DUZOFARM
Active material: Naftidrofuril
When ATH: C04AX21
CCF: Preparation, improves cerebral and peripheral circulation
ICD-10 codes (testimony): I61, I63, I69, I73.0, I73.1, I73.9, I79.2
When CSF: 01.14
Manufacturer: UNIPHARM AD (Bulgaria)
Pharmaceutical form, composition and packaging
Pills, Film-coated orange, round, lenticular.
| 1 tab. | |
| naftidrofuryl oxalate | 50 mg |
Excipients: lactose monohydrate, microcrystalline cellulose, wheat starch, kopovydon, colloidal silicon dioxide, magnesium stearate, talc.
The composition of the shell: Titanium dioxide, talc, magnesium stearate, macrogol 6000, methacrylic acid and ethyl acrylate copolymer, colorant sunset yellow (E110).
10 PC. – blisters (3) – packs cardboard.
Pharmacological action
Preparation, improves cerebral and peripheral circulation. It has a vasodilating effect. Reduces round and increases cardiac output, without causing significant effect on heart rate and blood pressure. Vasodilating effect Duzofarma® it is the result of direct action myotropic, antagonistic towards serotonin 5HT2 receptors and alpha-adrenoceptor blocking action.
It has m-anticholinergic action. It has a positive effect on cell metabolism, improving the utilization of oxygen and glucose. This effect is due to its ability to increase ATP levels and inhibit the enzyme succinate dehydrogenase. It enables the utilization of glucose by the citric acid cycle and increases the conversion of succinic acid, fumaric. The result is increased cell resistance (incl. of the brain) hypoxia. Besides, Duzofarm® lowers elevated blood viscosity.
Pharmacokinetics
Absorption
Duzofarm® It is almost completely absorbed by ingestion. Food has virtually no effect on its absorption. After a single dose 100 mg Cmax observed through 45-60 and m is 175 ug / ml. Treated hepatic recirculation, thereby finding its longer plasma.
Binding
Linking blood protein – 80%. It penetrates through the BBB. Cmax in the brain tissue is achieved through 60 m. Through 24 h after administration its concentration in tissues brain 3 times higher, than in plasma. No data on the penetration Duzofarma® through the placenta and breast milk.
Metabolism
Metabolized mainly in the liver by hydrolysis, which is carried out by plasma esterases. The main metabolites are studied nafronovaya acid and diethylaminoethanol, which has a stimulating effect on the CNS.
Deduction
T1/2 is 1-2 hours at a single dose 100 mg 3.5 no – upon receipt of dose 200 mg. Excreted from the body mainly through the intestine and a small amount of the kidneys.
Pharmacokinetics in special clinical situations
No data on changes in the rate of its removal in violation of liver or kidney function.
Age did not affect the pharmacokinetic parameters of the drug.
Testimony
- Recovery period cerebrovascular;
- Peripheral circulatory disorders (intermittent claudication, Raynaud's disease, sores).
Dosage regimen
The drug is prescribed inside. Swallow whole tablets, drinking plenty of fluids (water).
At cerebrovascular disorders drug administered in a daily dose 300 mg (by 2 tab. 3 times / day).
At peripheral circulatory disorders daily dose is 500-600 mg, razdelennaya of 3 admission.
Duzofarm® It recommended for long-term therapy (to 6 Months).
Dose adjustment when kidney or liver failure not required.
Side effect
When administered in doses ranging from 300 to 600 mg Duzofarm® generally well tolerated.
From the digestive system: nausea, vomiting, epigastric pain, kišečnaâ how, diarrhea, decreased appetite, reversible increases in liver enzymes, ulceration of the gastric mucosa.
CNS: headache, dizziness, sleep disturbance.
Other: allergic reactions.
Contraindications
- Myocardial infarction (acute stage);
- Hypotension;
- Hemorrhagic stroke (acute stage);
- Epilepsy;
- Increased convulsive readiness;
- Chronic heart failure stage II-III (III-IV functional class NYHA classification);
- Taxiaritmii;
- Up to 18 years (efficacy and safety have not been established);
- Individual hypersensitivity to the drug.
FROM caution should be prescribed the drug for angle-closure glaucoma, prostatic hyperplasia.
Pregnancy and lactation
Duzofarm® not teratogenic, but unnecessarily. special studies of its safety in pregnant women has not been, It recommended to prescribe the drug only in cases, when the benefits of treatment to the mother outweighs the potential risk to the fetus.
We do not recommend taking the drug while breastfeeding.
Cautions
At the beginning of treatment is recommended to control the individual tolerance of the drug and the possibility of hypotensive effect in patients.
The drug contains lactose monohydrate, so it should not appoint lactase deficiency, galactosemia or malabsorption syndrome glucose / galactose.
Patients with celiac disease (celiac disease) should be considered, that is included in the tablet wheat starch.
Effects on ability to drive vehicles and management mechanisms
Duzofarm® no adverse effects on psychomotor reaction and the ability to drive a car.
Overdose
Symptoms: increased severity of side effects, ventricular arrhythmia, anxiety, decrease in blood pressure, bradycardia.
Treatment: gastric lavage, the appointment of activated charcoal and laxatives, symptomatic treatment. No specific antidote.
Drug Interactions
Enhances the hypotensive effect of antihypertensive drugs. In this regard, we recommend more frequent monitoring of blood pressure at the beginning of treatment Duzofarmom® and antihypertensive drugs at the same time.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year.
