Sava Ivabradine 5 medicine for chronic angina (5 blisters x 10 tablets)

Pregnant and lactating women.

Precautions when using

arrhythmia

Ivabradine is not effective for treating or preventing arrhythmia and may also lose effect when there is tachycardia (for example, ventricular tachycardia or ventricular tachycardia). Therefore, it is not recommended to use Ivabradine for patients with atrial fibrillation or other arrhythmias that interact with the function of the sinus node. Regular clinical monitoring in patients who use Ivabradine to see if there is atrial fibrillation (prolonged or dramatic), including electrocardiogram measurement when indicated of clinical (for example, seriously in case of angina, hitting chest drums, abnormal vascular).

Patients with atrial block - ventricular 2

Do not use Ivabradine.

Patients with slow heart rate

Do not start IVABRADINE treatment for patients with heart rate at leave before treatment less than 60 times/minute. If during the treatment process, the heart rate is less than 50 times/minute or the patient has symptoms related to the heartbeat, such as dizziness, fatigue or hypotension, the dose must be reduced. Discontinue IVABRADINE treatment if the heart rate is less than 50 times/minute or if the symptoms of slow heart rate persist.

Combining anti -angina drugs

It is not recommended to combine Ivabradine with calcium blockers that reduce heart frequency such as verapamil or diltiazem. There is no data on safety when coordinating Ivabradine with nitrates and with dihydropyridine calcium blockers like amlopidine. IVABRADINE has not been defined with an increase in effect when coordinated with calcium blockers dihydropyridine.

Chronic heart failure

Heart failure must be adequately controlled before considering Ivabradine. Contraindicated to use Ivabradine in patients with heart failure III - IV according to NYHA's classification, due to lack of data on clinical validity and safety. Caution should be careful with patients with disordered left ventricular dysfunction as well as patients with heart failure II according to NYHA due to the small number of patients studying.

stroke

It is not recommended to use Ivabradine immediately after the stroke, because there is no enough data for these cases.

visual function

Ivabradine affects the function of the retina. So far there has been no evidence of the harmful effects of Ivabradine in the retina, it is unclear the effects of Ivabradine treatment lasted for a year on the retinal function. It is necessary to consider using the drug when there is any pathology related to visual function. Also cautious with patients with pigmentitis.

Patients with hypotension

Lack of data in patients with hypotension is mild and moderate. Therefore, IVABRADINE should therefore be used for these objects. Ivabradine contraindicated for patients with serious hypotension (blood pressure

Atrial fibrillation - arrhythmia

There is no evidence of the risk of heartbeat (excessive) when returning to the sinus rhythm if the heart shake is started for patients to use Ivabradine. However, when not enough data, it is advisable to consider deformity 24 hours after the last dose of Ivabradine.

Used in patients with congenital QT syndrome or treatment with drugs that extend the qt segment

Avoid use in patients with congenital QT syndrome or treatment with drugs that extend the QT segment. If you find it necessary, you need to monitor the heart very carefully.

Used in patients with medium liver failure

Be careful when taking Ivabradine for patients with medium liver failure.

Used with patients with serious renal failure

Be careful when using Ivabradine for patients with severe renal impairment (creatinine clearance

Because the tablet contains lactose, it should not be used for patients with genetic problems (rare) such as galactose intolerance, or deficiency of Lapp Lactase or Glucose - Galactose.

The ability to drive and operate machinery

Special research on the possible effects of Ivabradine on the ability to drive has been conducted on healthy volunteers without evidence of driving impairment. The results showed that Ivabradine did not affect the ability to drive and operate machinery.

However, Ivabradine can cause temporary glare. It should be noted that such dazzling phenomenon when driving or using machines in cases may have a sudden change in light intensity, especially when driving at night.

Pregnancy

There is no adequate data on Ivabradine use for pregnant women. Research on animal reproduction shows that this drug is poisonous with embryos and monsters. The risk of this drug is unknown. So contraindications used during pregnancy.

Breastfeeding period

Animal research shows Ivabradine excreted in milk. Therefore contraindicating mothers use Ivabradine during breastfeeding.

