Canceled South Africa · SAHPRA

GRANTYL 1 mg/1 ml

Granisetron Hydrochloride

43/5.7.2/0527 alimentary tract and metabolism INN generic

What it does

Granisetron is a medication used to prevent nausea and vomiting.

Commonly used for: nausea and vomiting after chemotherapy, nausea and vomiting after surgery

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
43/5.7.2/0527
Registration date
2015/03/23
Expiry date
-
Status
Canceled
Active ingredient
Granisetron Hydrochloride
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
A04AA - Serotonin (5HT3) antagonists
RxNorm RxCUI
26237
Manufacturer / MAH
-
Applicant / LTR
Ascendis Pharma (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:13:44 · updated 2026-09-13 04:00:21

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Granisetron is a medication used to prevent nausea and vomiting.

What it treats

  • nausea and vomiting after chemotherapy
  • nausea and vomiting after surgery

How it works

Granisetron blocks signals in the brain that trigger nausea and vomiting.

Who it's for

It is for adults and children who are experiencing nausea and vomiting due to medical treatments or surgery.

Cautions

  • • Be careful if you are taking other medications that can cause serotonin syndrome, a serious condition that affects the brain.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Granisetron

BNF-referenced

Granisetron is a selective serotonin 5-HT3 receptor antagonist used primarily for the prevention and treatment of nausea and vomiting associated with cytotoxic chemotherapy and postoperative settings. It acts by blocking the 5-HT3 receptors located in the central nervous system and gastrointestinal tract, thereby inhibiting the emetic response. Granisetron is available in various forms including injectable solutions and tablets.

Indications

  • Nausea and vomiting induced by cytotoxic chemotherapy
  • Prevention of postoperative nausea and vomiting

Dosage

Children: For children aged 6 months to 17 years, refer to the BNF for Children for appropriate dosing guidelines, as individual dosage may vary based on age, weight, and specific treatment protocols.

Adults: For intravenous administration, the typical adult dose is 1 mg, given before the induction of anesthesia, diluted in 5 mL and administered over 30 seconds. For prevention of nausea and vomiting related to chemotherapy, it can be given for 3-5 days as needed.

Mechanism of action

Granisetron works by selectively blocking the 5-HT3 receptors, which are involved in the vomiting reflex. By antagonizing these receptors in both the central nervous system and the gastrointestinal tract, granisetron reduces the stimulation of the vomiting center, thus preventing nausea and vomiting.

Pharmacodynamics

Granisetron's pharmacodynamic effects are primarily based on its ability to inhibit the action of serotonin at the 5-HT3 receptor sites. This action reduces the incidence of nausea and vomiting, especially in patients undergoing chemotherapy or surgery. The onset of action is typically rapid, with significant effects observed within 30 minutes to 2 hours after administration.

Pharmacokinetics

Granisetron is well-absorbed when administered intravenously or orally. It exhibits a volume of distribution of approximately 4-5 L/kg and is primarily metabolized in the liver via cytochrome P450 enzymes. The elimination half-life ranges from 9 to 13 hours, allowing for once-daily dosing in many cases. Granisetron is primarily excreted in urine, with a small percentage excreted unchanged.

Adverse effects

  • Extrapyramidal symptoms
  • QT interval prolongation
  • Serotonin syndrome
  • Decreased appetite
  • Dry mouth
  • Flushing
  • Generalized edema
  • Vertigo
  • Dystonia

Precautions

  • Caution is advised in hepatic impairment
  • Patients should avoid sun exposure to the patch site during use and for 10 days after removal

Pregnancy

Manufacturer advises to avoid use during pregnancy.

Breast-feeding

Avoid; no information available regarding safety during breastfeeding.

Storage

Store in a dry place, protected from light. Keep out of reach of children.

Formulations

  • {'formulation': 'Powder for solution for infusion', 'strength': '1 mg per 1 ml', 'pack_size': '10 ampoules'}
  • {'formulation': 'Granisetron 3 mg/3 ml concentrate for solution for injection', 'pack_size': '10 ampoules'}
  • {'formulation': 'Granisetron 1 mg tablets', 'pack_size': '10 tablets'}
  • {'formulation': 'Granisetron 2 mg tablets', 'pack_size': '10 tablets'}
  • {'formulation': 'Transdermal patch', 'strength': '3.1 mg per 24 hours', 'pack_size': '1 patch'}
BNF 85 (British National Formulary) p.492 BNF for Children 2019-2020 p.293 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Granisetron

PubChem CID 5284566

Molecular formula: C18H24N4O

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.