Tolterodine tartrate extended-release tablets

Pharmacological action: This product is used to relieve the symptoms of frequent urination, urgency and urgency incontinence caused by overactive bladder. It is a competitive M cholinergic receptor blocker. The results of animal experiments indicate that this product has higher selectivity for the bladder than the salivary glands, but this has not yet been clinically confirmed. After oral administration, this product is metabolized by the liver into the active metabolite 5-hydroxymethyl derivative, which has the main pharmacological effect. Its anticholinergic activity is similar to that of this product. Both are highly selective for M cholinergic receptors, and have very weak effects or affinity on receptors of other neurotransmitters and potential cell targets (such as calcium channels).

The active ingredient of this product is tolterodine tartrate. Chemical name: (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-amphetamine L()-tartrate.

This product is a film-coated tablet, which appears white or off-white after removing the coating.

This product is indicated for the treatment of symptoms of frequent urination, urgency and/or urge incontinence caused by overactive bladder.

Oral administration: the recommended dose is 4 mg (1 tablet) once a day.

The side effects of this product are generally tolerable and disappear after discontinuation of the drug. This product has mild to moderate anticholinergic effects and may cause dry mouth, indigestion and reduced tears. Common (>1/100) Autonomic nervous system: dry mouth Gastrointestinal system: indigestion, constipation, abdominal pain, flatulence, vomiting Systemic: headache Eyes: dry eyes Skin: dry skin Mental: drowsiness, nervousness Central nervous system: paresthesia Not very common (<1/100) Autonomic nervous system: dysregulation Systemic: chest pain Rare (1/1000) Systemic: allergic reaction

This product is contraindicated in the following cases. 1. People who are allergic to this product. 2. People with urinary retention, gastric retention, and uncontrolled narrow-angle glaucoma. 3. People with myasthenia gravis, severe ulcerative colitis, and toxic megacolon.

Precautions for children: The safety and effectiveness of tolterodine for children has not been established. Precautions for pregnancy and lactation: Pregnant women should use this product with caution. If you take this product during lactation, you should stop breastfeeding. Pregnant mice were given 20 mg/kg/d of tolterodine (equivalent to 14 times the human dose), and no abnormalities or malformations were observed. When pregnant mice were given a dose of 30-40 mg/kg/d, stillbirths and reduced fetal weight occurred in the mice, and the incidence of abnormal events in fetal mice increased (cleft palate, abnormal toes, abdominal hemorrhage, and various skeletal abnormalities, mainly reduced ossification). The AUC value at this dose is about 20-25 times that of humans taking tolterodine. Rabbits were given 0.8 mg/kg/d of tolterodine subcutaneously, and the resulting AUC was 100 μg.h/L, which is about 3 times the human dose. This dose does not cause embryotoxicity or teratogenicity. Since there are no studies on the use of tolterodine extended-release tablets in pregnant women, tolterodine should only be used during pregnancy when it is clear that the potential benefits of tolterodine to the mother outweigh the potential risks to the fetus. Tolterodine tablets can be excreted in the milk of mice. When female mice were given tolterodine 20 mg/kg/d during lactation, the natural weight gain of the pups they fed was slightly reduced, but the weight gradually recovered during maturity. It is not clear whether tolterodine is excreted in human milk. Therefore, tolterodine extended-release tablets should not be used during lactation, and breastfeeding should be stopped if it is needed. Precautions for the elderly: The safety of tolterodine in elderly patients is not completely different from that in young patients. It is not recommended that elderly patients make dose adjustments when using tolterodine.

When co-administered with other drugs with anticholinergic effects, the therapeutic effect can be enhanced but also the adverse reactions. Conversely, muscarinic receptor agonists can reduce the efficacy of this product. Other drugs may interact with this product in pharmacokinetic terms because they require cytochrome P4502D6 (CYP2D6) or CYP3A4 for metabolism or can inhibit cytochrome activity. For example, co-administration with fluoxetine (fluoxetine is a strong inhibitor of CYP2D6, and fluoxetine is metabolized to demethylfluoxetine, which is an inhibitor of CYP3A4) can slightly increase the amount of unbound tolterodine and its 5-hydroxymethyl metabolite, but this does not cause an interaction of obvious clinical significance. If a stronger CYP3A4 inhibitor such as a macrocyclic antibiotic (erythromycin and clomiphene) is to be used in combination

Sealed and stored at room temperature (10~30℃). Valid for 2 years.

4mg

24 months

Nanjing Meirui Pharma Co., Ltd.

• Founded in:

  1996-03-19

• Address:

  No. 50, Xingang Avenue, Nanjing Economic and Technological Development Zone

• Tax NO.:

  9132010060894355X2

• Registered Funds:

  173.452212 million yuan

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