Egudin 5 Medisun Treatment Treatment Symptom 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

Egudin® 5 drugs are indicated for treatment of non -control urinary symptoms due to urge (urination) and/or urination many times and urine in patients with increased bladder syndrome.

Pharmacokology

Mechanism of action

solifenacin is a fighting antagonist with Muscarinic receptor. Muscarinic receptor plays an important intermediate role in the function of the Cholinergic system (sympathetic nerves), including causing bladder smooth spasm and stimulating salivation.

Pharmaceutical effect

The treatment of solifenacin success dose of 5 mg and 10 mg daily has been studied in some random clinical trials, controlled, double blindness in men and women with increased bladder activity. The results showed that both dose of 5 mg and 10 mg had a significant improvement in the main and secondary indicators compared to placebo. The effect is observed within a week after the beginning of treatment and stability for 12 weeks. Long -term open research shows the efficiency maintained for at least 12 months.

After 12 weeks of treatment, about 50% of patients with urination are not self -control before the treatment is no longer on the situation, and an additional 35% of patients have reduced the number of urination to less than 8 times/day. Treatment of symptoms of increased bladder activity also benefits when measuring a number of criteria for quality of life, such as health awareness, impact of non -control urination, role limit, physical limitations, social limitations, emotions, severity of symptoms, measures to measure severity and sleep/energy.

Pharmacokinetics

absorption

On a healthy volunteer, the peak of plasma (cmax) of Solifenacin is achieved within 3-8 hours after drinking. In a stable state, CMAX reaches about 32.3 - 62.9 ng/ml, corresponding to the dose of 5 and 10 mg. The absolute bioavailability of solifenacin is about 90%. Solifenacin concentration in plasma ratio is the dose ratio. Food does not affect the absorption of solifenacin.

Distribution

solifenacin binds to human plasma proteins at about 98%, mainly with α1-acid glycoprotein. Solifenacin is distributed high to non-central nervous systems (Non-NCS), the average distribution volume in a stable state is 600L.

Metabolism

solifenacin is metabolized in the liver, the main excretion path is through CYP3A4; However, there is still other alternative metabolic pathway. The main metabolic lines of solifenacin are through the N -position oxidation of Quinuclidin and hydroxylation of 4R position of the tetrahydroisoquinolin. An active metabolic substance is 4R hydroxy solifenacin (appearing at low concentrations, insignificant clinical activity) and three inactive metabolites (N -glucuronid, N -OXID and 4R -Hydroxy - N -olid of Solifenacin) have been found in human plasma after drinking.

Elimination

After taking the 10 mg dose of [‘C] –Solifenacin Succinat on a healthy volunteer, 69.2% of the dose is recovered in urine and 22.5% in feces after more than 26 days. Under 15% of the dosage is recovered in urine in the form of non -metabolized solifenacin. The main metabolites determined in the urine are N-OXID of solifenacin, 4r-hydroxy solifenacin and 4r-hydroxy-N-oly-olyacin; In fertilizer is 4r-hydroxy solifenacin. Salifenacin waste sale time when used is about 45 - 68 hours.

Special subjects:

Elderly:

Research on elderly volunteers (65 - 80 years old) shows that CMAX, AUC and Solifenacin's disposal time are about 20-25% higher than young volunteers (18 - 55 years old).

Children:

Solifenacin's pharmacokinetics have not been established in children.

Sex:

Solifenacin's

pharmacokinetics is not significantly affected by gender.

Race:

The number of subjects of different races is not enough to conclude about the effects of race on the pharmacokinetics of Solifenacin.

Patients with renal failure:

There is a increase of 2.5 times auc and 1.6 times the sale time of solifenacin in patients with severe renal impairment. Solifenacin sucinat dose is not recommended in patients with severe renal impairment (

Patients with liver failure:

There is an increase in AUC and 2 times the sale of solifenacin's exhaust time in medium liver failure patients. The dose of solifenacin success is not recommended in patients with medium liver failure (Child - Pugh B).

Before taking Egudin 5 Medisun Treatment Treatment Symptom Symptoms (3 blisters x 10 tablets)

How to use

use by oral.

Egudin should be swallowed with water. Can be used during or outside meals.

Dosage

Dosage calculated by the dose of solifenacin success.

Adults (including the elderly)

Normal recommendations are 5 mg, once a day. If the dose of 5 mg is well tolerated, the dose can be increased up to 10 mg once a day.

Children

Safety and effectiveness of solifenacin in children has not been established. Therefore, this drug should not be used for children.

Patients with renal failure

Patients with mild to medium mild renal failure (ClCr> 30 ml/ minute): No dose adjustment.

Patients with severe renal impairment (CLCR ≤ 30 ml/ minute): daily dose does not exceed 5 mg.

Patients with liver failure

Patients with mild liver failure: No dose adjustment.

