Cosmox/Cosmox 457 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

Co-amoxiclav (amoxicillin & clavulanic acid). Per Cosmox 500 mg/125 mg FC tab Amoxicillin trihydrate 500 mg, K clavulanate 125 mg. Per 5 mL Cosmox 457 susp Amoxicillin trihydrate 400 mg, K clavulanate 57 mg

Indications/Uses

Cosmox For infections due to β-lactamase-producing strains (where amoxicillin alone is not appropriate) including resp tract, GUT & abdominal infections, cellulitis, animal bites, severe dental infections w/ spreading cellulitis. Cosmox 457 Short-term treatment of upper resp tract infections including ENT eg, tonsilitis, sinusitis, otitis media; lower resp tract infections eg, acute & chronic bronchitis, lobar & broncho-pneumonia; GUT infections eg, cystitis, urethritis, pyelonephritis, female genital infections, skin & soft tissue infections; bone & joint infections eg, osteomyelitis; other infections eg, septic abortion, puerperal/intra-abdominal sepsis, septicaemia, peritonitis & post-op surgical infections. Prophylaxis of infections associated w/ major surgical procedures eg, GIT, pelvic, head & neck, cardiac, renal, joint replacement & biliary tract.

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Dosage/Direction for Use

Cosmox Adult & childn ≥40 kg 625 mg every 12 hr or 375 mg every 8 hr. More severe & resp tract infections 625 mg every 8 hr. Severely impaired patient w/ GFR 10-30 mL/min 625 mg or 375 mg every 12 hr, depending on the severity of the infection; <10 mL/min GFR 625 mg or 375 mg every 24 hr depending on severity of the infection. Ped ≥40 kg Adult dose. Cosmox 457 Childn >6 yr (18-40 kg) 5 mL tid. Severe infections Increase up to 50 mg/kg/day in divided doses every 8 hr. 1-6 yr (10-18 kg) 5 mL tid, <12 mth 25 mg/kg/day.

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Overdosage

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Administration

May be taken with or without food: Preferably taken at the start of meals for better absorption & to reduce GI discomfort.

Contraindications

Hypersensitivity to β-lactams eg, penicillins or cephalosporins. Patients w/ history of co-amoxiclav-associated jaundice/hepatic dysfunction.

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Warnings

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Special Precautions

Hepatic dysfunction. Provide fluids, electrolytes & protein replacement therapy when indicated. May delay peristalsis eg, opiates & diphenoxylate w/ atropine. Pregnancy (especially 1st trimester) & lactation. Cosmox 457 Caution in patients w/ phenylketonuria due to aspartame content.

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Use In Pregnancy & Lactation

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Adverse Reactions

Gastritis, stomatitis, glossitis, black "hairy" tongue, indigestion, nausea, vomiting, diarrhea, enterocolitis, pseudomembranous colitis, candidiasis; skin rashes, urticaria; transient hepatitis, cholestatic jaundice; anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia & agranulocytosis.

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Drug Interactions

May decrease plasma conc of estriol, estradiol. Increased & prolonged blood levels of amoxicillin w/ probenecid. May increase incidence of rashes w/ allopurinol. Disulfiram (Antabuse)-like reaction w/ alcohol.

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Storage

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Description

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Action

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MIMS Class

Penicillins

ATC Classification

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Cosmox 500 mg/125 mg FC tab

Packing/Price

18's

Form

Cosmox 457 powd for susp 457 mg/5 mL

Packing/Price

70 mL x 1's

Cosmox/Cosmox 457

amoxicillin + clavulanic acid

Manufacturer:

Stallion Labs

Distributor:

Starpharm

Marketer:

Giyaan Pharma