Nitrogen forte - instructions for use, dose, side effects, contraindications

Excipients: neutral pellets (sucrose, corn starch), shellac, talc, dye diamond black (E 151), dye quinoline yellow (E 104), lactose, dye sunset yellow sunset (E 110), povidone.

Description:

Round, spotted tablets with a notch on one side, containing compressed pellets of orange and brownish-green color.

Pharmacotherapeutic group:vasodilator - nitrate

ATX: & nbsp

C.01.D.A.02 Nitroglycerine

Pharmacodynamics:

Nitrogen forte tablets contain nitroglycerine, which is dosed and slowly released from them.

The vasodilating effect is achieved by the nitric oxide release network, which is a natural endothelial relaxing factor - a mediator of the direct activation of guanylate cyclase.An increase in the concentration of cGMP leads to a relaxation of smooth muscle fibers (mainly venules and veins). This leads to a decrease in peripheral vascular resistance, an increase in the venous volume and a decrease in venous return.

The need for myocardium in oxygen decreases. At the same time, it has no significant effect on the frequency of contractions and the rhythm of the heart, both at rest and under physical exertion.

Has antianginal and spasmolytic effect, relaxes the smooth muscles of the vascular walls, bronchi, gastrointestinal tract, bile ducts, ureters.

Has a central inhibitory effect on sympathetic tone, inhibiting the vascular component of the formation of pain syndrome. Causes the expansion of cerebral vessels, which explains the headache when it is used.

With the prolonged and frequent use of long-acting nitrates, there is a development of tolerance to the drug (weakening of the therapeutic effect). After a break, the sensitivity is restored.

Due to the gradual release of nitroglycerin, its pharmacological effect occurs 20-45 minutes after administration, the maximum effect occurs after 90 minutes and lasts about 3-8 hours.

Pharmacokinetics:

Nitrogen forte is subjected to an intense "first pass" effect through the liver with rapid metabolism and excretion. When administered orally, bioavailability is no more than 10% compared to nitroglycerin administered sublingually. Glyceryl trinitrate is metabolized predominantly in the liver by reductive hydrolysis under the action of glutathione-dependent reductase of organic nitrates. It converts fat-soluble organic nitrates into inorganic nitrite and water-soluble metabolites devoid of nitro groups. These metabolites are less active than the starting materials.

Connection with blood plasma proteins - 60%. The total clearance was from 5.5 to 11 l / min, and the elimination half-life was from 2 to 33 minutes.

Indications:

Prevention of angina attacks, including patients who underwent myocardial infarction.

Contraindications:

- Hypersensitivity to nitrates or any other components of the drug;

- chronic heart failure with severe stenoses of the aortic, mitral valves or hypertrophic obstructive cardiomyopathy;

- acute myocardial infarction with low filling pressure of the left ventricle;

- cardiac tamponade;

- constructive pericarditis;

- severe arterial hypotension (systolic blood pressure (BP) less than 100 mm Hg, diastolic blood pressure (BP) less than 60 mm Hg. item);

- acute circulatory disturbance (shock, collapse);

- toxic pulmonary edema;

- craniocerebral trauma;

- disturbance of cerebral circulation, hemorrhagic stroke;

- increased intracranial pressure;

- angle-closure glaucoma;

- simultaneous administration of inhibitors of phosphodiesterase type 5 (PDE 5) - sildenafil, tadalafil, vardenafil;

- age under 18 years (effectiveness and safety not established);

- lactation period.

Carefully:

Severe anemia, hyperthyroidism, hypertrophic cardiomyopathy (possibly an increase in angina attacks), atherosclerosis, severe renal failure, severe hepatic insufficiency (risk of methaemoglobinaemia), pregnancy, increased peristalsis of the gastrointestinal tract, malnutrition, malabsorption syndrome.

Pregnancy and lactation:

Nitrogen forte can be used in pregnancy only in cases where the benefit of treatment for the mother exceeds the possible risk to the fetus.

It is not known whether nitroglycerine with breast milk, so during treatment with the drug, breastfeeding should be discontinued.

Dosing and Administration:

The drug should be taken on an empty stomach. The tablet is swallowed without chewing, with a small amount of liquid.

Doses of the drug Nitrogen forte are determined depending on the severity of the disease.

An individual design scheme should include 10-12 hour "non-nitric" period to prevent the development of tolerance to nitrates.

Patients usually take 1 or 2 tablets twice a day - in the morning and at noon. Due to the admission of an evening dose, 10-12 hour "non-negative" period.

Patients with a predominance of "nocturnal" attacks of angina pectoris Nitrogen forte should be appointed at noon and in the evening.

The maximum single dose is 13 mg.

Side effects:

Side effects are dose-dependent and in most cases are associated with the vasodilating effect of nitroglycerin.

From the side of the cardiovascular system: "nitrate" headache, dizziness, redness of the face, fever, tachycardia, palpitations, swelling of the ankles and lower legs, orthostatic hypotension,a marked decrease in blood pressure (AD), cyanosis, fainting, paradoxical bradycardia (with acute arterial hypotension and / or syncope), paradoxical angina with expressed sclerosis of the coronary arteries.

