INSTRUCTION

(information for professionals)

for medical use of the drug

DUZOFARM ®

 

Registration number: LSR-002740/09

Trade name DUZOFARM ®

Latin name - Dusopharm ®

Dosage Form: tablet , film-coated

Ingredients: 1 tablet film coating contains :

Active ingredient: 50 mg naftidrofuryl oxalate

Excipients : lactose monohydrate ; microcrystalline cellulose; wheat starch ; copovidone ; colloidal silicon dioxide ; magnesium stearate; talc.

Coat composition : titanium dioxide; talc; magnesium stearate; macrogol 6000 ; methacrylic acid -ethyl acrylate copolymer ; dye sunny sunset yellow E110 .

Description: Round, biconvex tablets, film-coated orange.

Pharmacotherapeutic group: vazodilyatiruyuschee means

ATC code: C04AX21

Pharmacological properties

Pharmacodynamics

Has a vasodilator effect, causing improves peripheral and cerebral circulation. Causes a decrease in peripheral vascular resistance and increases cardiac output, without causing any significant effect on heart rate and blood pressure. Vasodilator effect Duzofarma is the result of its direct myotropic antagonistic towards serotonin 5HT2 - receptors and alpha- adrenoceptor blocking action.

Has M -anticholinergic action. Has a positive effect on cellular metabolism, improving the utilization of oxygen and glucose. This effect of the drug is determined by its ability to increase ATP levels and inhibit the enzyme succinate dehydrogenase . Enables the utilization of glucose through the citric acid cycle and increases the conversion of succinic acid into fumaric acid. This increases the resistance of cells (including the brain) to hypoxia.

In addition, increased viscosity reduces Duzofarm blood.

 

Pharmacokinetics

Duzofarm almost completely absorbed by ingestion . Food virtually no effect on its absorption . After a single dose of 100 mg of the maximum plasma concentration observed after 45-60 minutes and is 175 ug / ml. Undergoes hepatic recycling that promotes longer finding it in the plasma. Linking blood protein - 80%. Penetrates the blood-brain barrier . The maximum concentration in the brain tissue after 60 minutes is observed . After 24 h after administration its concentration in the brain tissues of 3 times higher than in plasma. No data on the penetration Duzofarma through the placenta and breast milk.

Metabolized mainly in the liver by hydrolysis which is carried out by plasma esterases . The principal metabolites were studied nafronovaya acid and diethylaminoethanol , which has a stimulating effect on the central nervous system.

The half-life of 1-2 hours at a single dose of 100 mg, and 3.5 hours when receiving 200 mg. Excreted mainly through the intestines and kidneys in a small amount . No data on changes in the rate of its removal with abnormal liver function or renal function. Age did not affect the pharmacokinetic parameters of the drug.

 

Indications primeneiya

Recovery period of cerebral circulation ; peripheral circulatory disorders ( intermittent claudication , Raynaud's disease, trophic ulcers).

Contraindications

Individual hypersensitivity to the drug; myocardial infarction (acute stage); hypotension; hemorrhagic stroke (acute stage); epilepsy, increased convulsive readiness; chronic heart failure II-III stage (III-IV by NYHA - functional classification of heart failure of New York Heart Association); tachyarrhythmias.

Age 18 years (the efficacy and safety have not been established).

Precautions: angle-closure glaucoma ; prostatic hyperplasia.

 

Use during pregnancy and breastfeeding

Duzofarm not teratogenic , but because special studies of its safety in pregnant women has been conducted, it is recommended to prescribe a drug only when the benefits of treatment to the mother outweighs the potential risk to the fetus.

Not recommended taking the drug while breastfeeding.

 

Dosing and Administration

Inside. Tablets are taken as a whole, with plenty of fluids (water is recommended to drink).

Violations of cerebral circulation: a daily dose of 300 mg (2 tablets 3 times a day).

When peripheral blood flow disorders: daily doses - 500-600 mg , divided into 3 doses.

Duzofarm recommended for long-term oral therapy (up to 6 months).

Dose adjustment in renal / hepatic failure is not required.

 

Side effect

When administered in doses ranging from 300 to 600 mg Duzofarm generally well tolerated . Possible side effects: nausea, vomiting, epigastric pain, abdominal cramps, diarrhea, loss of appetite, headache, dizziness, sleep disturbances, reversible increases in liver enzymes, ulceration of the gastric mucosa , allergic reactions.

 

Overdose

Symptoms: increased severity of side effects, ventricular arrhythmia, anxiety, decreased blood pressure , bradycardia.

Treatment: gastric lavage, the appointment of activated charcoal and laxatives, symptomatic treatment. No specific antidote.

 

Interaction with other drugs

Enhances the hypotensive effect of antihypertensive drugs . In this connection, it is recommended more frequent monitoring of blood pressure at the beginning of the combined treatment Duzofarmom and antihypertensive agents simultaneously.

 

Cautions

Duzofarm no negative impact on psychomotor reaction and the ability to drive a car . Early treatment is recommended to control the individual tolerability and trace possible hypotensive effect of the respective patients.

Medicinal product contains lactose monohydrate, is therefore unsuitable for persons suffering from lactose deficiency , galactosemia or glucose- galactose malabsorption . Patients with celiac disease ( gluten enteropathy ) should be borne in mind that the tablet includes wheat starch .

 

Form of

Tablets, film-coated 50 mg.

10 film-coated tablets in blister PVC / aluminum foil.

3 blisters along with instructions for use in a cardboard box.

 

Storage conditions

In a dry, protected from light and out of reach of children at temperature not exceeding 25 ° C.

 

Shelf life

3 years.

Do not take it beyond the expiration date stated on the packaging!

 

Terms of supply of pharmacies

on prescription

 

Manufacturer

AO UNIPHARM

1797 Sofia, Bulgaria Str. "Tr.Stanoev" 3

 

Marketing in Russia

LLC «ESKO PHARMA»

115093, Moscow, ul. Pavlovian, 6

Tel.: +7 (495) 980 95 15

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