Granisetron (tablet): Difference between revisions

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|indicationType=prevention
|indicationType=prevention
|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]]
 
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
 
Granisetron hydrochloride tablets are indicated for the prevention of:
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
*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.


<!--Off-Label Use and Dosage (Pediatric)-->
====Dosage====
*Emetogenic Chemotherapy


<!--Guideline-Supported Use (Pediatric)-->
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.
|offLabelPedGuideSupport======Condition1=====


* Developed by:
*Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)


* Class of Recommendation:
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.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Strength of Evidence:
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Dosing Information
|fdaLIADPed=====Indications====
Granisetron hydrochloride tablets are indicated for the prevention of:


:* Dosage
*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.


=====Condition2=====
====Dosage====
*Emetogenic Chemotherapy


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
Safety and effectiveness in pediatric patients have not been established.


<!--Non–Guideline-Supported Use (Pediatric)-->
*Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)
|offLabelPedNoGuideSupport======Condition1=====


* Dosing Information
Safety and effectiveness in pediatric patients have not been established.


:* Dosage


=====Condition2=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Condition1



Revision as of 13:18, 15 May 2015

{{DrugProjectFormSinglePage |authorTag=Shanshan Cen, M.D. [1] |genericName=Granisetron hydrochloride |aOrAn=an |drugClass=antinauseant and antiemetic agent |indicationType=prevention |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 |blackBoxWarningTitle=ConditionName: |blackBoxWarningBody=ConditionName:

  • Content


|fdaLIADAdult=====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. |offLabelAdultGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Granisetron (tablet) in adult patients.

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

|fdaLIADPed=====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.



|contraindications=* Condition1

|warnings=* Description

Precautions

  • Description


|clinicalTrials=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=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

|drugInteractions=* Drug

  • Description

|useInPregnancyFDA=* Pregnancy Category |useInPregnancyAUS=* 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. |useInLaborDelivery=There is no FDA guidance on use of Granisetron (tablet) during labor and delivery. |useInNursing=There is no FDA guidance on the use of Granisetron (tablet) with respect to nursing mothers. |useInPed=There is no FDA guidance on the use of Granisetron (tablet) with respect to pediatric patients. |useInGeri=There is no FDA guidance on the use of Granisetron (tablet) with respect to geriatric patients. |useInGender=There is no FDA guidance on the use of Granisetron (tablet) with respect to specific gender populations. |useInRace=There is no FDA guidance on the use of Granisetron (tablet) with respect to specific racial populations. |useInRenalImpair=There is no FDA guidance on the use of Granisetron (tablet) in patients with renal impairment. |useInHepaticImpair=There is no FDA guidance on the use of Granisetron (tablet) in patients with hepatic impairment. |useInReproPotential=There is no FDA guidance on the use of Granisetron (tablet) in women of reproductive potentials and males. |useInImmunocomp=There is no FDA guidance one the use of Granisetron (tablet) in patients who are immunocompromised.

|administration=* Oral

  • Intravenous

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

  • Description

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

|overdose====Acute Overdose===

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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


|drugBox= |mechAction=*

|structure=*

File:Granisetron (tablet)01.png
This image is provided by the National Library of Medicine.

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

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

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

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

|howSupplied=* |packLabel= |fdaPatientInfo=There is limited information regarding Patient Counseling Information of Granisetron (tablet) in the drug label.

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

|brandNames=* ®[1]

|lookAlike=* A® — B®[2]

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