Generic name: tramadol hydrochloride
Dosage form: tablet, extended release
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RYZOLT® extended-release tablets should be taken once a day. The tablets should be swallowed whole with liquid and not split, chewed, dissolved or crushed. RYZOLT® tablets produce a continuous release of active ingredient over 24 hours: a repeat dosage within 24 hours is not recommended.
Treatment with RYZOLT® should be initiated at a dose of 100 mg/day. Daily doses should be titrated by 100 mg/day increments every 2-3 days (i.e., start 200 mg/day on day 3 or 4 of therapy) to achieve a balance between adequate pain control and tolerability for the individual patient. For patients requiring the 300 mg daily dose, titration should take at least 4 days (i.e. 300 mg/day on day 5). The usual daily dose is 200 or 300 mg. The daily dose and titration should be individualized for each patient. Therapy should be continued with the lowest effective dose. RYZOLT®should not be administered at a dose exceeding 300 mg per day.
For patients maintained on tramadol immediate release (IR) products, the 24-hour tramadol IR dose should be calculated and the patient should be initiated on a total daily dose of RYZOLT®rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with RYZOLT®, some patients maintained on tramadol IR products may not be able to convert to RYZOLT®. RYZOLT®should not be administered at a dose exceeding 300 mg per day. Do not use RYZOLT® with other tramadol products. (see WARNINGS).
Individualization of Dose
Good pain management practice dictates that analgesic dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol products in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.
Renal and Hepatic Disease
- Creatinine clearance less than 30 mL/min,
- Hepatic impairment.
(see PRECAUTIONS, Use in Renal and Hepatic Disease).
Geriatric patients (65 years of age and older)
In general, dose selection for patients over 65 years of age who may have decreased hepatic or renal function, or other concomitant diseases, should be initiated cautiously, usually starting at the low end of the dosing range. RYZOLT® should be administered with greater caution at the lowest effective dose in patients over 75 years, due to the potential for greater frequency of adverse events in this population.