Terodine tablets

Description

PROPERTIES:
TERODINE is a potent competitive muscarinic receptor antagonist showing a pronounced effect on bladder function. The main effects following the administration of TERODINE were an increase in residual urine, reflecting an incomplete emptying of the bladder and a decrease in detrusor pressure. Both TERODINE and its metabolite exhibit a high specificity for bladder muscarinic receptors (M3) therefore better tolerated than other antimuscarinic drugs.

Pharmacokinetic:
Tolterodine immediate release is rapidly absorbed, and maximum serum concentration typically occur within 1 to 2 hours after dose administration.
Tolterodine is highly bound to plasma proteins.
Tolterodine is extensively metabolized by the liver following oral dosing.
Excretion is almost 77% in urine and 17% in feces.

INDICATIONS:
Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency or urge incontinence.

DOSAGE:
The initial dose is 2 mg twice daily and may be lowered to 1 mg twice daily based on individual response and tolerability.

CONTRAINDICATIONS:
Urinary retention, gastric retention, glaucoma, hypersensitivity to the drug and in lactation

SIDE EFFECTS:
Dry mouth, dyspepsia, headache, constipation, xerophthalmia, and dizziness may occur.
Drug interactions:
It was observed that fluoxetine significantly inhibited the metabolism of tolterodine immediate release in extensive metabolizers, resulting in a 4.8-fold increase in tolterodine AUC. No dose adjustment is required when TERODINE and fluoxetine are coadministered.
Coadministration of tolterodine and warfarin, oral contraceptives or diuretics has no effect on their pharmacokinetics and no dose adjustment is required.

Pregnancy & lactation:
TERODINE should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus.
TERODINE should not be used in case of nursing mothers.

Precautions & warning:
Should be used with caution in patients with bladder outflow obstruction, gastro-intestinal obstructive disorders. Safety and effectiveness in pediatrics have not been established. Dosage should be reduced in patients with renal or hepatic insufficiency.

PACKING:
A box containing 10 tablets.

STORAGE:
Keep at a temperature below 30C.
Keep out of reach of children.

instructions to patients:
– Patients should be informed that TERODINE may produce the following effects: blurred vision, dizziness or drowsiness.
– Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug effect has been determined.