Augment 500 mg+125 mg

Description

Indications:

Co-amoxiclav is a combination antibiotic used for the short-term treatment of various bacterial infections. It is indicated for infections in the following areas:

• Upper respiratory tract infections (including ear, nose, and throat conditions) such as tonsillitis, sinusitis, and otitis media.
• Lower respiratory tract infections including acute and chronic bronchitis, as well as lobar and bronchopneumonia.
• Genito-urinary tract infections like cystitis, urethritis, and pyelonephritis.
• Skin and soft tissue infections.
• Bone and joint infections, such as osteomyelitis.
• Other infections, including septic abortion, puerperal sepsis, and intra-abdominal sepsis.

Note: Always use Co-amoxiclav according to the advice of a registered healthcare professional.

Composition:

Co-amoxiclav is available in various strengths and forms:

• 375 mg Tablet: Contains Amoxicillin 250 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 125 mg (as Potassium Clavulanate BP).
• 625 mg Tablet: Contains Amoxicillin 500 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 125 mg (as Potassium Clavulanate BP).
• 1 gm Tablet: Contains Amoxicillin 875 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 125 mg (as Potassium Clavulanate BP).
• Powder for Suspension (Regular): Each 5 ml of reconstituted suspension contains Amoxicillin 125 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 31.25 mg (as Potassium Clavulanate BP).
• Powder for Suspension (Forte): Each 5 ml of reconstituted suspension contains Amoxicillin 400 mg (as Amoxicillin Trihydrate BP) and Clavulanic Acid 57.5 mg (as Potassium Clavulanate BP).
• 1.2 gm Injection: Each vial contains a sterile mixture of Amoxicillin Sodium BP (equivalent to Amoxicillin 1 gm) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 200 mg).
• 0.6 gm Injection: Each vial contains a sterile mixture of Amoxicillin Sodium BP (equivalent to Amoxicillin 500 mg) and Clavulanate Potassium USP (equivalent to Clavulanic Acid 100 mg).

Pharmacology:

• Pharmacodynamics: Co-amoxiclav is an antibacterial combination consisting of Amoxicillin (a broad-spectrum antibiotic) and Clavulanic Acid (a beta-lactamase inhibitor). While Amoxicillin is effective against many Gram-positive and Gram-negative bacteria, it is susceptible to breakdown by beta-lactamase enzymes. Clavulanic Acid protects Amoxicillin by inhibiting these enzymes, thereby broadening the range of bacteria it can target.

• Pharmacokinetics: Both Amoxicillin and Clavulanic Acid have similar pharmacokinetic properties. After oral administration, peak serum levels of both occur approximately one hour later. Absorption is optimized when taken at the start of a meal. The drugs have low serum protein binding, with around 70% remaining free in the bloodstream. Doubling the dose increases serum levels proportionally.

Dosage:

• For Adults and Children Over 12 Years:

  • Tablets: The usual dose for adults is one 625 mg tablet every 12 hours or one 375 mg tablet every 8 hours. For more severe infections, the dose should be one 1 gm tablet every 12 hours or one 625 mg tablet every 8 hours.
  • Suspension:
    • Children 6-12 years: 2 teaspoonfuls every 8 hours.
    • Children 1-6 years: 1 teaspoonful every 8 hours.
    • Children under 1 year: 25 mg/kg/day, divided every 8 hours. For example, a 7.5 kg child would need 2 ml three times a day. Treatment should not exceed 14 days without a healthcare review.

• Forte Suspension:

  • For mild to moderate infections, the usual dose is 25/3.6 mg/kg/day.
  • For more severe infections, the dose increases to 45/6.4 mg/kg/day.
  • For children:
    • 2-6 years (13-21 kg): 2.5 ml twice a day (b.i.d).
    • 7-12 years (22-40 kg): 5 ml twice a day (b.i.d).

