SULFOCAMPHOCAINE-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Sulfocamphocaine-Darnitsa (Sulfocamphocaine-Darnitsa)

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. Cardiological preparations. ATC code C01EB.

Pharmacological Properties.

Pharmacodynamics.

Sulfocamphocaine-Darnitsya belongs to the group of analeptic medicinal agents. The mechanism of action of the medicinal product is due to stimulation of the central nervous system, primarily the centers of the medulla oblongata, both directly and via the carotid sinus. The drug exerts a tonic effect on the respiratory and vasomotor centers, enhances metabolic processes in cardiac muscle, increasing its sensitivity to sympathetic nerve influences. Sulfocamphocaine-Darnitsya affects blood vessels—there occurs redistribution of blood flow, with 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, as well as enhanced respiratory and glycolytic processes related to phosphorylation of macroergic compounds.

Pharmacokinetics.

Sulfocamphocaine-Darnitsya is rapidly absorbed following subcutaneous, intramuscular, and intravenous administration. In the body, it undergoes metabolism involving oxidation and conjugation with glucuronic acid. Metabolites are mainly excreted by the kidneys, and 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 to any other component of the drug; epilepsy, predisposition to convulsive states.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of Sulfocamphocaine-Darnitsia with other medicinal products may result in:

with agents that depress the central nervous system – reduced effect of the latter;

with anticholinesterase agents – reduced effect of the latter;

with succinylcholine – prolonged neuromuscular blockade caused by succinylcholine;

with MAO inhibitors – increased risk of arterial hypertension;

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

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

Alcohol consumption is not recommended during the use of 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 information regarding the use of Sulphocamphocaine-Darnytsia during pregnancy; therefore, the drug should not be used during pregnancy. The possibility of Sulphocamphocaine-Darnytsia passing into breast milk during lactation cannot be excluded. Hence, breastfeeding must be discontinued during treatment.

Ability to affect reaction speed when driving or operating machinery.

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

Administration and Dosage.

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

In acute cases, the medicinal product should be administered intravenously.

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

Children.

The medicinal product must not be used in 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, rash, and pruritus at the injection site.

Other: chills, involuntary urination.

Shelf life.

3 years.

Storage conditions.

Keep in the original packaging, out of the reach of children, at a temperature not exceeding 25 °C. Do not freeze.

Packaging.

2 ml in an ampoule; 5 ampoules in a contour cell pack; 2 contour cell packs in a carton.

Supply category.

Prescription only.

Manufacturer.

JSC "Pharmaceutical company "Darnytsia".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.