Sotivex Ha Nam drugs treated the symptoms of incontinence, patients with bladder syndrome increased activity (3 blisters x 10 tablets)

Dosage form Film bag tablets
Specifications Box of 3 blisters x 10 tablets
Ingredient Solifenacin success

Ingredient

Composition information	Content
Solifenacin success	5mg

Uses

indications

Sotivex drugs are indicated in the following cases:

Treatment of non -autonomous urinary tract symptoms (urine) and/or urination many times and urgently, may occur in patients with increased active bladder syndrome.

Pharmacology

Group Pharmacological Therapy: Anti -urinary antidipators, ATC code: G04B D08.

Mechanism of action:

solifenacin is a specific, competitive cholinergic receptor receptor.The bladder is active by the sympathetic nerve of the cholinergic system. Acetylcholine causes the bladder muscle contraction through the muscarin receptors in which the M3 subgroup is mainly related. In vitro and in vivo pharmacology studies show that Solifenacin is a muscarin receptor inhibitor M3. In addition, Solifenacin shows a specific antagonist for Muscarin receptor, indicating in low affinity or no affinity for different receptors and testing channels through testing.

Pharmacological effects:

Vesicare treatment with doses of 5mg and 10mg daily has been studied in some double, random, random clinical trials that are verified by the placebo in men and women with increased bladder activity.

As shown in the table below, both dose 5mg and 10mg of Vesicare have created a statistical improvement of the main criteria and sub -criteria compared to the placebo group. Observed effectively within 1 week of initial treatment and stability for 12 weeks. A long -term study knew that the name of the drug has proven to be maintained at least for 12 months. After 12 weeks of treatment, about 50% of patients with non -autonomous urination before the treatment has surpassed the non -autonomous urination, and in addition, 35% of patients achieve the number of urination less than 8 times a day. Treatment of increased bladder symptoms also achieved results in some criteria for measuring quality of life, such as health awareness, impact of non -autonomous urination, role limitations, physical limitations, social limitations, emotions, severity of symptoms, measures to measure heavy and sleep/energy.

Results (gross data) of 4 phase 3 studies have been verified with 12 weeks of treatment

5mg,

1 time/day

vesicare

10mg,

1 time/day

Tolterodine

2mg,

2 times/day

Number of urination/24 hours Version 1.4 2.3 2.7 Version (12%)

(19%)

(23%)

(16%) n 1138 552 1158

250 P* Binh 6.3 5.9 6.2 5.4 Version
(32%)
(49%) (55%) (39%) P*
Binh
2.9 2.6 2.9 2.3 Version (38%)
(58%)

(62%)
(48%) P* Binh 1.8 2.0 1.8
1.9
Version (22%)
(30%)
(33%) (26%) P* bottle 166ml 146ml 163ml 147ml (5%) (21%) (26%) (16%) P* Binh 3.0 2.8 2.7
2.7
Version (27%) (46%) (48%) (37%) P*
Vesicare 5mg has also been used in 2 of 4 studies and one of the studies including Tolterodine 2mg, 2 times/day.
Not all parameters and treatment groups are evaluated in each individual research. Therefore, the number of patients listed may vary according to the parameters and treatment groups.
* The P value to compare each pair with the placebo.
Dynamic pharmacokinetics

General characteristics
absorption
After taking vesicare tablets, the maximum solifenacin concentration in plasma (CMAX) is achieved after 3 hours to 8 hours. Time to achieve the highest concentration in plasma (TMAX) does not depend on the dose. CMAX and the area under the curve (AUC) increase proportional to the dose from 5mg to 40mg. Absolute bioavailability of about 90%.
Use food that does not affect CMAX and AUC of solifenacin.
Distribution
Solifenacin's apparent distribution volume after using intravenous tract is about 6001. Solifenacin is connected to a high level of plasma proteins (about 98%), mainly with α1 - glycoprotein.
Metabolism
solifenacin is strongly metabolized by the liver, mainly by Cytochrome P450 3A4 (CYP3A4). However, there are many metabolic lines that can be involved in the metabolism of solifenacin. The body clearance of Solifenacin is about 9.5L/hour and the last half -life of solifenacin is 45 - 68 hours. After oral use, 1 pharmacological metabolites (4R - hydroxy solifenacin) and 3 non -activity metabolites (N - glucuronid, n - oxid and 4r - hydroxy - n - oxide of solifenacin) have been seen in plasma outside Solifenacin.
Elimination
After taking a single dose of solifenacin 10mg with 14C radioactive, about 70% of radioactive is detected in urine and 23% in feces after 26 days. In urine, about 11% of radioactive is seen in the form of a constant active ingredient, about 18% in the form of N - oxide metabolites, 9% in the form of 4R - hydroxy - n - oxide and 8% metabolites in the form of 4R - hydroxy metabolites (active metabolites).
proportional to the dose
Pharmacokinetics is linear at the level of treatment.
The characteristics in patients
Age
No need to adjust the dose according to the patient's age. Studies on the elderly show that the absorption of solifenacin, which is treated in the form of an area under the curve (AUC) after using Solifenacin Succinate (5mg and 10mg, once a day) is similar between healthy elderly people (65 - 80 years old) and healthy young people (under 55 years old). The average absorption speed is indicated in the form of TMAX slower in the elderly and the last waste time is about 20% longer in the elderly. This moderate difference is thought to be clinical significance.
Solifenacin's
pharmacokinetics have not been identified in children and teenagers.
gender
Solifenacin's
pharmacokinetics is not affected by gender.
Race
Solifenacin's
pharmacokinetics is not affected by races.
kidney failure
The area under the curve (AUC) and the highest concentration in Solifenacin's plasma (CMAX) in patients with mild and moderate kidney failure is not significant than the data found in healthy volunteers. In patients with severe renal failure (Creatinine clearance ≤ 30ml/min), Solifenacin absorption is significantly higher in the control group with CMAX increasing by about 30%, AUC is 100%higher and T1/2 is 60%higher. Observed the statistical significance between creatinine and solifenacin clearance.
There is no study of pharmacokinetics in patients with blood decay.
Hepatic failure
In patients with average liver failure (Child - PUGH index from 7 to 9), CMAX is not affected, AUC increases 60% and T1/2 doubled. No research on pharmacokinetics of solifenacin in patients with severe liver failure.

