Clacido (500 mg+100 mg)/10 ml (IV Injection)

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, 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 of bactericidal activity
• Bactericidal activity against Gram-positive & Gram-negative microorganisms
• Clavulanic acid protection of Amoxicillin from degradation
• Optimized absorption at the start of a meal
• Peak serum levels occur about one hour after oral administration
• Low levels of serum binding for clavulanate and Amoxicillin

Dosage

• Adults and children over 12 years
• IV injection for adults and children
• Recommended daily dosage for mild to moderate infections
• Recommended dosages for serious infections
• Children's dosage based on age and weight
• Surgical prophylaxis dose
• Dosage adjustment for patients with renal impairment or severe hepatic dysfunction

Administration

• Oral dosage form without regard to meals
• Enhanced absorption when administered at the start of a meal
• IV injection suitable for intravenous administration only
• Intravenous injection over 2 minutes or slow intravenous infusion over 30 minutes
• Reconstituted vial must be used within 20 minutes and any unused material discarded

Interaction

• Prolongation of bleeding time and prothrombin time reported
• Potential reduction in efficacy of oral contraceptives
• Concomitant use with allopurinol may increase likelihood of allergic skin reactions

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 can be reduced by taking with meals
• Rare cases of hepatitis and cholestatic jaundice
• Rashes, angioedema, and anaphylaxis reported

Pregnancy & Lactation

• No teratogenic effect reported in animal studies
• Limited use in human pregnancy with no untoward effects
• Presence of Amoxicillin in breast milk during lactation

Precautions & Warnings

• Use with caution in patients on anticoagulation therapy or with severe hepatic dysfunction
• Dosage adjustment for patients with moderate or severe renal impairment
• Maintenance of adequate fluid intake and urinary output during high-dose administration

Use in Special Populations

• Dosage adjustment for patients with renal impairment
• Dose adjustment for patients with hepatic impairment

Overdose Effects

• Unlikely to occur
• Gastrointestinal symptoms and fluid/electrolyte imbalances may be evident
• Potential removal by haemodialysis

Therapeutic Class

• Broad spectrum penicillins

Reconstitution

• IV injection reconstitution with Water for Injection BP
• Avoidance of reconstitution or mixing with certain solutions or fluids
• Injection into infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes

Storage Conditions

• Storage below 25°C, protected from light and moisture
• Refrigeration of reconstituted suspension (not frozen) and use within 7 days
• Reconstituted vial use within 20 minutes

Related Brands

• Demoxiclave 875 mg+125 mg (Tablet) - drug-international-ltd
• Onclav 500 mg+125 mg (Tablet) - one-pharma-ltd
• Onclav (125 mg+31.25 mg)/5 ml (Powder for Suspension) - one-pharma-ltd
• Avloclav BID (400 mg+57.50 mg)/5 ml (Powder for Suspension) - aci-limited
• Avloclav (1 gm+200 mg)/20 ml (IV Injection) - aci-limited