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Granisetron Hydrochloride (Granisetron Hydrochloride)

Trade Name : Granisetron Hydrochloride

West-Ward Pharmaceuticals Corp

INJECTION

Strength 1 mg/mL

GRANISETRON HYDROCHLORIDE Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Granisetron Hydrochloride (Granisetron Hydrochloride) which is also known as Granisetron Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 1 mg/mL per ml. Read more

Granisetron Hydrochloride (Granisetron Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Serotonin Syndrome ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 08/2014
  • Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT) receptor antagonist indicated for:
  • Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT) receptor antagonist indicated for:
  • Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. ()
  • Adult Patientsn
  • Infusion Preparationn
  • Stabilityn
  • As a general precaution, Granisetron Hydrochloride Injection should not be mixed in solution with other drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
  • Pediatric Patientsn
  • [see Clinical Studies ()]
  • Prevention of chemotherapy-induced nausea and vomiting ()
  • Recommended dosage is 10 mcg/kg intravenously within 30 minutes before initiation of chemotherapy nn
  • Pediatric patients (2 to 16 years): Recommended dosage is 10 mcg/kg
  • Single-Use Vials for Injection: 1 mg/mLMulti-Use Vials for Injection: 4 mg/4 mL (1 mg/mL)
  • Injection 1 mg/mL (free base). ()
  • Granisetron Hydrochloride Injection is contraindicated in patients with known hypersensitivity (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components.
  • Hypersensitivity to granisetron or to any of its components. ()
  • No data
  • Granisetron hydrochloride does not stimulate gastric or intestinal peristalsis and should not be used instead of nasogastric suction. ()
  • QT prolongation has been reported with granisetron hydrochloride. Use with caution in patients with pre-existing arrhythmias or cardiac conduction disorders. ()
  • Hypersensitivity reactions, such as anaphylaxis, shortness of breath, hypotension, and urticaria, may occur in patients with known hypersensitivity to other selective 5-HT receptor antagonists. ()
  • Contains benzyl alcohol. ()
  • Serotonin syndrome has been reported with granisetron products, alone but particularly with concomitant use of serotonergic drugs. ()
  • QT prolongation has been reported with granisetron hydrochloride .
  • Most common adverse reactions:
  • u200bChemotherapy-induced nausea and vomiting (u22653%): Headache, and constipation ()
  • Granisetron does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system . 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 human microsomal studies, ketoconazole inhibited ring oxidation of granisetron hydrochloride. However, the clinical significance of pharmacokinetic interactions with ketoconazole is not known. In a human pharmacokinetic study, hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous granisetron hydrochloride. The clinical significance of this change is not known.
  • QT prolongation has been reported with granisetron hydrochloride. Use of granisetron hydrochloride in patients concurrently treated with drugs known to prolong the QT interval and/or are arrhythmogenic may result in clinical consequences.
  • Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) n
  • Granisetron Hydrochloride Injection, USP has been administered safely with benzodiazepines, neuroleptics, and anti-ulcer medications. ()
  • Does not appear to interact with emetogenic cancer chemotherapies. ()
  • Inducers or inhibitors of CYP450 enzymes may change the clearance and therefore the half-life of granisetron. () nn
  • Coadministration of granisetron hydrochloride with drugs known to prolong the QT interval and/or are arrhythmogenic may result in clinical consequences. ()
  • No data
  • Pregnancy: Use only if clearly needed. () nn
  • Nursing mothers: Caution should be exercised when administered to a nursing woman. () nn
  • Pediatric use: Safety and efficacy in pediatric patients have not been established for use in postoperative nausea and vomiting. () nn
