Demoxiclave 500 mg+125 mg

Indications:

Co-amoxiclav is prescribed for the short-term treatment of bacterial infections at various sites, including:

• Upper Respiratory Tract Infections: This includes conditions like tonsillitis, sinusitis, and otitis media (ear infections).
• Lower Respiratory Tract Infections: Co-amoxiclav is effective against acute and chronic bronchitis, as well as lobar and bronchopneumonia.
• Genito-Urinary Tract Infections: It is used to treat conditions like cystitis, urethritis, and pyelonephritis.
• Skin and Soft Tissue Infections: It is effective in treating infections of the skin and underlying tissues.
• Bone and Joint Infections: Such as osteomyelitis.
• Other Infections: Includes septic abortion, puerperal sepsis, and intra-abdominal sepsis, among others.

This medication should be taken as prescribed by a registered physician.

Composition:

• 375 mg Tablet: Each film-coated tablet contains 250 mg of Amoxicillin as Amoxicillin Trihydrate BP and 125 mg of Clavulanic Acid as Diluted Potassium Clavulanate BP.
• 625 mg Tablet: Each film-coated tablet contains 500 mg of Amoxicillin as Amoxicillin Trihydrate BP and 125 mg of Clavulanic Acid as Diluted Potassium Clavulanate BP.
• 1 gm Tablet: Each film-coated tablet contains 875 mg of Amoxicillin as Amoxicillin Trihydrate BP and 125 mg of Clavulanic Acid as Diluted Potassium Clavulanate BP.
• Powder for Suspension: Each 5 ml reconstituted suspension contains 125 mg of Amoxicillin as Amoxicillin Trihydrate BP and 31.25 mg of Clavulanic Acid as Diluted Potassium Clavulanate BP.
• Powder for Suspension (Forte): Each 5 ml reconstituted suspension contains 400 mg of Amoxicillin as Amoxicillin Trihydrate BP and 57.5 mg of Clavulanic Acid as Diluted 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 combines the broad-spectrum antibiotic Amoxicillin with Clavulanic Acid, a beta-lactamase inhibitor. Amoxicillin is effective against many Gram-positive and Gram-negative bacteria but is vulnerable to degradation by beta-lactamases. Clavulanic Acid neutralizes these enzymes, allowing Amoxicillin to maintain its effectiveness against a broader range of bacteria.

• Pharmacokinetics: Both components of Co-amoxiclav reach peak serum levels approximately one hour after oral administration. Absorption is enhanced when taken with the start of a meal. Around 70% of both clavulanate and amoxicillin remain free in the bloodstream, making the medication effective at the prescribed doses. Increasing the dosage leads to a proportional increase in serum concentration.

Dosage:

• For Adults and Children over 12 Years:

  • Tablets:

    • The standard dose is one 625 mg tablet every 12 hours or one 375 mg tablet every 8 hours.
    • For more severe infections, especially of the respiratory tract, the dose is increased to one 1 gm tablet every 12 hours or one 625 mg tablet every 8 hours.

  • Suspension:

    • For children aged 6-12 years: 2 teaspoonfuls every 8 hours.
    • For children aged 1-6 years: 1 teaspoonful every 8 hours.
    • For children under 1 year: 25 mg/kg/day in divided doses every 8 hours.

  • Forte Suspension:

    • For mild to moderate infections: 25/3.6 mg/kg/day.
    • For severe infections: 45/6.4 mg/kg/day.

  • IV Injection:

    • Adults: The typical dose is 1.2 gm every 8 hours. For more serious infections, it can be increased to 1.2 gm every 6 hours. For surgical prophylaxis, 1.2 gm is given at induction, with higher doses for high-risk surgeries.
    • Children: The dose is 30 mg/kg every 8 hours, increased in more severe infections to 30 mg/kg every 6 hours.

Administration:

• Oral Dosage: Co-amoxiclav can be taken without regard to meals, though absorption is maximized if taken at the start of a meal. This also reduces the risk of gastrointestinal discomfort.

• IV Injection: The IV injection is not intended for intramuscular or subcutaneous use. It should be administered intravenously either as a 2-minute injection or as a slow infusion over 30 minutes. The reconstituted solution must be used within 20 minutes, and any unused material should be discarded.

Interactions:

• Co-amoxiclav may prolong bleeding time and prothrombin time in some patients.
• It may reduce the effectiveness of oral contraceptives, and patients should be informed of this potential interaction.
• When used alongside allopurinol, there is a higher chance of allergic skin reactions.

Contraindications:

• Patients with a known allergy to penicillin or those who have had a history of an allergic reaction to beta-lactam antibiotics, such as cephalosporins, should avoid Co-amoxiclav.
• It is also contraindicated in individuals who have had previous episodes of cholestatic jaundice linked to Co-amoxiclav or penicillin.

Side Effects:

• Side effects are typically mild and temporary but may include diarrhea, nausea, vomiting, and candidiasis.
• Rarely, liver-related side effects such as hepatitis or cholestatic jaundice may occur, but these are usually reversible.
• Other less common side effects may include rashes, angioedema, or anaphylaxis, which may require immediate medical attention.

Pregnancy & Lactation:

• Animal studies have shown no teratogenic effects when Co-amoxiclav is administered during pregnancy. It has been used in limited human pregnancies without significant negative outcomes. However, the medication should only be used in pregnancy when absolutely necessary.
• Trace amounts of Amoxicillin may be found in breast milk.

Precautions & Warnings:

• Co-amoxiclav should be used cautiously in patients on anticoagulation therapy or with severe liver dysfunction. Adjustments may be required for patients with moderate or severe renal impairment.
• Adequate fluid intake and urinary output should be maintained during high-dose administration to reduce the risk of crystalluria.

Use in Special Populations:

• Renal Impairment: Dosage adjustments may be required for patients with renal impairment.
• Hepatic Impairment: The dose should be carefully managed, with regular monitoring of liver function.

Overdose Effects:

• Overdose is rare, but if it occurs, gastrointestinal symptoms and disturbances in fluid and electrolyte balance may be observed. Co-amoxiclav can be cleared from the circulation through hemodialysis.

Therapeutic Class: Broad-spectrum penicillins.

Reconstitution (IV Injection):

• The 1.2 gm IV injection is reconstituted by dissolving the powder in 20 ml of Water for Injection BP. The reconstituted solution should not be mixed with dextrose, sodium bicarbonate solutions, protein hydrolysates, blood, or plasma. However, it may be administered in an infusion containing glucose, bicarbonate, and dextran.

Storage Conditions:

• Co-amoxiclav should be stored below 25°C, away from light and moisture. Once reconstituted, the suspension should be refrigerated (but not frozen) and used within 7 days. The reconstituted IV vial must be used within 20 minutes.