Tolterodine tartrate

Crystalline Form I

Therapeutic Area

Genito-urinary system & sex hormones

Status

Commercial

EU DMF readiness

CEP

Other documentation

Canadian DMF

CAS No.

124937-52-6

Reference Product

Detrusitol/PFIZER

Drug description:

Tolterodine tartrate is a diphenylmethane derivative, acts as an anticholinergic agent.
It is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
It is formulated as film coated tablets for oral route of administration.

Mechanism of action:

Tolterodine is a competitive, specific muscarinic receptor antagonist with a selectivity for the urinary bladder over salivary glands in vivo. One of the tolterodine metabolites (5-hydroxymethyl derivative) exhibits a pharmacological profile similar to that of the parent compound. In extensive metabolizers this metabolite contributes significantly to the therapeutic effect.