Granisetron Hydrochloride

GRANISETRON HYDROCHLORIDE

Manufacturer: Mylan Institutional LLC

Score: 142.0

Quick Summary

Granisetron Hydrochloride is a serotonin-3 (5-HT3) receptor antagonist used for the prevention of nausea and vomiting associated with chemotherapy and postoperative nausea and vomiting. The recommended dosage for adults is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and 1 mg undiluted administered intravenously over 30 seconds for postoperative nausea and vomiting. The drug has been shown to be effective in clinical trials, but may have adverse reactions such as headache, constipation, and QT prolongation. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Prevention of nausea and vomiting associated with chemotherapy
Prevention and treatment of postoperative nausea and vomiting

Important Safety Information

Warning

QT prolongation has been reported with Granisetron Hydrochloride

Contraindications

Hypersensitivity to the drug or its components

Adverse Reactions

Headache
Constipation
Pain
Fever
Abdominal pain
Hepatic enzymes increased

Dosing Recommendations

General Guidance

No dose adjustments are necessary for patients with renal impairment, but caution should be exercised in patients with hepatic impairment

Chemotherapy-induced nausea and vomiting

Adult Dose

10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy

Pediatric Dose

10 mcg/kg for pediatric patients 2 to 16 years of age

Postoperative nausea and vomiting

Adult Dose

1 mg undiluted administered intravenously over 30 seconds

Pediatric Dose

Not recommended for pediatric patients

Special Population Considerations

Pregnancy

Use during pregnancy only if clearly needed
Reproduction studies have shown no evidence of impaired fertility or harm to the fetus

Nursing Mothers

Caution should be exercised when administering to nursing mothers
It is not known whether Granisetron is excreted in human milk

Pediatric Use

Safety and effectiveness have been established for pediatric patients 2 to 16 years of age for chemotherapy-induced nausea and vomiting
Not recommended for pediatric patients for postoperative nausea and vomiting due to lack of efficacy and QT prolongation

Geriatric Use

Safety and effectiveness have been established for geriatric patients
No differences in responses between elderly and younger patients have been identified

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