out of the reach of children and away from pets.

General information:

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

Zofran 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 Zofran. 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

More Zofran resources

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

Compare Zofran with other medications

Alcohol Dependence
Gastroenteritis
Nausea/Vomiting
Nausea/Vomiting, Chemotherapy Induced
Nausea/Vomiting, Postoperative
Nausea/Vomiting, Radiation Induced
Obsessive Compulsive Disorder
Postanesthetic Shivering
Pruritus