Olikard 60 retard - instructions for use, dose, side effects, contraindications

Peripheral vasodilator with predominant effect on venous vessels. Stimulates the formation of nitric oxide (endothelial relaxing factor) in the vascular endothelium, which causes activation of intracellular guanylate cyclase, which results in an increase in cGMP (a mediator of vasodilation). Reduces the need for myocardium in oxygen by reducing preload and postload (reduces the final diastolic volume of the left ventricle and reduces the systolic tension of its walls). Possesses coronary dilatation. Reduces the flow of blood to the right atrium, helps reduce pressure in a small circle of circulation and regression of symptoms with pulmonary edema. Promotes redistribution of coronary blood flow in the area with reduced blood circulation.Increases tolerance to physical activity in patients with coronary heart disease, angina pectoris.

It dilates the vessels of the brain, the dura mater, which can be accompanied by a headache.

The possibility of developing cross-tolerance to other nitrates is not ruled out. After a break in application, the sensitivity to it is quickly restored.

Pharmacokinetics:

Absorption is high, bioavailability is 90-100%. Time to reach the maximum concentration in blood plasma - 8 hours. The connection with blood plasma proteins is less than 4%. Isosorbide-5-mononitrate is almost completely metabolized in the liver. The resulting metabolites are inactive.

The half-life is 4-5 hours. Isosorbide-5-mononitrate is almost completely excreted by the kidneys in the form of metabolites, 2% is excreted unchanged.

Indications:

- Prevention of angina attacks in patients with ischemic heart disease.

- Treatment of chronic heart failure in combination therapy.

Contraindications:

- Increased individual sensitivity to the drug, the components of the drug and other nitro compounds;

- Acute circulatory failure (shock, vascular collapse);

- Acute myocardial infarction;

- Cardiogenic shock, if by means of intra-aortic counterpulsation or with the help of drugs having a positive inotropic effect, it is not possible to provide a sufficiently high final diastolic pressure in the left ventricle;

- Severe arterial hypotension and hypovolemia (systolic pressure below 90 mm Hg);

- Simultaneous reception sildenafila.

- Children under 18 years of age (efficacy not established).

Carefully:

Use with caution in: idiopathic hypertrophic subaortal stenosis, constrictive pericarditis and cardiac tamponade;

Low values of perfusion pressure, incl. with acute myocardial infarction or left ventricular failure of the heart; aortic and / or mitral stenosis; Orthostatic hypotension; diseases accompanied by increased intracranial pressure; severe anemia; angle-closure glaucoma; expressed renal and hepatic insufficiency.

Pregnancy and lactation:Application in pregnancy and during lactation is possible when comparing the benefits for the mother and the potential risk to the fetus and the baby.

Dosing and Administration:

Inside, the capsules are not chewed and washed down with a sufficient amount of liquid.

Olikard® 60 retard should be taken at 60 mg (1 capsule) 1 time per day. The duration of treatment is determined by the doctor.

Side effects:

From the side of the cardiovascular system: "nitrate" headache; a marked decrease in blood pressure (BP) and / or orthostatic arterial hypotension, which may be accompanied by a reflex increase in the heart rate, dizziness and weakness, sometimes, in rare cases, a marked decrease in blood pressure may be accompanied by an increase in symptoms of angina pectoris; transient hyperemia of the skin of the face and neck. Seldom were observed states of collapse, bradycardia.

From the gastrointestinal tract: nausea, vomiting. Allergic skin reactions, exfoliative dermatitis.

It is necessary to avoid continuous intake of Olikard® 60 retard in high doses in avoid the reduction of therapeutic effect.

Overdose:

Symptoms: marked decrease in arterial pressure, collapse, reflex tachycardia, headache, weakness, dizziness, skin flushing, nausea, vomiting and diarrhea.Large amounts of nitrite ion can cause methaemoglobinemia, cyanosis, dyspnoea and tachypnoe.

At very high doses of the drug, an increase in intracranial pressure with cerebral symptoms may develop. In chronic overdose, an elevated level of methemoglobin is detected.

Treatment: gastric lavage. If there is a marked decrease in blood pressure and / or shock, plasma-assisted therapy should be performed; in exceptional cases, can be administered by infusion norepinephrine and / or dopamine.

The use of epinephrine (adrenaline) and related compounds is contraindicated.

With methemoglobinemia: ascorbic acid - 1 g intravenously; 1% solution of methylthioninium chloride (methylene blue) - 1-2 mg / kg (up to 50 ml) intravenously; oxygen therapy, hemodialysis, blood transfusion.

Interaction:

Increases the concentration of dihydroergotamine in the blood plasma.

Reduces the effect of vasopressors.

Barbiturates accelerate metabolism and reduce the concentration of isosorbide-5-mononitrate in blood plasma.

When isosorbide-5-mononitrate is used together with antihypertensive agents, vasodilators, antipsychotics (antipsychotics), tricyclic antidepressants,procainamide, ethanol, quinidine, beta-adrenoblockers, slow calcium channel blockers, ethanol, dihydroergotamine and sildenafil, hypotensive effect may be enhanced.

When combined with amiodarone, propranolol, slow calcium channel blockers (verapamil, nifedipine, etc.), it is possible to increase the antianginal effect.

Under the influence of adrenostimulants, alpha-adrenoblockers (dihydroergotamine, etc.), it is possible to reduce the expression of the antianginal effect (excessive decrease in blood pressure and, as a consequence, coronary perfusion). When combined with m-holinoblokatorami (atropine and others) increases the likelihood of increased intraocular pressure.

Adsorbents, astringents and enveloping agents reduce the absorption of isosorbide mononitrate in the gastrointestinal tract.

Special instructions:Olikard 60 retard is not intended for arresting an acute attack of angina pectoris, acute myocardial infarction.

Effect on the ability to drive transp. cf. and fur:At the beginning of treatment, it is possible to reduce the ability for rapid reactions, during the treatment period it is necessary to refrain from engaging in potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules retard 60 mg.

Packaging:

10 capsules in PVC / Al blister. By 2, 5 or 10 blisters in a cardboard pack together with the instruction on

application.

Packing in bulk.

From 600 000 to 800 000 capsules in a black plastic bag.

The polyethylene bag is placed in a metal drum.

Storage conditions:In a place inaccessible to children, at a temperature of no higher than 25 ° C. List B.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015729 / 01

Date of registration:15.05.2009

Expiration Date:Unlimited

The owner of the registration certificate:Solvay PharmaceuticalsSolvay Pharmaceuticals Germany

Manufacturer: & nbsp

ABBOTT PRODUCTS, GmbH Germany

Representation: & nbspEBOBOT PRODUKTS LLCEBOBOT PRODUKTS LLCRussia

Information update date: & nbsp05.06.2017

Illustrated instructions

Instructions

Olicard® 60 retard (Olicard® 60 retard)