Granisetron Hydrochloride (Page 3 of 4)

ADVERSE REACTIONS

Chemotherapy-Induced Nausea and Vomiting

Over 3700 patients have received Granisetron HCl Tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.

Table 4.Other adverse events reported in clinical trials were:

Table 4 Principal Adverse Events in Clinical Trials

*
Adverse events were recorded for 7 days when granisetron hydrochloride tablets were given on a single day and for up to 28 days when granisetron hydrochloride tablets were administered for 7 or 14 days.
Metoclopramide/dexamethasone; phenothiazines/dexamethasone; dexamethasone alone; prochlorperazine.
Usually mild to moderate in severity.
Percent of Patients With Event
Granisetron HCl * tablets1 mg bid(n=978)Granisetron HCl * tablets2mg qd(n=1450)Comparator (n=599)Placebo(n=185)
Headache 21%20%13%12%
Constipation18%14%16%8%
Asthenia14%18%10%4%
Diarrhea8%9%10%4%
Abdominal pain6%4%6%3%
Dyspepsia4%6%5%4%

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 have been reported in a patient treated with Granisetron HCl 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.

*
Adverse events were generally recorded over 7 days post- granisetron hydrochloride Injection administration
Metoclopramide/dexamethasone and phenothiazines/dexamethasone.
Percent of Patients with Event
Granisetron hydrochloride * Injection40 mcg/kg(n=1268)Comparator (n=422)
Headache14%6%
Asthenia5%6%
Somnolence4%15%
Diarrhea4%6%
Constipation3%3%

Radiation-Induced Nausea and Vomiting

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

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 & ADMINISTRATION

Emetogenic Chemotherapy

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

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

Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)

There is no experience with oral Granisetron HCl in the prevention of radiation-induced nausea and vomiting in pediatric patients.

Use in the Elderly

HOW SUPPLIED

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 are available as 20 Unit Dose Tablets (Intended for institutional use only).

NDC 67877-184-20-20’s pack

NDC 67877-184-02-2’s pack

ASCEND

Mfd for: Ascend Laboratories

Montvale, NJ07645.

Granisetron Hydrochloride Tablets-20 Tablets

RX Only

NDC67877-184-20

Each tablet contains 1.12 mg of granisetron Hydrochloride equivalent to granisetron, 1 mg.

This unit-dose package is not-child-resistant. For institutional use only.

Dosage: Chemotherapy: 2 mg once daily or 1mg 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.

Radiation: Two 1mg tablets are taken within 1 hour of radiation. See accompanying prescribing information.

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

M.L.: 164/MN/AP/95/F/R

Mfd for: Ascend Laboratories,

Montvale, NJ07645.

Mfd by: Natco Pharma Limited,

Kothur — 509 228, AP, India.

carton label 20tablets
(click image for full-size original)

Blister Art Work

 blister art work 20 tablets
(click image for full-size original)

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