Granisetron (tablet)

Granisetron (tablet)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Shanshan Cen, M.D. [2]

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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)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Granisetron (tablet) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Granisetron (tablet) in pediatric patients.

Contraindications

Granisetron hydrochloride tablets are contraindicated in patients with known hypersensitivity to the drug or any of its components.

Warnings

Serotonin Syndrome

The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of granisetron and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue granisetron and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if granisetron is used concomitantly with other serotonergic drugs

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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Granisetron (tablet) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Granisetron (tablet) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Granisetron (tablet) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Granisetron (tablet) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Granisetron (tablet) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Granisetron (tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Granisetron (tablet) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Granisetron (tablet) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Granisetron (tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Granisetron (tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Granisetron (tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Granisetron (tablet) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Granisetron (tablet) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Granisetron (tablet) in the drug label.

Pharmacology

There is limited information regarding Granisetron (tablet) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Granisetron (tablet)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Granisetron (tablet) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Granisetron (tablet) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Granisetron (tablet) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Granisetron (tablet) in the drug label.

How Supplied

Storage

There is limited information regarding Granisetron (tablet) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Granisetron (tablet) in the drug label.

Precautions with Alcohol

• Alcohol-Granisetron (tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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