Clamox (125 mg+31.25 mg)/5 ml (Powder for Suspension)

Indications

• Short-term treatment of upper respiratory tract infections
• Short-term treatment of lower respiratory tract infections
• Genito-urinary tract infections treatment
• Skin and soft tissue infections treatment
• Bone and joint infections treatment
• Treatment of septic abortion
• Treatment of puerperal sepsis
• Treatment of intra-abdominal sepsis

Composition

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

Pharmacology

• Bactericidal activity against Gram-positive & Gram-negative microorganisms
• Clavulanic acid inactivates beta-lactamase enzymes
• Amoxicillin and clavulanate peak serum levels occur about one hour after oral administration
• Absorption of Co-amoxiclav is optimized at the start of a meal
• Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved

Dosage

• Adult dosage of 625 mg tablet every 12 hours
• Adult dosage of 1 gm tablet every 12 hours for more severe infections
• Children dosage of 2 teaspoonful every 8 hours (6-12 years)

Administration

• Oral dosage form can be taken without regard to meals
• IV injection is not suitable for intramuscular or subcutaneous administration
• IV injection should be administered intravenously by injection or slow intravenous infusion

Interaction

• Prolongation of bleeding time and prothrombin time reported in some patients
• Co-amoxiclav may reduce the efficacy of oral contraceptives
• Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions

Contraindications

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

Side Effects

• Uncommon side effects mainly of a mild nature
• Gastrointestinal side effects may be reduced by taking Co-amoxiclav at the start of meals
• Rare cases of hepatitis, cholestatic jaundice, and allergic skin reactions

Pregnancy & Lactation

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

Precautions & Warnings

• Use with care in patients on anticoagulation therapy
• Dosage adjustment needed in patients with moderate or severe renal impairment
• Adequate fluid intake and urinary output should be maintained during high dose administration

Use in Special Populations

• Dose adjustment needed in patients with renal impairment
• Dosage modification required for patients with hepatic impairment

Overdose Effects

• Overdose unlikely to occur
• Gastrointestinal symptoms and disturbance of fluid and electrolyte balances may be evident if overdose occurs
• Haemodialysis can remove Co-amoxiclav from the circulation

Therapeutic Class

• Broad spectrum penicillins

Reconstitution

• IV injection can be reconstituted by dissolving the powder in Water for Injection BP
• Reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes

Storage Conditions

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

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