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* Tiratam (levetiracetam) 100 mg/mL Oral Solution 120 ml.
* Indication and Usage:
Tiratam is indicated as adjunctive therapy in the treatment of partial onset seizures
in adults and children 4 years of age and older with epilepsy.
* Contraindications:
This product should not be administered to patients who have previously exhibited
hypersesnitivity to Levetiracetam or any of the inactive ingredients in Tiratam oral solution.
* Precautions:
In adults, Tiratam use is associated with the occurence of central nervous sysem adverse
events that can be classified into the following categories:
1) somnolence and fatigue,
2) coordication difficulties,
3) behavioral abnormalities.
* Pregnancy and Lactation:
Tiratam should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Levetiracetam is excreted in breast milk. Because of the potential for serious adverse reactions
in nursing infants from Tiratam, a decision should be made whether to discontinue nursing or
discontinue the drug, taking into account the importance of the drug to the mother.
* Dosage and administration:
– Adults 16 years and older:
Treatment should be initiated with a daily dose of 1000 mg / day, given as twice daily dosing
(500 mg BID).
Additional dosing increments may be given (1000 mg / day additional every 2 weeks) to
a maximum recommended daily dose of 3000 mg.
– Pediatric patients Ages 4 to <16 years:
Treatment should be initiated with a daily dose of 20 mg / kg in divided doses (10 mg / kg BID).
The daily dose should be increased every 2 weeks by increments of 20 mg / kg to the recommended
daily dose of 60 mg / kg (30 mg / kg BID).
* Store at controlled room temperature, not exceeding 25 degrees C.
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