From the gastrointestinal tract: dry mouth, nausea, vomiting and abdominal pain.

From the central nervous system: drowsiness, increased fatigue, rarely (especially with an overdose) - anxiety, psychotic reactions, inhibition, disorientation.

On the part of the hematopoiesis system: thrombocytopenia, methemoglobinemia.

Allergic reactions: rarely - skin rash, itching.

Other: blurred vision, hypothermia, sweating, development of tolerance (including cross-over to other nitrates).

Overdose:

Symptoms: headache, marked decrease in blood pressure (BP) (below 90 mm Hg) with orthostatic dysregulation, reflex tachycardia; dizziness may develop; asthenia, increased drowsiness, a feeling of heat, nausea, vomiting; In more severe cases (taking more than 20 mg / kg of nitroglycerin), too, sweating, dry mouth, visual impairment and collapse can occur.With the development of methemoglobinemia, hypoxia can lead to cyanosis, metabolic acidosis, seizures, dyspnoea and tachypnea, coma.

Treatment: In case of an overdose, if the patient is conscious, vomiting is necessary. When lowering blood pressure (BP), you must put the patient on his back, raise his legs and immediately call a doctor. Treatment is symptomatic. In more severe cases, infusion of liquids and phenylephrine, epinephrine and other vasoconstrictors is carried out to increase blood pressure (BP).

With methemoglobinemia, depending on the degree of severity, the following antidotes are recommended:

1. Ascorbic acid: 1 g. Inside or in the form of sodium salt intravenously.

2. Oxygenotherapy, hemodialysis, exchange blood transfusion.

Interaction:

Nitrogen forte is usually taken before meals.

Simultaneous intake of Nitros forte and alcohol can cause an additional reduction in blood pressure and collapse.

The hypotensive effect of Nitrogonum can be amplified at its simultaneous reception with blockers of "slow" calcium channels, beta-adrenoblockers, antihypertensive drugs, procainamide, diuretics,monoamine oxidase inhibitors (MAO), vasodilators, phenothiazines or tricyclic antidepressants. Against the background of quinidine and procainamide, orthostatic collapse may occur.

Simultaneous use of Nitrogen forte and inhibitors of phosphodiesterase type 5 (PDE-5) - sildenafil, tadalafil, vardenafil is not recommended, t. a sharp drop in blood pressure (BP) may occur.

Simultaneous use of Nitrogen forte and dihydroergotamine may increase the bioavailability of dihydroergotamine.

Combination of Nitrogen forte and heparin reduces the effectiveness of the latter, which may require an increase in the dose of heparin (after a drug cancellation, a reduction in the dose of heparin may be required).

Special instructions:

Nitrogen forte is not used to stop angina attacks.

For this, a high-speed nitroglycerine (sublingual forms).

The withdrawal of the drug is required only with pronounced side effects.

Doctors should inform patients about possible side effects and the necessary measures taken when they occur.

The patient is obliged to inform the attending physician of the side effects that occur.

Particular care should be taken in patients with severe anemia, hypertrophic cardiomyopathy, severe atherosclerosis and with dehydration.

According to the literature, caution is needed in severe hepatic insufficiency, hypothyroidism, hypothermia, malabsorption syndrome and eating disorders (insufficient food intake or unbalanced diet).

Patients previously treated with organic nitrates (isosorbide nitrate, isosorbide-5-mononitrate) may need a higher dose to produce the desired hemodynamic effect.

On the background of taking Nitrogen forte, it is possible to significantly reduce blood pressure (BP) and the appearance of dizziness during a sharp transition to a vertical position from the "lying" or "sitting" position, with the use of ethanol, exercise and hot weather, as well as increased angina with a sharp decrease arterial pressure (BP), ischemia, up to myocardial infarction and sudden death (paradoxical nitrate reactions).

It is necessary to warn the patient about the possible occurrence of a headache (especially at the beginning of treatment), which is due to the mechanism of action of Nitrogen forte.Severity of headache against the background of taking Nitrogen forte can be reduced by lowering its dose or by simultaneous intake of menthol-containing medicines (Validol).

If blurred vision or dry mouth is retained or severely expressed, treatment should be discontinued.

When treating Nitring forte at any time of the day, it is necessary to ensure the presence of a twelve-hour "non-nitrate" period. This helps prevent the development of tolerance to nitrates.

The withdrawal of the drug after long-term treatment with large doses should be carried out gradually. A sharp cessation of therapy can cause an exacerbation of coronary heart disease.

Effect on the ability to drive transp. cf. and fur:During treatment, the drug should not engage in activities that require increased concentration (driving, control of complex mechanisms).

Form release / dosage:

Tablets with sustained release, 6.5 mg.

Packaging:

For 25 tablets or 100 tablets in a glass bottle of amber color, with an aluminum cover with the control of the first opening, with an absorbent of cotton.

1 bottle in a cardboard pack together with instructions for use.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N014027 / 01

Date of registration:14.03.2008

Expiration Date:Unlimited

Date of cancellation:2017-04-28

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA-RUS, LLC Russia

KRKA, d.d. Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp28.04.2017

Illustrated instructions

Instructions

Nitroung forte (Nitrong forte)