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Ensuring that the new basic information is introduced
source:Vitalpharms Company Ltd.    Release date:2017-12-6 13:25:07

Ensuring that new pharmacokinetic

Ensuring that the new 2 week after oral work. Multiple oral dose, duration of less than 2 weeks. At peak time for 3 ~ 8 h. After oral tablet 5 mg, 10 mg, steady blood concentrations were 32.3 ng/ml, 62.9 ng/ml. The area under the curve of drugs for 411-1839 (ng h.)/ml. Oral bioavailability of about 90%, the volume distribution of 599 ~ 671 l. Drugs mainly combined with alpha 1 acid glycoprotein, plasma protein combined rate of 98%. Mainly by the CYP 3 a4 in the liver metabolism, active metabolite 4 r - hydroxy ensuring that new concentration is very low. About 3% ~ 6% in urine excretion of drugs, 22.5% from its droppings. The total clearance of 9.4 L/h. Meet half-life beta 40 ~ 68 h, severe renal damage can prolong 1.6 times.

Ensuring that new indications

Used to treat with urgency, urinary frequency, urgency, incontinence of overactive bladder.

Ensuring that new contraindicated

1. On par with the new allergies.

2. Patients with gastric retention.

3. The patients with urinary retention.

4. Uncontrolled closure Angle glaucoma patients.

5. Severe liver damage is not recommended.

Matters needing attention

1. (1) a history of long QT. (2) the liver and kidney damage. (3) control of closure Angle glaucoma patients. (4) the bladder outflow obstruction. (the above data are selected from abroad) 3. The influence of drugs on children: children's medication safety and effectiveness has not yet been set.

2. The influence of drugs on pregnancy: animal experiments confirmed that ensuring that new teratogenicity or embryo toxicity, but there is no related research of the human race. Pregnant women should weigh the pros and cons. The United States and the food and drug administration (FDA) on par with the new security classification of pregnancy for class C.

3. The influence of drugs on lactation: animals (mice) experiments show that the new can secrete into the milk, ensuring that nursing medication (100 mg a day, or higher doses), can cause fetal perinatal, and postnatal survival rate drop, weight gain slow, physical development delay. Is still a lack of human information, it is recommended that breastfeeding women stop breastfeeding or stop using drugs.

Ensuring that new adverse reactions

1. Can cause long QT.

2. The central nervous system: a rare headache.

3. The metabolic/endocrine system: visible sweating increases.

4. The gastrointestinal tract: (1) research, visible dry mouth (27% ~ 38%), constipation (16%). With 1.4% ~ 1.4% of the patients after drug dyspepsia (incidence) associated with the dose. (2) taking ensuring that new 10 mg in 3.3% of patients with nausea.

5. The respiratory system: can appear dry nasal mucosa (5%).

6. The urogenital system: (1) research, visible dysuria (5%), urinary retention (5%). (2) taking ensuring that new 10 mg in 4.8% of patients with urinary tract infection.

7. Skin: after a single oral dose of 10 mg, kidney damage can appear pitting edema.

8. Eye: there are five

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Vitalpharms Company Ltd.
Add.: 2/F, 3# Buliding, 169 Shihua Rd. West, Zhuhai, Guangdong, China.
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