Fimoxyclav 500 mg+125 mg (Tablet)

Indications

• Treatment of upper respiratory tract infections
• Treatment of lower respiratory tract infections
• Treatment of genito-urinary tract infections
• Treatment of skin and soft tissue infections
• Treatment of bone and joint infections
• Treatment of septic abortion
• Treatment of puerperal sepsis
• Treatment of intra-abdominal sepsis

Composition

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

Pharmacology

• Broad spectrum of bactericidal activity
• Inactivation of beta-lactamase enzymes
• Peak serum levels occur about one hour after oral administration
• Optimized absorption at the start of a meal
• Low levels of serum binding
• Doubling the dosage approximately doubles the serum levels achieved

Dosage

• Recommended dosage for adults and children over 12 years
• Dosage adjustment for children based on age
• IV injection dosage for adults and children

Administration

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

Interaction

• Prolongation of bleeding time and prothrombin time
• Reduction of efficacy of oral contraceptives
• Potential increased 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 may be reduced by taking with meals
• Rare occurrence of hepatitis and cholestatic jaundice
• Reported cases of erythema multiforme and Stevens-Johnson Syndrome
• Reported cases of angioedema and anaphylaxis

Pregnancy & Lactation

• No teratogenic effects observed in animal studies
• Limited use in human pregnancy with no untoward effects
• Presence of trace quantities of Amoxicillin in breast milk

Precautions & Warnings

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

Use in Special Populations

• Dosage adjustment for patients with renal impairment
• Caution and regular hepatic function monitoring for patients with hepatic impairment

Overdose Effects

• Unlikely occurrence of overdose
• Possible gastrointestinal symptoms and fluid/electrolyte imbalance
• Potential removal of Co-amoxiclav by haemodialysis

Therapeutic Class

• Broad spectrum penicillins

Reconstitution

• IV injection reconstitution with Water for Injection BP
• Avoid reconstitution or mixing with specific fluids
• Injection into drip tubing of infusion fluids over 3-4 minutes

Storage Conditions

• Storage below 25°C, protected from light and moisture
• Refrigeration of reconstituted suspension
• Reconstitution to be used within 7 days

Related Brands

• Fimoxyclav (500 mg+100 mg)/10 ml (IV Injection) - synovia-pharma-plc
• Fimoxyclav 250 mg+125 mg (Tablet) - synovia-pharma-plc
• Fimoxyclav 875 mg+125 mg (Tablet) - synovia-pharma-plc
• Fimoxyclav (125 mg+31.25 mg)/5 ml (Powder for Suspension) - synovia-pharma-plc
• Demoxiclave 500 mg+125 mg (Tablet) - drug-international-ltd