Patients with average liver failure (Child-Pugh b): Daily dose does not exceed 5 mg.

Persons who are taking strong CYP3A4 inhibitors (e.g. ketoconazole, iTraconazole, ritonavir, nelfinavir): daily dose does not exceed 5 mg.

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 overdose? Symptoms such as pupils, blurred vision, tremor and dry skin occur on the 3rd day in healthy volunteers to take the dose of 50 mg/day (5 times the maximum recommended dose) and cure within 7 days after stopping the drug.

In case of overdose, gastric lavage and use of appropriate support measures, electrocardiogram monitoring is also recommended.

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 Egudin® 5, you may experience unwanted effects (ADR).

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

The undesirable effects have been reported related to solifenacin listed in the table below according to the organ system and frequency. The frequency is classified as follows: Very common (≥ 1/10), common (≥ 1/100 to

Agency system

Very common

Common

Less

Rare

Very rare

Unknown

Cystitis

Hemorrhage

Mental disorders

delirium

Intence buds

dizziness

Headache

dry eyes

heart disorders

extends the range of qt

Atrial fibrillation

Brushing the chest drum

tachycardia

dry mouth

Constipation

Nausea

indigestion

Abdominal pain

Gastroesophageal reflux - esophagus

Dry throat

colon congestion

Solid manure

vomit

abdominal discomfort

Abnormal liver function test

Itching

Ban Ban

Diverse Redders

urticaria

Tharma

Peeling dermatitis

urinary retention

Peripheral edema

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

Egudin® 5 drugs contraindicated in the following cases:

Urinary retention.

Stomach fluid.

Glaucoma narrow angle uncontrolled.

Severe liver failure (Child-Pugh c).

Too hypersensitivity to any ingredients of the drug.

Be cautious when using

angioedema on the face, lips, tongue and/or larynx reported when using solifenacin, which occurs a few hours after the first dose or after taking multiple doses. Evaluation combined with upper respiratory edema can be life -threatening. If the angioedema in the tongue, the lower pharynx and the larynx occurs, the solifenacin should be stopped immediately and take appropriate measures to ensure the patient's airway. Rarely anaphylactic reactions in patients using Solifenacin Succinat. Do not use drugs in patients with hypersensitivity known or suspected to Solifenacin Succinat. In patients with anaphylactic reactions, solifenacin success should be discontinued and used appropriate treatments.

The anti -cholinergic effects have been reported when using the drug, including headaches, confusion, hallucinations and drowsiness. Patients should be monitored the above signs, especially after the beginning of treatment or increased dose. Advise patients not to drive or operate heavy machinery until they know the effects of the drug. If the patient has cholinergic effects, the decrease in the dose or the stop should be considered.

Use cautiously on the subjects:

Patients with clinical obstruction of clinical significance because it can cause urinary retention.

Patients with reduced intestinal motility.

Patients who are being treated with narrow -angle glaucoma.

Patients with liver failure, kidney failure.

Patients with a history of prolonged QT or patients taking the drug to extend the QT range.

The ability to drive and operate machinery

like other anti -cholinergic drugs, solifenacin can cause blurred vision, drowsiness and fatigue, so you should not drive or operate machinery while taking the drug.

Pregnancy

There is no full study of the effects of solifenacin on pregnant women. Solifenacin should not be used in pregnant women unless the maternal benefits are greater than the risk for the fetus.

The period of breastfeeding

There is no study of solifenacin's excretion into breast milk. Animal data shows Solifenacin excreted milk. It is necessary to consider the benefits of breastfeeding and the benefits of the treatment for the mother to decide for the child to stop feeding or stop/avoid using solifenacin.

Interactive drug

Metabolic drugs by Cytochrom P450: At the treatment concentration, Solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 originating from microsom liver.

CYP3A4 inhibitors: In vitro metabolic research shows that Solifenacin is the substrate of CYP3A4. CYP3A4 induction or inhibition drugs can change the pharmacokinetics of solifenacin.

Ketoconazole: After taking a dose of 10 mg of solifenacin success simultaneously with 400 mg of ketoconazole (a strong CYP3A4 inhibitor), the average cmax of solifenacin increases 1.5 times and AUC increases 2.7 times, corresponding. Therefore, solifenacin success dose should not exceed 5 mg when used simultaneously with ketoconazole or other strong CYP3A4 inhibitors.

Oral contraceptive pills: The presence of solifenacin does not significantly affect the plasma concentration of the combined birth control pills (Ethinyl estradiol/ levonorgestrel).

warfarin: Solifenacin does not significantly affect the pharmacokinetics of R-Warfarin or S-Warfarin.

Digoxin: Solifenacin does not significantly affect the pharmacokinetics of digoxin (0.125 mg/day) in healthy people.

Storage

Store in a dry place, avoid light, temperature not exceeding 30 ° C.

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