Tochek Sr

Uses

Tochek Sr Tartrate is used for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

Tochek Sr is also used to associated treatment for these conditions: Urinary Bladder, Overactive

How Tochek Sr works

Both tolterodine and its active metabolite, 5-hydroxymethyltolterodine, act as competitive antagonists at muscarinic receptors. This antagonism results in inhibition of bladder contraction, decrease in detrusor pressure, and an incomplete emptying of the bladder.

Dosage

Tochek Sr dosage

The recommended dose for tolterodine is 2 mg twice daily. In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.

The recommended total daily dose of tolterodine is 2 mg (1 mg b.i.d.) for patients with impaired renal function, impaired liver function, or receiving concomitant medication with potent CYP3A inhibitors, such as macrolide antibiotics (e.g. erythromycin and clarithromycin) or azole antifungal agents (e.g. ketoconazole, itraconazole and miconazole). After six months the need for further treatment should be considered.

Side Effects

Tochek Sr may cause mild to moderate antimuscarinic effects, like dryness of mouth, dyspepsia and/or reduced lacrimation.

Precaution

Tochek Sr should be used with caution in the following patients:

• at risk for urinary retention
• at risk for decreased gastrointestinal motility
• with impaired renal function
• with impaired hepatic function

Organic reasons for urge and frequency should be considered before treatment.

Interaction

Pharmacokinetic interactions are possible with other drugs metabolised by or inhibiting cytochrome P450 2D6 (CYP2D6) or CYP3A4. Concomitant treatment with fluoxetine does not result in a clinically significant interaction.

Ketoconazole, a potent inhibitor of CYP3A, significantly increased plasma concentrations of tolterodine when coadministered to poor metabolisers (i.e. persons devoid of CYP2D6 metabolic pathway).

Clinical studies have shown no interactions with warfarin or combined oral contraceptives (ethinyloestradiol or levonorgestrel).

Food Interaction

• Take with food.

Tochek Sr Alcohol interaction

[Moderate] GENERALLY AVOID:

Use of anticholinergic agents with alcohol may result in sufficient impairment of attention so as to render driving and operating machinery more hazardous.

In addition, the potential for abuse may be increased with the combination.

The mechanism of interaction is not established but may involve additive depressant effects on the central nervous system.

No effect of oral propantheline or atropine on blood alcohol levels was observed in healthy volunteers when administered before ingestion of a standard ethanol load.

However, one study found impairment of attention in subjects given atropine 0.5 mg or glycopyrrolate 1 mg in combination with alcohol.

Alcohol should generally be avoided during therapy with anticholinergic agents.

Patients should be counseled to avoid activities requiring mental alertness until they know how these agents affect them.

Tochek Sr Drug Interaction

Moderate: diphenhydramine, metoprolol, metoprolol, mirabegron, acetaminophen / hydrocodoneMinor: duloxetine, acetaminophenUnknown: aspirin, aspirin, calcium / vitamin d, apixaban, omega-3 polyunsaturated fatty acids, pregabalin, polyethylene glycol 3350, albuterol, levothyroxine, cyanocobalamin, ascorbic acid, cholecalciferol, cetirizine

Tochek Sr Disease Interaction

Major: angle-closure glaucoma, GI/urinary obstructionModerate: CNS, hepatic dysfunction, myasthenia gravis, QT prolongation, renal dysfunction

Volume of Distribution

• 113 ± 26.7 L

Half Life

1.9-3.7 hours

Elimination Route

Following administration of a 5-mg oral dose of 14C-tolterodine solution to healthy volunteers, 77% of radioactivity was recovered in urine and 17% was recovered in feces in 7 days.

Pregnancy & Breastfeeding use

There are no studies in pregnant women. Therefore, tolterodine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use of tolterodine during lactation should be avoided since no data on excretion of the drug into breast milk in humans is available.

Contraindication

Tochek Sr is contraindicated in those patients with urinary retention, uncontrolled narrow angle glaucoma, known hypersensitivity to tolterodine or any other component of the drug.

Special Warning

Pediatric use: Safety and effectiveness of tolterodine in children have not been established.

Geriatric use: No overall differences in safety were observed between the older and younger patients treated with Tochek Sr.

Acute Overdose

Overdosage with Tochek Sr Tartrate capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.

Storage Condition

Store in a cool and dry place. Protect from light. Keep out of the reach of children.

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