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

Indications

• Short-term treatment of bacterial infections
• 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 and Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP
• 625 mg tablet: Amoxicillin 500 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP
• 1 gm tablet: Amoxicillin 875 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP
• Powder for Suspension: Amoxicillin 125 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 31.25 mg as Diluted Potassium Clavulanate BP
• Powder for Suspension (Forte): Amoxicillin 400 mg as Amoxicillin Trihydrate BP and Clavulanic Acid 57.5 mg as Diluted Potassium Clavulanate BP
• 1.2 gm Injection: Amoxicillin Sodium BP (equivalent to Amoxicillin 1 gm) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 200 mg)
• 0.6 gm injection: Amoxicillin Sodium BP (equivalent to Amoxicillin 500 mg) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 100 mg)

Pharmacology

• Broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms
• Clavulanic acid inactivates a wide range of beta-lactamase enzymes
• Peak serum levels of both components occur about one hour after oral administration
• Both components have low levels of serum binding; about 70% remains free in the serum
• Doubling the dosage approximately doubles the serum levels achieved

Dosage

• Usual adult dose is one 625 mg Tablet every 12 hours or one 375 mg Tablet every 8 hours
• For more severe infections, the dose should be one 1 gm Tablet every 12 hours or one 625 mg Tablet every 8 hours
• Suspension dosage for Children: 6-12 years: 2 teaspoonful every 8 hours, 1-6 years: 1 teaspoonful every 8 hours, below 1 year: 25 mg/kg/day in divided doses every 8 hours

Administration

• Oral dosage form can be taken without regard to meals
• IV injection is not suitable for intramuscular or subcutaneous administration
• The reconstituted vial can be administered intravenously by injection (over 2 minutes) or slow intravenous infusion (30 minutes)

Interaction

• Prolongation of bleeding time and prothrombin time have been reported
• 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 a previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice

Side Effects

• Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis
• Hepatitis and cholestatic jaundice
• Urticarial and erythematous rashes
• Angioedema and anaphylaxis

Pregnancy & Lactation

• Animal studies have shown no teratogenic effect
• The use of Co-amoxiclav in pregnancy is not recommended unless considered essential by the physician
• Trace quantities of Amoxicillin can be detected in breast milk

Precautions & Warnings

• Use with care in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage should be adjusted in patients with moderate or severe renal impairment
• Adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria

Use in Special Populations

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

Overdose Effects

• Gastrointestinal symptoms and disturbance of fluid and electrolyte balances may be evident
• Co-amoxiclav may be removed from the circulation by haemodialysis

Therapeutic Class

Broad spectrum penicillins

Reconstitution

• 1.2 gm IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP
• Not suitable for reconstitution or mixing with certain solutions
• Reconstituted solution may be injected into the drip tubing of infusion fluids 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

Related Brands

• Avloclav (500 mg+100 mg)/10 ml (IV Injection) - aci-limited
• Avloclav (1 gm+200 mg)/20 ml (IV Injection) - aci-limited
• Avloclav BID (400 mg+57.50 mg)/5 ml (Powder for Suspension) - aci-limited
• Onclav (125 mg+31.25 mg)/5 ml (Powder for Suspension) - one-pharma-ltd
• Onclav 500 mg+125 mg (Tablet) - one-pharma-ltd