Sedoter
(1 mg & 2 mg Tablets)
Sedoter 2mg TabletsComposition:
Each film-coated tablet contains:
Tolterodine tartarate ...... 1 mg
Each film-coated tablet contains:
Tolterodine tartarate ...... 2 mg

Inactive ingredients:
Microcrystalline cellulose(Avicel PH 101), sodium starch glycolate, povidone K25, colloidal silicon dioxide (aerosil 200), magnesium stearate, dibasic calcium phosphate dehydrate.
Film-coat:
Hypromellose, polyethylene glycol 6000, titanium dioxide, FD&C blue No.2, purified water.

Indications:
SEDOTER is indicated for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

Pharmacokinetics properties:
Tolterodine is rapidly absorbed .Both tolterodine and the 5-hydroxymethyl metabolite reach maximal.
Serum concentrations 1 to 3 hours after dose.
Tolterodine half life is 2-3 hours in extensive metabolizers and about 10 hours in poor metabolizers (devoid of CYP2D6 activity). Steady state concentrations are reached within 2 days.
Food does not influence the exposure to the unbound tolterodine and the active 5-hydroxy metabolite in extensive metabolizers, although the tolterodine levels increase when taken with food.
Clinically relevant changes are likewise not expected in poor metabolizers.

Contraindications:
Sedoter 1 mgSEDOTER is contraindicated in patients with:
Hypersensitivity to the active ingredient or to any of SEDOTER ingredients.Urinary retention.Uncontrolled narrow-angle glaucoma.Myasthenia gravis.Severe ulcerative colitis.Toxic megacolon.
Pregnancy &lactation:

Pregnancy:
There are no adequate data from the use of tolterodine in pregnant women. Studies in animals have shown reproductive toxicity.
The potential risk for humans is unknown, consequently, Sedoter is not recommended during pregnancy.
Lactation:
No data concerning the excretion of tolterodine in human milk are available,therefore , SEDOTER should be avoided during lactation.

Special warnings & precautions of usages:

SEDOTER should be used with caution with patients with:
Significant bladder outlet obstruction at risk of urinary retention
Gastrointestinal obstructive disorders, e.g. pyloric stenosis
Renal impairment.
Hepatic diseases.
Autonomic neuropathy.
Hiatus hernia.
Risk for decreased gastro-intestinal motility.

Dosage and route of administration:
Adults (including elderly):
The initial recommended dose of SEDOTER is 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR < 30 ml /min) for whom the recommended dose is 1 mg twice daily.
In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.
The effect of treatment should be re-evaluated after 2-3 months.
Over dosage:
The highest dose given to human volunteers of tolterodine is 12.8 mg as a single dose.
The most severe adverse events observed were accommodation disturbances and micturition difficulties.
In the event of tolterodine overdose, treat with gastric lavage and give activated charcoal.

Treatment of over dosage symptoms as follows:
Severe central anticholinergic effects (e.g hallucinations, severe excitation) : treat with physostigmine.
Convulsions or pronounced excitation: treat with benzodlazepines.
Respiratory insufficiency: treat with artificial respiration.
Tachycardia: treat with beta blockers.
Urinary retention: treat it catheterization.
Mydriasis; treat with pilocarpine eye drops and/or place patient in dark room.
QT- prolongation: standard supportive measures should be adopted.
Storage:
Keep at temperature not exceeding 30°C.
Keep in dry place.
Keep out of reach and sight of children.

Presentation:
Carton box containing 3 ( Al/PVC strips each of 10 tablets in a carton box with pamphlet) blisters.