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Ryzolt

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Ryzolt

Ryzolt

INDICATIONS

RYZOLT™ (tramadol hydrochloride extended-release tablets) is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

DOSAGE AND ADMINISTRATION

RYZOLT™ (tramadol hydrochloride extended-release tablets) 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™ (tramadol hydrochloride extended-release tablets) tablets produce a continuous release of active ingredient over 24 hours: a repeat dosage within 24 hours is not recommended.

Patients Not Currently on Tramadol Immediate-Release Products

Treatment with RYZOLT™ (tramadol hydrochloride extended-release tablets) 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™ (tramadol hydrochloride extended-release tablets) should not be administered at a dose exceeding 300 mg per day.

Clinical experience suggests that signs and symptoms of withdrawal may be reduced by tapering medication when discontinuing tramadol therapy.

Patients Currently on Tramadol Immediate-Release Products

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™ (tramadol hydrochloride extended-release tablets) 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™ (tramadol hydrochloride extended-release tablets) , some patients maintained on tramadol IR products may not be able to convert to RYZOLT™ (tramadol hydrochloride extended-release tablets) . RYZOLT™ (tramadol hydrochloride extended-release tablets) 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

RYZOLT™ (tramadol hydrochloride extended-release tablets) should not be used in patients with:

  • Creatinine clearance less than 30 mL/min,
  • Hepatic impairment.

(See WARNINGS, 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™ (tramadol hydrochloride extended-release tablets) 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.

HOW SUPPLIED

RYZOLT™ (tramadol hydrochloride extended-release tablets) are supplied in a number of packages and dose strengths:

100-mg, white, beveled edge, round biconvex tablets, plain on one side and printed "PP 100" in black ink on the other side.

Bottle of 30 tablets – NDC 59011-334-30
Bottle of 90 tablets – NDC 59011-334-90

200-mg, white, beveled edge, round biconvex tablets, plain on one side and printed "PP 200" in black ink on the other side

Bottle of 30 tablets – NDC 59011-335-30
Bottle of 90 tablets – NDC 59011-335-90

300-mg, white, beveled edge, round biconvex tablets, plain on one side and printed "PP 300" in black ink on the other side

Bottle of 30 tablets – NDC 59011-336-30
Bottle of 90 tablets – NDC 59011-336-90

Store at 25°C (77°F); excursions permitted between 15-30°C (59 – 86°F). Dispense in a tight, light-resistant container.

Warning: keep out of reach of children.

Manufactured by: Confab Laboratories, Inc., Saint-Hubert, Quebec, Canada J3Y 3X3. Distributed by: Purdue Pharma L.P. Stamford, CT 06901-3431.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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