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Rezulin

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Rezulin

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

Rezulin (troglitazone (removed from the us market 3/21/00)) may be used concomitantly with a sulfonylurea or insulin to improve glycemic control. Rezulin (troglitazone (removed from the us market 3/21/00)) , as monotherapy, is indicated as an adjunct to diet and exercise to lower blood glucose in patients with type II diabetes (see

DOSAGE AND ADMINISTRATION

). Rezulin (troglitazone (removed from the us market 3/21/00)) should not be used as monotherapy in patients previously well-controlled on sulfonylurea therapy. For patients inadequately controlled with a sulfonylurea alone, Rezulin (troglitazone (removed from the us market 3/21/00)) should be added to. not substituted for. the sulfonylurea.

Management of type II diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient. This is important not only in the primary treatment of type II diabetes, but in maintaining the efficacy of drug therapy. Prior to initiation of Rezulin (troglitazone (removed from the us market 3/21/00)) therapy secondary causes of p.o. glycemic control, eg, infection or p.o. injection technique, should be investigated and treated.

DOSAGE AND ADMINISTRATION

Rezulin (troglitazone (removed from the us market 3/21/00)) should be taken with a meal.

Combination Therapy

Sulfony Iureas: Rezulin (troglitazone (removed from the us market 3/21/00)) in combination with a sulfonylurea should be initiated at 200 mg once daily. The current sulfonylurea dose should be continued upon initiation of Rezulin (troglitazone (removed from the us market 3/21/00)) therapy. For patients not responding adequate1, the Rezulin (troglitazone (removed from the us market 3/21/00)) dose should be increased at 2 to 4 weeks. The maximum recommended dose is 600 mg once daily. The dose of sulfonylurea may require lowering to optimize therapy.

Insulin: The current insulin dose should be continued upon initiation of Rezulin (troglitazone (removed from the us market 3/21/00)) therapy Rezulin (troglitazone (removed from the us market 3/21/00)) therapy should be initiated at 200 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of Rezulin (troglitazone (removed from the us market 3/21/00)) should be increased after approximately 2 to 4 weeks. The usual dose of Rezulin (troglitazone (removed from the us market 3/21/00)) is 400 mg once daily. The maximum recommended daily dose IS 600 mg It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomit ant insulin and Rezulin (troglitazone (removed from the us market 3/21/00)) . Further adjustments should be individualized based on glucose lowing response.

Monotherapy

Rezulin (troglitazone (removed from the us market 3/21/00)) monotherapy in patients not adequately controlled with diet alone should be initiated at 400 or 600 mg once daily. For patients not responding to 400 mg once daily, the Rezulin (troglitazone (removed from the us market 3/21/00)) dose should be increased to 600 m after 6-8 weeks. For patients not responding adequately to 600 mg after 6-8 weeks, 9 Rezulin (troglitazone (removed from the us market 3/21/00)) should be discontinued and alternative therapeutic options should be pursued. See CLINICAL PHARMACOLOGY, Clinical Studies, Monotherapy.

Patients With Renal Insufficiency: Dose adjustment in patients with renal insufficiency is not re uired (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Drug Metabolism). Out of 2938 patients, 148 (5%) had a serum creatinine 21.5 at baseline. Of these 148 patients, 145 had creatinine levels between 1.5 and 2.0, inclusive; only 3 patients had levels >2. 0. No consistent trend was seen in any of these adverse events, and no worsening of renal insufficiency was observed.

Patients With Hepatic Impairment: Rezulin (troglitazone (removed from the us market 3/21/00)) therapy should not be initiated if the patient exhibits clinical or laboratory evidence of active liver disease (eg, ALT> 3 ALT> 3 times the upper limit of normal). See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency and WARNINGS.

HOW SUPPLIED

Note: FDA removed from the US market 3/21/00

Rezulin (troglitazone (removed from the us market 3/21/00)) is available in 200, 300 and 400 mg tablets as follows:

200 mg Tablets: Yellow, oval, non- scored, film- coated tablet with PD 352 debossed on one side, and 200 on the other, available in: N 0071-0352-15 Bottles of 30 N 0071- 0352- 23 Bottles of 90 N 0071-0352-40 (10 x 10 unit-dose blisters)

300 mg Tablets: White, oval, non-scored, film-coated tablet with PD 357 debossed on one side and 300 on the other, available in: N 0071-0357-20 Bottles of 60 N 0071-0357-25 Bottles of 120

400 mg Tablets: Tan, oval, non-scored, film-coated tablet with PD 353 debossed on one side, and 400 on the other, available in: N 0071-0353-15 Bottles of 30 N 0071-0353-23 Bottles of 90 N 0071-0353-40 (10 x 10 unit-dose blisters)

Storage Store at controlled room temperature 20° C- 25° C (68° F-77° F). Protect from moisture and humidity.

Caution: Federal law prohibits dispensing without prescription

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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