Nisten 5mg tablets Davipharm treat coronary artery disease, angina (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Ivabradine

Ingredient

Composition information	Content
Ivabradine	5mg

Uses

Indications

Nisten drugs are indicated in the following cases:

Treatment of coronary artery disease.

Treatment of chronic stable angina symptoms in coronary patients with normal sinus node rhythm. Ivabradin is used for:

Patients in tolerance or contraindication to beta blockers.

Pharmacy

Ivabradin is a selective inhibitor and IF channel specific in the sinus node. Ivabradin inhibits the ion current through channel F (IF), which leads to a reduced heart frequency without affecting muscle spasms, transmission, or myocardial redness, without affecting the peripheral vascular tone.

IVABRADIN's main pharmaceutical properties are a decrease in the dosage dependent heart rate. Analysis of heart rate reduction at a dose of 20mg x 2 times/day shows the trend of plateau effects suitable for reducing the risk of slow heart rate less than 40 times/minute.

In the usual dose, Ivabradin causes a heart rate to decrease by 10 times/minute at leave and exertion. This helps reduce the card and consumes myocardial oxygen. Ivabradin does not affect the transmission in the heart, myocardial or heart -reducing properties:

In clinical physiological studies, Ivabradin does not work on the atrial -ventilated or ventricular or QT transmission time.

In the left ventricular disorder (LVEF left ventricle ratio 30 - 45%), Ivabradin does not have any harmful effects on LVEF.

pharmacokinetics

Ivabradin absorbed completely after drinking but bioavailability only reaches about 40% due to the first metabolism. The peak concentration is reached after about 1 hour when the stomach is hungry but lasts an additional 1 hour when saturated and the absorption increases about 20-30%. IVABRADLN binds with plasma proteins about 70%.

Ivabradin metabolizes the liver and intestines through the cytochrom P450 CYP3A4 into the main metabolic substance N - Desmethyl - Ivabradin (S - 18982). This substance is metabolized followed by CYP3A4. Ivabradin has a 2 -hour waste sale time. The metabolites are excreted in urine and feces. About 4% of the dose appears in urine in the intact form. Dynamic research shows that IVABRADIN is allocated into breast milk.

Before taking Nisten 5mg tablets Davipharm treat coronary artery disease, angina (2 blisters x 14 tablets)

How to use

Oral drugs.

Dosage

Coronary disease treatment

Normal starting dose: 5mg x 2 times/day.

After 3-4 weeks can increase to 7.5mg x 2 times/day depending on the response. If during the treatment of heart rate at a regular break less than 50 times/minute or patients with symptoms related to slow heart rate such as dizziness, fatigue, reducing blood pressure, the dose should be adjusted about 2.5mg x 2 times/day.

Should stop treatment if the heart rate remains less than 50 times/minute or long -lasting heart rate.

Treatment of chronic heart failure

Only use Ivabradin for patients with stable heart failure.

Normal starting dose is 5mg x 2 times/day. After 2 weeks, it can be increased to 7.5mg 2 times/day if the heart rate is free at 60 times/minute or decreases to 2.5mg 2 times/day if the heart rate is less than 50 times/minute or the patient has symptoms related to slow heart rate such as dizziness, fatigue, reducing blood pressure.

If the heart rate is about 50 - 60 times/minute, should maintain a dose of 5mg x 2 times/day.

Older people

In patients ≥ 75 years old, should start taking low doses (2.5mg 2 times/day) before increasing the dose if necessary.

kidney failure

Unsurting dose adjustment in patients with renal impairment has creatinine clearance above 15ml/min. There is no drug used in patients with creatinine clearance below 15ml/min. Hence should be cautious.

Hepatic failure

Unsurting dose adjustment in patients with mild liver failure. Use carefully in patients with medium liver failure. Contraindicated in patients with severe liver failure.

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? In the case of heartbeat with poor hemodynamic intolerance, symptoms can be treated with how to use intravenous beta stimulating drugs. Can temporary pacemaker can be placed if necessary.

What to do when forgetting 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 Nisten, you may experience unwanted effects (ADR).

Very common

First eye.

Common

Headache (usually in the first month of treatment), blurred vision, dizziness, slow heartbeat, atrial block, level 1, extra mind.

Not common

Eosperus increased eosin, hyper Urea, fainting, heartbeat, reducing blood pressure, shortness of breath, nausea, constipation, diarrhea, angiography, rash, mouse, weakness, fatigue, increased creatinine.

Rare

Red, itching, urticaria, uncomfortable.

Very rare

Atrial fibrillation, atrial atrial block 2, atrial atrial block, level 3, sinus impairment syndrome.

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

Nisten drugs are contraindicated in the following cases:

Hypersensitivity to Ivabradin or any ingredients of the drug.

Heart rate at rest less than 60 times/minute before treatment.

Cardiococci.

Acute myocardial infarction.

