Procoralan medicine 5mg Servier treat stable angina (4 blisters x 14 tablets)

Dosage form Box of 4 blisters x 14 tablets
Specifications Ivabradine

Ingredient

Composition informationContent
Ivabradine5mg

Uses

Indications

Procoralan medicine 5mg is indicated for use in the case of chronic stable angina treatment.

Ivabradin is indicated to treat chronic angina symptoms in adults with dynamic disease Coronary disease

  • In adults in tolerance or anti -determination with beta blockers.
  • Ivabradin is indicated in the treatment of chronic heart failure from NYHA II to IV, with systolic dysfunction, in patients with sinus arrhythmia and heart frequency> 75 beats/minute in combination with standard treatment including beta blockers or when beta blockers are contraindicated or when conderative blockers. Learning

    • Mechanism of impact

    IVABRADIN is a substance that reduces the heart frequency, due to the selective inhibition and specific inhibition effects of the heart rate center, which controls the spontaneous diastolic reducing in the sinus node and the heart frequency regulator. The effect on the heart of the drug is specific to the sinus button without affecting the transmission time in the atrial, atrial - ventricular, clear as well as no effect on the re -loss or heart muscle contraction.

    Ivabradin can also interact with the LH line in the retina, which is very similar to the LF line in the heart. This LH line is involved in the temporary resolution of the visual system by reducing the retinal response with dazzling light pulse.

    In cases of stimulation (for example, rapid change of brightness), ivabradin inhibits a part of LH line as the foundation for the dazzling phenomenon that can be encountered in patients. Phosphenes is described as a temporary glare in a certain region of the market.

    Pharmacological effect

    IVABRADIN's main pharmacological properties in humans are a specific reduction in heart frequency depending on the dose. Analysis of heart frequency reduction with doses of up to 20mg at a time and drink twice a day, it is clearly pointed to the tendency to reach the effect of a plateau along with a reduction in the risk of serious slow heart rate below 40 beats/minute.

    With the usual recommendations, the heart frequency decreases by about 10 beats/minute at leave and during practice. This leads to reducing the burden on the heart and reducing oxygen needs for the heart muscle.

    Ivabradin has no effect on the transmission in the heart, to the constraints of the heart (no effect inhibiting myocardial shrinking) or to the re -generation of the ventricle:

  • In clinical physiological studies, Ivabradin does not work on the atrial - ventricular or ventricular transmission time or editing the qt segment on the electrocardiogram. Learning

    absorption

    Ivabradin absorbs quickly and is almost completely after drinking with peak plasma concentrations after about 1 hour, if taken for drugs when hungry.

    The absolute bioavailability of film tablets is about 40%, due to the first metabolism in the intestine and liver. Food slowly absorbs drugs about 1 hour, increasing plasma medication concentration to 20-30%. It is recommended to take medicine at a meal to help reduce the change in each individual about the concentration of the drug.

    Distribution

    Ivabradin attaches about 70% to plasma proteins and integral distributed in a stable state of nearly 100 liters in patients.

    Peak concentration in plasma after long -term taken for recommended doses (5mg each time, 2 times a day) is 22ng/ml (CV = 29%). The average concentration in plasma is 10ng/ml in a stable state (CV = 38%).

    Metabolism

    Ivabradin is strongly metabolized through the liver and intestines, by oxidizing through only Cytochrome P450 3A4 (CYP3A4). The main metabolites are active as the derivative N - reducing methyl (S 18982) with a concentration of about 40% of the original Ivabradin active ingredient. The metabolism of this active metabolite also through CYP3A4.

    Ivabradin has weak affinity for CYP3A4, does not inhibit or clearly induced CYP3A4. Therefore, it is less likely that Ivabradin has changed the metabolism or plasma concentrations of the substrates of CYP3A4. In contrast, strong CYP3A4 inhibitors and strong CYP3A4 induction substances can have a significant impact on the concentration of Ivabradin in plasma.

    Elimination

    Ivabradin eliminates the main sale time of 2 hours (70 - 75% of the area under the curve) in plasma, while the effective selling time is 11 hours.

    General purification is about 400ml/min and the purification of the kidney is about 70 ml/min. Elimination of metabolites through feces and urine with similar amounts. About 4% of oral doses are excreted in the urine.

    Linear/non -linear: IVABRADIN's dynamics is linear with oral dose of 0.5 - 24mg.

    Special subjects:

    For the elderly: There is no difference in pharmacokinetics (area under the curve and peak concentration) when comparing the elderly patient (≥ ≥ 65 years) or very elderly (≥ 75 years old) and the common population.

