Amoclav Forte (400 mg+57.50 mg)/5 ml (Powder for Suspension)

Indications

• Upper respiratory tract infections (including ENT)
• 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
• Susceptible to degradation by (3-lactamases
• Inactivation of a wide range of beta-lactamase enzymes by Clavulanic Acid
• Peak serum levels of both components occur about one hour after oral administration
• Absorption of Co-amoxiclav is optimized at the start of a meal

Dosage

• Tablet for adults: one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours for usual adult dose
• Suspension for children 6-12 years: 2 teaspoonful every 8 hours
• Forte suspension recommended daily dosage: 25/3.6 mg/kg/day for mild to moderate infections

Administration

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

Interaction

• Prolongation of bleeding time and prothrombin time reported in some patients receiving Co-amoxiclav
• Reduction of efficacy of oral contraceptives

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 and mainly of mild and transitory nature
• Reported side effects include diarrhea, pseudomembranous colitis, indigestion, and hepatitis
• Angioedema and anaphylaxis reported

Pregnancy & Lactation

• Animal studies showed no teratogenic effect
• Use during pregnancy not recommended unless considered essential by physician
• 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 in patients with moderate or severe renal impairment

Use in Special Populations

• Dose adjustment in case of patients with renal impairment
• Administration in hepatic impairment with caution

Overdose Effects

• Problems of overdose 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 Water for Injection BP

Storage Conditions

• Should be stored below 25°C, protected from light and moisture

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