Monolong - instructions for use, doses, side effects, contraindications

Excipients: sugar spherical granules 109,000 mg or 163,490 mg respectively lactose -120,000 mg or 180,000 mg shellac 28.22 mg or 42.34 mg Eudragit L-100 1.440 mg or 2.160 mg Eudragit RS-100 1,440 mg or 2,160 mg, talc - 19,900 mg or 29,850 mg.

Capsule:

Housing - gelatin up to 100%.

Cap (for dosage of 40 mg): Azorubin dye (E 122) - 0.0353%, indigocarmine 2.2071%, (E 132) - 0.0154%, titanium dioxide gelatin - up to 100%.

Cap (for dosage of 60 mg): dye sunset yellow (E 110) - 0.0600%, dye quinoline yellow - 0.0038%, titanium dioxide - 1.6000%, gelatin - up to 100%.

* - the composition of sugar granules: sucrose: 81.75 mg or 122.61 mg respectively; corn starch: 27.25 mg or 40.88 mg respectively.

Description:

Dosage of 40 mg:

Hard gelatin capsules No. 1 with a colorless transparent case and a lid of violet color. The contents of capsules are spherical granules of white or white with a yellowish hue.

Dosage of 60 mg:

Hard gelatin capsules No. 0 with a colorless transparent body and an orange lid. The contents of capsules are spherical granules of white or white with a yellowish hue.

Pharmacotherapeutic group:Vasodilating agent - nitrate

ATX: & nbsp

C.01.D.A.14 Isosorbide mononitrate

Pharmacodynamics:

Has vasodilator and antianginal action.Reduces preload (by expanding the peripheral veins) and afterload (due to a decrease in the overall peripheral vascular resistance), reduces the need for myocardium in oxygen, dilates the coronary arteries and improves coronary blood flow, promotes its redistribution into the ischemic areas, reduces the terminal diastolic volume of the left ventricle and reduces systolic the tension of its walls. Increases tolerance to physical activity of patients with IHD, reduces pressure in a small circle of blood circulation.

Isosorbide mononitrate causes relaxation of the musculature of the bronchi, urinary tract, gallbladder muscles, biliary tract and esophagus, as well as the small and large intestine, including sphincters.

Pharmacokinetics:The drug is quickly and completely absorbed into the intestine after ingestion. Bioavailability ranges from 90 to 100%. There is a direct dependence of the concentration in the blood on the dose of the drug taken. Isosorbide mononitrate is excreted through the kidneys almost exclusively in the form of metabolites. Approximately 2% is displayed unchanged. The half-life is 4-5 hours.

Indications:

- Preventing attacks of angina pectoris.

- Treatment of chronic heart failure in combination with cardiac glycosides, diuretics, ACE inhibitors, arterial vasodilators.

- Increased pressure in a small circle of blood circulation (pulmonary hypertension).

Contraindications:

- Hypersensitivity to organic nitrates;

- acute circulatory disorders (shock, vascular collapse);

cardiogenic shock if a sufficiently high final diastolic pressure in the left ventricle is not achieved by using intra-aortic counterpulsation or by administering drugs that have a positive inotropic effect;

- simultaneous administration of a phosphodiesterase inhibitor sildenafil (Viagra®, Viagra), since sildenafil potentiates the antihypertensive effect of nitrates;

- severe arterial hypotension (systolic blood pressure less than 90 mm Hg, diastolic pressure less than 60 mm Hg);

- hemorrhagic stroke, angle-closure glaucoma, craniocerebral trauma, hyperthyroidism, idiopathic hypertrophic subaural stenosis, glucose-6-phosphate dehydrogenase deficiency, hepatic and renal insufficiency, age under 18 years.

Carefully:

- Constrictive pericarditis, pericardial tamponade;

- low filling pressure in acute myocardial infarction, impaired left chamber function (left ventricular failure). Do not lower the systolic blood pressure below 90 mmHg;

- aortic and / or mitral stenosis, a tendency to orthostatic disorders of vascular regulation, severe cerebral atherosclerosis, diseases accompanied by intracranial hypertension.

Monolong should not be used to stop acute attacks of angina and acute myocardial infarction.

Pregnancy and lactation:For safety reasons, Monolong can be used during pregnancy and lactation only if the benefit to the mother exceeds the potential risk to the fetus / child, since there is currently insufficient data on the effects of its use in pregnant women and nursing mothers.

Dosing and Administration:

Capsules swallow whole, washed down with water. For faster absorption, the drug is preferably taken for 1 hour or 2 hours after a meal.