    Renal failure: Effect of renal failure (creatinine clearance from 15 - 60ml/min) on Ivabradin's dynamics is at least, suitable for the purification of the glomerular participation (about 20%) to the total elimination of iVabradine and main metabolites S 18982.

    Hepatic failure: For patients with mild liver failure (Child - Pugh to 7) The area under the curve of Ivabradin and of the main metabolites is about 20% higher than the person with normal liver function. The data is not strong enough to conclude for medium liver failure. There is no data on patients with severe liver failure.

    Pediatric: IVABRADIN pharmacokinetics on children with chronic heart failure from 6 months to under 18 years of age is similar to pharmacokinetics described in the elderly when applying the dose mode based on age and weight.

    Related between pharmacokinetic/pharmacokinetic (PK/PD): Analysis of pharmacokinetics/pharmacokinetic relevance shows that the heart frequency decreases is almost linear when increasing the concentrations of Ivabradine and S18982 in plasma until the dose of 15 - 20mg, twice a day. With higher doses, the reduction of heart frequency will no longer be proportional to Ivabradine concentration in plasma and tend to reach the plains.

    Ivabradin's high concentration may be encountered when combined with Ivabradin with strong CYP3A4 inhibitors that can lead to excessive heart frequency reduction. While that risk will decrease when combined with moderate inhibitors CYP3A4.

    Ivabradin's pharmacokinetics/pharmacokinetics relationship on children with chronic heart failure from 6 months to under 18 years of age similar to the pharmacokinetic/pharmacokinetic relationship has been described in adults.

    • Before taking Procoralan medicine 5mg Servier treat stable angina (4 blisters x 14 tablets)

    How to use

    Procoralan medicine 5mg is used orally, bright and dark during meals.

    Dosage

    Adults

    Treatment of chronic stable angina symptoms

    The recommended treatment or adjustment of treatment dose takes place when conducting many heart frequency measurements as well as electrocardiogram control or 24 -hour outpatient monitoring.

    The starting dose of Ivabradin should not exceed 5 mg twice daily in patients under 75 years old. After three to four weeks of treatment, if the patient still has symptoms, if the starting dose is well tolerated and if the heart rate is over 60 beats/minute, the next dose increases in patients with a dose of 2.5 mg twice daily or 5 mg twice daily. The maintenance dose should not exceed 7.5 mg twice daily.

    If there is no improvement in symptoms of angina within 3 months after arising, it is necessary to stop the treatment with Ivabradin.

    In addition, the stop treatment should be considered if there is only limited response to symptoms and when there is no clinical decrease in the heart frequency at the end of three months.

    If during treatment, the heart rate decreases continuously to less than 50 beats/minute at vacation or patients with symptoms related to slow heart rate such as dizziness, fatigue or hypotension, treatment dose should be reduced, maybe 2.5 mg twice daily (half of 5mg twice daily). After reducing the dose, it is necessary to monitor the heart frequency. It is necessary to stop treating if the heart frequency is maintained at less than 50 beats/minute or the symptoms of the heart rate continue to continue when the dose is reduced.

    Treatment of chronic heart failure

    The treatment is only started in patients with stable heart failure. Treatment doctors are recommended to have experience in the treatment chronic heart failure .

    IVABRADin's usual initial initials for 5mg twice daily.

    After two weeks of treatment, the dose may increase to 7.5mg twice daily if the heart frequency is continuously over 60 beats/minute or decrease to 2.5mg twice daily (half of 5mg twice daily) if the heart frequency is continuously under 50 beats/minute or in case of symptoms related to bradycardia such as dizziness, fatigue or drop in blood pressure. If the heart frequency is between 50 and 60 beats/minute, maintain the dose of 5mg twice daily.

    If during the treatment process, the heart frequency at a decrease at less than 50 beats/minute or the patient has symptoms related to the slow heart rate, the dose should be reduced to a lower dose in patients who are using 7.5mg twice daily or 5mg twice daily. If the heart rate increases stably over 60 beats/minute at vacation, patients who are taking a dose of 2.5mg or 5mg twice daily can be adjusted to a higher dose.

    Must stop treatment in case the heart frequency is maintained below 50 beats/minute or symptoms of heart rate still exist.

    Special subjects

    Elderly:

  • In patients aged 75 and older, should consider using lower doses (2.5mg twice daily. For example, half a tablet 5mg twice daily) before increasing the dose if necessary.
  • There is no need to adjust the dose in patients with renal impairment and have creatinine clearance above 15ml/min.
  • No dose adjustment in patients with mild liver failure.
  • The efficiency and safety of IVABRADIN in the treatment of chronic heart failure in children under the age of 18 has not been set.

