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Granisetrone (Tablets, Concentrate) Instructions for Use

ATC Code

A04AA02 (Granisetron)

Active Substance

Granisetron (Rec.INN registered by WHO)

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.

It relieves vomiting caused by excitation of the parasympathetic nervous system due to serotonin release by enterochromaffin cells.

Pharmacokinetics

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

Plasma protein binding is 65%.

It is rapidly metabolized by demethylation and oxidation.

T1/2 is 3.1-5.9 hours. In cancer patients, T1/2 increases to 10-12 hours.

It is 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

ICD-10 code Indication
R11 Nausea and vomiting
Y43.1 Antineoplastic antimetabolites
Y43.3 Other antineoplastic drugs
Y84.2 Radiological procedure and radiotherapy
ICD-11 code Indication
MD90 Nausea or vomiting
PK81.C Radiotherapy causing injury or harm in the course of therapeutic use
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.

Tablets, Concentrate

Adults: for oral administration, a single dose is 1 mg; for IV infusion, a single dose is 3 mg; for IV injection (slowly, not less than 30 seconds), a single dose is 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 of age for oral administration, a single dose is 1 mg.

The frequency and duration of use are determined individually.

Adverse Reactions

Possible transient increase in the activity of hepatic transaminases in the blood, 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, so use is possible only in cases of extreme necessity. If use is necessary during lactation, 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 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.

Medical Disclaimer

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

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Granisetron Film-coated tablets 1 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 200, 250, 300, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on the cross-section of the tablet, two layers are visible – a core of almost white color and a film coating.

1 tab.
Granisetron hydrochloride 1.12 mg,
   Equivalent to granisetron content 1 mg

Excipients : lactose monohydrate (milk sugar) – 75.38 mg, microcrystalline cellulose (MCC-101) – 20 mg, sodium carboxymethyl starch – 2 mg, hypromellose – 1 mg, magnesium stearate – 0.5 mg.

Film coating composition hypromellose – 1.74 mg; macrogol-4000 – 0.42 mg; titanium dioxide – 0.84 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (4) – cardboard packs.
30 pcs. – blister packs (5) – cardboard packs.
30 pcs. – blister packs (10) – cardboard packs.
50 pcs. – blister packs (1) – cardboard packs.
50 pcs. – blister packs (2) – cardboard packs.
50 pcs. – blister packs (3) – cardboard packs.
50 pcs. – blister packs (4) – cardboard packs.
50 pcs. – blister packs (5) – cardboard packs.
50 pcs. – blister packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Granisetron Concentrate for solution for infusion 1 mg/ml: 1 ml or 3 ml amp. 1, 2, 5, or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion clear, colorless or slightly yellowish.

1 ml
Granisetron hydrochloride 1.12 mg,
   Equivalent to granisetron content 1 mg

Excipients : sodium chloride – 9 mg, citric acid monohydrate – 2 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH 5.0-7.0, water for injections – to 1 ml.

1 ml – ampoules (1) – blister packs (1) – cardboard packs.
1 ml – ampoules (1) – blister packs (2) – cardboard packs.
1 ml – ampoules (5) – blister packs (1) – cardboard packs.
1 ml – ampoules (5) – blister packs (2) – cardboard packs.

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

Manufactured By

R-Pharm JSC (Russia)

Dosage Form

Bottle Rx Icon Granisetron Concentrate for solution for infusion 1 mg/1 ml: fl. 1 or 3 ml, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion clear, colorless.

1 ml
Granisetron hydrochloride 1.42 mg,
   Equivalent to granisetron content 1 mg

Excipients : sodium chloride – 9 mg, citric acid monohydrate – 2 mg, water for injections – to 1 ml, hydrochloric acid – q.s., sodium hydroxide – q.s.

* Used if necessary in the technological process to adjust the pH value to 5.3±0.3.

1 ml – vials of colorless glass (5) type I – cardboard packs.
1 ml – vials of colorless glass (10) type I – cardboard packs.
3 ml – vials of colorless glass (5) type I – cardboard packs.
3 ml – vials of colorless glass (10) type I – cardboard packs.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Labesfal-Laboratorios Almiro, S.A. (Portugal)

Dosage Form

Bottle Rx Icon Granisetron Kabi Concentrate for solution for infusion 1 mg/1 ml: amp. 1 ml or 3 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

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

1 ml
Granisetron (as hydrochloride) 1 mg

Excipients : sodium chloride – 9 mg, citric acid monohydrate – 2 mg, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections – to 1 ml.

1 ml – glass ampoules of 1 ml volume (5) – blister packs (1) – cardboard packs.
1 ml – glass ampoules of 1 ml volume (5) – blister packs (2) – cardboard packs.
3 ml – glass ampoules of 3 ml volume (5) – blister packs (1) – cardboard packs.
3 ml – glass ampoules of 3 ml volume (5) – blister packs (2) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Pharmaceutical Works, Private Limited Company (Hungary)

Dosage Form

Bottle Rx Icon Granisetron-Teva Concentrate for solution for infusion 1 mg/1 ml: amp. 1 or 3 ml, 5 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion 1 ml
Granisetron 1 mg

1 ml – ampoules of colorless glass (5) type I – cardboard packs.
3 ml – ampoules of colorless glass (5) type I – cardboard packs.

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