Zylopen 875 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 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) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 100 mg)

Pharmacology

• Broad spectrum of bactericidal activity
• Susceptible to degradation by (3-lactamases
• Inactivation of a wide range of beta-lactamase enzymes
• Peak serum levels of both components occur about one hour after oral administration
• Optimized absorption at the start of a meal

Dosage

• One 625 mg Tablet every 12 hours for adults
• Two teaspoonful every 8 hours for children 6-12 years
• 25 mg/kg/day in divided doses every 8 hours for children below 1 year
• 1.2 gm every 8 hours for adults for IV Injection
• 1.2 gm at induction for surgical prophylaxis in adults

Administration

• Oral dosage form can be taken without regard to meals
• Oral administration at the start of a meal enhances absorption of clavulanate potassium
• IV injection is 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
• Reduced efficacy of oral contraceptives
• Concomitant use of allopurinol can increase likelihood of allergic skin reactions

Contraindications

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

Side Effects

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

Pregnancy & Lactation

• No teratogenic effect observed in animal studies
• Use in pregnancy not recommended unless considered essential by physician
• Trace quantities detected in breast milk during lactation

Precautions & Warnings

• Use with care in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage adjustment for 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 for patients with renal impairment
• Dose with caution and monitor hepatic function in patients with hepatic impairment

Overdose Effects

• Gastrointestinal symptoms and disturbance of fluid and electrolyte balances may be evident
• May be removed from 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
• Should not be reconstituted or mixed with Dextrose solution, Sodium Bicarbonate solution, Protein Hydrolysates, blood or plasma, Intravenous lipids
• Reconstituted solution may be injected into infusion fluids containing glucose, bicarbonate and dextran

Storage Conditions

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

Related Brands

• Zylopen 250 mg+125 mg (Tablet) - radiant-pharmaceuticals-ltd
• Zylopen 500 mg+125 mg (Tablet) - radiant-pharmaceuticals-ltd
• Bioclavid 250 mg+125 mg (Tablet) - sandoz-a-novartis-division
• Bioclavid 875 mg+125 mg (Tablet) - sandoz-a-novartis-division
• Bioclavid 500 mg+125 mg (Tablet) - sandoz-a-novartis-division