Bendazole

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BENDAZOL (BENDAZOL)

Composition:

Active substance: bendazol

1 ml of solution contains 10 mg of bendazol calculated as 100 % dry substance;

Excipients: ethanol 96 %, glycerol, hydrochloric acid, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear colorless liquid, sometimes with a slightly yellowish or greenish tint.

Pharmacotherapeutic group. Peripheral vasodilators. ATC code C04AX.

Pharmacological Properties

Pharmacodynamics

A vasodilatory and spasmolytic agent. Exerts hypotensive and vasodilating effects, stimulates spinal cord function, and has moderate immunostimulatory activity.

Exerts a direct spasmolytic effect on smooth muscles of blood vessels and internal organs. The drug induces a short-term (2–3 hours) and moderate hypotensive effect and is well tolerated. It causes transient dilation of cerebral vessels in chronic brain hypoxia due to local circulatory disturbances (cerebral arterial sclerosis). Facilitates synaptic transmission in the spinal cord. Possesses immunomodulatory activity. By regulating the balance of cGMP and cAMP concentrations in immune cells, it increases cGMP levels, leading to proliferation of mature sensitized T- and B-lymphocytes, secretion of mutual regulatory factors, cooperative reactions, and activation of the final effector cell functions. The drug stimulates antibody production, enhances phagocytic activity of leukocytes and macrophages, and improves interferon synthesis, although the immunomodulatory effect develops slowly.

Pharmacokinetics

After intramuscular administration, the drug rapidly enters the systemic circulation. Maximum blood concentration is reached within 15–30 minutes after administration. Duration of action is 2–3 hours. Metabolized in the liver.

The metabolites of bendazole are two conjugates formed as a result of methylation and carboethoxylation of the imino group of the imidazole ring of bendazole: 1-methyl-2-benzylbenzimidazole and 1-carboethoxy-2-benzylbenzimidazole.

Metabolites are excreted predominantly in urine.

Clinical characteristics.

Indications.

As an adjunctive agent in vascular spasms (hypertensive disease exacerbation, hypertensive crises) and smooth muscle spasms of internal organs (spasms of gastric pylorus, intestines).

Contraindications.

Hypersensitivity to bendazole hydrochloride or to any of the excipients of the medicinal product. Conditions characterized by decreased muscle tone, convulsive syndrome, severe cardiac insufficiency. Hypotension. Chronic nephritis with edema and impaired renal nitrogen excretion function. Bleeding gastric or duodenal ulcer. Diabetes mellitus.

Interaction with other medicinal products and other forms of interaction.

If the patient is taking any other medicinal products, consultation with a physician regarding the possibility of using this drug is mandatory.

Papaverine hydrochloride, theobromine, and salsolin – when used concomitantly with bendazole, the pharmacological action spectrum of papaverine hydrochloride, theobromine, and salsolin is expanded.

Barbiturates – when used concomitantly with bendazole, the efficacy of long-acting barbiturates, particularly phenobarbital, is enhanced.

Phentolamine, antihypertensive agents (drugs affecting the renin-angiotensin system), and diuretics – when used concomitantly with bendazole, the hypotensive effect is enhanced.

β-blockers – when used concomitantly with bendazole, the hypotensive effect of the latter remains unchanged; however, with prolonged use, bendazole prevents the increase in total peripheral resistance caused by β-blockers.

Special precautions for use.

Consult a physician before starting treatment!

Bendazole in the form of injections is an auxiliary agent used in arterial hypertension when sensitive to other antihypertensive agents. Combination with other antihypertensive drugs is recommended in the treatment of arterial hypertension.

Prolonged use of bendazole as an antihypertensive agent is not advisable in elderly patients due to the possibility of worsening ECG parameters and reduced cardiac output.

Prolonged treatment of arterial hypertension with bendazole is not recommended, especially in elderly patients.

The product contains a small amount of ethanol (alcohol), less than 100 mg/dose.

Use during pregnancy or breastfeeding.

Do not use the drug during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

During treatment, caution should be exercised when driving vehicles or operating complex machinery. If dizziness occurs, avoid potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Method of Administration and Dosage.

For adults and children aged 12 years and older, bendazole should be administered intravenously, intramuscularly, or subcutaneously. To control hypertensive crises, inject 3–5 ml of a 1% solution (30–50 mg) intravenously or intramuscularly. In cases of significant increase in arterial pressure, intramuscular administration of 2–3 ml of a 1% solution (20–30 mg) 2–3 times daily is indicated. The treatment course is determined individually by a physician; on average, it lasts 8–14 days.

Children.

The drug is contraindicated for children under 12 years of age.

Overdose.

Symptoms: hypotension, sweating, sensation of warmth, dizziness, nausea, mild headache, which quickly resolve after discontinuation of the drug.

Treatment: Discontinue the drug. In cases of pronounced hypotension, under arterial pressure monitoring, administer transfusion therapy, vasoconstrictive agents, and cardiac glycosides. Further treatment is symptomatic.

Side effects.

Central nervous system: dizziness, headache.

Cardiovascular system: palpitations, chest pain; with prolonged use – worsening of ECG parameters due to decreased cardiac output; hypotension.

Respiratory system, thoracic organs and mediastinum: dry cough, rhinitis, dyspnea.

Gastrointestinal tract: nausea, heartburn.

Immune system: pruritus, hyperemia, rash, urticaria.

General disorders: sensation of warmth, increased sweating, facial flushing.

Injection site reactions: local pain, changes at the injection site.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after drug registration is important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility.

Bendazole is incompatible with salicylates and benzoates, as precipitation of bendazole salicylate or benzoate may occur.

Packaging. 1 ml or 5 ml in an ampoule; 5 ampoules per blister; 1 or 2 blisters or 100 ampoules per carton.

Prescription status. Prescription only.

Manufacturer. Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address and location of business activity.

36 Severina Pototskoho Street, Kharkiv, Kharkiv Oblast, 61115, Ukraine.