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

Pharmacology

• Pharmacodynamic properties: Broad spectrum of bactericidal activity
• Pharmacokinetic properties: Peak serum levels reached after one hour, optimized absorption at the start of a meal, low serum binding for both components

Dosage

• Adults: 625mg Tablet every 12 hours or 375mg Tablet every 8 hours
• Children: 2 teaspoonful (6-12 years), 1 teaspoonful (1-6 years), 25 mg/kg/day for children below 1 year

Administration

• Oral dosage form can be taken without regard to meals
• IV injection suitable for intravenous administration only, to be used within 20 minutes after reconstitution

Interaction

• Prolongation of bleeding time and prothrombin time reported in some patients
• Reduced efficacy of oral contraceptives when used concomitantly

Contraindications

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

Side Effects

• Uncommon and mainly of a mild and transitory nature
• Gastrointestinal side effects can be reduced by taking Co-amoxiclav at the start of meals

Pregnancy & Lactation

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

Precautions & Warnings

• Use with care in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage adjustment for patients with moderate or severe renal impairment
• Adequate fluid intake and urinary output maintenance during high dose administration

Use in Special Populations

• Dose adjustment for patients with renal impairment
• Dosage caution and hepatic function monitoring for patients with hepatic impairment

Overdose Effects

• Gastrointestinal symptoms and fluid/electrolyte balance disturbance may occur
• Haemodialysis for Co-amoxiclav removal

Therapeutic Class

Broad spectrum penicillins

Reconstitution

• 1.2 gm IV injection reconstituted with 20 ml Water for Injection BP
• Not to be reconstituted or mixed with certain fluids
• Injected into the drip tubing of compatible infusion fluids over 3-4 minutes

Storage Conditions

• Below 25°C, protected from light and moisture
• Reconstituted suspension refrigeration and use within 7 days
• Reconstituted vial use within 20 minutes

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