Severe blood pressure lower ( Severe liver failure.

Sinus impairment syndrome.

Atrial sinus block.

acute or unstable heart failure.

Use a pacemaker.

Unstable angina.

Atrial block - Ventricular 3.

Collaborate with strong cytochrom P450 3A4 inhibitors such as Azol antifungal (ketoconazole, iTraconazole), macrolid antibiotics (clarithromycin, erythromycin oral, josamycin, telithromycin), HIV Protase inhibitors (Nelfinavir, Ritonavir), Ritonavir) nefazodon.

Pregnant and lactating women.

Precautions when using

arrhythmia

Ivabradin is not effective in treating or preventing arrhythmia and seems to be ineffective when a tachycardia occurs (such as ventricular or ventricular tachycardia). Therefore, IVABRADIN should therefore be in patients with atrial fibrillation or other arrhythmias that affect the sinus function.

Patients treated with Ivabradin must be clinically monitored regularly to detect atrial fibrillation (continuous or trigger), which should be monitored if there are clinical signs. The risk of atrial fibrillation is higher in patients with chronic heart failure treatment with Ivabradine. The atrial fibrillation is more common in patients with simultaneous use of amiodaron or anti -arrhythmic drug group I.

Closely monitor patients with chronic heart failure with interior conduction disorders (left -branch clogs, right branches) and loss of ventricular synchronization.

Patients with atrial atrial block 2

Do not recommend IVABRADIN in patients with atrium block level 2.

Patient with a bradycardia

Do not use Ivabradin in patients with heart rate at rest less than 60 times/minute before treatment. During treatment should be adjusted to reduce the dose if the heart rate is less than 50 times/minute or the person has symptoms related to the heart rate such as dizziness, fatigue, reducing blood pressure. Treatment should be stopped if the heart rate remains less than 50 times/minute or prolonged slow heart rate.

Coordinate with calcium channel blockers

Do not coordinate ivabradin with calcium channel blockers reducing heart rate such as verapamil or diltiazem. There is no safety data when coordinating Ivabradin with nitrates and Calci dihydropyridin channel blockers like amlodipine.

Chronic heart failure

Must stabilize heart failure before treatment with Ivabaradin. Use carefully in patients with heart failure IV in NYHA due to lack of data in this group of patients.

shock

Do not use Ivabradin immediately after shock.

Visual influence

Ivabradin affects the function of the retina. So far there is no evidence of the harmful effects of the drug in the retina. The drug should be stopped if any visual injury occurs. Should be careful in patients with pigmentitis.

Patients with blood pressure loss

There is no sufficient data in patients with mild to moderate blood pressure, so be cautious in these patients. IVABRADIN ATTRACTIVE IN PATIENT PATIENTS (

Patients with congenital QT syndrome or being treated with drugs that can extend QT.

Do not use Ivabradin in patients with congenital QT syndrome or are being treated with drugs capable of prolonging QT. If it is necessary to coordinate, the heart must be closely monitored.

To be out of reach of children.

The ability to drive and operate machinery

The drug does not affect the ability to drive and operate machinery.However, iVABRADIN can cause a fireflock when there is a sudden change in light intensity, especially when driving at night. So be cautious.

Pregnancy

Do not use Ivabradin for pregnant women.

Breastfeeding period

Drug interaction

Contraindicated IVABRADIN combination with drugs capable of inhibiting CYP3A4 such as Azol antifungal (ketoconazol, otraconazol), Macrolid antibiotics (Clarithromycin, Erythromycin oral, Josamycin, Josamycin, Telithromycin) (Nelfinavir, Ritonavir) and Nefazodon. Ketoconazole (200mg once a day) and josamycin (1g x 2 times/ day) increase the average plasma concentration of Ivabradin to 7-8 times.

Do not coordinate Ivabradin with drugs that can extend QT such as Mach heart medications (quinidin, disopyramid, beepridil, sotalol, ibutilid, amiodaron), not cardiovascular drugs (pimozid, ziprasidon, SERTINDOL, Mefloquin, halofantrin, pentamidin, cisapid, cisapid, cisapid, cisapid, cisapid, cisapid erythromycin static Mach).
Caution when coordinated:

Average CYP3A4 inhibitors: When using Ivabradin simultaneously with medium CYP3A4 inhibitors (such as fluconazol), should start at 2.5mg x 2 times/day if the heart rate is over 60 times/minute and must be closely monitored.

Grapefruit juice: Ivabradin concentration increases about 2 times when used with grapefruit juice. Therefore, grapefruit juice should therefore be treated with drugs.

CYP3A4 induction drugs: CYP3A4 induction drugs (such as rifampicin, barbiturat, phenytoin, st. IVABRADIN, ST. John's World reduces half Ivabradin levels to avoid coordination.

Storage

In a dry place, avoid light, thermal do not exceed 30 ° C.

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