Instructions Nicotinic acid tablets 50 mg container No. 50
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 break under a magnifying glass, a relatively homogeneous structure is visible.
Pharmacotherapeutic group
Peripheral vasodilators. Nicotinic acid and its derivatives. ATC 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 is also involved in phosphate transport. Nicotinic acid deficiency leads to pellagra. Nicotinic acid improves carbohydrate metabolism, dilates blood vessels. It has lipoproteinemic activity, and in hypercholesterolemia it reduces the cholesterol/phospholipid ratio.
Pharmacokinetics
Absorbed over 6–8 hours, as nicotinic acid is gradually and evenly released from the tablet. About 50% is absorbed within the first hour, and about 96% by the eighth hour. Metabolized in the liver, kidneys, and muscles. Metabolism products are excreted by the kidneys.
Indication
Prevention and treatment of pellagra (vitamin PP deficiency);
atherosclerosis; hypoacid gastritis; vascular spasms (of the brain, kidneys, extremities); facial nerve neuritis; ulcers and wounds of various localization and genesis that do not heal for a long time.
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 medicinal products 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 potentiates the effects of fibrinolytic agents, antispasmodics and cardiac glycosides, and the toxic effects of alcohol on the liver.
Simultaneous use with methyldopa or β-adrenergic blockers leads to a significant decrease in blood pressure, and with antidiabetic agents - to a decrease in the hypoglycemic effect of the latter.
Nicotinic acid is incompatible with vitamins B1, B12, B6, euphylline, salicylates, tetracycline, sympathomimetics, and hydrocortisone.
Acute vascular insufficiency may occur when alcohol is consumed during treatment with nicotinic acid.
Application features
To minimize side effects and improve treatment tolerability, it is recommended to:
During treatment, monitor blood glucose levels and liver function to detect side effects of nicotinic acid; take nicotinic acid only with food, which promotes gradual absorption of the drug and reduces 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 arterial 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 (cheese) in the diet, or to use methionine and other lipotropic agents.
It is inappropriate to use nicotinic acid to correct dyslipidemia in patients with diabetes.
Ability to influence 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.
Use during pregnancy or breastfeeding
It is not recommended to prescribe the drug during pregnancy or breastfeeding.
Method of administration and doses
Take orally after meals.
For pellagra, adults are prescribed 100 mg 2–4 times a day for 15–20 days; children over 12 years old are prescribed 50 mg 2 times a day. The maximum dose is 3 times a day.
For other diseases, adults should be prescribed 50 mg (up to 100 mg) 2 times a day, children over 12 years old - 25 mg (the tablet has a dividing line) 2 times a day.
The highest doses for adults: single dose – 100 mg, daily dose – 500 mg.
The highest 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 - to 2-3 g.
Children
It is not recommended to prescribe the medicine to children under 12 years of age.
Overdose
Symptoms: High doses of nicotinic acid can cause peripheral vasodilation, flushing, nausea, vomiting, heartburn, diarrhea, increased liver enzyme activity, brown skin pigmentation, rarely - hyperuricemia, skin itching, headache, arterial hypotension, loss of consciousness, dizziness, skin paresthesias (tingling, burning sensation, sensation of heat, crawling sensation), impaired glucose metabolism, visual impairment, cholestatic jaundice.
Treatment: The drug should be discontinued. 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 skin itching, rash.
On the part of the liver and biliary tract: with prolonged use - fatty liver, increased blood levels of aspartate aminotransferase (AST), 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, as well as acanthosis (brown spots on the skin with a velvety surface). 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, myalgia, hypotension, rhinitis may occur. Blurred vision, eyelid edema, myopathy, exfoliative dermatitis are possible. Cases of rhabdomyolysis have been reported with the use of nicotinic acid with lovastatin.
Expiration date
4 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Packaging
50 tablets per container. 1 container per cardboard pack.
Vacation category
Without a prescription.
Producer
Technolog PJSC.
Location of the manufacturer and its business address
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
