Fixbact Dosage & Drug Information

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

Concise Prescribing Info

Contents

Cefixime

Indications/Uses

Infections due to susceptible microorganisms: Acute bronchitis, acute exacerbations of chronic bronchitis, bronchiectasis w/ infection, secondary infections in chronic resp tract diseases, pneumonia; UTI including pyelonephritis & cystitis; gonococcal urethritis; cholecystitis, cholangitis; scarlet fever; sinusitis, tonsillitis, pharyngitis, otitis media; typhoid fever (enteric fever) including multi-drug resistant typhoid fever.

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Dosage/Direction for Use

Adult 400 mg daily or 200 mg every 12 hr. Uncomplicated cervical/urethral gonococcal infections 400 mg as single dose. Childn 8 mg/kg daily as single daily dose or in 2 divided doses. Infections due to Strep pyogenes Administer for at least 10 days. Childn >50 kg or >12 yr Adult dose. Patient w/ renal impairment CrCl 21-60 mL/min or patient who are on renal hemodialysis 75% of standard dose at standard dosing interval (ie, 300 mg daily), CrCl 20 mL/min or patient on continuous ambulatory peritoneal dialysis ½ the standard dose at standard dosing interval (ie, 200 mg daily).

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Overdosage

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Administration

Should be taken with food.

Contraindications

History of allergy to cefixime or other cephalosporins; hypersensitivity to penicillins.

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Special Precautions

Patient allergic to any drug; atopic individuals; patients w/ history of colitis. Risk of Clostridium difficile-associated diarrhea & colitis. May be associated w/ fall in prothrombin activity. Monitor prothrombin time in patients w/ renal/hepatic impairment or poor nutritional state, those receiving protracted course of antimicrobial therapy & patients previously stabilized on anticoagulant therapy, & administer exogenous vit K as indicated. Long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi. Safety & efficacy have not been established in patients w/ GI malabsorption. False +ve reaction for ketones in the urine using nitroprusside; glucose in urine using Clinitest, Benedict's or Fehling's soln; direct Coombs' test. Patients w/ renal impairment. Pregnancy. Consider temporary discontinuation of breast-feeding during treatment. Not recommended for childn <6 mth.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anaphylactic/anaphylactoid reactions (including shock & fatalities), skin rashes, urticaria, fever, pruritus, arthralgia, angioedema, facial edema; erythema multiforme, SJS, TEN, serum sickness-like reactions. Diarrhea, loose or frequent stools, abdominal pain, anorexia, flatulence, dry mouth, dyspepsia, nausea, & vomiting; pseudomembranous colitis. Transient elevation of ALT, AST, alkaline phosphatase, hepatitis, & jaundice. Transient elevations in BUN or creatinine levels, & rarely, acute renal failure. Headache, dizziness, nervousness, insomnia, somnolence, malaise, fatigue, seizures. Transient thrombocytopenia, leukopenia, neutropenia & eosinophilia; prolongation of prothrombin time (rarely). Hyperbilirubinemia. Rarely, genital pruritus, vaginitis, & candidiasis.

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Drug Interactions

Reports of elevated levels of carbamazepine. Increased prothrombin time w/ warfarin & other anticoagulants. Reports of increased peak serum conc & AUC & decreased renal clearance & vol of distribution w/ probenecid. Decreased peak serum conc & AUC w/ salicylates.

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Storage

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Description

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Action

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MIMS Class

Cephalosporins

ATC Classification

J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Fixbact FC tab 200 mg

Packing/Price

30's (P45/film-coated tab, P1,350/box)

Fixbact

cefixime

Manufacturer:

NGB Laboratories

Distributor:

Bell-Kenz Pharma

Marketer:

AMB HK