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Granisetron
Overview
What is Granisetron?
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 molecular formula is CHNO•HCl, while its chemical structure is:
Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C. Granisetron hydrochloride injection, USP 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, 2 mg; benzyl alcohol, 10 mg, as a preservative; sodium hydroxide and hydrochloric acid, as pH adjusters.
The solution’s pH ranges from 4.0 to 6.0.
What does Granisetron look like?
What are the available doses of Granisetron?
Single-Use Vials for Injection: 1 mg/mL
Multi-Use Vials for Injection: 4 mg/4 mL
What should I talk to my health care provider before I take Granisetron?
How should I use Granisetron?
Granisetron hydrochloride injection, USP is a serotonin-3 (5-HT) receptor antagonist indicated for:
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What interacts with Granisetron?
Sorry No Records found
What are the warnings of Granisetron?
Sorry No Records found
What are the precautions of Granisetron?
Sorry No Records found
What are the side effects of Granisetron?
Sorry No records found
What should I look out for while using Granisetron?
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.
What might happen if I take too much Granisetron?
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.
How should I store and handle Granisetron?
Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].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 Number Volume66758-035-01 Carton of 1 x 1 mL Single-Use Vial66758-036-01 Carton of 1 x 4 mL Multi-Use VialStore single-use vials and multi-use vials at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].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.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 Number Volume66758-035-01 Carton of 1 x 1 mL Single-Use Vial66758-036-01 Carton of 1 x 4 mL Multi-Use VialStore single-use vials and multi-use vials at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].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.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 Number Volume66758-035-01 Carton of 1 x 1 mL Single-Use Vial66758-036-01 Carton of 1 x 4 mL Multi-Use VialStore single-use vials and multi-use vials at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].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.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 Number Volume66758-035-01 Carton of 1 x 1 mL Single-Use Vial66758-036-01 Carton of 1 x 4 mL Multi-Use VialStore single-use vials and multi-use vials at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].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.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 Number Volume66758-035-01 Carton of 1 x 1 mL Single-Use Vial66758-036-01 Carton of 1 x 4 mL Multi-Use VialStore single-use vials and multi-use vials at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].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.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 Number Volume66758-035-01 Carton of 1 x 1 mL Single-Use Vial66758-036-01 Carton of 1 x 4 mL Multi-Use VialStore single-use vials and multi-use vials at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].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.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 Number Volume66758-035-01 Carton of 1 x 1 mL Single-Use Vial66758-036-01 Carton of 1 x 4 mL Multi-Use VialStore single-use vials and multi-use vials at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Granisetron is a selective 5-hydroxytryptamine (5-HT) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT; 5-HT; 5-HT; 5-HT; for alpha-, alpha- or beta-adrenoreceptors; for dopamine-D; or for histamine-H; benzodiazepine; picrotoxin or opioid receptors.
Serotonin receptors of the 5-HT type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy-induced vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT receptors. This evokes vagal afferent discharge and may induce vomiting. Animal studies demonstrate that, in binding to 5-HT receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.
In most human studies, granisetron has had little effect on blood pressure, heart rate or ECG. No evidence of an effect on plasma prolactin or aldosterone concentrations has been found in other studies.
Granisetron hydrochloride injection exhibited no effect on oro-cecal transit time in normal volunteers given a single intravenous infusion of 50 mcg/kg or 200 mcg/kg. Single and multiple oral doses slowed colonic transit in normal volunteers.
Non-Clinical Toxicology
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.Potential Effects of Coadministration of Drugs Highly Bound to Plasma Proteins
In a study comparing prothrombin time AUC (0-120 hr) following dosing with warfarin (0.75 mg/kg) before and after 21 days of dosing with either sertraline hydrochloride (50-200 mg/day) or placebo, there was a mean increase in prothrombin time of 8% relative to baseline for sertraline hydrochloride compared to a 1% decrease for placebo (p<0.02). The normalization of prothrombin time for the sertraline hydrochloride group was delayed compared to the placebo group. The clinical significance of this change is unknown. Accordingly, prothrombin time should be carefully monitored when sertraline hydrochloride therapy is initiated or stopped.
Cimetidine
CNS Active Drugs
In a placebo-controlled trial in normal volunteers, the administration of two doses of Sertraline hydrochloride did not significantly alter steady-state lithium levels or the renal clearance of lithium.
