Cefacef Dosage & Drug Information

Concise Prescribing Info Bahasa 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

Uncomplicated UTI, otitis media, pharyngitis, tonsillitis, acute bronchitis & acute exacerbations of chronic bronchitis, uncomplicated gonorrhea. Typhoid fever in childn w/ multi-resistant to standard treatment.

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Dosage/Direction for Use

Adult Usual dose: 50-100 mg twice daily. Renal impairment CrCl >60 mL/min Standard dose, 21-60 mL/min or on renal hemodialysis 75% of the standard dose (eg, 300 mg daily), <20 mL/min or on continuous ambulatory peritoneal dialysis 50% of the standard dose (eg, 200 mg daily). Uncomplicated gonorrhea 400 mg as single dose. Childn >30 kg Recommended daily dose: 50-100 mg twice daily. Childn ≤30 kg 1.5-3 mg/kg twice daily. More severe or intractable infections Up to 6 mg/kg daily in divided doses twice daily. More severe or intractable infections May be increased up to 200 mg twice daily. Uncomplicated cervical/urethral gonorrhea 400 mg as a single dose. Childn Typhoid fever 10-15 mg/kg/day for 2 wk.

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Overdosage

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Administration

May be taken with or without food: May be taken w/ food or milk to reduce GI discomfort.

Contraindications

History of shock or hypersensitivity. Hypersensitivity to cephalosporins.

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Special Precautions

Sensitivity to penicillin; history of allergy eg, bronchial asthma, rash, urticaria; impaired renal function; patient w/ poor oral nutrition or under therapy w/ parenteral nutrition; history of GI disease eg, colitis. Childn w/ otitis media should be treated w/ syr only. Discontinue if superinfection occurs. Periodic monitoring of renal function is recommended. Vit K deficiency syndrome may develop. False +ve results may occur w/ urine sugar tests using Benedict's soln, Fehling's soln, & Clinitest. Pregnancy & lactation. Childn <6 mth including newborns & prematures. Elderly or debilitated patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Shock; +ve direct Coombs' test; hypersensitivity reactions eg, rash, urticaria, erythema, pruritus or fever; transient increase of SGPT, SGOT & alkaline phosphatase, diarrhea, abdominal pain, vomiting, pseudomembranous colitis, anorexia, heartburn, constipation, dizziness, headache, candidiasis. Cefacef Nausea, dyspepsia, flatulence; hematologic reactions; genital pruritus, vaginitis, TEN, superinfection, renal & hepatic dysfunction, toxic nephropathy, hemorrhagic bleeding & colitis; neutropenia, agranulocytosis, increase in bilirubin & LDH. Cefacef 200 Granulocytopenia or eosinophilia & thrombocytopenia; acute renal insufficiency; stomach discomfort; interstitial pneumonia; Vit K or B group deficiencies; false +ve results may occur w/ urine sugar tests using Benedict's & Fehling's soln & Clinitest.

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Drug Interactions

Cefacef 200 Concomitant administration w/ anticoagulants (eg, warfarin) may prolong prothrombin time, w/ or w/o bleeding. Increased plasma conc of carbamazepine. Increased bioavailability w/ nifedipine. Increased plasma conc & AUC w/ probenecid. Decreased renal clearance & distribution vol of probenecid. Increased plasma conc w/ salicylate.

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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

Cefacef cap 100 mg

Packing/Price

3 × 10's (Rp603,000/boks)

Form

Cefacef dry syr 100 mg/5 mL

Packing/Price

30 mL x 1's (Rp82,900/boks)

Form

Cefacef 200 FC caplet 200 mg

Packing/Price

1 × 10's (Rp261,000/boks)

Cefacef

cefixime

Manufacturer:

Caprifarmindo