Granisetron Hydrochloride (Page 4 of 4)

Radiation-Induced Nausea and Vomiting

In controlled clinical trials, the adverse events reported by patients receiving granisetron tablets and concurrent radiation were similar to those reported by patients receiving granisetron 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 (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

Granisetron Hydrochloride Tablets USP are available as:
White colored, triangular shaped, biconvex, film-coated tablets with debossing of ‘1GN’ on one side and plain surface on the other side.

Granisetron HCl tablets, USP are available as 20 Unit Dose Tablets (Intended for institutional use only) and 2’s pack.

NDC 63850-0005-1-20’S Pack

NDC No. 63850-0005-2 – 2’S Pack

Storage

Store between 20º to 25ºC (68º and 77ºF) [see USP Controlled Room Temperature]. Keep container closed tightly. Protect from light. Retain in carton until time of use.

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 symptoms with or without gastrointestinal symptoms.

Manufactured by:
NATCO PHARMA LIMITED
Kothur- 509 228,
India.

Granisetron Hydrochloride Tablets USP, 1 mg *- Blister of 20 (2×10) Unit Dose Tablets

R_X only
NDC 63850-0005-1
*Each tablet contains 1.12 mg granisetron hydrochloride USP equivalent to granisetron,1 mg
This unit-dose package is not-child-resistant.
For institutional use only.
Dosage: Chemotherapy: 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 tablets is given up to 1 hour before chemotherapy and the second tablets 12 hours after the first.
Radiation: Two 1 mg tablets are taken within 1 hour of radiation. See accompanying prescribing information.
Storage between 20° and 25°(68° and 77°F) [see USP Controlled Room Temperature]. protect from light. Retain in carton until time of use.Uint dose Tablets-Foil

Carton Label

Granisetron hydrochloride 1 mg _blister of 2×20’sGranisetron hydrochloride 1 mg _ carton 2×20’s

Granisetron Hydrochloride Tablets USP, 1mg* — Blister of 2 Tablets

R_x only
NDC 63850-0005-2
*Each tablet contains 1.12 mg granisetron hydrochloride USP equivalent to granisetron,1 mg
This unit-dose package is not-child-resistant.

Dosage: Chemotherapy: 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 tablets is given up to 1 hour before chemotherapy and the second tablets 12 hours after the first.
Radiation: Two 1 mg tablets are taken within 1 hour of radiation. See accompanying prescribing information.
Storage between 20° and 25°(68° and 77°F) [see USP Controlled Room Temperature]. protect from light. Retain in carton until time of use.Foil_ 2 Tablets

Carton Label

GRANISETRON HYDROCHLORIDE granisetron hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63850-0005 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 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape TRIANGLE Size 7mm Flavor Imprint Code 1GN Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63850-0005-1 10 TABLET, FILM COATED in 1 BLISTER PACK None 2 NDC:63850-0005-2 2 TABLET, FILM COATED in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078969 06/22/2009

Labeler — Natco Pharma Limited (650224736)

Establishment
Name	Address	ID/FEI	Operations
Natco Pharma Limited-Pharma Division		918588174	MANUFACTURE (63850-0005)

Revised: 10/2019 Natco Pharma Limited