Pecrandil 5 Hataphar tablets prevent and treat long -term angina (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Nicorandil

Ingredient

Composition information	Content
Nicorandil	5mg

Uses

indications

Pecrandil 5 drugs are indicated in the following cases:

prevention and long -term treatment of chronic stable stable angina.

Nicorandil activates potassium channel, increasing the polarization of vascular cell membranes has the effect of dilating artery smooth muscle, thus reducing the burden. In addition, the activation of potassium canal has the effect of giving the heart muscle to adapt to local myocardial ischemia.

Thanks to the nitrate group, Nicorandil also relaxes blood vessel muscles, especially the venous system through an increase in the ring monophosphate guanosine (CGMP) in intracellular. Thus reduces the amount of blood on the heart and reduces the burden.

Nicorandil has been shown to directly affect the coronary artery, on both normal and narrow segments without coronary blood robbery. Moreover, reducing the end of the diastolic and blood vessels will reduce blood vessel resistance in peripheral vessels. Finally, the oxygen balance in the heart muscle and blood flow to the narrow areas of the heart muscle is improved.

Moreover, Nicorandil has been shown to have anti -spasms in both In Vitro and In Vivo and reverse the coronary spasms caused by methacholine or noradrenaline. Nicorandil does not work directly on myocardial contraction.

Dynamic pharmacokinetics

Nicorandil pharmacokinetics have a linear range of 5 mg to 40 mg.

absorption

After drinking, Nicorandil is absorbed quickly and completely through the digestive tract, not affected by food. Absolute bioavailability of about 75%. Peak concentration in plasma (CMAX) is achieved after drinking 30-60 minutes. The concentration in plasma and the area under the curve (AUC) indicates that there is linear with the dose and stable state quickly achieved when taking the dose repeated (within 4-5 days). In a stable state, the cumulative ratio (based on AUC) is about 2 for tablets of 20 mg and 1.7 for tablets of 10 mg.

Distribution

The drug is distributed systemic, regardless of the dose, within the scope of treatment. Nicorandil is less associated with plasma protein (about 25%).

Metabolism

Nicorandil is mainly metabolized in the liver by reducing nitrate into non -activity compounds on the heart. In plasma, Nicorandil in the form of unchanged accounts for about 45.5%, N- (2-Hydroxyethyl) -Nicotinamide accounts for about 40.5%and other types of metabolism accounts for 20%.

Nicorandil is excreted mainly in urine. The substance in the form does not change (1% smaller than the dose, appears in urine after 0 to 48 hours). N- (2-Hydroxyethyl) -Nicotinamide is the most metabolite (about 8.9% compared to the dose within 48 hours). Next are Nicotinuric acid (5.7%), nicotinamide (1.34%), N-methylnicotinamide (0.61%) and nicotinic acid (0.40%). Those are the main metabolites of Nicorandil.

Elimination

Plasma concentration decreases in two stages:

Fast emissions: The sale time is about 1 hour, which includes about 96% of plasma concentrations.

Slow elimination phase: The sale time is about 12 hours, after taking the dose of 20 mg.

Nicorandil and its metabolites are mainly eliminated by the urinary tract, a small amount of stool

Before taking Pecrandil 5 Hataphar tablets prevent and treat long -term angina (6 blisters x 10 tablets)

How to use

oral, oral drugs, during and after eating. Take medicine with 1 cup of water, do not chew tablets, take 2 times a day in the morning and evening.

Dosage

Adults

Initial doses 10 mg x 2 times/day (or 5 mg x 2 times/day in patients with headaches), then increased gradually.

Normal dose 10 - 20 mg x 2 times/day.

Dosage should be adjusted according to the patient's response level, which can increase to 40 mg x 2 times/day if necessary.

Elderly

No dose adjustment. Should use the lowest dose effectively.

Children

It is not recommended for children and people under 18 years of age because they do not have enough data on safety and efficiency.

Patients with liver failure, kidney failure

No dose adjustment.

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? If necessary, increase the volume of circulatory plasma by appropriate infusion. In cases of life -threatening, can consider using vascular contractions.

No specific antidote.

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 Pecrandil 5, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache, dizziness.

Cardiovascular: Increasing heart rate after high doses. blood vessels: vasodilation causes blushing. digestive: Nausea, vomiting, rectal bleeding.

The body feels weak.

Uncommon, 1/1000

Cardiovascular: reducing blood pressure.

Thich.

Muscle aches.

Rare, 1/10000

Digestive: abdominal pain, gastrointestinal ulcers such as gastritis, mouth ulcers, tongue ulcers, intestinal tract and anal ulcer; The ulcers, if progressing, can develop into perforation, leakage, or abscess.

skin: different forms of rash, itching.

musculoskeletal: muscle pain.

Very rare, ADR

Metabolism and nutrition: hyperkalemia.

Digestive: gastrointestinal bleeding.

Mile liver: cholestatic hepatitis, jaundice.

