DETROTAC 1
-
Chemical Name:
Tolterodine Tartarate -
Therapeutic Category:
Urinary tract drugs -
Pharmacologic Category:
Anticholinergic Agent -
Pharmaceutical Form:
Tablets -
Composition:
Tolterodine Tartarate 1mg
DETROTAC
Film Coated Tablets
Tolterodine Tartrate
Antimuscarine
1.PHARMACOLOGY:
Tolterodine tartrate shows selectivity for the urinary bladder.
Tolterodine tartrate is rapidly absorbed (77%) and maximum serum concentrations typicallly occur within 1 to 2 hours after dose administration.
Food intake increases its bioavailability (average increase 53%).
Tolterodine tartrate is metabolized in the liver forming pharmacologically active metabolite, which exhibits an antimuscarinic activity similar to that of Tolterodine tartrate.
Tolterodine tartrate is highly bound to plasma proteins.
Following oral administration 77% was recovered in urine and 17% was recovered in feces.
2.INDICATIONS:
DETROTAC is indicated in the treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence.
3.CONTRAINDICATIONS:
DETROTAC is contraindicated in patients with urinary retention, gastric retention, or narrow-angle glaucoma.
DETROTAC is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
4.PRECAUTIONS:
- Tolterodine tartrate should be administered with caution to patients with significant bladder outflow obstruction because of the risk of urinary retention.
- Tolterodine tartrate should be administered with caution to patients with gastrointestinal obstructive disorders, such as pyloric stenosis, because of the risk of gastric retention.
- Patients with significantly reduced hepatic function should not receive doses greater than 1 mg twice daily.
- Patients with renal impairment should be treated with caution.
Pregnancy and Lactation: Tolterodine tartrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because Tolterodine tartrate is excreted in human milk, nursing while on Tolterodine tartrate is not recommended.
Pediatric Use: The safety and effectiveness of Tolterodine tartrate in pediatric patients have not been established.
5.SIDE EFFECTS:
Dry mouth, dyspepsia, headache, constipation, abnormal vision, dry eyes, and urinary retention are expected side effects of antimuscarinic agents.
6.DRUG INTERACTIONS:
Patients receiving cytochrome P-450 2D6 inhibitors should not receive doses of Tolterodine tartrate greater than 1 mg twice daily.
7.DOSAGE & ADMINISTRATION:
The initial recommended dose is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on tolerability and individual response.
For patients with significantly reduced hepatic function or who are currently taking drugs that are inhibitors of cytochrome, the recommended dose is 1 mg twice daily.
8.PACKAGING & COMPOSITION:
- DETROTAC 1 – F.C.Tablets: A Pack of 20 f.c.tablets. Each f.c.tablet contains Tolterodine Tartrate 1 mg.
- DETROTAC 2 – F.C.Tablets: A Pack of 20 f.c.tablets. Each f.c.tablet contains Tolterodine Tartrate 2 mg.
9.STORAGE CONDITIONS:
Store DETROTAC – F.C.Tablets at temperature between (15-30)°C.
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