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Serotonin (Solution) Instructions for Use

ATC Codes

A03FA (Gastrointestinal motility stimulants)

B02BX (Other systemic hemostatics)

Active Substance

Serotonin

Clinical-Pharmacological Group

Hemostatic agent

Pharmacotherapeutic Group

Hemostatic, serotonergic agent

Pharmacological Action

Hemostatic and serotonergic agent.

The hemostatic effect is due to its ability to increase platelet aggregation and capillary resistance, 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

After IV or IM administration, it is rapidly distributed throughout organs and tissues, remaining in the plasma for 8 hours. After IM administration, Cmax in plasma is reached within 0.5-1 hour. It is metabolized by deamination. It does not have a cumulative effect.

Indications

Functional intestinal obstruction; 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

ICD-10 code Indication
D61 Other aplastic anemias
D69.0 Allergic purpura
D69.3 Idiopathic thrombocytopenic purpura
D69.5 Secondary thrombocytopenia
K56.6 Other and unspecified intestinal obstruction
T66 Unspecified effects of radiation (radiation sickness)
Y43.1 Antineoplastic antimetabolites
Y43.3 Other antineoplastic drugs
ICD-11 code Indication
3A70.Z Aplastic anemia, unspecified
3B64.1 Acquired thrombocytopenia
3B64.10 Immune thrombocytopenic purpura
3B64.11 Secondary thrombocytopenia
3B64.12 Drug-induced thrombocytopenic purpura
3B64.13 Alloimmune thrombocytopenia
4A44.92 IgA vasculitis
4A85.02 Drug-induced cytopenia
4A85.03 Drug-induced vasculitis
8E61.0 Radiation-induced brain injury
8E61.1 Radiation-induced spinal cord injury
DA91.Z Unspecified obstruction of small intestine
DB30.Z Unspecified obstruction of large intestine
DE2Z Diseases of the digestive system, unspecified
NF00 Exposure to radiation, not elsewhere classified
PL00 Drugs, medicaments or biological substances causing injury or harm in therapeutic use

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the solution by intramuscular (IM) or intravenous (IV) injection.

Determine the dosage individually based on the specific indication, clinical severity, and patient characteristics.

For hemostatic indications, including thrombocytopenia and hemorrhagic vasculitis, administer 5 mg to 10 mg daily.

For the management of functional intestinal obstruction, administer 5 mg to 20 mg daily.

Divide the total daily dose into two separate administrations.

Adjust the treatment duration based on the therapeutic effect achieved and the patient’s tolerance.

For IV administration, dilute the required dose in 100 ml to 200 ml of 0.9% sodium chloride solution.

Infuse the IV solution slowly, at a rate of approximately 20 to 30 drops per minute.

Avoid rapid intravenous injection to prevent pain along the vein and cardiovascular reactions.

If adverse reactions occur during infusion, stop administration for 2-3 minutes, then resume at a slower rate.

Do not administer concomitantly with calcium chloride preparations.

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 BP.

Local reactions: pain along the vein (with rapid administration), with IM administration – pain at the injection site.

Contraindications

Hypersensitivity to serotonin adipinate; glomerulonephritis (acute and chronic); severe renal impairment (oligo- and anuria); arterial hypertension (including hypertensive crisis); acute thrombosis of arteries and veins; angioneurotic edema; bronchial asthma; diseases accompanied by hypercoagulation; pregnancy; childhood.

With caution

Patients with diseases of the cardiovascular system.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Breastfeeding is not a contraindication for use.

Use in Renal Impairment

Use is contraindicated in patients with kidney disease.

Pediatric Use

Use is contraindicated in childhood.

Special Precautions

Do not administer with calcium chloride preparations.

If adverse reactions develop, it is recommended to stop the administration for 2-3 minutes, then continue administration at a slower rate.

Drug Interactions

Do not administer with calcium chloride preparations!

Serotonin potentiates the effect of narcotic, hypnotic, and analgesic drugs.

Diosmin, when used concomitantly, enhances the vasoconstrictive effect of serotonin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Pharmashchita SPC, SE (Russia)

Dosage Form

Bottle Rx Icon Serotonin Solution for intravenous and intramuscular administration 10 mg/1 ml: amp. 5 pcs.

Dosage Form, Packaging, and Composition

Solution for IV and IM administration 1 ml
Serotonin adipinate 10 mg

1 ml – ampoules (5) – trays (1) – cardboard packs.

Marketing Authorization Holder

Lorr+K, LLC (Russia)

Manufactured By

Academician E.I. Chazov NMRC Of Cardiology Of The Ministry Of Health Of The Russian Federation, FSBI (Russia)

Dosage Form

Bottle Rx Icon Serotonin adipate Solution for intravenous and intramuscular injection 10 mg/1 ml: amp. 1 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for IV and IM administration in the form of a transparent, colorless or slightly colored liquid with a faint smell of hydrogen sulfide.

1 amp. (1 ml)
Serotonin adipinate 10 mg

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

1 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.

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