Skin: Keeping water, edema, skin and ulcerative mucosa (mainly surrounding anal and genital organs).

Eye: conjunctivitis, conjunctivitis and corneal ulcer.

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

Pecrandil 5 drugs contraindicated in the following cases:

Hypersensitivity to nicorandil or any ingredients of the drug.

Patients with shock (including cardiac shock), severe hypotension, or left ventricular dysfunction with low filling pressure or cardiac loss.

Using 5-phophodiesterase inhibitors, because it can lead to severe blood pressure loss.

Using Ganylate Cyclase stimulants to dissolve riociguat, because it can lead to severe reduced blood pressure.

Patients with reduced fluid volume.

acute pulmonary edema.

Be cautious when used

Gastrointestinal ulcer has been recorded when using Nicorandil. The drug can cause ulcers in different positions in the body. When detecting patients showing signs of gastrointestinal ulcers, Nicorandil should be stopped immediately. The ulcer progresses, should stop using Nicorandil. Health care experts need to be aware of the importance of timely diagnosis of nicorandil ulcers and withdraw Nicorandil treatment dose in the event of those ulcers. Based on the available information, the time from the beginning of using Nicorandil to the beginning of ulcers is right after the start of nicorandil treatment for a few years later.

Secondary gastrointestinal bleeding has been reported when using Nicorandil. Patients who are being treated with nicorandil use simultaneously acetylsalicylic acid or NSAIDs at high risk of severe complications such as gastrointestinal bleeding. So be careful when using acetylsalicylic acid simultaneously or NSAID and Nicorandil.

If the ulcer progresses into holes, leaks, or abscesses formation, patients with excess inflammation may be at risk of the formation of fistula or perforation in Nicorandil treatment.

Demonstration of the gastrointestinal tract when used simultaneously Nicorandil and Corticosteroids have been reported. Therefore, recommendations need to be cautious when using simultaneously.

Eye ulcer: Very rare conjunctivitis, conjunctiva ulcers and corneal ulcer when using nicorandil. Patients must be notified of signs and symptoms, closely monitored for corneal ulcers. If the ulcer progresses, Nicorandil must be stopped.

Hypotension: Need to be cautious when Nicorandil is used with other drugs that have the effect of lowering blood pressure.

Heart failure: Due to lack of data, need to be cautious when using Nicorandil in patients with heart failure III, IV according to the classification under the American Heart Association (NYHA).

Hyperbysical hyperkalemia: serious hyperkalemia has been reported, but very rare. Nicorandil should be used carefully when combined with other drugs that can increase potassium levels.

Moisture: The drug is very sensitive to moisture. Therefore, patients need advice to keep the drug in the blister until used.

Children's patients: The drug is not recommended in children when safe and effective, which has not been stable in this group of patients.

Lack of G6PD: Nicorandil should be used carefully in patients with glucose-6-phosphate dehydrogenase deficiency (G6PD). Nicorandil works partially through its organic nitrate group. The metabolism of organic nitrate can lead to nitrite formation may cause methemoglobin risk in patients with G6PD deficiency.

The ability to drive and operate machinery

Nicorandil's hypotension effects can reduce driving or using machinery. This hypotension can increase when used with alcohol or drugs that have the effect of lowering blood pressure (for example, vasodilators, three -round antidepressants). Patients should be warned and should not drive or operate machinery until the ability to drive and operate machines.

Pregnancy

Although animal studies do not show any teratogenic effects of Nicorandil, drug products have not been studied during pregnancy. Hence should be avoided for pregnant women.

The period of breastfeeding

It is not known whether the drug is excreted in breast milk, so it is not recommended to use this drug for breastfeeding women.

Drug interaction

simultaneous use of nicorandil and 5-phosphodiesterase inhibitors, for example, Sildenafil, Tadalafil, Vardenafil, are contraindicated because it can lead to serious hypotension.

Simultaneously use the stimulant Ganylate Cyclase (riociguat) is contraindicated because it can lead to serious hypotension.

Nicorandil's treatment can lower blood pressure of high blood pressure patients. If Nicorandil is used simultaneously with antihypertensive drugs or other drug products with antihypertensive effects (for example, vasodilators, three -ring antidepressants, alcohol), the effect of lowering blood pressure may increase.

dapoxetine should be prescribed cautious in patients using nicorandil because they can lower blood pressure.

Demonstrate puncture when used simultaneously Nicorandil VA Corticosteroid has been reported. Need to be cautious when used simultaneously.

In patients using NSAIDs, acetylsalicylic acid in both cardiovascular and anti -inflammatory dose, there is a risk of increasing serious complications such as gastrointestinal ulcers, perforation and gastrointestinal bleeding.

Be careful when Nicorandil is used in combination with other drugs that can increase potassium concentration.

The metabolism of nicorandil is not significantly affected by cimetidine (a CYP inhibitor) or rifampicin (a CYP3A4 induction). Nicorandil does not affect the pharmacological of acenocoumarol.

Storage

In a dry place, temperatures below 30 ° C.

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