• Intravenous (IV) Injection:

  • Adults: Usually, 1.2 gm every 8 hours. For more serious infections, the dose may increase to 1.2 gm every 6 hours. For surgical prophylaxis, 1.2 gm at induction, with up to 2-3 gm every 8 hours for high-risk procedures (e.g., colorectal surgery).
  • Children:
    • 0-3 months: 30 mg/kg every 8 hours.
    • 3 months to 12 years: 30 mg/kg every 8 hours, with increases to 30 mg/kg every 6 hours for severe infections.

Administration:

• Oral dosage form: Co-amoxiclav can be taken without regard to meals; however, absorption is enhanced if taken at the start of a meal. To minimize gastrointestinal discomfort, it is advisable to take Co-amoxiclav at the beginning of meals.

• IV Injection: Co-amoxiclav IV injection is administered intravenously either by injection (over 2 minutes) or slow infusion (over 30 minutes). Reconstituted vials must be used within 20 minutes.

Drug Interactions:

• Prolongation of bleeding time and prothrombin time may occur in some patients.
• Co-amoxiclav may reduce the effectiveness of oral contraceptives.
• The combination with allopurinol may increase the risk of allergic skin reactions, but no data is available for their concurrent use.

Contraindications:

• Co-amoxiclav is contraindicated for patients with a known hypersensitivity to penicillin or any other beta-lactam antibiotics, such as cephalosporins.
• It is also contraindicated in individuals with a history of cholestatic jaundice associated with Co-amoxiclav or penicillin.

Side Effects:

• Common: Diarrhea, indigestion, nausea, vomiting, and candidiasis. To reduce these effects, Co-amoxiclav should be taken with meals.
• Rare: Hepatitis, cholestatic jaundice (usually reversible), skin rashes, erythema multiforme, Stevens-Johnson syndrome, and exfoliative dermatitis.
• Serious: Angioedema, anaphylaxis, and other allergic reactions.

Pregnancy & Lactation:

• Animal studies have shown no teratogenic effects with Co-amoxiclav. Although limited human data exists, Co-amoxiclav should only be used during pregnancy if deemed essential by a healthcare provider.
• Small amounts of Amoxicillin are excreted in breast milk, so caution is advised when used during lactation.

Precautions & Warnings:

• Use with caution in patients on anticoagulant therapy or those with severe hepatic dysfunction.
• Adjust dosages for patients with moderate to severe renal impairment.
• During high-dose treatment, maintain adequate fluid intake and urinary output to prevent crystalluria.

Use in Special Populations:

• Renal Impairment: Dose adjustments are necessary based on the severity of renal dysfunction.
  • Mild impairment (Creatinine clearance >30 ml/min): No dosage change.
  • Moderate impairment (Creatinine clearance 10-30 ml/min): One 375 mg or 625 mg tablet every 12 hours, or 1.2 gm IV followed by 0.6 gm IV every 12 hours.
  • Severe impairment (Creatinine clearance <10 ml/min): One 375 mg tablet every 12 hours or 1.2 gm IV followed by 0.6 gm IV every 24 hours. Dialysis patients may require additional doses during and after dialysis.

Overdose Effects:

• Overdose is rare, but may cause gastrointestinal disturbances and electrolyte imbalance. Co-amoxiclav can be removed via hemodialysis.

Therapeutic Class:

• Broad-spectrum penicillins

Reconstitution for IV Injection:

• Reconstitute 1.2 gm IV injection with 20 ml of Water for Injection BP. It should not be mixed with dextrose solutions, sodium bicarbonate, or proteinaceous fluids. The reconstituted solution may be injected into the infusion drip tubing of fluids containing glucose, bicarbonate, or dextran.

Storage Conditions:

• Store below 25°C, away from light and moisture.
• Reconstituted suspension should be refrigerated (but not frozen) and used within 7 days. Any unused IV reconstituted material should be discarded within 20 minutes.

Note: Always consult a registered healthcare provider before using this medication.