Fimoxyclav BID (400 mg+57.50 mg)/5 ml (Powder for Suspension)

Indications

• Upper respiratory tract infections
• Lower respiratory tract infections
• Genito-urinary tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Other infections

Composition

• 375 mg tablet: Amoxicillin 250 mg, Clavulanic Acid 125 mg
• 625 mg tablet: Amoxicillin 500 mg, Clavulanic Acid 125 mg
• 1 gm tablet: Amoxicillin 875 mg, Clavulanic Acid 125 mg
• Powder for Suspension: Amoxicillin 125 mg, Clavulanic Acid 31.25 mg
• Powder for Suspension (Forte): Amoxicillin 400 mg, Clavulanic Acid 57.5 mg
• 1.2 gm Injection: Amoxicillin Sodium 1 gm, Clavulanate Potassium 200 mg
• 0.6 gm injection: Amoxicillin Sodium 500 mg, Clavulanate Potassium 100 mg

Pharmacology

• Broad spectrum of bactericidal activity
• Inactivation of a wide range of beta-lactamase enzymes
• Peak serum levels occur about one hour after oral adminstration
• Optimized absorption at the start of a meal

Dosage

• Adults and children over 12 years
• Tablet dosage for different types of infections
• Suspension dosage for different age groups
• Recommended dosage for IV Injection in adults and children

Administration

• Oral dosage can be taken without regard to meals
• IV injection suitable for intravenous administration
• Reconstituted vial to be administered over 2 minutes or slow infusion over 30 minutes

Interaction

• Prolongation of bleeding time and prothrombin time reported
• Reduction in efficacy of oral contraceptives
• Concomitant use of allopurinol may increase likelihood of allergic skin reactions

Contraindications

• History of Penicillin hypersensitivity
• Possible cross-sensitivity with other beta-lactam antibiotics
• Contraindicated for patients with previous Co-amoxiclav or Penicillin-associated cholestatic jaundice

Side Effects

• Uncommon and mainly of a mild and transitory nature
• Reported side effects include diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting, hepatitis, cholestatic jaundice, rashes, angioedema, anaphylaxis

Pregnancy & Lactation

• No teratogenic effect shown in animal studies
• Limited use in human pregnancy with no untoward effect
• Trace quantities of Amoxicillin can be detected in breast milk during lactation

Precautions & Warnings

• Use with care in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage adjustment in case of moderate or severe renal impairment
• Maintenance of adequate fluid intake and urinary output during high dose administration

Use in Special Populations

• Dose adjustment for patients with renal impairment
• Caution and regular monitoring in case of hepatic impairment

Overdose Effects

• Problems of overdose unlikely to occur
• Possible gastrointestinal symptoms and fluid/electrolyte imbalance
• Removal from circulation by haemodialysis

Therapeutic Class

• Broad spectrum penicillins

Reconstitution

• IV injection reconstituted in Water for Injection BP
• Reconstituted solution may be injected into infusion fluids containing glucose, bicarbonate and dextran over 3-4 minutes

Storage Conditions

• Store below 25°C, protected from light and moisture
• Reconstituted suspension to be kept in refrigerator and used within 7 days
• Reconstituted vial to be used within 20 minutes

Related Brands

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