Fimoxyclav (500 mg+100 mg)/10 ml (IV Injection)

Indications

• Short-term treatment of bacterial infections
• Upper respiratory tract infections (e.g. tonsillitis, sinusitis, otitis media)
• Lower respiratory tract infections (e.g. bronchitis, pneumonia)
• Genito-urinary tract infections (e.g. cystitis, pyelonephritis)
• Skin and soft tissue infections
• Bone and joint infections (e.g. osteomyelitis)
• Other infections (e.g. septic abortion, intra-abdominal sepsis)

Composition

• 375 mg tablet
• 625 mg tablet
• 1 gm tablet
• Powder for Suspension
• Powder for Suspension (Forte)
• 1.2 gm Injection
• 0.6 gm injection
• Amoxicillin 250 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 125 mg (as Diluted Potassium Clavulanate BP)
• Amoxicillin 500 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 125 mg (as Diluted Potassium Clavulanate BP)
• Amoxicillin 875 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 125 mg (Diluted Potassium Clavulanate BP)
• Amoxicillin 125 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 31.25 mg (as Diluted Potassium Clavulanate BP)
• Amoxicillin 400 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 57.5 mg (as Diluted Potassium Clavulanate BP)
• Amoxicillin Sodium BP (equivalent to Amoxicillin 1 gm) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 200 mg)
• Amoxicillin Sodium BP (equivalent to Amoxicillin 500) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 100 mg)

Pharmacology

• Bactericidal activity against Gram-positive & Gram-negative microorganisms
• Broad-spectrum antibacterial combination
• Clavulanic acid inactivates beta-lactamase enzymes
• Peak serum levels one hour after oral administration
• Optimized absorption with the start of a meal

Dosage

• Adults and children over 12 years
• Tablet and Suspension dosing for various infections
• IV Injection dosing for adults and children
• Gradual increase in dosage for more serious infections

Administration

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

Interaction

• Prolongation of bleeding time and prothrombin time
• Reduction in efficacy of oral contraceptives
• Concomitant use with allopurinol and its effects

Contraindications

• History of Penicillin hypersensitivity
• Possible cross-sensitivity with other beta-lactam antibiotics
• Previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice

Side Effects

• Uncommon side effects
• Gastrointestinal side effects with oral therapy
• Rare cases of hepatitis and cholestatic jaundice
• Occurrence of urticarial and erythematous rashes
• Reports of angioedema and anaphylaxis

Pregnancy & Lactation

• No teratogenic effect based on animal studies
• Limited use in human pregnancy with no untoward effect
• Trace quantities of Amoxicillin in breast milk during lactation

Precautions & Warnings

• Use with care in patients on anticoagulation therapy
• Dosage adjustment in case of severe hepatic dysfunction
• Adjustment in case of renal impairment
• Adequate fluid intake and urinary output maintenance for high doses

Use in Special Populations

• Dose adjustment for patients with renal impairment
• Dosage reduction in cases with hepatic impairment

Overdose Effects

• Unlikelihood of occurrence
• Gastrointestinal symptoms and disturbance of fluid and electrolyte balances if encountered
• Potential removal from circulation by haemodialysis

Therapeutic Class

Broad spectrum penicillins

Reconstitution

• IV injection reconstitution with Water for Injection BP
• Suitable injection mixing guidelines

Storage Conditions

• Storage below 25°C, protected from light and moisture
• Refrigerated storage for reconstituted suspension
• Time constraints for reconstituted vial usage

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