Indication and Usage
Tyclav® is indicated for short-term treatment of bacterial infections at the following sites:
1. Upper respiratory tract infections (including ENT); e.g., tonsillitis, sinusitis,
otitis media.
2. Lower respiratory tract infections; e.g., acute and chronic bronchitis, lobar
and bronchopneumonia.
3. Genito-urinary tract infections; e.g., cystitis, urethritis, pyelonephritis.
4. Skin and soft tissue infections.
5. Bone and joint infections; e.g., osteomyelitis.
6. Other infections; e.g., septic abortion, puerperal sepsis, intra-abdominal
sepsis, etc.
Dosage and Administrations
Dose of Tablets
Adults and children over 12 years:
The usual adult dose is one Tyclav® 625 Tablet every 12 hours or one Tyclav®
375 Tablet every 8 hours. For more severe infections and infections of the
respiratory tract, the dose should be one Tyclav® 1 g Tablet every 12 hours or
one Tyclav® 625 Tablet every 8 hours.
Dose of Powder for Suspensions
Tyclav® Powder for Suspension:
Neonate: 0.25 ml/kg 3 times daily.
1 month–1 year: 0.25 ml/kg 3 times daily, dose doubled in severe infection.
1–6 years: 5 ml 3 times daily or 0.25 ml/kg 3 times daily, dose doubled in
severe infection.
6–12 years: 10 ml 3 times daily, dose doubled in severe infection.
Tyclav® bid Powder for Suspension:
2 month-2 years: 0.15 ml/kg twice daily, doubled in severe infection.
2-6 years (13-21 kg): 2.5 ml twice daily, doubled in severe infection.
7-12 years (22-40 kg): 5 ml twice daily, doubled in severe infection.
12-18 years (over 40 kg): 10 ml twice daily, three times daily in severe
infection.
Dose of Injections:
Adults
Usually 1.2 g every 8 hours, increased in more severe infections to 1.2 g
every 6 hours.
Adult dosage for surgical prophylaxis
The usual dose is 1.2 g at induction, for high risk procedures (e.g., colorectal
surgery) up to 2-3 further doses of 1.2 g may be given every 8 hours.
Children
0 to 3 months: 30 mg/kg every 8 hours (every 12 hours in the perinatal period
and in premature infants).
3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more
serious infections to 30 mg/kg every 6 hours.
Precautions
Tyclav® should be used with care in patients on anti-coagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of high dose of Tyclav® adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
Contraindications
History of Penicillin hypersensitivity. Attention should be paid to possible cross sensitivity with other beta-lactam antibiotics e.g., cephalosporins. Also contraindicated for patients with previous history of Tyclav® or penicillin associated cholestatic jaundice.
Side Effects
Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature. Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported. If gastrointestinal side effects occur with oral therapy, that may be reduced by taking Tyclav® at the start of
meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Urticarial and erythematous rashes sometimes occur.
Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported. In common with other beta-lactam antibiotics angioedema and anaphylaxis have been reported.
Use in Pregnancy and Lactation
Amoxicillin and Clavulanic acid has been used orally in human pregnancy in a limited number of cases with no untoward effect; however use of Tyclav® in pregnancy is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
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