Before taking Sotivex Ha Nam drugs treated the symptoms of incontinence, patients with bladder syndrome increased activity (3 blisters x 10 tablets)

How to use

vesicare is used orally and should swallow whole tablets with water. The drug can be used or not with food.

Dosage

Adults, including the elderly

The recommended dose is 5mg of solifenacin success once a day. If necessary, the dose can be increased to 10mg solifenacin success, once a day.

Children and teenagers

Safety and efficiency in children have not been determined. Therefore, do not recommend Vesicare for children.

Patients with renal failure

No dose adjustment for patients with mild to moderate renal failure (Creatinine clearance> 30ml/minute). Patients with severe renal failure (Creatinine clearance ≤ 30ml/min) should be treated carefully and not more than 5mg once a day (see the pharmacokinetic properties).

Patients with liver failure

No dose adjustment for patients with mild liver failure. Patients with average liver failure (Child - PUGH index from 7 to 9) should be treated carefully and does not use more than 5mg once a day (see the pharmacokinetic properties).

Strong Cytochrome P450 3A4 inhibitors

Maximum vesicare dose should be limited to 5mg when treated simultaneously with ketoconazole or with other doses of treatment of other strong CYP3A4 inhibitors such as ritonavir, nelfinarir, iTraconazole (see the interaction with other drugs and other types of interactions).

What to do when overdose?

Symptoms

Solifenacin Succinate overdose is likely to lead to serious anti -cholinergic effects. The highest solifenacin Succinate dose inadvertently drinking wrong in a patient is 280mg for 5 hours, resulting in changes in mental state without hospitalization.

Treatment

In case of overdose Solifenacin Succinate, patients should be treated with activated carbon. Gastric lavage is useful if done within 1 hour, but should not cause vomiting.

As well as other anti -cholinergic drugs, it is possible to treat symptoms as follows:

Severe central cholinergic anti -the hallucinations or obvious agitation: Physostigmin or Carbachol treatment. Tieu: Treatment with urinary catheter. Heart diseases have been relevant (such as myocardial ischemia, arrhythmia, congestive heart failure).

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

Due to the pharmacological effect of solifenacin, Vesicare can cause unwanted anti -cholinergic effects (generally) light or medium levels. The frequency of unwanted cholinergic resistance effects depends on the dose.

The most reported side reaction has been reported to Vesicare is dry mouth. This reaction occurs in 11% of patients treated by 5mg once a day, in 22% of patients treated by 10mg once a day and in 4% of patients treated with placebo. The level of dry mouth is usually mild and only occasionally leads to stopping treatment.

In general, the harmony with the drug is very high (about 99%) and about 90% of patients treated with Vesicare have completed the full 12 -week research stage. The group of media according to Meddra's classification

is very common

≥ 1/10

often meet

≥ 1/100,

less common
≥ 1/1000, rare
≥ 1/10,000, very rare

Unknown (not estimated from existing data)

Cystitis

Swang* Fuzzy Eye dry

Brushing chest drum*

Tournament*
Twisted*

respiratory, chest and mediastinum disorders Vomiting
indigestion
Abdominal pain

Gastroesophageal reflux disease - Esophagus
Dry sore throat

intestinal obstruction

vomiting* liver dysfunction*

Ban*

Demonstration of urticaria*
Evaluation* Weak*

kidney and urinary disorders Difficulty kidney failure* External

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Contraindicated use of solifenacin in patients with urinary retention, stomach - severe intestines (including enlarged colon), severe muscle weakness or narrow -angle glaucoma and patients at risk for these conditions.

