Ranclav 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 Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Co-amoxiclav (Amoxicillin & clavulanic acid). Per 625 mg FC tab Clavulanate K 125 mg, amoxicillin 500 mg. Per 1 g FC tab Clavulanate K 125 mg, amoxicillin 875 mg. Per 228.5 mg/5 mL BID susp Clavulanate K 28.5 mg, amoxicillin 200 mg. Per 457 mg/5 mL BID susp Clavulanate K 57 mg, amoxicillin 400 mg

Indications/Uses

675-mg FC tab: Lower resp tract infections (eg, pneumonia, bronchitis), acute otitis media, sinusitis, UTI, skin & soft tissue infections. 1-g FC tab: Upper including otorhinolaryngeal (eg, sinusitis, otitis media, tonsilitis) & lower (eg, lobar & bronchopneumonia, acute & chronic bronchitis) resp tract infections, GUT infections (eg, cystitis, urethritis, pyelonephritis), skin & soft tissue infections (eg, boils, abscesses, cellulitis, wound infections), bone & joint infections (eg, osteomyelitis), dental infections (eg, dentoalveolar abscess), septic abortion, puerperal sepsis, intra-abdominal sepsis. Susp: Short-term treatment of bacterial infections at the following sites when amoxicillin resistant β-lactamase producing strains are suspected as a cause: Upper (including ENT; particularly sinusitis, otitis media, recurrent tonsillitis) & lower (particularly acute exacerbations of chronic bronchitis, lobar & bronchopneumonia) resp tract infections, UTI (particularly cystitis).

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Dosage/Direction for Use

FC tab Mild to moderate infections Adult & childn ≥12 yr 625 mg bid. 625-mg FC tab Severe infections & resp tract infections 625 mg every 8 hr. 1-g FC tab Severe infections 1 g bid. Dental infections (eg, dentoalveolar abscess) Adult & childn >12 yr 1 g bid for 5 days. Severe renal impairment (CrCl <10 mL/min) Not >625 mg every 24 hr. Moderate renal impairment 625 mg bid. Susp Adult & childn (wt >40 kg) 250-500 mg every 8 hr or 500-875 mg every 12 hr. Max: 2-3 g/day. Childn (wt <40 kg) 20-50 mg/kg/day divided every 8-12 hr or 125-250 mg every 8 hr or 200-400 mg every 12 hr. Dose interval: Renal impairment CrCl >15-30 mL/min Every 8 hr, 10-30 mL/min Every 12 hr, <10 mL/min Every 24 hr.

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Overdosage

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Administration

May be taken with or without food: Take at the start of meals for better absorption & to reduce GI discomfort. 1-g tab: Swallow whole, do not chew. Tab may be broken in half & swallowed w/o chewing.

Contraindications

Penicillin hypersensitivity. Possible cross-sensitivity w/ β-lactam antibiotics. History of penicillin-associated jaundice/hepatic dysfunction.

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Warnings

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Special Precautions

History of penicillin hypersensitivity & or multiple allergens sensitivity. Pseudomembranous colitis. FC tab: Childn <12 yr. 1-g tab: Severe hepatic dysfunction. Do not use in patients w/ moderate to severe renal impairment (CrCl <30 mL/min). Patients receiving anticoagulants. Susp: Phenylketonurics. 1-g FC tab & susp: Superinfections w/ mycotic or bacterial pathogens may occur during therapy. Avoid in pregnancy especially 1st trimester. False +ve results w/ copper-reduction test & Coombs' test.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhoea, indigestion, nausea, vomiting, mucocutaneous candidiasis, discomfort, anorexia, flatulence, dyspepsia, gastritis, stomatitis, glossitis, black or hairy tongue & enterocolitis; antibiotic associated pseudomembranous colitis; erythematous rash & urticaria; angioedema, serum sickness; anemia, thrombocytopenia, leukopenia, agranulocytosis.

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Drug Interactions

Decreased renal tubular secretion w/ probenecid. Increased incidence of rash w/ allopurinol. 1-g FC tab & susp: Anticoagulants. May reduce efficacy of OCs.

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Caution For Usage

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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.

Thai FDA Category

Presentation/Packing

Form

Ranclav 1 g FC tab

Packing/Price

10 × 2's;25 × 4's;3 × 4's

Form

Ranclav 625 mg FC tab

Packing/Price

10 × 10's

Form

Ranclav 228.5 mg/5 mL BID oral susp

Packing/Price

70 mL x 1's

Form

Ranclav 457 mg/5 mL BID oral susp

Packing/Price

50 mL x 1's;70 mL x 1's

Ranclav

amoxicillin + clavulanic acid

Manufacturer:

Ranbaxy

Distributor:

DKLL