Tolterodine for the treatment of overactive bladder with symptoms of urinary urgency

TOLTERODINE
2 mg Film Coated Tablet

TOLTERODINE :

Each film coated tablet contains: 2 mg tolterodine tartrate

Mechanism of action :

TOLTERODINE is a competitive. specific muscarinic receptor antagonist which exhibits a selectivity for the urinary bladder over salivary glands. Tolterodine has a high specificity for muscarinic receptors.

Absorption :

TOLTERODINE is rapidly absorbed. Both tolterodine and the 5-hydroxymethyl metabolite reach maximal serum concentrations 1-3 hours after dose administration

Bioavallability :

Food does not influence the exposure of the unbound tolterodine although the tolterodine levels increase when taken with food.

Indications :

TOLTERODINE is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency and/or urge incontinence.

Contraindications :

TOLTERODINE is contraindicated in patients with:
⦁ Urine retention
⦁ Known hypersensitivity to tolterodine or its exciplents
⦁ Severe ulcerative colitis
⦁ Autonomic neuropathy
⦁ Glaucoma
⦁ Pregnancy & lactadon: except in urgent case using adequate concentration.

Side effects :

TOL TERODINE may cause mild-to-moderate annmuscarinic effects, like dryness of the mouth, dyspepsia and reduced lacrimation.

Interactions :

The antimuscarinic effect ofTOLTERODINE may become more pronounced when administered to patients receiving fluoxetinc.-

Warnings and Precautions :

TOLTERODINE should be used with caution in the followiog patients:
o Patients at risk of urine retention
⦁ Patients with impaired hepatic function
⦁ Machines users and Driven: Since TOLTERODI ‘E may cause accommodation disturbances and influence reaction time.

Dosage and Administration :

-The TOLTERODINE recommended dose is 1 tablet 2mgtwice a day.
-In the case of’rroubtcs e side-effects the dose may be reduced from 2mg to I mg twice a day.
-The recommended dose is I mg twice a day for patients with impaired reduced renal function, impaired liver function, or receiving concomitant ketoconezole.

Overdosage :

Overdosage with TOLTERODINE can potentially result in severe central anti muscarinic effects and should be treated accordingly.

Package & Storage :

Package: Box of3 blisters (each one contains 10 tablets).
Storage: To be stored in a cool dry place, away from light and in a temperature not exceeding 30°C.

Produced by :

Sabaa International Company-for pharmaceutical and Chemical industries S.A.E.
Keep all medicine out of reach of children

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