Tyclav 625

Indications

Co-amoxiclav is used for the short-term treatment of various bacterial infections, including upper respiratory tract infections such as tonsillitis, sinusitis, and otitis media; lower respiratory tract infections including acute and chronic bronchitis, and both lobar and bronchopneumonia; genito-urinary tract infections like cystitis, urethritis, and pyelonephritis; skin and soft tissue infections; bone and joint infections such as osteomyelitis; and other infections including septic abortion, puerperal sepsis, and intra-abdominal sepsis.

Composition

The 375 mg tablet contains 250 mg Amoxicillin as Amoxicillin Trihydrate BP and 125 mg Clavulanic Acid as Diluted Potassium Clavulanate BP. The 625 mg tablet contains 500 mg Amoxicillin as Amoxicillin Trihydrate BP and 125 mg Clavulanic Acid as Diluted Potassium Clavulanate BP. The 1 gm tablet contains 875 mg Amoxicillin as Amoxicillin Trihydrate BP and 125 mg Clavulanic Acid as Diluted Potassium Clavulanate BP. The powder for suspension comes in two forms: regular, with each 5 ml containing 125 mg Amoxicillin and 31.25 mg Clavulanic Acid, and Forte, with each 5 ml containing 400 mg Amoxicillin and 57.5 mg Clavulanic Acid. The 1.2 gm injection contains Amoxicillin Sodium BP (equivalent to 1 gm Amoxicillin) and Clavulanate Potassium USP (equivalent to 200 mg Clavulanic Acid). The 0.6 gm injection contains Amoxicillin Sodium BP (equivalent to 500 mg Amoxicillin) and Clavulanate Potassium USP (equivalent to 100 mg Clavulanic Acid).

Pharmacology

Pharmacodynamically, Co-amoxiclav combines Amoxicillin, a broad-spectrum antibiotic, with Clavulanic Acid, a beta-lactamase inhibitor. Amoxicillin is effective against many Gram-positive and Gram-negative microorganisms but can be degraded by beta-lactamases. Clavulanic Acid inactivates these enzymes, protecting Amoxicillin and extending its spectrum of activity. Pharmacokinetically, both components peak in serum about an hour after administration. Optimal absorption occurs when taken at the start of a meal. Both clavulanate and Amoxicillin have low serum binding, with about 70% remaining free in the serum. Doubling the dose roughly doubles serum levels.

Dosage

For adults and children over 12 years, the usual dose is one 625 mg tablet every 12 hours or one 375 mg tablet every 8 hours. For more severe infections, the dose may be increased to one 1 gm tablet every 12 hours or one 625 mg tablet every 8 hours. For children, the suspension dosage varies by age: 2 teaspoonfuls every 8 hours for children aged 6-12 years; 1 teaspoonful every 8 hours for children aged 1-6 years; and 25 mg/kg/day in divided doses every 8 hours for children below 1 year. Forte suspension is used for serious infections, with dosages of 25/3.6 mg/kg/day for mild to moderate infections and 45/6.4 mg/kg/day for more serious infections. For IV injection, adults typically receive 1.2 gm every 8 hours or every 6 hours for severe infections. For surgical prophylaxis, 1.2 gm at induction or up to 2-3 gm every 8 hours may be given for high-risk procedures. Children receive 30 mg/kg every 8 hours or every 6 hours for severe infections.

Administration

Oral dosages can be taken with or without food, but absorption is enhanced when taken at the start of a meal. For IV injection, it is administered intravenously by injection or slow infusion. The reconstituted solution must be used within 20 minutes.

Interaction

Co-amoxiclav may prolong bleeding time and prothrombin time. It can reduce the efficacy of oral contraceptives and may interact with allopurinol, increasing the risk of allergic skin reactions. There are no specific data on the concurrent use of Co-amoxiclav and allopurinol.

Contraindications

Co-amoxiclav is contraindicated in patients with hypersensitivity to penicillins or other beta-lactam antibiotics and those with a history of cholestatic jaundice from Co-amoxiclav or Penicillin.

Side Effects

Side effects are typically mild and transient, including diarrhea, nausea, and rash. Rarely, more serious conditions such as Stevens-Johnson Syndrome or exfoliative dermatitis may occur. Gastrointestinal issues may be minimized by taking the medication with meals.

Pregnancy & Lactation

Co-amoxiclav has shown no teratogenic effects in animal studies. Use during pregnancy is not recommended unless essential. Trace amounts of Amoxicillin may be present in breast milk.

Precautions & Warnings

Use Co-amoxiclav with caution in patients on anticoagulant therapy or with severe hepatic dysfunction. Dosage adjustments are necessary for renal impairment. High doses should be administered with adequate fluid intake to prevent crystalluria.

Use in Special Populations

Dosage adjustments are required for patients with renal impairment. For children, similar dosage reductions apply. Hepatic impairment requires cautious dosing and regular monitoring.

Overdose Effects

Overdose may result in gastrointestinal symptoms and electrolyte imbalances. Hemodialysis can help remove the drug from circulation.

Therapeutic Class

Broad-spectrum penicillins.

Reconstitution

For IV injection, reconstitute 1.2 gm with 20 ml Water for Injection BP. Avoid mixing with dextrose, bicarbonate solutions, or proteinaceous fluids. The reconstituted solution can be injected into infusion fluids containing glucose, bicarbonate, and dextran.

Storage Conditions

Store below 25°C, protected from light and moisture. Refrigerate reconstituted suspension and use within 7 days. Use reconstituted vials within 20 minutes.