    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

    Overdose of Procoralan 5mg can lead to a serious and prolonged slow rhythm.

    How to handle

    Serious slow pace needs symptomatic treatment in deep specialties. In the case of a slow -intolered hemodynamic rhino, it may be necessary to consider symptomatic treatment, including intravenous beta stimulants like isoprenaline. If necessary, temporarily placing a pacemaker.

    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 Procoralan 5mg , you may experience unwanted effects (ADR).

    Very common, ADR> 1/10

  • Visual disorders: Phosphene (phosphene).
  • visual disorders: blurred vision. 1/100)
  • Blood disorders and lymphatic systems: leukemia. Heartycard associated. Slow rhythm.
  • Cardiovascular disorders: Atrial AI Block, Grade 2, Grade 3.

    Notify the doctor the 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

    Procoralan medicine 5mg Contraindications for the following cases:

  • Hypersensitivity to any ingredient of the drug.
  • Cardiococci shock. Dinh.
  • Depends on the pacemaker. Telithromycin), HIV Protease inhibitors (Nelfinavir, Ritonavir), Nefazodone. Toan.

    • Be cautious when using

    Lack of benefits of clinical results in patients with stable angina symptoms. Ivabradin is only indicated in patients with chronic stable angina because this drug does not bring the benefits on the heart.

    heart rate measurement:

  • Because the heart rate may fluctuate over time, it is necessary to consider conducting heart rate measurement, electrocardiogram control or 24 -hour outpatient monitoring when determining the heart frequency at leave before treatment with iVABRADIN, which can be applied to monitor treatment for patients with heart frequency under 50 beats/minute after reducing the dose.

    • arrhythmia:

  • Ivabradin is not effective for treating or preventing arrhythmia and may also lose effect when there is tachycardia (for example: ventricular or ventricular tachycardia). Therefore, it is not recommended to use Ivabradin for atrial fibrillation patient or other arrhythmias that interact with the function of the sinus button.

    Patients with atrial block - Ventricity 2:

  • Do not use Ivabradin.

    • Used for patients with a slow heart rate:

  • Do not start ivabradin treatment for patients with heart rate before treatment before treatment less than 70 beats/minute. Discontinue IVABRADIN treatment if the heart rate is less than 50 times/minute or if the symptoms of slow heart rate exist.

    • Coordination of calcium channel blockers:

  • It is not recommended to coordinate Ivabradin with calcium blockers that reduce heart frequency such as verapamil or diltiazem. With Calcium blockers Dihydropyridine.

    • Chronic heart failure:

  • Heart failure must be adequately controlled before considering using Ivabradin. The number of researchers is still small.

    • stroke:

  • It is not recommended to use Ivabradin right after the stroke, because there is not enough data for these cases.

    • visual function:

  • Ivabradin affects the function of the retina. So far, there has been no evidence of the harmful effects of Ivabradin in the retina, it is currently unclear the effects of IVABRADIN treatment that lasts over a year on the retinal function.

    Patients with hypotension:

  • Lack of data in patients with hypotension is mild and medium and therefore, it is necessary to use Ivabradin carefully for these objects.

    Atrial fibrillation - arrhythmia:

  • There is no evidence of the risk of slow heartbeat (excess) when returning to the sinus rhythm if the heart shake is started for patients to use Ivabradin.

    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 it is necessary to coordinate like this, the heart should be monitored very carefully.

    Patients with hypertension need to change blood pressure treatment:

  • When changing treatment in patients with chronic heart failure with Ivabradin, blood pressure should be monitored for an appropriate time due to studies showing that patients using iVabradin have more hypertension than placebo, but these periods are mainly passing after changing blood pressure treatment and does not affect the effectiveness of IVABRADIN.

    excipients:

  • 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

    A study conducted on healthy volunteers to assess the effect of Ivabradin on driving ability shows no change. However, cases affecting the ability to drive due to visual effects have been reported during circulation.

    Ivabradin can temporarily cause dazzling eye phenomenon. The ability to appear dazzling eye phenomenon should be noted in the case of driving and operating machines whose light intensity changes suddenly. Especially driving at night. Ivabradin does not affect the ability to operate machinery.

    Pregnancy

  • Women who are likely to be pregnant: Need to use appropriate contraception during treatment.

    Animal studies have shown toxicity on reproduction. These studies have shown the consequences of fetal poisoning and teratogenicity. These risks on people are not known. Therefore, Ivabradine is contraindicated during pregnancy.

