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Nicotinic acid 0.05 g container 50 pcs.

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Papazol Darnitsa is a combined drug that contains the alkaloid papaverine and the imidazole derivative bendazole.

NICOTINIC ACID tablets 50 mg

Instruction

For medical use of the medicinal product

Nicotinic acid

(Nicotinic acid)

Composition:

Active ingredient: nicotinic acid;

1 tablet contains 50 mg of nicotinic acid;

excipients: glucose monohydrate, magnesium stearate.

Dosage form.

Pills.

Main physicochemical properties: single-layer tablets of round shape, white or almost white color, with a line, the upper and lower surfaces of which are convex. On the fracture under a magnifying glass, a relatively homogeneous structure is visible.

Pharmacotherapeutic group.

Peripheral vasodilators: nicotinic acid and its derivatives.

PBX code C04A C01.

Pharmacological properties.

Pharmacodynamics.

Nicotinic acid is a prosthetic group of enzymes codehydrase I and codehydrase II – enzymes that transfer hydrogen and carry out redox processes. Codehydrase II also plays a role in the transport of phosphate. Nicotinic acid deficiency leads to the occurrence of pellagra. Nicotinic acid improves carbohydrate metabolism, dilates blood vessels. It has lipoproteinemic activity, and in hypercholesterolemia it reduces the cholesterol / phospholipids ratio.

Pharmacokinetics.

Absorbed within 6-8 hours, as nicotinic acid is gradually and evenly released from the tablet. About 50% is absorbed during the first hour, and about 96% by the eighth hour. Metabolized in the liver, kidneys and muscles. Metabolism products are excreted by the kidneys.

Clinical characteristics.

Indication.

  • Prevention and treatment of pellagra (vitamin deficiency); atherosclerosis; hypoacid gastritis; vascular spasms (brain, kidneys, extremities); facial nerve neuritis; long-lasting wounds and ulcers of various localization and genesis.

Contraindication.

Hypersensitivity to nicotinic acid or to other components of the drug. arterial hypertension (severe forms), gastric and duodenal ulcers (in the acute stage), severe liver dysfunction, including cirrhosis, active hepatitis.

Decompensated diabetes mellitus, urolithiasis, hyperuricemia, gout.

Recent myocardial infarction, history of sudden decrease in peripheral vascular resistance.

Interaction with other drugs and other types of interactions.

Oral contraceptives and isoniazid reduce the conversion of tryptophan to nicotinic acid and thus may increase the need for nicotinic acid.

Nicotinic acid reduces the effectiveness and toxicity of probenecid, neomycin, barbiturates, anti-tuberculosis drugs, and sulfonamides.

Antibiotics may increase skin redness caused by nicotinic acid.

Acetylsalicylic acid reduces the effect of skin redness caused by nicotinic acid.

Lovastatin, pravastatin are not recommended for combination with nicotinic acid due to increased risk of adverse reactions. There are reports of cases of rhabdomyolysis when nicotinic acid is used with lovastatin.

Caution should be exercised when combining with antihypertensive agents (possible enhancement of the hypotensive effect), anticoagulants, acetylsalicylic acid (due to the risk of hemorrhage).

The drug enhances the effect of fibrinolytic agents, antispasmodics and cardiac glycosides, and the toxic effect of alcohol on the liver.

Simultaneous use with methyldopa or β-adrenergic blockers leads to a strong decrease in blood pressure; with antidiabetic agents – to the hypoglycemic effect of the latter.

Nicotinic acid is incompatible with vitamins B1 , B12 , B6 , euphylline, salicylates, tetracycline, sympathomimetics, and hydrocortisone.

Drinking alcohol during treatment with nicotinic acid may cause acute vascular insufficiency.

Application features.

To minimize side effects and improve treatment tolerability, it is recommended:

  • During treatment, it is necessary to monitor blood glucose levels and liver function in order to detect side effects of nicotinic acid;
  • take nicotinic acid only with food, which leads to gradual absorption of the drug and helps reduce side effects;
  • do not take nicotinic acid with hot drinks (especially coffee), alcohol;
  • Do not take a hot shower (bath) immediately after taking the drug.

