Medicinal Products

DETRUSITOL 1 mg

Generic drug of the therapeutic class: Urology nephrology
active ingredients: Tolterodine
laboratory: Pfizer Holding France

Coated tablet
Box of 28
All forms

Indication

Symptomatic treatment of urge urinary incontinence and / or pollakiuria and urge urgency that may be observed in patients with overactive bladder.

Dosage DETRUSITOL 1 mg Film-coated tablet Box of 28

- Adults (elderly subjects included):
. The recommended dose is 2 mg twice daily, except in patients with hepatic or renal impairment (glomerular filtration <= 30 ml / min) for which the recommended dose is 1 mg twice daily (see section 4.2). care and precautions for use). In the case of uncomfortable side effects, the dose may be reduced from 2 mg to 1 mg twice daily.
. The effect of the treatment should be re-evaluated after 2-3 months (see section on pharmacodynamic properties).
- Children: The efficacy of DETRUSITOL has not been demonstrated in children (see section 5.1 Pharmacodynamic properties). Therefore, DETRUSITOL is not recommended in children.

Against indications

CONTRAINDICATED:
Tolterodine is contraindicated in patients with:
- known hypersensitivity to tolterodine or excipients,
- urinary retention,
- uncontrolled closed angle glaucoma,
- myasthenia,
- severe ulcerative colitis,
- a toxic megacolon.
NOT RECOMMENDED :
- Children: The efficacy of DETRUSITOL has not been demonstrated in children (see section 5.1 Pharmacodynamic properties). Therefore, DETRUSITOL is not recommended in children.
- Pregnancy: There is insufficient data on the use of tolterodine in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk in pregnant women is not known. As a result, DETRUSITOL is not recommended during pregnancy.
- Breast-feeding: no data on the passage of tolterodine in breast milk is available. The use of tolterodine should be avoided during breastfeeding.
- Concomitant treatment with strong CYP3A4 inhibitors should be avoided [see section on interactions: concomitant systemic therapy with potent CYP3A4 inhibitors such as macrolides (eg erythromycin and clarithromycin), antifungal agents (eg ketoconazole and itraconazole) and anti-protease inhibitors is not recommended due to increased plasma concentrations of tolterodine in poor CYP2D6 metabolisers, with consequent risk of overdose].

Detrusitol side effects

- Due to its pharmacological effect, tolterodine may cause mild to moderate anticholinergic effects, such as dry mouth, dyspepsia and decreased tear secretion.
- The table below presents the data obtained with DETRUSITOL during the clinical trials and according to the data available since its commercialization. The most commonly reported adverse event was dry mouth, which occurred in 35% of DETRUSITOL-treated patients compared to 10% of placebo-treated patients. Headaches were also very commonly reported, in 10.1% of patients treated with DETRUSITOL and in 7.4% of patients treated with placebo.
- Infections and infestations:
Frequent (> = 1/100 and <1/10) : Bronchitis.
- Immune system disorders:
. Uncommon (> = 1/1000 and <1/100) : Allergic reactions.
. Unknown (can not be estimated from the available data) : Anaphylactoid reactions.
- Psychiatric disorders:
. Uncommon (> = 1/1000 and <1/100) : Nervousness.
. Unknown (can not be estimated from the available data) : Confusion, hallucinations, disorientation.
- disorders of the nervous system:
. Very common (> = 1/10): Headache.
. Frequent (> = 1/100 and <1/10) : Dizziness, drowsiness, paresthesia.
. Uncommon (> = 1/1000 and <1/100) : Memory problems.
- Eye disorders:
Frequent (> = 1/100 and <1/10) : Decreased lacrimal secretion, impaired vision including accommodation disturbance.
- Affections of the ear and labyrinth:
Frequent (> = 1/100 and <1/10) : Dizziness.
- Cardiac disorders:
. Frequent (> = 1/100 and <1/10) : Palpitations.
. Uncommon (> = 1/1000 and <1/100) : Tachycardia, heart failure, arrhythmia.
- Vascular disorders:
Unknown (can not be estimated from the available data) : Redness.
- Gastrointestinal disorders:
. Very common (> = 1/10): Dry mouth.
. Frequent (> = 1/100 and <1/10) : Dyspepsia, constipation, abdominal pain, flatulence, vomiting, diarrhea.
. Uncommon (> = 1/1000 and <1/100) : Gastroesophageal reflux.
- Skin and subcutaneous tissue disorders:
. Frequent (> = 1/100 and <1/10) : Dryness of the skin.
. Unknown (can not be estimated from the available data) : Angioedema.
- Renal and urinary disorders:
Frequent (> = 1/100 and <1/10) : Dysuria, urinary retention.
- General disorders and anomalies at the site of administration:
Common (> 1/100, <1/10) : Fatigue, chest pain, peripheral edema.
- Investigations:
Frequent (> = 1/100 and <1/10) : Weight gain.
Cases of worsening of dementia symptoms (eg, confusion, disorientation, delirium) have been reported after initiation of tolterodine therapy in patients taking cholinesterase inhibitors for the treatment of dementia.
CHILDREN:
In two 12-week, randomized, placebo-controlled, double-blind, placebo-controlled pediatric studies that included 710 pediatric patients, the proportion of patients with urinary tract infections, diarrhea, and abnormal behavior was higher in patients treated with tolterodine than placebo [urinary tract infection: tolterodine 6.8%, placebo 3.6%; diarrhea: tolterodine 3.3%, placebo 0.9%; abnormal behavior: tolterodine 1.6%, placebo 0.4% (see section 5.1).

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