Altacef Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Cefuroxime axetil

Indications/Uses

Mild to moderate infections caused by susceptible strains of designated microorganisms: Pharyngitis/tonsilitis caused by Strep pyogenes; acute bacterial otitis media caused by Strep pneumoniae, H. influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Strep pyogenes; acute bacterial maxillary sinusitis caused by Strep pneumoniae or H. influenzae (non-β-lactamase-producing strains only); acute bacterial exacerbations of chronic bronchitis & secondary bacterial infections of acute bronchitis caused by Strep pneumoniae, H. influenzae (β-lactamase -ve strains), or Haemophilus parainfluenzae (β-lactamase -ve strains); uncomplicated skin & skin structure infections caused by Staph aureus (including β-lactamase-producing strains) or Strep pyogenes; uncomplicated UTI caused by E. coli or Klebsiella pneumoniae; uncomplicated gonorrhea, urethral & endocervical, caused by penicillinase-producing & non-penicillinase-producing strains of Neisseria gonorrhoeae & uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase-producing strains of Neisseria gonorrhoeae; early Lyme disease (erythema migrans) caused by Borrelia burgdorferi.

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Dosage/Direction for Use

Adult & adolescent ≥13 yr Pharyngitis/tonsilitis, acute bacterial maxillary sinusitis 250 mg bid for 10 days. Acute bacterial exacerbations of chronic bronchitis, uncomplicated skin & skin structure infections 250 or 500 mg bid for 10 days. Secondary bacterial infections of acute bronchitis 250 or 500 mg bid for 5-10 days. Uncomplicated UTI 250 mg bid for 7-10 days. Uncomplicated gonorrhea 1,000 mg once daily single dose. Early Lyme disease 500 mg bid for 20 days. Ped patient who can swallow tab whole Acute otitis media, acute bacterial maxillary sinusitis 250 mg bid for 10 days. Patient w/ renal impairment CrCl 10 to <30 mL/min Standard individual dose given every 24 hr, CrCl <10 mL/min (w/o hemodialysis) Standard individual dose given every 48 hr, hemodialysis Give a single additional standard dose at the end of each dialysis.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to cefuroxime (as axetil) or cephalosporins.

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Warnings

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Special Precautions

Cross-hypersensitivity among β-lactam antibiotics. Perform careful inquiry before therapy to determine whether patient has had previous hypersensitivity reactions to cefuroxime (as axetil) products, other cephalosporins, penicillins, or other drugs. Reports of Clostridium difficile associated diarrhea. Prolonged administration may result in overgrowth of non-susceptible microorganisms (Candida, Enterococci, Clostridium difficile). May be associated w/ a fall in prothrombin activity. Monitor prothrombin time in patients at risk & administer exogenous vit K as indicated. Risk of diarrhea; watery & bloody stools. Caution in individuals w/ history of colitis; patients concurrently receiving potent diuretics. Safety & effectiveness have not been established in patients w/ GI malabsorption. Should be used during pregnancy only if clearly needed. Consider discontinuing nursing temporarily during treatment.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypersensitivity reactions (ie, anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, urticaria, drug fever); pseudomembranous colitis; hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, increased prothrombin time; hepatic impairment including hepatitis & cholestasis, jaundice; seizure, encephalopathy; erythema multiforme, SJS, TEN; renal dysfunction. Cephalosporin-class antibiotics: Toxic nephropathy, aplastic anemia, hemorrhage, increased BUN, increased creatinine, false +ve test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin, agranulocytosis.

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Drug Interactions

Increased AUC w/ probenecid. Lower bioavailability w/ drugs that reduce gastric acidity. Lower estrogen absorption & reduced efficacy of combined estrogen/progesterone OCs. False +ve reaction for glucose in the urine may occur w/ Cu reduction tests (Benedict's or Fehling's soln). False -ve result may occur in the ferricyanide test.

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Storage

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Description

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Action

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MIMS Class

Cephalosporins

ATC Classification

J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Altacef FC tab 500 mg

Packing/Price

50's (P2,315/pack)

Altacef

cefuroxime

Manufacturer:

Glenmark

Distributor:

Glenmark