Amotid CL 500 mg+125 mg (Tablet)

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, 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 Sodium (equivalent to 1 gm), Clavulanate Potassium (equivalent to 200 mg)
• 0.6 gm injection: Amoxicillin Sodium (equivalent to 500 mg), Clavulanate Potassium (equivalent to 100 mg)

Pharmacology

• Broad spectrum bactericidal activity
• Susceptible to degradation by (3-lactamases
• Clavulanic acid inactivates beta-lactamase enzymes
• Extends antibiotic spectrum

Dosage

• Adults and children over 12 years
• Tablet dosage for different infection severities
• Suspension dosage for different age groups
• Recommended daily dosage for mild to moderate and serious infections
• IV injection dosage for adults and children

Administration

• Oral dosage form without regard to meals
• Enhanced absorption when taken at start of a meal
• IV injection not suitable for intramuscular or subcutaneous administration
• Reconstituted vial administration intravenously by injection or slow intravenous infusion

Interaction

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

Contraindications

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

Side Effects

• Uncommon and mostly mild and transitory
• Gastrointestinal side effects may be reduced by taking with meals
• Rare cases of hepatitis, cholestatic jaundice, rashes, angioedema, and anaphylaxis

Pregnancy & Lactation

• Animal studies show no teratogenic effect
• Limited human use during pregnancy with no untoward effect
• Use in pregnancy not recommended unless essential
• Trace quantities in breast milk during lactation

Precautions & Warnings

• Use with care in patients on anticoagulation therapy or severe hepatic dysfunction
• Dosage adjustment for moderate or severe renal impairment
• Maintain adequate fluid intake and urinary output during high doses

Use in Special Populations

• Dosage adjustment for renal impairment in adults and children
• Dose with caution and monitor hepatic function in hepatic impairment

Overdose Effects

• Unlikely to occur
• Possible gastrointestinal symptoms and fluid/electrolyte imbalance
• Can be removed by haemodialysis

Therapeutic Class

• Broad spectrum penicillins

Reconstitution

• IV injection reconstitution with Water for Injection BP
• Not to be mixed with certain solution types
• Reconstituted solution may be injected into infusion fluids containing glucose, bicarbonate, and dextran

Storage Conditions

• Store below 25°C, protected from light and moisture
• Reconstituted suspension to be kept in the refrigerator and used within 7 days
• Reconstituted vial to be used within 20 minutes

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