Augment 500 mg+125 mg (Tablet)

Indications

• Short-term treatment of bacterial infections
• Upper respiratory tract infections (tonsillitis, sinusitis, otitis media)
• Lower respiratory tract infections (acute and chronic bronchitis, lobar and bronchopneumonia)
• Genito-urinary tract infections (cystitis, urethritis, pyelonephritis)
• Skin and soft tissue infections
• Bone and joint infections (osteomyelitis)
• Other infections (septic abortion, puerperal sepsis, intra-abdominal sepsis etc.)

Composition

• 375 mg tablet
• 625 mg tablet
• 1 gm tablet
• Powder for Suspension
• Powder for Suspension (Forte)
• 1.2 gm Injection
• 0.6 gm injection
• Amoxicillin 250 mg as Amoxicillin Trihydrate BP
• Amoxicillin 500 mg as Amoxicillin Trihydrate BP
• Amoxicillin 875 mg as Amoxicillin Trihydrate BP
• Clavulanic Acid 125 mg as Diluted Potassium Clavulanate BP
• Clavulanic Acid 31.25 mg as Diluted Potassium Clavulanate BP
• Clavulanic Acid 57.5 mg as Diluted Potassium Clavulanate BP
• Clavulanic Acid 200 mg as Clavulanate Potassium USP
• Clavulanic Acid 100 mg as Clavulanate Potassium USP

Pharmacology

• Antibacterial combination of Amoxicillin and Clavulanic Acid
• Broad spectrum of bactericidal activity
• Inactivation of beta-lactamase enzymes
• Peak serum levels occur about one hour after oral administration
• Optimized absorption at the start of a meal

Dosage

• Adults and children over 12 years
• Tablet dosage for different infections severity
• Suspension dosage for different age groups
• Forte suspension dosage for mild to moderate infections
• IV Injection dosage for adults and children

Administration

• Oral dosage form
• IV injection administration
• Enhanced absorption when administered at the start of a meal
• Intravenous injection over 2 minutes

Interaction

• Prolongation of bleeding time and prothrombin time
• Reduction of oral contraceptives efficacy
• Concomitant use of allopurinol
• No data on concomitant use of Co-amoxiclav and allopurinol

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

• Uncommon and of mild and transitory nature
• Gastrointestinal side effects may be reduced by taking at the start of meals
• Rare cases of hepatitis, cholestatic jaundice, urticarial and erythematous rashes
• Potential occurrence of angioedema and anaphylaxis

Pregnancy & Lactation

• No teratogenic effect in animal studies
• Limited use in human pregnancy with no untoward effect
• Not recommended in pregnancy unless considered essential
• 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 in moderate or severe renal impairment
• Importance of maintaining adequate fluid intake and urinary output

Use in Special Populations

• Dose adjustment in patients with renal impairment
• Dose adjustment in hepatic impairment

Overdose Effects

• Unlikely occurrence of overdose problems
• Possible gastrointestinal symptoms and disturbance of fluid and electrolyte balances
• Removal from circulation by haemodialysis if necessary

Therapeutic Class

• Broad spectrum penicillins

Reconstitution

• IV injection reconstitution in Water for Injection BP
• Not suitable for reconstitution or mixing with certain fluids
• Injection into drip tubing of infusion fluids

Storage Conditions

• Should be stored below 25°C, protected from light and moisture
• Reconstituted suspension stored in the refrigerator (not frozen) and used within 7 days
• Reconstituted vial must be used within 20 minutes

Related Brands

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• Fortimox 500 mg+125 mg (Tablet) - kumudini-pharma-ltd
• Fimoxyclav ES (600 mg+42.9 mg)/5 ml (Powder for Suspension) - synovia-pharma-plc