Sullivan 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 Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Co-amoxiclav (amoxicillin & clavulanic acid). Per 625 mg FC tab Amoxicillin trihydrate 500 mg, clavulanic acid 125 mg. Per 1 g FC tab Amoxicillin trihydrate 875 mg, clavulanic acid 125 mg. Per 5 mL of 125 mg/31.25 mg susp Amoxicillin trihydrate 125 mg, clavulanic acid 31.25 mg. Per 5 mL of 250 mg/62.5 mg susp Amoxicillin trihydrate 250 mg, clavulanic acid 62.5 mg. Per 5 mL of 400 mg/57 mg susp Amoxicillin trihydrate 400 mg, clavulanic acid 57 mg

Indications/Uses

UTI. Tab 625 mg/Powd for oral susp 125 mg/31.25 mg/Powd for oral susp 250 mg/62.5 mg/Powd for oral susp 400 mg/57 mg Actinomycosis, anthrax, biliary tract infections, bronchitis, endocarditis (particularly prophylaxis), gastroenteritis (including salmonella enteritis), gonorrhea, Lyme disease mouth infections, otitis media, pneumonia, spleen disorders, pneumococcal infections prophylaxis, typhoid & paratyphoid fever. Tab 1 g Lower resp tract infections, acute otitis media, sinusitis, UTI, skin & soft tissue infections caused by susceptible pathogens. Bacterial infections caused by β-lactamase producing strains. Recurrent tonsillitis; acute exacerbations of chronic bronchitis, bronchopneumonia; UTI especially recurrent & complicated but not prostatitis; septic abortion, pelvic or puerperal sepsis & intra-abdominal sepsis; cellulitis, animal bites & severe dental abscess w/ spreading cellulitis.

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Dosage/Direction for Use

Tab 625 mg Adult & childn >2 yr Severe infections 625 mg. Tab 1 g Severe infections 1 tab every 12 hr. 125 mg/31.25 mg susp Childn 7-12 yr 10 mL; 2-6 yr 5 mL. Infant 9-12 mth 2.5 mL. 250 mg/62.5 mg susp Childn 7-12 yr 5 mL; 2-6 yr 2.5 mL. All doses to be taken tid. 400 mg/57 mg susp Childn 7-12 yr 5 mL every 12 hr; 2-6 yr 2.5 mL every 12 hr; 9 mth-1 yr 1.25 mL every 12 hr; <20 kg 20-40 mg/kg daily in divided dose every 12 hr.

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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

History of allergic reaction to β-lactams or penicillins. Tab 625 mg/Powd for oral susp 125 mg/31.25 mg/Powd for oral susp 250 mg/62.5 mg/Powd for oral susp 400 mg/57 mg History of co-amoxiclav associated jaundice or hepatic dysfunction.

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Special Precautions

Changes in LFT results. Use w/ caution in patients w/ evidence of hepatic dysfunction. Avoid if glandular fever is suspected. Prolonged use may occasionally result in overgrowth of non-susceptible organisms. Severe renal impairment. Tab 1 g Avoid in pregnancy.

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Use In Pregnancy & Lactation

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Adverse Reactions

SJS; nausea, vomiting. Tab 625 mg/Powd for oral susp 125 mg/31.25 mg/Powd for oral susp 250 mg/62.5 mg/Powd for oral susp 400 mg/57 mg Hepatitis & cholestatic jaundice. Clavulanic acid: Erythema multiforme, TEN, exfoliative dermatitis, diarrhea, rashes & antibiotic associated colitis. Tab 1 g Diarrhea, fungal or bacterial superinfection, convulsions (at high doses or in patients w/ renal impairment), morbilliform rash in patients w/ mononucleosis; hemolytic anemia, reversible agranulocytosis; indigestion, black hairy tongue; serum sickness-like syndrome, urticaria, hypersensitivity, vasculitis; mucocutaneous candidiasis; increased AST/ALT; headache, dizziness, reversible hyperactivity; interstitial nephritis; vag mycosis; rash, pruritus; severe hypersensitivity reactions, including anaphylactoid & severe cutaneous reactions (eg, acute generalized exanthematous pustulosis); Clostridium difficile-associated diarrhea or pseudomembranous colitis.

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Drug Interactions

1 g Decreased renal tubular secretion w/ probenecid & amoxicillin combination but not amoxicillin-clavulanate. Can increased allergic skin reactions w/ allopurinol; lower estrogen reabsorption & reduced efficacy of combined OCs; carefully monitor prothrombin time or INR if co-administration of acenocoumarol or warfarin is necessary; reported reduction in pre-dose conc in patients receiving mycophenolate mofetil.

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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.

Regulatory Classification

Presentation/Packing

Form

Sullivan FC tab 1 g

Packing/Price

30's

Form

Sullivan FC tab 625 mg

Packing/Price

100's (P4,500/pack)

Form

Sullivan 125 mg/31.25 mg/5 mL powd for oral susp

Packing/Price

60 mL x 1's (P189/bottle)

Form

Sullivan 250 mg/62.5 mg/5 mL powd for oral susp

Packing/Price

60 mL x 1's (P240/bottle)

Form

Sullivan 1.2 g powd for inj

Packing/Price

1's

Form

Sullivan 600 mg powd for inj

Packing/Price

1's

Form

Sullivan 400 mg/57 mg/5 mL powd for oral susp

Packing/Price

70 mL x 1's (P380/bottle)

Form

Sullivan 375 mg tab

Packing/Price

80's

Sullivan

amoxicillin + clavulanic acid

Manufacturer:

Lloyd

Distributor:

Medhaus