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
