Duofix 375 mg+20 mg

Description

Indications
Co-amoxiclav is prescribed for the short-term treatment of various bacterial 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 such as acute and chronic bronchitis, and lobar and bronchopneumonia.
• Genito-Urinary Tract Infections including cystitis, urethritis, and pyelonephritis.
• Skin and Soft Tissue Infections.
• Bone and Joint Infections such as osteomyelitis.
• Other Infections like septic abortion, puerperal sepsis, and intra-abdominal infections.

Take the medicine as per the advice of a registered medical practitioner.

Composition

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

Pharmacology
Pharmacodynamic Properties:
Co-amoxiclav is a combination of Amoxicillin, an antibiotic, and Clavulanic Acid, a beta-lactamase inhibitor. Amoxicillin exhibits broad-spectrum bactericidal activity against various Gram-positive and Gram-negative microorganisms. However, it is vulnerable to degradation by beta-lactamases, which some microorganisms produce. Clavulanic Acid inhibits a broad range of beta-lactamase enzymes, including those from microorganisms resistant to penicillins and cephalosporins, thus protecting Amoxicillin from degradation and enhancing its efficacy.

Pharmacokinetic Properties:
The pharmacokinetics of Amoxicillin and Clavulanic Acid are closely matched. Both peak in the bloodstream approximately 1 hour after oral administration. Absorption is optimized when Co-amoxiclav is taken with food, and both components have low serum binding—around 70% remains free in the bloodstream. Doubling the dosage of Co-amoxiclav doubles the serum concentration.

Dosage
Adults and Children over 12 years:

• Tablet:
  • The typical adult dose is one 625 mg tablet every 12 hours or one 375 mg tablet every 8 hours.
  • For more severe infections, such as respiratory 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 into doses every 8 hours (e.g., a 7.5 kg child requires 2 ml suspension three times a day). Treatment should not exceed 14 days without a reassessment.
• Forte Suspension:
  • For mild to moderate infections: 25/3.6 mg/kg/day (e.g., recurrent tonsillitis, bronchitis, and skin infections).
  • For more serious infections: 45/6.4 mg/kg/day (e.g., otitis media, sinusitis, bronchopneumonia, and urinary tract infections).

  Children 2-12 years:

  • Mild to moderate infections:
    • 2-6 years (13-21 kg): 2.5 ml twice daily.
    • 7-12 years (22-40 kg): 5 ml twice daily.
  • Serious infections:
    • 2-6 years (13-21 kg): 5 ml twice daily.
    • 7-12 years (22-40 kg): 10 ml twice daily.
• IV Injection:
  • Adults: Typically 1.2 gm every 8 hours; for more severe infections, increase to 1.2 gm every 6 hours.
  • For surgical prophylaxis: 1.2 gm at induction. For high-risk procedures (e.g., colorectal surgery), up to 2-3 gm may be given every 8 hours.

  Children:

  • 0 to 3 months: 30 mg/kg every 8 hours (every 12 hours for perinatal and premature infants).
  • 3 months to 12 years: Usually 30 mg/kg every 8 hours, increased to every 6 hours for more severe infections.

Take the medicine as per the advice of a registered medical practitioner.

Administration

• Oral Dosage: Co-amoxiclav can be taken without regard to meals; however, absorption is enhanced when it is taken at the start of a meal. To minimize gastrointestinal discomfort, it is recommended to take the medication with food.
• IV Injection: Co-amoxiclav injection is not suitable for intramuscular or subcutaneous administration. The reconstituted vial should be administered intravenously either via injection (over 2 minutes) or slow intravenous infusion (over 30 minutes). The reconstituted solution must be used within 20 minutes and any unused material should be discarded.

Take the medicine as per the advice of a registered medical practitioner.

Interaction
Prolonged bleeding time and prothrombin time have been observed in some patients receiving Co-amoxiclav. As with other broad-spectrum antibiotics, Co-amoxiclav may reduce the effectiveness of oral contraceptives, so patients should be warned accordingly. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There is limited data on the co-administration of Co-amoxiclav and allopurinol.

Contraindications
Co-amoxiclav is contraindicated in patients with a history of penicillin hypersensitivity. Caution should be exercised as cross-sensitivity may occur with other beta-lactam antibiotics like cephalosporins. It is also contraindicated in patients with a history of Co-amoxiclav or penicillin-associated cholestatic jaundice.

Side Effects
Side effects are uncommon and typically mild and transient. They may include diarrhea, pseudomembranous colitis, indigestion, nausea, vomiting, and candidiasis. To minimize gastrointestinal side effects, it is recommended to take Co-amoxiclav at the start of meals. Hepatitis and cholestatic jaundice have been reported but are usually reversible. Rashes, including urticarial and erythematous rashes, have been observed. Rarely, more severe conditions like erythema multiforme, Stevens-Johnson syndrome, and exfoliative dermatitis may occur. As with other beta-lactam antibiotics, cases of angioedema and anaphylaxis have been reported.

Pregnancy & Lactation
Animal studies have shown no teratogenic effects with Co-amoxiclav. Limited human data suggests that the drug does not cause harm during pregnancy; however, its use should be reserved for cases where it is deemed essential by the healthcare provider. Amoxicillin is excreted in breast milk, but no issues have been observed in nursing infants. If additional Vitamin D3 is prescribed to a breastfeeding infant, the total dosage should be considered.

Precautions & Warnings
Co-amoxiclav should be used cautiously in patients receiving anticoagulants or those with severe hepatic dysfunction. In patients with moderate to severe renal impairment, the dosage should be adjusted. Adequate fluid intake and urinary output should be maintained during high-dose therapy to prevent crystalluria.

Use in Special Populations

• Renal Impairment:
  • Mild impairment: No dosage change needed.
  • Moderate impairment: Adjust to one 375 mg tablet or 625 mg tablet every 12 hours or 1.2 gm IV followed by 0.6 gm IV every 12 hours.
  • Severe impairment: Limit to one 375 mg tablet every 12 hours or 1.2 gm IV followed by 0.6 gm IV every 24 hours. Additional doses may be necessary during dialysis.