Doses should be adjusted in accordance with the features and tolerability of the drug by individual patients.If the patient's condition worsens or the effectiveness of the drug decreases, an increase in the dose of the drug may be required.

Treatment is recommended to begin with a dosage form with the smallest content of isosorbide mononitrate, that is, 40 mg once a day. If this dose is not enough - you can increase it to 60 mg once a day.

In rare cases, the dose may be increased to 80 mg per day (2 capsules of 40 mg). The duration of treatment and increasing the dose is determined by the doctor. The effectiveness and safety of the drug in children is not established.

Side effects:

A "nitrate" headache may occur at the beginning of the treatment. When continuing therapy, it usually decreases after a few days.

After the first dose or after increasing the dose, blood pressure may decrease and / or develop orthostatic hypotension, which may be accompanied by tachycardia, dizziness, and weakness.

Very rarely there may be nausea, vomiting, reddening of the face and skin allergic reactions.

In rare cases, a marked decrease in blood pressure is accompanied by a heavier symptom of angina (paradoxical reactionon nitrates).

Occasionally, there were cases of collapoid states, sometimes with bradyarrhythmia and syncope.

Notes:

The development of tolerance, as well as cross-tolerance with other nitrocompounds in long-term continuous treatment with high doses of isosorbide mononitrate, is described. To prevent a decrease or loss of effectiveness, you should avoid continuous intake of high doses of the drug, as well as prescribing the drug more than 2 times a day.

The use of Monolong can lead to transient hypoxemia due to the relative redistribution of blood flow to the hypoventilation alveolar segments. This may be the trigger mechanism of ischemia in patients with coronary heart disease.

Overdose:

Symptoms of overdose:

Reduction of blood pressure with orthostatic dysregulation, reflex tachycardia and headache. Asthenia, dizziness, drowsiness, sweating, hot flashes, nausea and vomiting, hyperpnoea diarrhea, dyspnoea, bradycardia, increased intracranial pressure, paralysis, coma may develop.

In chronic overdose, an increase in the level of methemoglobin is possible.

Therapy for overdose

In addition to general recommendations, such as gastric lavage and placement of the patient in a horizontal position, the legs are high, with a pronounced decrease in sertral pressure and / or in patients in shock should be administered fluid; In exceptional cases, to improve blood circulation, infusions of norepinephrine and / or dopamine may be administered.

The introduction of epinephrine and related compounds is contraindicated.

With methemoglobinemia - intravenously 1% solution of methylene blue, 1-2 mg / kg.

Interaction:

When used with other vasodilators, antihypertensive drugs, beta-adrenoblockers, slow calcium channel blockers, antipsychotic agents or tricyclic antidepressants, amiodarone, with a phosphodiesterase inhibitor sildenafil (Viagra®, Viagra), as well as with alcohol, potentiation of the antianginal effect of Monolong .

With simultaneous administration of Monolong and dihydroergotamine, an increase in the level of dihydroergotamine and potentiation of hypertensive action can occur.

The therapeutic effect of norepinephrine decreases with simultaneous administration with nitro drugs.

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 digestive tract.

Under the influence of sympathomimetics, alpha-adrenergic blockers (dihydroergotamine, etc.), it is possible to reduce the expression of the antianginal effect (excessive decrease in blood pressure and, as a consequence, coronary perfusion). Barbaturates accelerate metabolism and reduce the concentration of isosorbide mononitrate in the blood.

Special instructions:During the treatment with the drug should be excluded from drinking alcohol.

Effect on the ability to drive transp. cf. and fur:During treatment it is not recommended to drive vehicles and engage in other potentially dangerous activities requiring a fast psychomotor reaction.

Form release / dosage:

Capsules with a sustained release of 40 mg and 60 mg.

Packaging:10 capsules per blister of aluminum foil and PVC film. 3 blasters or 6 blisters for 10 capsules in a cardboard box together with instructions for use.

Storage conditions:Store in a dry place at a temperature of no higher than 25 ° C.Keep out of the reach of children.

Shelf life:

4 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N014587 / 01

Date of registration:13.05.2009 / 10.01.2014

Expiration Date:Unlimited

The owner of the registration certificate:STS Chemical Industries Co., Ltd.STS Chemical Industries Co., Ltd. Israel

Manufacturer: & nbsp

CTS Chemical Industries, Ltd. Israel

Information update date: & nbsp02.06.2018

Illustrated instructions

Instructions

Monolong (Monolong)