Drugplain

Granisetron Hydrochloride 1 mg/mL

Granisetron Hydrochloride · INJECTION, SOLUTION · Eugia US LLC

No Recall History
Plain English

Granisetron Hydrochloride is a injection, solution containing granisetron hydrochloride at 1 mg/mL, taken intravenous. Manufactured by Eugia US LLC.

Key Facts

Brand Name
Granisetron Hydrochloride
Generic Name
Granisetron Hydrochloride
NDC Code (Product)
55150-175
Manufacturer
Eugia US LLC
Strength
1 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA204238
Marketing Start
07/06/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea150 reports
febrile neutropenia142 reports
pyrexia140 reports
diarrhoea127 reports
vomiting106 reports
decreased appetite89 reports
off label use86 reports
neutropenia82 reports
anaemia80 reports
neutrophil count decreased79 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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 & Administration

​ 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.

Warnings

WARNINGS Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT 3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients s…

Contraindications

CONTRAINDICATIONS Granisetron hydrochloride is contraindicated in patients with known hypersensitivity to the drug or any of its components.

Drug Interactions

Drug Interactions Granisetron does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system in vitro . There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs; however, in humans, granisetron hydrochloride injection has been safely administered with drugs representing benzodiazepines, neuroleptics, and anti-ulcer medications commonly prescribed with antiemetic treatments. Granisetron hydrochloride injection also does not appear to interact with emetogenic cancer chemotherapies. Because granisetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron. No specific interaction studies have been conducted in anesthetized patients. In addition, the activity of the cytochrome P-450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by granisetron hydrochloride in vitro . In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of granisetron hydrochloride. However, the clinical significance of in viv…

Adverse Reactions

ADVERSE REACTIONS QT prolongation has been reported with granisetron hydrochloride (see PRECAUTIONS and Drug Interactions ). Chemotherapy-Induced Nausea and Vomiting Over 3700 patients have received granisetron hydrochloride tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens. In patients receiving granisetron hydrochloride tablets 1 mg twice a day for 1, 7 or 14 days, or 2 mg daily for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed inTable 4. Table 4 Principal Adverse Events in Clinical Trials Percent of Patients With Event Granisetron Hydrochloride 1 Tablets 1 mg twice a day (n=978) Granisetron Hydrochloride 1 Tablets 2 mg once a day (n=1450) Comparator 2 (n=599) Placebo (n=185) Headache 21% 20% 13% 12% Constipation 18% 14% 16% 8% Asthenia 14% 18% 10% 4% Diarrhea 8% 9% 10% 4% Abdominal pain 6% 4% 6% 3% Dyspepsia 4% 6% 5% 4% 1 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. 2 Metoclopramid…

Frequently Asked Questions

What is Granisetron Hydrochloride used for?

Granisetron Hydrochloride contains Granisetron Hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Granisetron Hydrochloride a controlled substance?

Granisetron Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Granisetron Hydrochloride?

The generic name for Granisetron Hydrochloride is Granisetron Hydrochloride. There are 3 other brand versions of Granisetron Hydrochloride.

What is the NDC code for Granisetron Hydrochloride 1 mg/mL?

The NDC (National Drug Code) for Granisetron Hydrochloride 1 mg/mL is 55150-175, listed by Eugia US LLC.

Product NDC

55150-175

Package NDC

55150-175-01

Other Granisetron Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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