Pectrol tablets retard 60 mg, 30 pcs. (isosorbide mononitrate)

Release form

Sustained-release tablets.

Packing

30 pcs.

Pharmacological action

Peripheral vasodilator with a primary effect on the venous vessels.

Pectrol stimulates the formation of nitric oxide (endothelial relaxing factor) in the vascular endothelium, causing activation of intracellular guanylate cyclase, which results in an increase in cGMP (vasodilation mediator). Vasodilation reduces the venous return to the heart (preload), reducing the load on the heart, which reduces the oxygen demand of the myocardium. The dilating effect of nitrates on arteries and arterioles reduces OPSS (afterload).

Pectrol has a coronary expansion effect. Reduces blood flow to the right atrium, helps to reduce pressure in the pulmonary circulation and regression of symptoms in pulmonary edema. Promotes redistribution of coronary blood flow in an area with reduced blood supply.

Pectrol increases exercise tolerance in patients with coronary artery disease, angina pectoris. Expands the vessels of the brain, dura mater, which may be accompanied by a headache. It inhibits platelet aggregation, reduces platelet thromboxane synthesis.

As with other nitrates, cross tolerance develops. After cancellation (interruption of treatment), sensitivity is quickly restored.

Antianginal effect occurs 30-40 minutes after ingestion and lasts up to 8-10 hours.

Indications

Prevention of angina attacks in patients with coronary heart disease

Chronic heart failure (as part of combination therapy).

Contraindications

Hypersensitivity to nitrates or other components of the drug.

Arterial hypotension and hypovolemia (systolic blood pressure below 100 mmHg, diastolic blood pressure below 60 mm Hg, central venous pressure below 4-5 mm Hg)

Acute heart failure

Shock

Vascular collapse

Left ventricular failure with low end diastolic pressure

Acute myocardial hypertension )

Cardiac tamponade

Toxic pulmonary edema

Diseases of

Accompanied by increased intracranial pressure (including hemorrhagic stroke, traumatic brain injury)

Lactation period

Age to 18 years (efficacy and safety not established).

Caution:

Mitral valve prolapse

aortic and / or mitral stenosis

tendency to orthostatic disturbances of vascular regulation

constrictive pericarditis

Advanced age

Severe anemia

thyrotoxicosis

Hypertrophic cardiomyopathy (possibly more frequent angina attacks)

renal failure

Liver failure (risk of methemoglobinemia) .

Special instructions

Pectrol is not intended to relieve an attack of angina pectoris.

The proper use of isosorbide mononitrate ensures a period with a low concentration of nitrate, which is necessary to prevent the development of tolerance to nitrates.

As with all nitrates, it is important to strictly follow the instructions for dosing Pectrol and observe the 12-hour interval between doses. In this case, a period of low concentration is achieved.

Composition

Active ingredient:

Isosorbide-5-mononitrate 60.0 mg.

Excipients:

Hypromellose

Carnauba wax

Purified stearic acid

Lactose monohydrate

Magnesium stearate

Silicon dioxide purified

Talc

Titanium dioxide srdlkrd iron Oxide red.

Dosage and administration

Pectrol is taken orally after a meal, swallowed whole and washed down with a glass of water. The usual initial dose is 40 mg once a day (in the morning). The dose of the drug can be increased to 60 mg once a day or up to 80 mg (40 mg 2 times a day).

Side effects of the

From the cardiovascular system: "nitrate" headache, dizziness, transient hyperemia of the facial skin, sensation of heat, tachycardia, marked decrease in blood pressure in rare cases - increased angina attacks (paradoxical reaction), orthostatic collapse.

From the gastrointestinal tract: nausea, vomiting, there may be a sensation of a light burning sensation of the tongue, dry mouth.

From the side of the central nervous system: stiffness, drowsiness, blurred vision, decreased ability to quickly psychic and motor reactions (especially at the beginning of treatment) in rare cases - cerebral ischemia.

Allergic reactions: skin rash, in some cases - exfoliative dermatitis.

Others: development of tolerance (including cross-tolerance to other nitrates).

Drug interaction

Pectrol® with simultaneous use increases the concentration of dihydroergotamine in the blood plasma.

Barbiturates accelerate biotransformation and reduce the concentration of isosorbide mononitrate in the blood.

When used together with antihypertensive drugs, vasodilators, antipsychotics (antipsychotics), tricyclic antidepressants, novocainamide, ethanol, quinidine, beta-blockers, slow calcium channel blockers, dihydroergothenamine and dihydroergothenamine are possible.

With a combination of amiodarone, propranolol, slow calcium channel blockers (including verapamil, nifedipine), acetylsalicylic acid and Pectrol, an antianginal effect may be enhanced.

Influenced by beta-adrenostimulants, alpha-adrenergic blocking agents (including dihydroergotamine), a decrease in the severity of the antianginal effect (tachycardia, an excessive decrease in blood pressure) is possible.

When combined with m-anticholinergics (including atropine), the likelihood of increased intraocular pressure increases.

Adsorbents, astringents and enveloping agents reduce the absorption of isosorbide-5-mononitrate in the digestive tract.

Overdose

Symptoms: headache, dizziness, palpitations, hyperthermia, hyperemia of the skin, sweating, nausea, vomiting, diarrhea, methemoglobinemia (cyanosis, anoxia), hyperpnea, dyspnea, cerebrospinal pressure, cerebrospinal pressure, bradypardia, fainting, paralysis, coma.

Treatment: gastric lavage, with methemoglobinemia - inside or in / in ascorbic acid - 1 g, in / in 1% solution of methylene blue 1-2 mg / kg with severe arterial hypotension - in / in phenylephrine (mesatone). Epinephrine and its related compounds are ineffective.

Storage Conditions

In a dark place at a temperature not exceeding 25 ° C.

Deystvuyuschee substances

isosorbide mononitrate

Pharmacy terms of delivery

Prescription

Dosage form

tablet prolong.

Indications

Hronycheskaya failure circulation, angina

KRKA d.d. Novo mesto AO, Slovenia



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