Duzopharm tablets p / o 50mg, No. 60

Х Violation of cerebral circulation against the background of atherosclerotic lesions of the vessels of the brain and cerebral vascular insufficiency, especially in old age.

Х Peripheral circulation disorders: intermittent claudication syndrome, Raynaud's disease and syndrome, calf muscle cramps, leg pain at rest, paresthesia, acrocyanosis.

Х Trophic disorders (long-term non-healing ulcers, diabetic retinopathy).

Inside.

The tablets are taken whole with at least a glass of liquid, it is recommended to drink it with water. Duzopharm is indicated for long-term oral therapy.

In case of cerebral circulation disorders: it is recommended to take the drug in a daily dose of 300 mg to 600 mg, divided into three doses in a single dose of 100 mg.

In case of peripheral circulatory disorders: it is recommended to take the drug in a daily dose of 400 to 600 mg, in a single dose of 200 mg.

The duration of therapy and dosage are determined by the doctor depending on the clinical condition of the patient. No dose adjustment is required for renal / hepatic impairment.

1 film-coated tablet contains:

active substance: naftidrofuril oxalate 50 mg.

excipients: lactose monohydrate 47.50 mg, microcrystalline cellulose 63.50 mg, wheat starch 28.00 mg, sodium starch glycolate (type A) 4.80 mg, copovidone 10.00 mg, crospovidone 4.80 mg, silicon dioxide colloidal 4.00 mg, magnesium stearate 7.20 mg, talc 10.20 mg. composition of the film shell: titanium dioxide 1.04 mg, talc 1.99 mg, macrogol 6000 0.182 mg, methacrylic acid and ethyl acrylate copolymer 0.68 mg, dibutyl phthalate 0.068 mg, sunset yellow dye E110.

• Increased individual sensitivity to the drug,

• myocardial infarction (acute stage);

• arterial hypotension;

• hemorrhagic stroke (acute stage);

• epilepsy, increased convulsive readiness;

• chronic heart failure II-III st. (NYHA III-IV - functional classification of heart failure by the New York Heart Association);

• tachyarrhythmias.

• Age up to 18 years (efficacy and safety have not been established).

• With care: angle-closure glaucoma, prostatic hyperplasia.

pharmachologic effect

Naphtidrofuril has a vasodilating effect, as a result of which it improves peripheral and cerebral circulation. It causes a decrease in peripheral vascular resistance and increases the cardiac output without significantly affecting the heart rate and blood pressure. The vasodilating effect of naftidrofuril is the result of its selective action on 5HT2 receptors of platelets and vascular smooth muscle. Due to vasodilation due to the action of naftidrofuril, there is an improvement in microcirculation in peripheral tissues, brain and retina. It has an M-anticholinergic effect. Under conditions of ischemia, naftidrofuril causes a decrease in anaerobic metabolism, which leads to an increase in the concentration of adenosine triphosphate and a decrease in the lactate pyruvate coefficient.As a result, the resistance of cells (including the brain) to hypoxia increases. The drug improves cognitive function of the brain, reduces episodes of dizziness and headache, and induces improved sleep. Naphtidrofuril improves blood rheology by inhibiting platelet aggregation and increasing the elastic properties of erythrocytes.

Pharmacokinetics

Naphtidrofuril is almost completely absorbed when taken orally. Food has practically no effect on its absorption. After taking a single dose of 100 mg, the maximum plasma concentration is observed after 45-60 minutes and is 175 ?g / ml. Undergoes hepatic recirculation, which contributes to its longer stay in plasma. Communication with blood proteins - 80%. Penetrates the blood-brain barrier. The maximum concentration in the brain tissue is observed after 60 minutes. 24 hours after administration, its concentration in the brain tissues is 3 times higher than in plasma. There is no data on the penetration of naftidrofuril through the placenta and into breast milk. It is metabolized mainly in the liver by hydrolysis, which is carried out by plasma esterases. The main metabolites studied are naphronic acid and diethylaminoethanol,which has a stimulating effect on the central nervous system. The half-life is 1-2 hours when taking a single dose of 100 mg and 3.5 hours when taking 200 mg. It is excreted from the body mainly through the intestines and in a small amount by the kidneys. There is no evidence of a change in the rate of its elimination in case of impaired liver or kidney function. Age does not affect the pharmacokinetic parameters of the drug

Application during pregnancy and breastfeeding

Duzopharm does not have a teratogenic effect, but because special studies of its safety in pregnant women have not been conducted; it is recommended to prescribe the drug only in cases where the benefits of treatment for the mother outweigh the potential risk to the fetus. It is not recommended to take the drug during breastfeeding.

Side effect

When taken orally in doses from 300 to 600 mg, Duzofarm is well tolerated in general. Nausea, vomiting, epigastric pain, intestinal colic, diarrhea, loss of appetite, headache, dizziness, sleep disturbance, reversible increases in the activity of liver enzymes, gastric ulcers, allergic reactions.

Overdose

Symptoms: increased severity of side effects, ventricular apathy, anxiety, decreased blood pressure, bradycardia. Treatment: gastric lavage, the appointment of activated charcoal and laxatives, symptomatic treatment. There is no specific antidote.

Interaction with other medicinal products

Strengthens the antihypertensive effect of antihypertensive drugs. In this regard, more frequent monitoring of blood pressure is recommended at the beginning of treatment with Duzofarm and antihypertensive drugs simultaneously.

special instructions

Duzopharm does not have a negative effect on psychomotor reactions and the ability to drive a car. At the beginning of treatment, it is recommended to monitor the individual tolerance of the drug and monitor the possible hypotensive effect in the respective patients. The medicinal product contains lactose monohydrate, therefore it is unsuitable for persons suffering from lactose deficiency, galactosemia or glucose-galactose malabsorption syndrome. Patients with celiac disease (gluten enteropathy) should take into account that the tablet contains wheat starch.