SULFOCAINE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SULFOCAINE (SULFOCAINE)

Composition:

Active substances: DL-sulfocamphoric acid, novocaine;

1 ml of solution contains: DL-sulfocamphoric acid 49.6 mg, novocaine base 50.4 mg;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Cardiovascular agents. Other cardiovascular agents.

ATC Code C01EB.

Pharmacological Properties

Pharmacodynamics

Sulfocaine belongs to the group of analeptic medicinal agents. Its mechanism of action is due to stimulation of the central nervous system, primarily the centers of the medulla oblongata, both directly and via the carotid sinus. The medicinal product Sulfocaine exerts a tonic effect on the respiratory and vasomotor centers, enhances metabolic processes in cardiac muscle, and increases its sensitivity to sympathetic nerve influences. Sulfocaine affects blood vessels—resulting in redistribution of blood flow, constriction of blood vessels in abdominal organs, increased venous vessel tone, slight increase in blood flow to the heart, improved coronary circulation, and enhanced blood supply to the brain and lungs. The cardiotonic effect is associated with adrenosensitizing action, intensified respiratory processes, and enhanced glycolysis related to phosphorylation of macroergic compounds.

Pharmacokinetics

The medicinal product Sulfocaine is rapidly absorbed following subcutaneous, intramuscular, and intravenous administration. In the body, it undergoes metabolism involving oxidation and conjugation with glucuronic acid. Metabolites are primarily excreted by the kidneys, and the urine has the odor of the medicinal product. Partly, the drug is eliminated through exhaled air via the respiratory tract and with bile.

Clinical characteristics.

Indications.

Acute and chronic respiratory failure; acute heart failure in geriatrics; respiratory depression in pneumonia and other infectious diseases; cardiogenic and anaphylactic shock; alcohol intoxication, mild forms of intoxication with sedatives.

Contraindications.

Hypersensitivity to camphor, procaine, or other components of the drug; epilepsy, predisposition to convulsive states.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of the medicinal product Sulfocamphocaine with other medicinal products may result in:

with drugs that depress the central nervous system – weakening of their effects;

with anticholinesterase agents – reduced effect of the latter;

with suxamethonium – prolonged neuromuscular blockade caused by suxamethonium;

with MAO inhibitors – increased risk of arterial hypertension;

with cardiac glycosides, diuretics, analgesics, steroid hormones – enhanced analeptic effect of sulfocamphocaine.

The drug may occasionally be prescribed to reduce side effects during chemotherapy with 5-fluorouracil.

Alcohol consumption is not recommended during treatment with this medicinal product.

Special precautions for use.

Use with caution in patients with arterial hypotension (due to the hypotensive effect of novocaine).

Use during pregnancy or breastfeeding.

There is no objective evidence-based medical data on the use of the medicinal product Sulphocaine during pregnancy; therefore, the drug should not be used during pregnancy. Penetration of the medicinal product Sulphocaine into breast milk cannot be excluded; hence, breastfeeding must be discontinued during its use.

Ability to influence reaction speed when driving or operating machinery.

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

Dosage and Administration

Administer the medicinal product Sulphocaine subcutaneously, intramuscularly, or intravenously (slowly, as bolus or by infusion) to adults at a single dose of 2 ml. For dilution, use 0.9% sodium chloride solution. If necessary, the medicinal product may be administered 2–3 times daily. The maximum daily dose for adults is 12 ml.

In acute cases, administer the medicinal product intravenously.

In chronic respiratory insufficiency and cardiac insufficiency, administer intramuscularly or subcutaneously. The treatment course may last 20–30 days.

Children.

Do not administer the medicinal product to children.

Overdose.

Symptoms: headache, dizziness; in acute poisoning – facial flushing, pathological motor activity, delirium, epileptiform seizures.

Treatment: antipsychotic and anticonvulsant agents. In cases of mild psychomotor agitation – tranquilizers or sedatives.

Adverse Reactions

Gastrointestinal disorders: Dyspeptic disorders.

Nervous system disorders: Headache, dizziness, tremor, paresthesia, seizures.

Cardiovascular system disorders: Decreased or increased blood pressure, palpitations, chest pain.

Blood and lymphatic system disorders: Methemoglobinemia.

Immune system disorders: Hypersensitivity reactions, including angioneurotic edema, anaphylactic shock, skin rashes, pruritus, hyperemia, urticaria.

General disorders and administration site conditions: Hyperemia, rashes, and pruritus at the injection site.

Other: Chills, involuntary urination.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: 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.

Packaging. 2 ml in an ampoule. 10 ampoules in a cardboard pack.

Prescription status. Prescription only.

Manufacturer. LLC "FARMASEL".

Manufacturer's address and location of its business activities.

3, Vul. Prorizna, Kvitneve, Brovary District, Kyiv Oblast, 07408, Ukraine.