Prescription Drug Information: Granisetron Hydrochloride (Page 3 of 3)

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 (see PRECAUTIONS and Drug Interactions).

OVERDOSAGE

There is no specific treatment for granisetron hydrochloride overdosage. In case of overdosage, symptomatic treatment should be given. Overdosage of up to 38.5 mg of granisetron hydrochloride injection has been reported without symptoms or only the occurrence of a slight headache.

DOSAGE AND ADMINISTRATION

Emetogenic Chemotherapy

The recommended adult dosage of oral granisetron hydrochloride 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.

Use in the Elderly, Renal Failure Patients or Hepatically Impaired Patients

No dosage adjustment is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)

The recommended adult dosage of oral granisetron hydrochloride is 2 mg once daily. Two 1 mg tablets are taken within 1 hour of radiation.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Use in the Elderly

No dosage adjustment is recommended.

HOW SUPPLIED

White to off-white film coated triangular shaped biconvex tablet debossed with “G1” on one side and plain on the other side.


1 mg Bottle of 20 Tablets: NDC 42043-390-20


1 mg Unit of Use 2s: NDC 42043-390-02

1 mg 20 (2 x 10) Unit Dose Tablets: NDC 42043-390-21 (intended for institutional use only)

Storage

Store between 20° and 25°C (68° and 77°F). [see USP Controlled Room Temperature]. Keep container closed tightly. Protect from light.

PATIENT COUNSELING INFORMATION

Advise patients of the possibility of serotonin syndrome with concomitant use of granisetron and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptomswith or without gastrointestinal symptoms.

Manufactured for : OrchidPharma, Inc.

Princeton, NJ 08540, USA

Manufactured by : Orchid Healthcare

(a division of Orchid Pharma Ltd.)

Irungattukottai — 602 117, India

Revised:11/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OrchidPharma

NDC 42043-390-20

Granisetron Hydrochloride Tablets, USP

1 mg*

20 Tablets

Rx only

Container Label
(click image for full-size original)

OrchidPharma

20 (2 x 10)

Unit Dose Tablets

NDC 42043-390-21

Granisetron Hydrochloride Tablets, USP

1 mg*

Rx only

* Each tablet contains 1.12 mg granisetron hydrochloride USP equivalent to granisetron, 1 mg.

Intended For Institutional Use Only.

Blister Carton 2s
(click image for full-size original)
GRANISETRON HYDROCHLORIDE granisetron hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42043-390
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRANISETRON HYDROCHLORIDE (GRANISETRON) GRANISETRON 1 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off white) Score no score
Shape TRIANGLE (Triangular Biconvex) Size 7mm
Flavor Imprint Code G1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42043-390-02 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42043-390-00)
1 NDC:42043-390-00 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42043-390-02)
2 NDC:42043-390-21 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42043-390-40)
2 NDC:42043-390-40 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42043-390-21)
3 NDC:42043-390-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078678 04/12/2016
Labeler — OrchidPharma Inc (809429207)
Registrant — Orchid Pharma Ltd (650133507)
Establishment
Name Address ID/FEI Operations
Orchid Healthcare (a division of Orchid Pharma Ltd) 650288850 analysis (42043-390), manufacture (42043-390), pack (42043-390), label (42043-390)

Revised: 01/2022 OrchidPharma Inc

Page 3 of 3 1 2 3

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.