Augclav 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 Side Effects Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Co-amoxiclav (amoxicillin & clavulanic acid). Per 625 mg tab Amoxicillin trihydrate 500 mg, clavulanate K 125 mg. Per 1 g tab Amoxicillin trihydrate 875 mg, clavulanate K 125 mg. Per 228 mg/5 mL syr Amoxicillin trihydrate 200 mg, clavulanate K 28 mg. Per 457 mg/5 mL syr Amoxicillin trihydrate 400 mg, clavulanate K 57 mg

Indications/Uses

URTI (acute & chronic sinusitis & otitis, peritonsillar abscess), lower resp tract (bronchitis, pneumonia), UTI, gonorrhoea, cholecystitis, chancroid. Gynecological, skin & soft tissue, bone & joint, & odontogenic infections. Gm +ve & -ve mixed infections eg, chronic sinusitis & otitis, peritonsillar & mammary abscess, aspiration pneumonia, peritonitis, cholangitis, post-op intra-abdominal complications, abdominal infections. 625-mg tab: GI infection. 1-g tab: Gonorrhoea. 228 mg/5 mL & 457 mg/5 mL: Bites of animals & man.

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Dosage/Direction for Use

Max amoxicillin daily dose: Adult 6 g, childn 45 mg/kg. Max clavulanic acid (in K salt form) daily dose: Adult 600 mg, childn 10 mg/kg. 625-mg tab Adult & childn >12 yr Severe infection 1 tab tid. Moderate renal insufficiency (CrCl 10-30 mL/min) Reduce dose or dose interval prolonged to 12 hr, respectively; anuria ≥48 hr. Max treatment: Not to exceed 14 days. 1-g tab Adult & childn >12 yr, 40 kg Moderate infections One 625-mg tab every 12 hr. Severe infections One 1-g tab every 12 hr. Moderate renal insufficiency (CrCl <10 mL/min) One 625-mg tab every 12 hr. Severe renal insufficiency (CrCl <10 mL/min) One 1-g tab every 24 hr. Anuria Dosing interval should be prolonged to ≥48 hr. 228 mg/5 mL & 457 mg/5 mL dry syr Childn <40 kg 25-45 mg/kg (amoxicillin based) daily divided into 2 equal doses. Otitis, sinusitis, lower resp tract infections & other severe infections 45 mg/kg (amoxicillin based) daily every 12 hr. Moderate infections 25 mg/kg daily every 12 hr.

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Overdosage

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Administration

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

Contraindications

Hypersensitivity to amoxicillin, clavulanic acid, penicillins. Lymphatic leukemia, infectious mononucleosis.

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Special Precautions

History of allergic reactions. May produce agitation, insomnia, dizziness & seizures if ingested in large quantities. Not to be used in patients w/ infectious mononucleosis, cholestatic jaundice or hepatic dysfunction. Consider adequate dose adjustment & prolonged dosing interval in patients w/ severe renal impairment. History of renal impairment in anamnesis. Hepatic impairment. Pregnancy & lactation. Tab: Not to given in childn <12 yr (40 kg). 625-mg tab: Discontinue use if rash occurs.

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Use In Pregnancy & Lactation

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Adverse Reactions

GI disturbances eg, nausea, vomiting, diarrhea; bacterial resistance or superinfections; stomatitis, vaginitis, pseudomembranous colitis w/ severe diarrhea; skin reactions eg, pruritus, maculopapular exanthema, rash, angioneurotic edema, anaphylactic shock; leukopenia, thrombocytopenia, eosinophilia.

Drug Interactions

Increased MTX toxicity. Increased incidence of exanthema w/ allopurinol. Physical & chemical incompatibility w/ aminoglycosides. Prolonged prothrombin time w/ anticoagulants. Concomitant use w/ disulfiram. False +ve glucose reactions in urine & +ve Coombs test.

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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

Augclav dry syr 228 mg/5 mL

Packing/Price

70 mL x 1's

Form

Augclav dry syr 457 mg/5 mL

Packing/Price

70 mL x 1's

Form

Augclav tab 1 g

Packing/Price

1 × 10's;2 × 7's

Form

Augclav tab 625 mg

Packing/Price

3 × 10's

Augclav

amoxicillin + clavulanic acid

Manufacturer:

Pharmahof

Distributor:

Pharmahof