Evoxil CV 500 mg+125 mg (Tablet)

Indications

• Treatment of upper respiratory tract infections
• Treatment of lower respiratory tract infections
• Treatment of genito-urinary tract infections
• Treatment of skin and soft tissue infections
• Treatment of bone and joint infections
• Treatment of other infections

Composition

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

Pharmacology

• Broad spectrum bactericidal activity
• Susceptibility to degradation by beta-lactamases
• Inactivation of beta-lactamase enzymes by clavulanic acid
• Optimized absorption at the start of a meal
• Low levels of serum binding for both clavulanate and amoxicillin

Dosage

• Usual adult dose: 625 mg tablet every 12 hours
• More severe infections: 1 gm tablet every 12 hours
• Suspension for children 6-12 years: 2 teaspoonful every 8 hours
• IV Injection for adults: 1.2 gm every 8 hours

Administration

• Oral dosage form can be taken without regard to meals
• IV Injection administered over 2 minutes or slow intravenous infusion over 30 minutes
• Reconstituted vial must be used within 20 minutes

Interaction

• Prolongation of bleeding time and prothrombin time reported
• Reduction of efficacy of oral contraceptives
• Concomitant use of allopurinol can increase allergic skin reactions

Contraindications

• History of Penicillin hypersensitivity
• Contraindicated for patients with previous history of Co-amoxiclav or Penicillin-associated cholestatic jaundice

Side Effects

• Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting, and candidiasis reported
• Rare instances of hepatitis, cholestatic jaundice, urticarial and erythematous rashes
• Angioedema and anaphylaxis reported

Pregnancy & Lactation

• No teratogenic effect shown in animal studies
• Use in pregnancy not recommended unless considered essential by the physician
• Trace quantities of Amoxicillin detected in breast milk

Precautions & Warnings

• Use with care in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage adjustment in case of moderate or severe renal impairment

Use in Special Populations

• Dose adjustment in case of renal impairment
• Monitoring of hepatic function in case of hepatic impairment

Overdose Effects

• Unlikely to occur
• Possible gastrointestinal symptoms and disturbance of fluid and electrolyte balances

Therapeutic Class

Broad spectrum penicillins

Reconstitution

• IV injection reconstituted with 20 ml Water for Injection BP
• Not suitable for mixing with various solutions such as dextrose solution and protein hydrolysates

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

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