  • Geriatric use: No differences in responses between the elderly and younger patients were observed in reported clinical experience. ()
  • There is no specific antidote for Granisetron Hydrochloride Injection 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.
  • Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT) receptor antagonist. Chemically it is -N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C18H24N4Ou2022HCl, while its chemical structure is:
  • Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20u00b0C. Granisetron Hydrochloride Injection is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration.
  • Granisetron Hydrochloride Injection, USP 1 mg/mL is available in 1 mL single-use and 4 mL multi-use vials.
  • 1 mg/mL: Each mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid anhydrous, 2 mg; and benzyl alcohol, 10 mg, as a preservative. The solutionu2019s pH ranges from 4.0 to 6.0; pH adjusted with sodium hydroxide/hydrochloric acid.
  • No data
  • In a 24-month carcinogenicity study, rats were treated orally with granisetron 1, 5 or 50 mg/kg/day (6, 30 or 300 mg/m2/day). The 50 mg/kg/day dose was reduced to 25 mg/kg/day (150 mg/m2/day) during week 59 due to toxicity. For a 50 kg person of average height (1.46 m2 body surface area), these doses represent 16, 81 and 405 times the recommended clinical dose (0.37 mg/m2, iv) on a body surface area basis. There was a statistically significant increase in the incidence of hepatocellular carcinomas and adenomas in males treated with 5 mg/kg/day (30 mg/m2/day, 81 times the recommended human dose based on body surface area) and above, and in females treated with 25 mg/kg/day (150 mg/m2/day, 405 times the recommended human dose based on body surface area). No increase in liver tumors was observed at a dose of 1 mg/kg/day (6 mg/m2/day, 16 times the recommended human dose based on body surface area) in males and 5 mg/kg/day (30 mg/m2/day, 81 times the recommended human dose based on body surface area) in females. In a 12-month oral toxicity study, treatment with granisetron 100 mg/kg/day (600 mg/m2/day, 1622 times the recommended human dose based on body surface area) produced hepatocellular adenomas in male and female rats while no such tumors were found in the control rats. A 24-month mouse carcinogenicity study of granisetron did not show a statistically significant increase in tumor incidence, but the study was not conclusive.
  • Because of the tumor findings in rat studies, Granisetron Hydrochloride Injection should be prescribed only at the dose and for the indication recommended .
  • Granisetron was not mutagenic in an Ames test and mouse lymphoma cell forward mutation assay, and mouse micronucleus test and and rat hepatocyte UDS assays. It, however, produced a significant increase in UDS in HeLa cells and a significant increased incidence of cells with polyploidy in an human lymphocyte chromosomal aberration test.
  • Granisetron at subcutaneous doses up to 6 mg/kg/day (36 mg/m2/day, 97 times the recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
  • Single-Day Chemotherapyn
  • Cisplatin-Based Chemotherapyn
  • Granisetron Hydrochloride Injection was also evaluated in a randomized dose response study of cancer patients receiving cisplatin u226575 mg/m. Additional chemotherapeutic agents included: anthracyclines, carboplatin, cytostatic antibiotics, folic acid derivatives, methylhydrazine, nitrogen mustard analogs, podophyllotoxin derivatives, pyrimidine analogs, and vinca alkaloids. Granisetron Hydrochloride Injection doses of 10 and 40 mcg/kg were superior to 2 mcg/kg in preventing cisplatin-induced nausea and vomiting, but 40 mcg/kg was not significantly superior to 10 mcg/kg (see Table 4).
  • Granisetron Hydrochloride Injection was also evaluated in a double-blind, randomized dose response study of 353 patients stratified for high (u226580 to 120 mg/m) or low (50 to 79 mg/m) cisplatin dose. Response rates of patients for both cisplatin strata are given in Table 5.
