Tolterodine Tartrate (tolterodine tartrate)

For the management of urge urinary incontinence, urgency, and frequency in patients with overactive bladder, the usual initial adult dosage of tolterodine tartrate is 2 mg twice daily as conventional tablets or 4 mg once daily as extended-release capsules. Dosage may be reduced to 1 mg twice daily (as conventional tablets) or 2 mg once daily (as extended-release capsules) according to individual response and tolerance. In addition, patients receiving drugs that inhibit the cytochrome P-450 isoenzyme 3A4 should receive a reduced dosage of 1 mg of tolterodine tartrate twice daily (as conventional tablets) or 2 mg once daily (as extended-release capsules). (See Cytochrome P-450 Isoenzyme 3A4 Inhibitors under Drug Interactions: Drugs Affecting Hepatic Microsomal Enzymes.) However, the manufacturer states that efficacy data for the lower dosage (i.e., 2 mg) of extended-release capsules are limited.

Renal or hepatic impairment may substantially affect the disposition of tolterodine. Therefore, the recommended dosage of tolterodine tartrate is 1 mg twice daily (as conventional tablets) or 2 mg once daily (as extended-release capsules) in patients with substantially reduced renal or hepatic function.

Tolterodine tartrate is administered orally. Tolterodine tartrate extended-release capsules should be administered with adequate amounts of fluid and swallowed whole.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Reproduction studies in mice using tolterodine tartrate dosages of 20 mg/kg daily (about 14 times the usual human exposure based on unbound tolterodine concentrations) have not revealed evidence of fetal anomalies or malformations. However, embryolethality, reduced fetal weight, and increased incidence of fetal abnormalities (e.g., cleft palate, digital abnormalities, intra-abdominal hemorrhage, skeletal abnormalities including reduced ossification) were observed in mice receiving tolterodine tartrate dosages of 30-40 mg/kg daily (20-25 times the human systemic exposure based on AUC comparisons). In addition, no evidence of embryotoxicity or teratogenicity was observed in rabbits receiving tolterodine tartrate dosages of 0.8 mg/kg daily subcutaneously (approximately 3 times the human systemic exposure at the recommended human dosage based on AUC comparisons). There are no adequate and controlled studies to date using tolterodine tartrate in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus.

It is not known whether tolterodine is distributed into human milk. However, the drug is distributed into milk in mice. Administration of tolterodine tartrate dosages of 20 mg/kg to nursing mice resulted in slightly decreased body weight gain, although offspring regained the weight during maturation. The manufacturer states that tolterodine tartrate should not be used in nursing women, and a decision should be made whether to discontinue nursing or the drug in these patients.

No enhanced messaging available.