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

Pharmacology

• Broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms
• Inactivation of a wide range of beta-lactamase enzymes
• Effective extension of the antibiotic spectrum to embrace a wide range of microorganisms
• Closely matched pharmacokinetics of the two components

Dosage

• Usual adult dose: one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours
• Children 1-6 years: 1 teaspoonful every 8 hours
• Children below 1 year: 25 mg/kg/day in divided doses every 8 hours
• For serious infections: 45/6.4 mg/kg/day for the treatment of more serious infections

Administration

• Oral dosage form can be taken without regard to meals
• IV injection is not suitable for intramuscular or subcutaneous administration
• Reconstituted vial must be used within 20 minutes and discarded

Interaction

• Prolongation of bleeding time and prothrombin time
• Reduction in the efficacy of oral contraceptives
• Potential increase in allergic skin reactions when used with allopurinol

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 at the start of meals
• Rare occurrence of hepatitis, cholestatic jaundice, and allergic skin reactions

Pregnancy & Lactation

• No teratogenic effect shown in animal studies
• Limited use in human pregnancy with no untoward effects reported
• Use in pregnancy not recommended unless considered essential by the physician

Precautions & Warnings

• Care should be taken in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage adjustment in patients with renal impairment

Overdose Effects

• Problems of overdose are unlikely to occur
• Gastrointestinal symptoms and disturbance of fluid and electrolyte balances may be evident

Therapeutic Class

• Broad spectrum penicillins

Reconstitution

• IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP
• Reconstituted solution may be injected into the drip tubing of infusion fluids

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

Related Brands

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