Patients with hypersensitivity to the active ingredient or any component of excipients. ketoconazole.

Caution when using

Read the instructions carefully before use. If you need more information, please consult your doctor.

This drug is only used by a doctor.

It is necessary to assess other causes of urination (heart failure or kidney disease) before Vesicare treatment. If there is a urinary tract infection, it is necessary to start the appropriate antibacterial treatment.

Should be cautious when using Vesicare in patients:

The urine escape from the bladder is at risk of clinical significance. Average (Child - PUGH index from 7 to 9, see the dose and usage and pharmacokinetic characteristics), and the dose must not exceed 5mg for these patients. Administration and/or people who are simultaneously using drugs (such as bisphosphonate) can cause or increase esophagitis.

The extension of the QT and Twisted interval has been observed in patients with risk factors available, such as long -term QT interval and hypokalemia.

Safety and effectiveness have not been determined in patients with neurological causes of increased bladder motor activity.

Patients with rare genetic problems in tolerance Galactose, Lapp Lactase deficiency or malposure - Galactose should not use this drug.

Thiche with airway obstruction has been reported in some patients using solifenacin success. If the angioedema occurs, solifenacin success should be discontinued and appropriate treatment and/or need to take measures.

Anaphylaxis has been reported in some patients treated with solifenacin success, in patients with anaphylactic reaction, so the solifenacin success and appropriate treatment and/or/or need to take measures.

The maximum effect of Vesicare can be determined as soon as possible after 4 weeks.

The effect of the drug on the ability to drive and operate machinery

Because solifenacin is like other anti -cholinergic drugs that can cause blurred vision and in the case of less sleep and fatigue (see unwanted effects), the ability to drive and operate machinery can be adversely affected.

Use drugs for women during pregnancy and lactation

Pregnant women

There is no clinical data in pregnant women while using solifenacin. Animal studies do not show direct harmful effects on fertility, embryo/fetal development or childbirth. It is unclear the risk that may be available to people, need to be cautious when prescribing pregnant women.

breastfeeding

There is no data on the excretion of solifenacin into breast milk. In mice, solifenacin and/or its metabolites are excreted into milk and cause non -developing in newly dependent rats depending on the dose (see section of preclinical safety data). So avoid using Vesicare while breastfeeding.

Drug interaction

Pharmacological interaction:

Concentrated with other drugs with anti -cholinergic properties can lead to unexpected treatment and effects. There should be a distance of about 1 week after stopping treatment with Vesicare, before starting treatment with other anti -cholinergic drugs. The treatment effect of solifenacin may be reduced when used simultaneously with the cholinergic receptor owner.

solifenacin can reduce the effects of stimulating drugs of gastric tract, like metoclopramide and cisapride.

Pharmacokinetic interaction:

In vitro studies have shown that at treatment concentrations, Solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6 or 3A4 derived from human liver microsom. Therefore, solifenacin is not sure to change the clearance of drugs metabolized by these CYP enzymes.

Effects of other drugs on pharmacokinetics of solifenacin:

solifenacin is metabolized by CYP3A4. Concentrated with ketoconazole (200mg/day), is a strong CYP3A4 inhibitor, resulting in a 2 -fold increase in the area under the curve (AUC) of Solifenacin, while ketoconazole at a dose of 400mg/day leads to tripled AUC of Solifenacin. Therefore, the maximum Vesicare dose should be limited to 5mg, when used simultaneously with ketoconazole or other doses of treatment of other strong CYP3A4 inhibitors (such as Ritonavir, Nelfinavir, Itraconazole) (see the dosage and usage).

Contraindications to solifenacin and a strong CYP3A4 inhibitor in patients with severe kidney failure or medium liver failure.

Enzyme induction effect on the pharmacokinetics of solifenacin and its metabolites have not been studied, as well as no research on the effects of CYP3A4 substrates that have higher affinity on solifenacin absorption. Because solifenacin is metabolized by CYP3A4, pharmacokinetics interactions may be available to other CYP3A4 substrates with higher affinity (such as Verapamil, Diltiazem) and CYP3A4 induction substances (such as Rifampicin, Phenytoin, Carbamazepine).

The effect of solifenacin on pharmacokinetics of other drugs:

Oral contraceptives

Using Vesicare does not see the pharmacokinetic interaction of solifenacin on oral contraceptives for oral orally (ethinylestradiol/levonogestrel).

warfarin

Using Vesicare does not change the pharmacokinetics of R - Warfarin or S - Warfarin or other effects on prothrombin period.

digoxin

Using Vesicare does not see the effect on pharmacokinetics of digoxin.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children, read the user manual carefully before use.

Other drugs

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