Cordinik® tablets

Registration number: ЛСР-006552/09
Trade name: Cordinik
International non-patented name (INN): nicorandil.
Drug form: tablets.
Description: white or yellowish-white or grayish-white flat cylindric tablets with a bevel.
Composition:
for 10 mg dose:
drug substance: nicorandil 10 mg;
excipients: potato starch, micriocystrlline cellulose 102, calcium stearate;
for 20 mg dose:
drug substance: nicorandil 20 mg;
excipients: potato starch, micriocystrlline cellulose 102, calcium stearate;
Pharmakotherapeutic group: antianginal aid – activator of K-canals.
АТХ Code: С01DX16.
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Pharmacological properties

Pharmacodynamics. Nicorandil has an antianginal effect due to its nitrate-like properties and the ability to open K-canals. Due to a K-canal opening nicorandil produce a hyper-polarization of the cell membrane, and nitrate-like effect is an increase of an intracellular contents of cyclic guanil monophosphate (cGMP). These pharmacological effects lead to the relaxation of smooth muscle cells and to the protection of myocardium form ischemia. Hemodynamic effects are balanced decrease of pre- and postload (differently from nitrates and “slow” calcium canals blockers (SCCB), they are effect mainly on pre- and postload, respectively). Taking into account a selective vasodilation of coronary arteries, a total load on ischemied myocardium would be minimal. Nicorandil does not affect a myocardial contractability, virtually does not change a heart rate (HR). It decrease a systemic arterial blood pressure (ABP) by less then 10 %, has a positive effect on a cerebral circulation in patients after the cerebral ischemic attack. Nicorandil has no effect on lipid and glucose metabolism parameters. Nicorandil blocks an anginal attack (with a decrease of the pain syndrome) 4-7 minutes after the sublingual application, and totally block the pain syndrome after 12-17 minutes.

Pharmacokinetics. Nicorandil is absorbed quickly and totally from the gastrointestinal tractus, its maximal concentration in plasma is reached after 0,5-1 hour. The drug is not metabolized intensively in a liver, half-life time is 50 minutes, excreted mainly by kidneys.

Nicorandil  binds with plasma proteins by little degree, a free fraction in plasma is near 75%.

Pharmacokinetic parameters are insignificantly dependent on patient's age, background pathology of liver or kidneys, concomitant therapy.

Indications

• stopping of angina pectoris attacks;

• prevention of stable stenocardia attacks (in combination with other anianginal medicines) or as a monotherapy (in the cases of intolerability to beta-adrenoreceptor antagonists and SCCB).

Contraindications

• an increased sensitivity to the drug;

• acute myocardial infarction (and 3 months after);

• cardiogenic shock, collapse;

• unstable ischemic heart disease;

• chronic cardiac insufficiency III or IV functional class (NYHA classification);

• prominent bradyarrhythmia (HR under 50 bpm);

• atrioventicular block, II and III stage;

• left ventricle insufficiency with a low filling pressure;

• arterial hypotension (systolic ABP under 100 mm Hg);

• concomitant use of phosphodiesterase-5 inhibitors (sildenafil, vardenafil, tadalafil);

• pregnancy and lactation;

• age under 18 years (effectiveness and safety were not established).

Use with caution:

Heart rhythm disturbances, atrioventicular block (I stage), Prinzmetal's angina, arterial hypotension, renal and/or hepatic impairments, hypovolemia, lung edema, closed-angle glaucoma, hyperpotassemia, anemia.

Method of use and dosages

Orally, with water, use independently on meals.

The drug dose is adjusted individually in dependence on severity and duration of a disease.

Angina attack stopping.

Coronel ® has to be used immediately after first signs of an attack: 1 tablet of Coronel® 20 mg has to be placed sub-lingually until it fully dissolves, without swallowing.

Prevention stable angina attacks (long-lasting therapy of a stable angina).

Coronel® is usually used from 10 to 20 mg 3 times a day. Maximum daily dose is 80 mg.

If a headache appears, an initial dosage can be decreased.

Side effects

Cardiovascular system: palpitations, tachycardia, ABP decrease, hot flushes on the face, peripheral edemas.

Central nervous system: weakness, headache (does not require the drug withdrawal, can be relieved by the initial dose decrease), dizziness, tinnitus, insomnia.

Digestive tract: nausea, vomiting, unpleasant feelings in the stomach, feeling of the stomach overfilling, stomatitis (very rare); in some cases - aspartate amine transferase and alanine aminotransferase increase (hepatic amine transferases), base phosphatase increase.

Hypersensitivity reactions: allergic reactions are possible.

Over-dosage

Symptoms: prominent ABP decrease, tachicardia.

Treatment: gastric lavage, charcoal use (especially during first 2 hours after overdosage),    cardiovascular system support, pose with raised extremities, symptomatic and supportive treatment, i/v injections of calcium gluconate and dopamine. Treatment with hemodialysis al also possible.

Interaction with other medicines

In a concomitant use with  antidepressants, phosphodiesterase-5 inhibitors (sildenafil, vardenafil, tadalafil), vasodilators, hypotensive medicines, tricyclic antidepressants, beta-adrenoreceptors antagonists, monoamine oxidase (MAO) inhibitors and ethanol – an increase of the antianginal effect.

Precautions

A withdrawal from the drug has to be performed gradually.

During the treatment with Coronel® it is necessary to control ABP, ECG parameters, sodium and potassium ions levels in blood; an increase of present cardiac rhythm  disturbances is possible. It is necessary to use precautions when driving vehicles and performing other potentially dangerous activities where an increase attention concentration and rate of psycho-motoric reactions are necessary.

Drug form

For FSME «CSCB» and CAS «ОCPC». 10 mg and 20 mg tablets.

10 tablets in blister.

10, 20 or 30 tablets in sealed polymer can.

Can or 2, 3 or 6 blisters are packed into a carton box with an instruction.

For  «Pik-pharma Pro» Ltd.

10 tablets in blister.

10, 20 or 30 tablets in sealed polymer can.

Can or 2, 3 or 6 blisters are packed into a carton box with an instruction.

Keeping conditions

Keep in protected from direct light place at temperature not higher than 25 °С. Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiry date.

Selling conditions

By prescription.

Manufacturer

PIQ-PHARMA Ltd., 129010 Moscow, Spassky blind alley, 2/1.

Manufactured by:

FSME «Central scientific constructor bureau» (FSME «CSCB»), 109240, Moskow, ул. Goncharnaya st., 20

or

CAS «Obninsk chemical pharmaceutical company» (CAS «OCPC»),

249036 Kaluzhskaya region, Obninsk, Koroleva st. 4

or

PIQ-PHARMA PRO Ltd, 188663 Leningradskaya region, Vsevolozhsky district, Kuzmolovsky, Workshop # 92.

 

Claims have to be sent to

PIQ-PHARMA Ltd. Phone/fax: (495) 925-57-00.

 

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