GRANISETRON HYDROCHLORIDE - granisetron hydrochloride injection
WOCKHARDT LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection.
Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993 INDICATIONS AND USAGEGranisetron hydrochloride injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for:
DOSAGE AND ADMINISTRATION
Prevention of chemotherapy-induced nausea and vomiting (2.1):
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions:
To report SUSPECTED ADVERSE REACTIONS, contact Wockhardt USA LLC. at 1-800-346-6854 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION. Revised: 9/2011 |
Percent of Patients With Reaction | ||
---|---|---|
Granisetron Hydrochloride Injection 40 mcg/kg (n=1268) | Comparator1
(n=422) |
|
Headache | 14% | 6% |
Constipation | 3% | 3% |
It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when granisetron hydrochloride injection is administered to a nursing woman.
Peak Plasma Concentration (ng/mL) | Terminal Phase Plasma Half-Life (h) | Total Clearance (L/h/kg) | Volume of Distribution (L/kg) |
|
---|---|---|---|---|
Cancer Patients | ||||
Mean | 63.8* | 8.95* | 0.38* | 3.07* |
Range | 18.0 to 176 | 0.90 to 31.1 | 0.14 to 1.54 | 0.85 to 10.4 |
Volunteers | ||||
21 to 42 years | ||||
Mean | 64.3† | 4.91† | 0.79† | 3.04† |
Range | 11.2 to 182 | 0.88 to 15.2 | 0.20 to 2.56 | 1.68 to 6.13 |
65 to 81 years | ||||
Mean | 57.0† | 7.69† | 0.44† | 3.97† |
Range | 14.6 to 153 | 2.65 to 17.7 | 0.17 to 1.06 | 1.75 to 7.01 |
Granisetron Hydrochloride Injection | Placebo | P-Value | |
---|---|---|---|
Number of Patients | 14 | 14 | |
Response Over 24 Hours | |||
Complete Response2 | 93% | 7% | <0.001 |
No Vomiting | 93% | 14% | <0.001 |
No More Than Mild Nausea | 93% | 7% | <0.001 |
Granisetron Hydrochloride Injection (mcg/kg) | P-Value (vs. 2 mcg/kg) |
||||
---|---|---|---|---|---|
2 | 10 | 40 | 10 | 40 | |
Number of Patients | 52 | 52 | 53 | ||
Response Over 24 Hours | |||||
Complete Response2 | 31% | 62% | 68% | <0.002 | <0.001 |
No Vomiting | 38% | 65% | 74% | <0.001 | <0.001 |
No More Than Mild Nausea | 58% | 75% | 79% | NS | 0.007 |
Granisetron Hydrochloride Injection (mcg/kg) | P-Value (vs. 5 mcg/kg) |
||||||
---|---|---|---|---|---|---|---|
5 | 10 | 20 | 40 | 10 | 20 | 40 | |
High-Dose Cisplatin | |||||||
Number of Patients | 40 | 49 | 48 | 47 | |||
Response Over 24 Hours | |||||||
Complete Response2 | 18% | 41% | 40% | 47% | 0.018 | 0.025 | 0.004 |
No Vomiting | 28% | 47% | 44% | 53% | NS | NS | 0.016 |
No Nausea | 15% | 35% | 38% | 43% | 0.036 | 0.019 | 0.005 |
Low-Dose Cisplatin | |||||||
Number of Patients | 42 | 41 | 40 | 46 | |||
Response Over 24 Hours | |||||||
Complete Response2 | 29% | 56% | 58% | 41% | 0.012 | 0.009 | NS |
No Vomiting | 36% | 63% | 65% | 43% | 0.012 | 0.008 | NS |
No Nausea | 29% | 56% | 38% | 33% | 0.012 | NS | NS |
Granisetron Hydrochloride Injection | Chlorpromazine1 | P-Value | |
---|---|---|---|
Number of Patients | 133 | 133 | |
Response Over 24 Hours | |||
Complete Response2 | 68% | 47% | <0.001 |
No Vomiting | 73% | 53% | <0.001 |
No More Than Mild Nausea | 77% | 59% | <0.001 |
Granisetron Hydrochloride Injection Dose (mcg/kg) | |||
---|---|---|---|
10 | 20 | 40 | |
Number of Patients | 29 | 26 | 25 |
Median Number of Vomiting Episodes | 2 | 3 | 1 |
Complete Response Over 24 Hours1 | 21% | 31% | 32% |
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride injection |
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Labeler - WOCKHARDT LIMITED (650069115) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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WOCKHARDT LIMITED | 676257570 | manufacture |