Fimoxyclav 250 mg+125 mg (Tablet)

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
• Ability to inactivate a wide range of beta-lactamase enzymes
• Optimized absorption at the beginning of a meal
• Low levels of serum binding for both components
• Approximately doubled serum levels with doubled dosage

Dosage

• Different dosages for adults and children
• Recommended dosage based on severity of infection
• Optimized absorption when taken at the start of a meal

Administration

• Oral dosage form can be taken without regard to meals
• Enhanced absorption when administered at the start of a meal
• IV injection for intravenous administration
• Reconstituted vial to be used within 20 minutes

Interaction

• Prolongation of bleeding time and prothrombin time reported
• Potential reduction of efficacy of oral contraceptives
• Concomitant use with allopurinol can increase the likelihood of allergic skin reactions

Contraindications

• History of Penicillin hypersensitivity
• Possible cross-sensitivity with other beta-lactam antibiotics

Side Effects

• Uncommon and mainly of a mild and transitory nature
• Gastrointestinal side effects can be reduced by taking with meals
• Rare occurrences of hepatitis, cholestatic jaundice, and skin reactions
• Reports of angioedema and anaphylaxis

Pregnancy & Lactation

• Animal studies showed no teratogenic effect
• Limited human use during pregnancy with no untoward effect
• Trace quantities of Amoxicillin detected in breast milk during lactation

Precautions & Warnings

• Caution in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage adjustment required for patients with moderate or severe renal impairment
• Maintain adequate fluid intake and urinary output during high dose administration

Use in Special Populations

• Dose adjustment for patients with renal or hepatic impairment

Overdose Effects

• Problems of overdose unlikely but may result in gastrointestinal symptoms and electrolyte imbalance
• Potential removal from circulation by haemodialysis

Therapeutic Class

Broad spectrum penicillins

Reconstitution

• IV injection can be reconstituted with Water for Injection BP
• Not suitable for reconstituting with certain solutions
• Reconstructed solution can be injected into infusion fluids over 3-4 minutes

Storage Conditions

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

Related Brands

• Amoclav 875 mg+125 mg (Tablet) - techno-drugs-ltd
• Amoclav (1 gm+200 mg)/20 ml (IV Injection) - techno-drugs-ltd
• Amoclav (125 mg+31.25 mg)/5 ml (Powder for Suspension) - techno-drugs-ltd
• Amoclav 500 mg+125 mg (Tablet) - techno-drugs-ltd
• Amoclav Forte (400 mg+57.50 mg)/5 ml (Powder for Suspension) - techno-drugs-ltd