Avomit^® (Concentrate) Instructions for Use

Marketing Authorization Holder

Biocad, JSC (Russia)

Manufactured By

Biocad, JSC (Russia)

Or

PK-137, LLC (Russia)

ATC Code

A04AA02 (Granisetron)

Active Substance

Granisetron (Rec.INN registered by WHO)

Dosage Form

Avomit®

Concentrate for solution for infusion 1 mg/1 ml: vial 1 ml or 3 ml 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion as a clear, colorless liquid.

Excipients: sodium chloride – 9 mg, citric acid monohydrate – 2 mg, hydrochloric acid – to pH 5.3±0.3, sodium hydroxide – to pH 5.3±0.3, water for injections – to 1 ml.

1 ml – vials (1) – cardboard packs.
1 ml – vials (1) – contour cell packs (1) – cardboard packs.
1 ml – vials (5) – contour cell packs (1) – cardboard packs.
3 ml – vials (1) – cardboard packs.
3 ml – vials (1) – contour cell packs (1) – cardboard packs.
3 ml – vials (5) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Serotonin 5-HT₃ receptor antagonist. Central-acting antiemetic drug

Pharmacotherapeutic Group

Antiemetic agents; serotonin 5-HT₃ receptor antagonists

Pharmacological Action

Antiemetic agent. Selective antagonist of serotonin 5HT₃ receptors. Relieves vomiting caused by stimulation of the parasympathetic nervous system due to serotonin release from enterochromaffin cells.

Pharmacokinetics

After IV administration at doses of 20 mcg/kg or 40 mcg/kg, the mean C_max in blood plasma is 13.7 mcg/L and 42.8 mcg/L, respectively.

Plasma protein binding is 65%.

Rapidly metabolized via demethylation and oxidation.

T_1/2 is 3.1-5.9 hours. In cancer patients, T_1/2 increases to 10-12 hours. Excreted in urine and feces mainly as conjugates; 8-15% is found unchanged in urine.

Indications

Prevention and treatment of nausea and vomiting induced by cytostatic chemotherapy in adults and children over 2 years of age.

Prevention and treatment of nausea and vomiting during radiotherapy in adults.

Prevention and treatment of postoperative nausea and vomiting in adults.

ICD codes

Dosage Regimen

Adults for oral administration single dose – 1 mg, for IV infusion single dose – 3 mg, for IV injection (slowly, not less than 30 seconds) single dose – 1 mg.

Maximum dose – 9 mg/day.

Children IV drip single dose – 40 mcg/kg (but not more than 3 mg). Children over 12 years for oral administration single dose – 1 mg.

The frequency and duration of use are determined individually.

Adverse Reactions

Possible transient increase in blood liver transaminases activity, constipation, headache, skin rash.

Contraindications

Breastfeeding, children under 2 years of age, hypersensitivity to granisetron.

Use in Pregnancy and Lactation

The safety of granisetron treatment during pregnancy has not been established, therefore use is only possible in cases of extreme necessity. If use during lactation is necessary, breastfeeding should be discontinued.

Use in Hepatic Impairment

Dosage adjustment is not required.

Use in Renal Impairment

Dosage adjustment is not required.

Pediatric Use

Contraindicated for use in children under 2 years of age.

Granisetron is not used for the treatment and prevention of postoperative nausea and vomiting in children.

Geriatric Use

Dosage adjustment is not required.

Special Precautions

Use with caution in patients with symptoms of intestinal obstruction.

Granisetron is not used for the treatment and prevention of postoperative nausea and vomiting in children.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.