Drug interaction

should not be coordinated with Ivabradine with substances that extend the qt segment

Cardiovascular drugs extend the QT segment (for example: Quinidine, Sotalol, Disopyramide, Bepridil, Ibutilide, Amiodazone).

Non -cardiovascular drugs extend the QT segment (for example: Pimozide, Ziprasidone, Serttindole, Mefloquine, Halofantrine, Pentanidine, Cisapride, Erythromycin Venous).

Avoid combining cardiovascular and non -cardiovascular drugs that extend the QT segment along with Ivabradine because of the severity of the QT segment may be more serious due to heart rate decrease.

If you need to coordinate, you must closely monitor the heart state.

Ivabradine is only metabolized through CYP3A4 and is a very weak inhibitor of this cytochrome. Ivabradine shows no effect on metabolism and to plasma concentrations of other substrates of CYP3A4 (light, medium and strong inhibitors). CYP3A4 inhibitors and induction have the ability to interact with Ivabradine and affect the metabolism and pharmacokinetics of Ivabradine at clinical significance.

Determined drug interaction research is CYP3A4 inhibitors that increase the concentration of Ivabradine in plasma, while induction substances reduce IVABRADINE concentration. Increasing the plasma concentration of Ivabradine may be related to excessive risk of slow heart rate.

Contraindicated Ivabradine combination with strong CYP3A4 inhibitors such as Azole antifungal drugs (ketoconazole, iTraconazole), macrolide antibiotics (clarithromycin, erythromycin oral, josamycin, telithromycin), HIV Protase inhibitors (Nefinavir, Ritonavir) and Ritona) Mefazodone. Strong CYP3A4 inhibitors such as ketoconazole (200 mg, once a day) or josamycin (1 g, twice a day) increase the level of Ivabradine in plasma to 7 to 8 times.

Do not coordinate with Ivabradine with moderate inhibitors CYP3A4

Researching specific interactions on volunteers and on patients shows that if Ivabradine is used with diltiazem or verapamil (which reduces the heart rate), will increase the concentration of Ivabradine (increasing the area under the curve to 2-3 times) and slowing the heart rate is 5 beats per minute. Do not recommend coordination of Ivabradine with these drugs.

Be cautious when combining drugs with moderate inhibitors CYP3A4

Combining Ivabradine with moderate inhibitors CYP3A4 (e.g. Fluconazole) can be carefully conducted with the starting dose of 2.5 mg each time, twice a day. Should only be coordinated when the heart rate at rest> 60 beats/min, then closely monitor the heart rate.

grapefruit juice

Combination of drinking with grapefruit juice increases Ivabradine concentration 2 times. So during the drinking period Ivabradine, it is necessary to limit eating grapefruit.

CYP3A4 induction substances

CYP3A4 induction substances (for example, rifampicin, barbiturates, phenytoin, hypericum Perforatum (St. John’s World) can reduce the concentration and effectiveness of iVabradine. If combined with CYP3A4 induction substances, Ivabradine dose adjustments.

Coordinate Ivabradine 10 mg x 2 times/day with St. John’s Wort shows half of the area under the curve of Ivabradine. Therefore, it is necessary to limit the use of St. John’s Wort during Ivabradine.

Other combinations

Research on specific interactions shows that there is no clinical significance of the following drugs to the pharmacokinetics and pharmacokinetics of IVABRADINE: Proton inhibitor (omeprazole, Lansoprazole), Sildenafil, HMG - CoA - Reductase inhibitors (Simvastatin), Calcium inhibitors of Calcium Dihydropyrine (Amlodyrin lacidipine), digoxin and warfarin. In addition, Ivabradine does not affect the pharmacokinetics of Simvastatin, Amlodipine, Lacidipine, does not affect the pharmacokinetics and pharmacodynamics of Digoxin, Warfarin and does not affect ASPIRIN pharmacology.

Clinical tests III with the following preparations are used unlimited, so it has been regularly coordinated with iVABRADINE and has not seen a problem of safety: Angiotensin transition inhibitors, Angiotensin II receptor antagonists, diuretics, short and long -acting nitrate, HMG - CoA - Reductase, fibrate, fibrate, anti -pump drugs Oral form, aspirin and other anti -platelets.