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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.)

Rezulin

SIDE EFFECTS

Two patients in the clinical studies developed reversible jaundice: one of these patients had a liver biopsy which was consistent with an idiosyncraticdrug reaction. An additional patient had a liver biopsy associated which was also consistent with an Idiosyncratic drug reaction. Symptoms that are with hepatic dysfunction have been reported, including: nausea, vomitin abdominal pain, fatigue, anorexia, dark urine, abnormal liver function tests (including increased ALT, AST, LDH, alkaline phosphatase, bilirubin). Also see WARNINGS.

The overall incidence and types of adverse reactions reported in placebo- controlled clinical trials for Rezulin (troglitazone (removed from the us market 3/21/00)) - treated patients and placebo- treated patients are shown in Table 6. In patients treated with Rezulin (troglitazone (removed from the us market 3/21/00)) in glyburide- controlled studies (N= 550) or uncontrolled studies (N= 510), the safety profile of Rezulin (troglitazone (removed from the us market 3/21/00)) appeared similar to that displayed in Table 6. The incidence of withdrawals during clinical trials was similar for patients treated with placebo or Rezulin (troglitazone (removed from the us market 3/21/00)) (4%).

TABLE 6.

North American Placebo- Controlled Clinical Studies:

Adverse Events Reported at a Frequency > 5% of Rezulin (troglitazone (removed from the us market 3/21/00)) - Treated Patients

% of Patients

 

Placebo

N = 492

Rezulin (troglitazone (removed from the us market 3/21/00))

N = 1450

 

Placebo

N = 492

Rezulin (troglitazone (removed from the us market 3/21/00))

N = 1450

Infection

22

18

Nausea

4

6

Headache

11

11

Rhinitis

7

5

Pain

14

10

Diarrhea

6

5

Accidental Injury

6

8

Urinary Tract Infection

6

5

Asthenia

5

6

Peripheral Edema

5

5

Dizziness

5

6

Pharyngitis

4

5

Back Pain

4

6

. . .


Types of adverse events seen when Rezulin (troglitazone (removed from the us market 3/21/00)) was used concomitantly with insulin (N= 543) were similar to those during Rezulin (troglitazone (removed from the us market 3/21/00)) monotherapy (N= 1731), although hypoglycemia occurred on insulin combination therapy (see PRECAUTIONS).

Laboratory Abnormalities

Hematologic: Small decreases in hemoglobin, hematocrit, and neutrophil counts (within the normal range) were more common in Rezulin (troglitazone (removed from the us market 3/21/00)) -treated than placebo-treated patients and may be related to increased plasma volume observed with Rezulin (troglitazone (removed from the us market 3/21/00)) treatment. Hemoglobin decreases to below the normal range occurred in 5% of Rezulin (troglitazone (removed from the us market 3/21/00)) -treated and 4 % of placebo-treated patients.

Lipids: Small changes in serum lipids have been observed (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical effects).

Serum Transaminase Levels: During all clinical studies in North America, a total of 48 of 2510 (1.9%) Rezulin (troglitazone (removed from the us market 3/21/00)) -treated patients and 3 of 475 (0.6%) placebo-treated patients had ALT levels greater than 3 times the upp er limit of normal. During controlled clinical trials. 2.2% of Rezulin (troglitazone (removed from the us market 3/21/00)) treated patients had reversible elevations in AST or ALT greater than 3 times the upper limit of normal, compared with 0.6% of patients receiving placebo. Hyperbilirubinemia (> 1.25 upper limit of normal) was found in 0.7% of Rezulin (troglitazone (removed from the us market 3/21/00)) -treated patients compared with 1.7% of patients receiving placebo. In the population of patients treated with Rezulin (troglitazone (removed from the us market 3/21/00)) , mean and median values for bilirubin, AST, ALT, alkaline phosphatase, and GGT were decreased at the final visit compared with baseline, while values or LDH were increased slightly (see WARNINGS).

Postintroduction Reports

Adverse events associated with Rezulin (troglitazone (removed from the us market 3/21/00)) that have been reported since market introduction, that are not listed above, and for which causal relationship to drug has not been established include the following congestive heart failure, weight gain, edema, fever, abnormal lab tests including increased CPK and creatinine, hyperglycemia, syncope, anemia, malaise.

Read the Rezulin (troglitazone (removed from the us market 3/21/00)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Oral Contraceptives: Administration of Rezulin (troglitazone (removed from the us market 3/21/00)) with an oral contraceptive containing ethinyl estradiol and norethindrone reduced the plasma concentrations of both by approximately 30% which could result in loss of contraception. Therefore, a higher dose of oral contraceptive or an alternative method of contraception should be considered.

Terfenadine: Coadministration of Rezulin (troglitazone (removed from the us market 3/21/00)) with terfenadine decreases the plasma concentration of both terfenadine and its active metabolite by 50-70% and may result in decreased efficacy of terfenadine.

Cholestyramine: Concomitant administration of cholestyramine with Rezulin reduces the absorption of troglitazone by 70%; thus, coadministration of cholestyramine and Rezulin (troglitazone (removed from the us market 3/21/00)) is not recommended.

Glyburide: Coadministration of Rezulin and glyburide does not appear to alter troglitazone or glyburide pharmacokinetics.

Digoxin: Coadministratjon of Rezulin (troglitazone (removed from the us market 3/21/00)) with digoxin does not alter the steady-state pharmacokinetics of digoxin.

Warfarin: Rezulin (troglitazone (removed from the us market 3/21/00)) has no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin therapy.

Acetaminophen: Coadministration of acetaminophen and Rezulin (troglitazone (removed from the us market 3/21/00)) does not alter the pharmacokinetics of either drug.

Metformin: No information is available on the use of Rezulin (troglitazone (removed from the us market 3/21/00)) with metformin.

Ethanol: A single administration of a moderate amount of alcohol did not increase the risk of acute hypoglycemia in Rezulin (troglitazone (removed from the us market 3/21/00)) -treated patients with type II diabetes mellitus.

The above interactions with terfenadine and oral contraceptives suggest that troglitazone may induce drug metabolism by CYP3A4. Studies have not been performed with other drugs metabolized by this enzyme such as: astemizole, calcium channel blockers, cisapride, corticosteroids cyclosporine. HMG-CoA reductase inhibitors, tacrolimus, triazolam, and trimetrexate. The possi bility of altered safety and efficacy should be considered when Rezulin (troglitazone (removed from the us market 3/21/00)) is used concomitantly with these drugs.

Patients stable on one or more of these agents when Rezulin (troglitazone (removed from the us market 3/21/00)) is started should be closely monitored and their therapy adjusted as necessary.

Read the Rezulin Drug Interactions Center for a complete guide to possible interactions

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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