Dinaton^® (Solution) Instructions for Use

Marketing Authorization Holder

Arm, LLC (Russia)

Manufactured By

Pharmazashchita SPC, FSUE FMBA of Russia (Russia)

Or

Ecofarmplus, JSC (Russia)

ATC Codes

A03AE (Serotonin receptor antagonists)

B02BX (Other systemic hemostatics)

Active Substance

Serotonin (Grouping name)

Dosage Form

Dinaton®

Solution for intravenous and intramuscular administration 10 mg/1 ml: amp. 1 ml 5 pcs., amp. 5 ml 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a colorless or slightly colored, transparent liquid with a faint hydrogen sulfide odor.

Excipients: sodium dimercaptopropanesulfonate monohydrate (unitiol) – 1.5 mg, water for injections – up to 1 ml.

1 ml – glass ampoules (5) – contour cell packs (1) – cardboard boxes.
5 ml – glass ampoules (1) – contour cell packs (1) – cardboard boxes.
5 ml – glass ampoules (5) – contour cell packs (1) – cardboard boxes.

Clinical-Pharmacological Group

Hemostatic agent

Pharmacotherapeutic Group

Hemostatic, serotonergic agent

Pharmacological Action

Hemostatic and serotonergic agent. The hemostatic effect of Dinaton^® is due to its ability to increase platelet aggregation and capillary stability, as well as to reduce bleeding time.

Serotonin causes vasoconstriction of the kidneys and has an antidiuretic effect. It binds to serotonin receptors of the smooth muscles of internal organs and normalizes their contractile activity (endogenous vasomotion, peristalsis).

The manifestation of the normalization of smooth muscle function is the stabilization of hemodynamics, restoration of the motor-evacuation function of the gastrointestinal tract, and reduction of local hypoxia.

Pharmacokinetics

It is rapidly deaminated in the blood plasma and loses its activity. Does not have a cumulative effect.

Indications

• Functional intestinal obstruction (FIO);
• Hemorrhagic syndrome: in Werlhof’s disease, during treatment with cytostatics, in acute, subacute and chronic radiation sickness, in malignant neoplasms;
• Hypo- and aplastic anemia;
• Thrombocytopenia;
• Hemorrhagic vasculitis.

ICD codes

Dosage Regimen

For the prevention and treatment of obstruction (FIO) intravenously into a central vein at a rate of 5-10 mg/h, having previously dissolved the contents of the ampoule (10 mg) in 100-200 ml of saline. When administered into a peripheral vein, 10-20 mg should be dissolved in 200-400 ml of saline. The maximum daily dose can reach 360 mg or more.

Intravenously: 20-50 mg is diluted in 200-400 ml of 0.9% sodium chloride solution; administered by drip (30 drops/min) 2-3 times a day until the appearance or intensification of weakened peristalsis and clinical manifestations of restoration of the motor-evacuation function of the gastrointestinal tract.

For the prevention and treatment of hemorrhagic syndrome , associated with Werlhof’s disease, treatment with cytostatics, radiation sickness, malignant neoplasms, hypo- and aplastic anemias, thrombocytopenia, hemorrhagic vasculitis start with intravenous administration, then switch to intramuscular injections. The initial dose is 5 mg; in the absence of side effects, the dose is increased to 10 mg, use no more than 15-20 mg/day. The course of treatment is on average 10 days.

Intravenously: 5-10 mg of the drug is diluted in 100-150 ml of 0.9% sodium chloride solution or in 5-10 ml of 0.9% sodium chloride solution, followed by dilution in 100-150 ml of 5% dextrose solution (plasma, preserved blood) and administered by drip (no more than 30 drops/min) no more than 2 times a day.

Intramuscularly: 5-10 mg is diluted in 5 ml of 0.5% lidocaine solution; administered 2 times a day with intervals of at least 4 hours.

Adverse Reactions

From the urinary system: decreased diuresis.

From the digestive system: abdominal pain, nausea, diarrhea.

From the respiratory system: difficulty breathing.

From the cardiovascular system: cardialgia, increased blood pressure.

Others: pain along the vein (with rapid administration), with intramuscular administration – pain at the injection site, feeling of heaviness in the occipital region.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Precautions for use

If side effects occur, it is necessary to stop the administration of the drug for 2-3 minutes and then continue at a lower rate.

Contraindications

• Hypersensitivity to any component of the drug;
• Glomerulonephritis (acute and chronic);
• Kidney disease;
• Oligo- and anuria;
• Arterial hypertension;
• Acute thrombosis;
• Angioneurotic edema;
• Bronchial asthma;
• Diseases accompanied by hypercoagulation.

Use in Pregnancy and Lactation

The effect of the drug during pregnancy has not been studied, since the drug is rapidly deaminated in the bloodstream.

Breastfeeding is not a contraindication for its use.

Use in Renal Impairment

The use of the drug is contraindicated in patients with kidney disease.

Special Precautions

Effect of the drug on the ability to drive vehicles, mechanisms

There is no information on the adverse effect of Dinaton^® on the ability to drive vehicles and mechanisms.

Overdose

Symptoms: skin hyperemia, tachypnea.

Treatment: specific treatment is not required. It is necessary to stop the administration of the drug for 5-10 minutes and then continue at a lower rate.

Drug Interactions

Serotonin potentiates the effect of narcotic, hypnotic and analgesic drugs. Concomitant administration with calcium chloride preparations is not recommended.

If you are taking other medications, be sure to consult your doctor before taking the drug.

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.