Vesicare 5mg drug Astellas treats non -autonomous urinary symptoms (3 blisters x 10 tablets)

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

Ingredient

Composition information	Content
Solifenacin success	5mg

Uses

indications

vesicare 5mg medicine is indicated in the following cases:

Treatment of non -autonomous urination (urination) and (or (or) urination many times and urgently, may occur in patients with bladder syndrome, . 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.

Studies on pharmacological in vitro and in vivo show that Solifenacin is an Muscarin receptor competion inhibitor. 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.

Pharmacokinetics

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 participate in the transformation of 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).

Before taking Vesicare 5mg drug Astellas treats non -autonomous urinary symptoms (3 blisters x 10 tablets)

How to use

vesicare is used orally and should swallow the whole tablet 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

Patients with liver failure

No dose adjustment for patients with mild liver failure . Patients with average liver failure (Child - Pugh from 7 to 9) should be treated carefully and not exceeding 5mg once a day.

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, nelfivarir, iTraconazole.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when using overdose?

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.

How to handle

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.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using vesicare 5mg medicine , you may experience unwanted effects (ADR).

Common, ADR> 1/100

eye disorders: blurred vision.

Stomach - intestinal disorders: constipation, nausea, indigestion , abdominal pain.

Uncommon, 1/1000

Eye disorders: dry eyes.

Gastrointestinal disorders: Disease gastroesophageal reflux - esophagus, dry throat.

Infections and parasites: Urinary tract infections, cystitis.

Nervous disorders: Drowsiness, taste disorders.

respiratory disorders, chest and mediastinum: dry nose.

Skin and subcutaneous tissue disorders: Dry skin.

Kidney and urinary disorders: difficulty urinating.

Systemic disorders and local usage: Fatigue, peripheral edema.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

contraindicated

vesicare 5mg drug contraindicated in the following cases:

Patients with urinary retention, stomach - severe intestines (including large colon colon), severe muscle weakness or narrow -angle glaucoma and patients at risk of these conditions. (See the pharmacokinetic properties).

Be cautious when using

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 using simultaneous drugs (such as bisphosphonate) can cause or increase the possibility of 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 ability to drive and operate machinery

Because Solifenacin is like other anti -cholinergic drugs that can cause blurred vision and in the case of rarity is drowsiness and fatigue, the ability to drive and operate machinery can be adversely affected.

Pregnancy

There is no clinical data in pregnant women while using solifenacin. It is unclear the risk that may be available to people, need to be cautious when prescribing pregnant women.

Lactation period

There is no data on the excretion of solifenacin into breast milk. 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.

The effect 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).

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).

Storage

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

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