|indication=[[nausea]] and [[vomiting]] associated with:1) initial and repeat courses of emetogenic cancer therapy, including high-dose [[cisplatin]];2) [[radiation]], including total body irradiation and fractionated abdominal radiation
|indication=[[nausea]] and [[vomiting]] associated with:1) initial and repeat courses of emetogenic cancer therapy, including high-dose [[cisplatin]];2) [[radiation]], including total body irradiation and fractionated abdominal radiation
|adverseReactions=[[asthenia]], [[headache]], [[somnolence, and [[fever]]
|adverseReactions=[[asthenia]], [[headache]], [[somnolence]], and [[fever]]
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Overview
Granisetron (tablet) is an antinauseant and antiemetic agent that is FDA approved for the prevention of nausea and vomiting associated with:1) initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin;2) radiation, including total body irradiation and fractionated abdominal radiation. Common adverse reactions include asthenia, headache, somnolence, and fever.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Granisetron hydrochloride tablets are indicated for the prevention of:
Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
Dosage
Emetogenic Chemotherapy
The recommended adult dosage of oral granisetron hydrochloride tablets is 2 mg once daily or 1 mg twice daily. In the 2 mg once-daily regimen, two 1 mg tablets are given up to 1 hour before chemotherapy. In the 1 mg twice-daily regimen, the first 1 mg tablet is given up to 1 hour before chemotherapy, and the second tablet 12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given. Continued treatment, while not on chemotherapy, has not been found to be useful.
Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)
The recommended adult dosage of oral granisetron hydrochloride tablets is 2 mg once daily. Two 1 mg tablets are taken within 1 hour of radiation.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Granisetron (tablet) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Granisetron (tablet) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
Granisetron hydrochloride tablets are indicated for the prevention of:
Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
Dosage
Emetogenic Chemotherapy
Safety and effectiveness in pediatric patients have not been established.
Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Contraindications
Condition1
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Granisetron (tablet) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Granisetron (tablet) in the drug label.