Dibazol-Darnitsa - instructions for use, doses, side effects, contraindications

Excipients: ethanol 80.74 mg, glycerol in terms of 100% anhydrous substance 108.00 mg, 0.1 M solution of hydrochloric acid 10.0 μl, water for injection up to 1 ml.

Description:Transparent colorless or with slightly yellowish or grayish tinge liquid.

Pharmacotherapeutic group:Vasodilating agent.

ATX: & nbsp

C.04.A.X Other peripheral vasodilators

Pharmacodynamics:

Vasodilatory and antispasmodic. Has hypotensive, vasodilating effect, stimulates the function of the spinal cord, has moderate immunostimulating activity.

Has direct spasmolytic effect on smooth muscles of blood vessels and internal organs. The drug causes a short (2-3 hours) and a moderate hypotensive effect, is well tolerated. Causes a brief expansion of cerebral vessels in chronic brain hypoxia caused by local circulatory disorders (cerebral artery sclerosis).

It facilitates synaptic transmission in the spinal cord.

Has immunomodulating activity. Due to the regulation of the relation

concentrations of cGMP and cAMP in immune cells increases the cGMP content that leads to the proliferation of mature sensitized T and B lymphocytes, their secretion of mutually regulating factors, cooperative reaction and activation of the final effector function of the cells. The drug stimulates the production of antibodies, enhances the phagocytic activity of leukocytes, macrophages, improves the synthesis of interferon, but the immunomodulating effect develops slowly.

Pharmacokinetics:With intramuscular injection, the drug quickly enters the systemic circulation. The maximum concentration in the blood is observed after 15-30 minutes from the moment of administration. The duration of action is 2-3 hours. Metabolised in the liver. Biotransformation products of dibazol are two conjugates formed as a result of methylation and carboethoxylation of the imidazole of the imidazole ring of dibasol: 1-methyl-2-benzylbenzimidazole and 1-carboethoxy-2-benzylbenzimidazole.

Metabolism products are excreted mainly with urine.

Indications:Hypertensive crisis, spasms of smooth muscles of internal organs (stomach ulcer, spasms of the pylorus and intestines).

Contraindications:Hypersensitivity to the drug. Diseases accompanied by increased muscle tone or convulsive syndrome, age to 18 years (efficacy and safety not established).

Carefully:Carefully used in elderly patients.

Pregnancy and lactation:

As there is no data on the safety of the Dibazol-Darnitsa preparation for the fetus, its can not be used during pregnancy.During lactation, the issue of stopping breastfeeding during treatment with Dibasol-Darnitsa should be resolved.

Dosing and Administration:

Enter intravenously or intramuscularly.

When hypertensive crisis is administered intravenously or intramuscularly 30-40 mg (3-4 ml of 10 mg / kg solution.For smooth muscle spasms, the drug is administered at a dose of 10-20 mg (1-2 ml 10 mg / kg solution) intramuscularly. Simultaneously with the drug Dibasol-Darnitsa You can also use other antihypertensives.

Side effects:When used in large doses - a feeling of heat, increased sweating, dizziness, nausea, headache. When the dose is lowered or the drug is withdrawn, these side effects quickly disappear. Allergic reactions are possible.

Overdose:

Symptoms: sweating, a feeling of heat, dizziness, nausea, mild headache, which quickly pass with withdrawal of the drug.

Treatment. Cancel the drug. With severe hypotension under the control of blood pressure, transfusion therapy, vasoconstrictors, cardiac glycosides are prescribed. Further treatment is symptomatic.

Interaction:

Bendazole prevents beta-adrenergic blockers caused by an increase in total peripheral vascular resistance. With the simultaneous use of bendazole and phentolamine, the hypotensive effect of bendazole is enhanced. Bendazole strengthens antihypertensive effect of antihypertensive and diuretic agents.

Special instructions:

Long-term use of dibazol in elderly patients can cause deterioration of electrocardiogram parameters, reduction of cardiac output.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, one should refrain from driving and other potentially activities that require concentration and high the rate of psychomotor reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection.

Packaging:

1 ml or 5 ml in ampoules of clear glass.

It is allowed to paste a label with self-adhesive paper on the ampoule.

5 ampoules with a knife for opening ampoules or a scapegrator ampoule into a contour mesh package (cassette). Two contoured cells with instructions for medical use in a pack.

For 10 ampoules of 1 ml or 5 ml with instructions for medical use and a knife for opening ampoules or a scarifier

Ampoule in a box with a corrugated liner.

Boxes are pasted with a label-parcel post.

When packaging ampoules with a color ring or break point, knives for opening ampoules or ampoule scalers are not included.

Storage conditions:Keep out of reach of children, at a temperature of 5 ° C to 25 ° C.

Shelf life:4 years. Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N010634 / 01

Date of registration:08.07.2011

The owner of the registration certificate:DARNITSA PHARMACEUTICAL FIRM, CJSCDARNITSA PHARMACEUTICAL FIRM, CJSC Ukraine

Manufacturer: & nbsp

DARNITSA PHARMACEUTICAL FIRM, PAO Ukraine

Information update date: & nbsp25.04.2013

Illustrated instructions

Instructions

Dibazol-Darnitsa (Dibazol-Darnitsa)