Granisetron (tablet)

Revision as of 14:55, 15 May 2015 by Shanshan Cen (talk | contribs)
Jump to navigation Jump to search

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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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

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

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

Chemotherapy-Induced Nausea and Vomiting

In patients receiving granisetron hydrochloride tablets 1 mg twice a day for 1, 7 or 14 days, or 2 mg once a day for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed in Table 4.

This image is provided by the National Library of Medicine.

Other adverse events reported in clinical trials were:

  • Gastrointestinal: In single-day dosing studies in which adverse events were collected for 7 days, nausea (20%) and vomiting (12%) were recorded as adverse events after the 24-hour efficacy assessment period.
  • Hepatic: In comparative trials, elevation of AST and ALT (>2 times the upper limit of normal) following the administration of granisetron hydrochloride tablets occurred in 5% and 6% of patients, respectively. These frequencies were not significantly different from those seen with comparators (AST: 2%; ALT: 9%).
  • Cardiovascular: Hypertension (1%); hypotension, angina pectoris, atrial fibrillation, and syncope have been observed rarely.
  • Central Nervous System: Dizziness (5%), insomnia (5%), anxiety (2%), somnolence (1%). One case compatible with, but not diagnostic of, extrapyramidal symptoms has been reported in a patient treated with granisetron hydrochloride tablets.
  • Hypersensitivity: Rare cases of hypersensitivity reactions, sometimes severe (eg, anaphylaxis, shortness of breath, hypotension, urticaria) have been reported.
  • Other: Fever (5%). Events often associated with chemotherapy also have been reported: leukopenia (9%), decreased appetite (6%), anemia (4%), alopecia (3%), thrombocytopenia (2%).

Over 5000 patients have received injectable granisetron hydrochloride in clinical trials.

Table 5 gives the comparative frequencies of the five commonly reported adverse events (≥ 3%) in patients receiving granisetron hydrochloride injection, 40 mcg/kg, in single-day chemotherapy trials. These patients received chemotherapy, primarily cisplatin, and intravenous fluids during the 24-hour period following granisetron hydrochloride injection administration.

This image is provided by the National Library of Medicine.

In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to granisetron hydrochloride, except for headache, which was clearly more frequent than in comparison groups.

Radiation-Induced Nausea and Vomiting

In controlled clinical trials, the adverse events reported by patients receiving granisetron hydrochloride tablets and concurrent radiation were similar to those reported by patients receiving granisetron hydrochloride tablets prior to chemotherapy. The most frequently reported adverse events were diarrhea, asthenia, and constipation. Headache, however, was less prevalent in this patient population.

Postmarketing Experience

QT prolongation has been reported with granisetron hydrochloride

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

{{#ask: Page Name::Granisetron (tablet) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Granisetron (tablet) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

Drug Shortage Status

Price

References

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

  1. Empty citation (help)
  2. "http://www.ismp.org". External link in |title= (help)

{{#subobject:

 |Page Name=Granisetron (tablet)
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Granisetron (tablet)
 |Label Name=Granisetron (tablet)11.png

}}

{{#subobject:

 |Label Page=Granisetron (tablet)
 |Label Name=Granisetron (tablet)11.png

}}