Instructions for Dibazol-Darnitsa injection solution 1% ampoule 1 ml No. 10
Composition
active ingredient: bendazole;
1 ml of solution contains bendazole hydrochloride 10 mg;
Excipients: ethanol 96%, glycerol, hydrochloric acid, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless or slightly yellowish or greenish liquid.
Pharmacotherapeutic group
Peripheral vasodilators. ATC code C04A X.
Pharmacological properties
Pharmacodynamics.
Vasodilating and antispasmodic. Has hypotensive, vasodilating effects, stimulates spinal cord function, and has moderate immunostimulating activity.
It has a direct antispasmodic effect on the smooth muscles of blood vessels and internal organs. The drug causes a short-term (2-3 hours) and moderate hypotensive effect, is well tolerated. Causes short-term expansion of cerebral vessels in chronic brain hypoxia caused by local circulatory disorders (sclerosis of cerebral arteries). Facilitates synaptic transmission in the spinal cord. Has immunomodulatory activity. By regulating the ratio of concentrations of cyclic guanosine monophosphate (cGMP) and cyclic adenosine monophosphate (cAMP) in immune cells, it increases the content of cGMP, which promotes the proliferation of mature sensitized T- and B-lymphocytes, their secretion of mutual regulatory factors, cooperative reaction and activation of the final effector function of cells. The drug stimulates the production of antibodies, enhances the phagocytic activity of leukocytes and macrophages, and improves the synthesis of interferon, but the immunomodulatory effect develops slowly.
Pharmacokinetics.
When administered intramuscularly, the drug quickly penetrates the systemic bloodstream. The maximum concentration in the blood is observed 15-30 minutes after administration. Duration of action: 2-3 hours. Metabolized in the liver.
The products of dibazole biotransformation are two conjugates formed as a result of methylation and carboethoxylation of the imino group of the imidazole ring of dibazole: 1-methyl-2-benzylbenzimidazole and 1-carboethoxy-2-benzylbenzimidazole.
Metabolic products are excreted mainly in the urine.
Indication
As an additional remedy for spasms of blood vessels (exacerbation of hypertension, hypertensive crises) and smooth muscles of internal organs (spasms of the pylorus of the stomach, intestines); in the treatment of nervous diseases (mainly residual effects of poliomyelitis, peripheral paralysis of the facial nerve, polyneuritis).
Contraindication
Hypersensitivity to bendazole hydrochloride or to any of the excipients of the drug. Diseases with decreased muscle tone, convulsive syndrome, severe heart failure. Hypotension. Chronic nephritis with edema and impaired nitrogen-excreting kidney function. Bleeding gastric and duodenal ulcers. Diabetes mellitus.
Interaction with other medicinal products and other types of interactions
If the patient is taking any other medications, it is imperative to consult a doctor regarding the possibility of using this medication.
Papaverine hydrochloride, theobromine, salsolin – when used in combination with dibazole, the spectrum of pharmacological action of papaverine hydrochloride, theobromine, salsolin expands.
Barbiturates – when used in combination with Dibazol, the effectiveness of long-acting barbiturates, in particular phenobarbital, is enhanced.
Phentolamine, antihypertensive drugs (drugs that affect the renin-angiotensin system), saluretics - when used in combination with dibazole, the hypotensive effect is enhanced.
β-blockers – when used in combination with dibazole, the hypotensive effect of the latter does not change, but with prolonged use, dibazole prevents the increase in total peripheral resistance caused by β-blockers.
Application features
Before starting treatment, you should consult a doctor!
Dibazol-Darnitsa in the form of injections is an auxiliary agent used for arterial hypertension in case of sensitivity to other antihypertensive drugs. In the treatment of arterial hypertension, it is recommended to combine it with other antihypertensive drugs.
Long-term use of Dybazol-Darnitsa as an antihypertensive agent for elderly patients is not advisable due to the possibility of worsening ECG parameters and decreased cardiac output.
It is not recommended for long-term treatment of arterial hypertension, especially in elderly patients.
Important information about excipients.
This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose.
Use during pregnancy or breastfeeding
Do not use the medicine during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment, caution should be exercised when driving vehicles and working with complex mechanisms, and in case of dizziness, refrain from potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Method of administration and doses
Adults and children over 12 years of age should be given Dibazol-Darnitsa intravenously, intramuscularly or subcutaneously. To relieve hypertensive crises, 3-5 ml of a 1% solution (30-50 mg) should be administered intravenously or intramuscularly. With a significant increase in blood pressure, intramuscular administration of the drug is indicated at 2-3 ml of a 1% solution (20-30 mg) 2-3 times a day. The course of treatment is determined by the doctor individually, on average 8-14 days.
Children
The medicine should not be prescribed to children under 12 years of age.
Overdose
Symptoms: hypotension, sweating, feeling of heat, dizziness, nausea, mild headache, which quickly disappear upon discontinuation of the drug.
Treatment. Discontinue the drug. In case of severe hypotension, while controlling blood pressure, prescribe transfusion therapy, vasoconstrictors, cardiac glycosides. Further treatment is symptomatic.
Side effects
On the part of the respiratory system, chest organs and mediastinum: dry cough, runny nose, difficulty breathing.
Gastrointestinal: nausea, burning in the throat.
From the nervous system: dizziness, headache.
On the part of the cardiovascular system: palpitations, pain in the heart area, with prolonged use - deterioration of ECG indicators due to a decrease in cardiac output; decrease in blood pressure.
On the part of the immune system: itching, hyperemia, rash, urticaria.
General disorders: feeling hot, increased sweating, facial flushing.
Injection site reactions: local soreness, changes at the injection site.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. It allows for continued monitoring of the benefit-risk balance of the medicinal product concerned. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
4 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Incompatibility
Dibazol-Darnitsa is incompatible with salicylates and benzoates, as dibazol salicylate or benzoate precipitates.
Packaging
1 ml or 5 ml in an ampoule; 5 ampoules in a contour blister pack; 2 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