    Breastfeeding period

  • Animal studies have shown ivabradin excreted through breast milk. Therefore, ivabradine is contraindicated during breastfeeding. Women need to be treated with Ivabradin should stop breastfeeding and choose other food methods for their children.

    • Drug interaction

    Pharmacological interaction

    Simultaneous use is not recommended:

    substances that extend the qt segment:

  • Cardiovascular medicine extends the QT segment (for example: quinidine , sotalol, disopyramide, bepridil, ibutilide, amiodazone). Pentanidine, cisapride, erythromycin).

    • Avoid combining cardiovascular and non -cardiovascular drugs that extend the QT segment along with Ivabradin because the situation of extending the QT segment may be more serious due to reduced heart rate. If it is necessary to coordinate, closely monitor the heart state (see caution at use).

    Use Caution Causes:

  • Diuretics reduce potassium (thiazide diuretic and diuretics): Hypotension can increase the risk of arrhythmia. Because ivabradine can cause a slow heart rate, the result of a combination of hypokalemia and reduced heart rate is a serious base factor, especially in patients with congenital QT syndrome or drug use.

    • Pharmacokinetic interaction

    Cytochrom P450 3A4 (CYP3A4):

    Ivapradine is only metabolized through CYP3A4 and is a very weak inhibitor of this cytochrom. Ivabradin 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 Ivabradin and affect the metabolism and pharmacokinetics of Ivabradin at clinical significance.

    Determined drug interactive research is CYP3A4 inhibitors that increase the concentration of Ivabradin in plasma, while induction substances reduce IVABRADIN levels. Increasing plasma concentrations of Ivabradin may be associated with excessive risk of slow heart rate.

    Simultaneous use is contraindicated:

  • Combining Ivabradin with strong CYP3A4 inhibitors such as Azole antifungal drugs (ketoconazole, iTraconazole), macrolide antibiotics ( clarithromycin , erythromycin oral, josamycin, telithromycin), HIV -protease inhibitors (Nefinir, NEFINAD, NEFINA Ritonavir) and Mefazodone (see the control item). Strong CYP3A4 inhibitors such as ketoconazole (200mg, once a day) or josamycin (1g, 2 times a day) increase the level of Ivabradin in plasma to 7 to 8 times. Or Verapamil (which reduces the heart rate) will increase the concentration of Ivabradin (increase the area under the curve to 2-3 times) and slow down the heart rate is 5 beats per minute. It is not recommended to coordinate Ivabradin with the above drugs

    • Simultaneous use is not recommended:

  • Grapefruit juice cluster: Ivabradine concentration increases twice when used with grapefruit juice. Therefore, avoid using grapefruit juice during treatment with Ivabradin.

    • Use Caution Causes:

  • Average inhibitors CYP3A4: simultaneous use of Ivabradine with other medium inhibitors CYP3A4 (e.g. Fluconazole) can be considered at the starting dose of 2.5mg twice daily and if the heart frequency is over 70 beats/minute, with heart frequency monitoring. [(Example: Rifampicin, Barbiturates, Phenytoin, Hypericum Perforatum [St. John’s World) can reduce the concentration and activity level of IVABRADIN. The simultaneous use of CYP3A4 induction substances may need to adjust the dose of Ivabradin. Simultaneous use of Ivabradin 10mg twice a day with St .john’s World has shown that the area under the curve (AUC) of Ivabradin is half reduced. Use St. John’s World should be limited during treatment with Ivabradin.

    • Other coordinates:

  • Specific studies on drug interactions - The drug has proven that there is no significant influence on the following drugs on the pharmacokinetics and pharmacokinetics of Ivabradin: Proton pump inhibitors (Omeprazole, Lansoprazole), Sildenafil, HMG inhibitors of Coa Reductase (Simvastatin), Calcropridine channel medications (Amlodipine, Lacidipine), Digoxin and Warfarin. In addition, there is no significant clinical influence of Ivabradin on the pharmacokinetics of Simvastatin, Amlodipine, Lacidipine, on the pharmacokinetics and pharmacokinetics of Digoxin, Warfarin and on Aspirin's pharmacological force. Safety: Angiotensin transferring enzyme inhibitors, Angiotensin II antagonists, beta blockers, diuretics, aldosterone anti -drugs, fast and prolonged effects, HMG CoA Reductase eliminating enzyme inhibitors, fibrate drugs, proton pump inhibitors, oral diabetes, Aspirin and other platelets. Studies on drug interaction so far are only conducted in adults.

    • Storage

    Store drugs under 30 ° C.

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