DETROL® LA (tolterodine tartrate) extended release capsules Description

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Prescribing Information

DETROL^® LA (tolterodine tartrate) extended release capsules
Description


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DETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L- hydrogen tartrate. The empirical formula of tolterodine tartrate is C₂₆H₃₇NO₇, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below.

Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between noctanol and water is 1.83 at pH 7.3.

DETROL LA for oral administration contains 2 mg or 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2. The 2 mg capsules also contain yellow iron oxide. Both capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.

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DETROL LA Safety Information

DETROL LA capsules are once daily extended release capsules indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Important Safety Information

DETROL LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who have demonstrated hypersensitivity to the drug or its ingredients.

DETROL LA capsules should be used with caution in patients with clinically significant bladder outflow obstruction, gastrointestinal obstructive disorders, controlled narrow-angle glaucoma, and significantly reduced hepatic or renal function.

Dry mouth was the most frequently reported adverse event (DETROL LA 23% vs placebo 8%); others (≥4%) included headache (DETROL LA 6% vs placebo 4%), constipation (DETROL LA 6% vs placebo 4%), and abdominal pain (DETROL LA 4% vs placebo 2%).

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DETROL^®LA (tolterodine tartrate extended release capsules)