Use with caution in patients with hemorrhages, glaucoma, renal failure, moderate hypotension, hyperacid gastritis, gastric ulcer and duodenal ulcer (in remission phase). Nicotinic acid should be used with caution in individuals who abuse alcohol, patients with unstable angina and acute myocardial infarction, who are receiving nitrates, calcium channel antagonists and beta-blockers.

With prolonged use of nicotinic acid in high doses, fatty infiltration of the liver may develop, therefore monitoring of liver function is necessary.

It is necessary to regularly monitor the level of uric acid in the blood due to its possible increase as a result of prolonged therapy.

To prevent liver complications, it is recommended to include foods rich in methionine (cottage cheese) in the diet or to use methionine and other lipotropic agents.

The drug contains glucose, which should be taken into account by patients with diabetes.

It is inappropriate to use nicotinic acid to correct dyslipidemia in patients with diabetes.

Use during pregnancy or breastfeeding.

It is not recommended to prescribe the drug to women during pregnancy or breastfeeding.

The ability to influence the reaction speed when driving vehicles or other mechanisms.

Studies on the effect of the drug on reaction speed have not been conducted, however, the possible occurrence of dizziness and drowsiness when using nicotinic acid should be taken into account.

Method of administration and doses.

Apply internally after meals.

For pellagra, adults are prescribed 100 mg 2-4 times a day for 15-20 days; children from 12 years old – 50 mg 2-3 times a day.

For other diseases, adults are prescribed 50 mg (up to 100 mg) 2 times a day, children from 12 years old – 25 mg (the tablet has a dividing line) 2 times a day.

Higher doses for adults: single dose – 100 mg, daily dose – 500 mg.

Higher doses for children: single dose – 50 mg, daily dose – 200 mg.

In case of atherosclerosis (in the absence of side effects), a single dose can be gradually increased to 500 mg-1 g, and the daily dose can be increased to 2-3 g.

Children.

It is not recommended to prescribe the drug to children under 12 years of age.

Overdose.

Symptoms: large doses of nicotinic acid can cause peripheral vasodilation, skin redness, nausea, vomiting, heartburn, diarrhea, increased activity of liver enzymes, brown skin pigmentation, less often – hyperuricemia, skin itching, headache, arterial hypotension, possible loss of consciousness, dizziness, skin paresthesias (tingling, burning sensation, sensation of heat, crawling sensation), impaired glucose metabolism, visual impairment, cholestatic jaundice.

Treatment. It is necessary to stop taking the drug, therapy is symptomatic.

Adverse reactions.

Cardiovascular system: feeling of hot flushes, which may be accompanied by shortness of breath, tachycardia, palpitations, sweating, chills, edema.

From the side of the central nervous system and peripheral nervous system: paresthesia, dizziness, headache.

Skin: hyperemia of the skin of the face and upper body with a tingling and burning sensation, dry skin and mucous membranes of the eyes, debilitating itching of the skin, rash.

From the liver and biliary tract: with prolonged use – fatty liver, increased blood levels of aspartate aminotransferase (ATS), lactate dehydrogenase (LDH), alkaline phosphatase.

Metabolic: with prolonged use in large doses – decreased glucose tolerance, increased blood glucose levels, blood uric acid levels, hypophosphatemia.

Other: allergic reactions (including urticaria).

Very rarely, while taking nicotinic acid in patients with coronary heart disease, the frequency of atrial arrhythmias increases, and acanthosis (brown spots on the skin with a velvety surface) also occurs. Rarely, retinal edema may occur. These symptoms are transient and disappear after discontinuation of the drug.

When taking high doses: hyperpigmentation, cramps, diarrhea, nausea, vomiting, anorexia, exacerbation of gastric ulcer, jaundice, amblyopia, decreased platelet count, prolonged prothrombin time. Insomnia, muscle pain, hypotension, rhinitis may occur. Blurred vision, eyelid edema, myopathy, exfoliative dermatitis may occur. Cases of rhabdomyolysis have been reported with the use of nicotinic acid with lovastatin.

Expiration date.

4 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 degrees Celsius.

Packaging.

50 tablets in a container. 1 container in a cardboard pack.

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