  • For both the low and high cisplatin strata, the 10, 20, and 40 mcg/kg doses were more effective than the 5 mcg/kg u00a0dose u00a0in u00a0preventing u00a0nausea u00a0and u00a0vomiting u00a0within u00a024 u00a0hours u00a0of u00a0chemotherapy u00a0administration. u00a0The 10 mcg/kg dose was at least as effective as the higher doses.
  • Moderately Emetogenic Chemotherapyn
  • In other studies of moderately emetogenic chemotherapy, no significant difference in efficacy was found between granisetron hydrochloride doses of 40 mcg/kg and 160 mcg/kg.
  • Repeat-Cycle Chemotherapyn
  • Pediatric Studiesn
  • A second pediatric study compared Granisetron Hydrochloride Injection 20 mcg/kg to chlorpromazine plus dexamethasone in 88 patients treated with ifosfamide u22653 g/m/day for two or three days. Granisetron Hydrochloride Injection was administered on each day of ifosfamide treatment. At 24 hours, 22% of Granisetron Hydrochloride Injection patients achieved complete response (no vomiting and no moderate or severe nausea in 24 hours) compared with 10% on the chlorpromazine regimen. The median number of vomiting episodes with Granisetron Hydrochloride Injection was 1.5; with chlorpromazine it was 7.
  • Granisetron Hydrochloride Injection, USP 1 mg/mL (free base), is supplied in 1 mL Single-Use Vials and 4 mL Multi-Use Vials. CONTAINS BENZYL ALCOHOL.
  • NDC 0143-9744-10 (Cartonu00a0of 10 x 1mL Single-Use Vials)NDC 0143-9745-10 (Cartonu00a0of 10 x 4 mL Multi-Use Vials)NDC 0143-9745-05 (Cartonu00a0of 5 x 4 mLu00a0Multi-Use Vials)
  • Store single-use vials and multi-use vials at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). [See USP Controlled Room Temperature]
  • Discard unused portion for the single-use vials.
  • Once the multi-use vial is penetrated, its contents should be used within 30 days.
  • Do not freeze. Protect from light. Retain in carton until time of use.
  • Patients should be informed that the most common adverse reactions for the indication of chemotherapy induced nausea and vomiting are headache and constipation (see Table 1).
  • Patients should be advised of the risk of allergic reactions if they have a prior allergic reaction to a class of antiemetics known as 5-HT receptor antagonists.
  • Electrocardiogram changes (QT prolongation) have been reported with the use of granisetron hydrochloide. Patients should be cautioned about the use of this drug if they have heart problems or take medications for heart problems.
  • Patients should be informed that Granisetron Hydrochloride Injection (1 mg/mL) contains benzyl alcohol and may cause serious side effects in newborns.
  • 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:HIKMA FARMACu00caUTICA (PORTUGAL), S.A.Estrada do Rio da Mu00f3, nu00ba 8, 8A e 8B - Fervenu00e7a,2705 u2013 906 Terrugem SNTPORTUGAL
  • Distributed by:WEST-WARDA HIKMA COMPANYEatontown, NJ 07724 USA
  • Revised: July 2016
  • PIN225-WES/6
  • NDC 0143-9744-01n n 1u00a0mg/mLFor Intravenous Use OnlyRx ONLY1 mL Single-Use Vialn See package insert.n n
  • u00a0
  • Arrayn- Array
  • u00a0
  • u00a0
  • NDC 0143-9744-1010 x 1 mL Single-Use Vialsn For Intravenous Use Only*Each mL contains, in sterile aqueoussolution, Granisetron Hydrochloride, USP,1.12 mg, equivalent to granisetron, 1 mg,Sodium Chloride, USP, 9 mg, Citric Acid,NF, 2 mg, Benzyl Alcohol, NF, 10 mg, as apreservative. pH adjusted with sodiumhydroxide/hydrochloric acid.n n 10 mcg/kg administeredintravenously either undiluted over30 seconds, or diluted with 0.9% sodiumchloride or 5% dextrose and given over5 minutes. See package insert.n n n
  • u00a0
  • u00a0
  • u00a0
  • Arrayn- Array
  • NDC 0143-9745-01n n n n For Intravenous Use OnlyRx ONLY4u00a0mL Multi-Use Vialn See package insert.n n
  • u00a0
  • Arrayn- Array
  • u00a0
  • NDC 0143-9745-1010 xu00a04 mL Multi-Use Vialsn For Intravenous Use OnlyRx ONLY*Each mL contains, in sterile aqueoussolution, Granisetron Hydrochloride, USP,1.12 mg, equivalent to granisetron, 1 mg,Sodium Chloride, USP, 9 mg, Citric Acid,NF, 2 mg, Benzyl Alcohol, NF, 10 mg, as apreservative. pH adjusted with sodiumhydroxide/hydrochloric acid.n See package insert.n n
  • Arrayn- Array
  • No data

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