Nonetheless, at this time, it is recommended that plasma lithium levels be monitored following initiation of Sertraline hydrochloride therapy with appropriate adjustments to the lithium dose.
In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline (q.d.) co-administration to steady state was associated with a mean increase in pimozide AUC and C of about 40%, but was not associated with any changes in EKG. Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline, the effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of Sertraline hydrochloride and pimozide should be contraindicated (see ).
Results of a placebo-controlled trail in normal volunteers suggest that chronic administration of sertraline 200 mg/day does not produce clinically important inhibition of phenytoin metabolism. Nonetheless, at this time, it is recommended that plasma phenytoin concentrations be monitored following initiation of Sertraline Hydrochloride therapy with appropriate adjustments to the phenytoin dose, particularly in patients with multiple underlying medical conditions and/or those receiving multiple concomitant medications.
The effect of Sertraline hydrochloride on valproate levels has not been evaluated in clinical trials. In the absence of such data, it is recommended that plasma valproate levels be monitored following initiation of Sertraline hydrochloride therapy with appropriate adjustments to the valproate dose.
The risk of using sertraline hydrochloride in combination with other CNS active drugs has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of sertraline hydrochloride and such drugs is required.
There is limited controlled experience regarding the optimal timing of switching from other drugs effective in the treatment of major depressive disorder, premenstrual dysphoric disorder to sertraline hydrochloride. Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents. The duration of an appropriate washout period which should intervene before switching from one selective serotonin reuptake inhibitor (SSRI) to another has not been established.
Monoamine Oxidase Inhibitors
Drugs Metabolized by P450 2D6
Serotonergic Drugs:
Triptans:
Sumatriptan
Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs)
Hypoglycemic Drugs
Atenolol
Digoxin
Microsomal Enzyme Induction
Drugs that Interfere with Hemostasis (Non-selective NSAIDs, Aspirin, Warfarin, etc.)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs or SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when Sertraline hydrochloride is initiated or discontinued.
Electroconvulsive Therapy
Alcohol
Carcinogenesis
Impairment of Fertility
Pregnancy-Nonteratogenic Effects
Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 – 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (including sertraline hydrochloride) in pregnancy and PPHN. Other studies do not show a significant statistical association.
Physicians should also note the results of a prospective longitudinal study of 201 pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission. Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy.
When treating a pregnant woman with sertraline hydrochloride, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. This decision can only be made on a case by case basis (see ).
Labor and Delivery
Nursing Mothers
Pediatric Use
The safety of Sertraline hydrochloride use in children and adolescents with OCD, ages 6-18, was evaluated in a 12-week, multicenter, placebo-controlled study with 187 outpatients, ages 6-17, and in a flexible dose, 52 week open extension study of 137 patients, ages 6-18, who had completed the initial 12week, double-blind, placebo-controlled study. Sertraline hydrochloride was administered at doses of either 25 mg/day (children, ages 6-12) or 50 mg/day (adolescents, ages 13-18) and then titrated in weekly 25 mg/day or 50 mg/day increments, respectively, to a maximum dose of 200 mg/day based upon clinical response. The mean dose for completers was 157 mg/day. In the acute 12 week pediatric study and in the 52 week study, Sertraline hydrochloride had an adverse event profile generally similar to that observed in adults.
Sertraline pharmacokinetics were evaluated in 61 pediatric patients between 6 and 17 years of age with major depressive disorder or OCD and revealed similar drug exposures to those of adults when plasma concentration was adjusted for weight (see under ).
Approximately 600 patients with major depressive disorder or OCD between 6 and 17 years of age have received Sertraline hydrochloride in clinical trials, both controlled and uncontrolled. The adverse event profile observed in these patients was generally similar to that observed in adult studies with sertraline hydrochloride (see ). As with other SSRIs, decreased appetite and weight loss have been observed in association with the use of Sertraline hydrochloride. In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50-200 mg) outpatient trials for major depressive disorder (n=373), there was a difference in weight change between sertraline and placebo of roughly 1 kilogram, for both children (ages 6-11) and adolescents (ages 12-17), in both cases representing a slight weight loss for sertraline compared to a slight gain for placebo. At baseline the mean weight for children was 39.0 kg for sertraline and 38.5 kg for placebo. At baseline the mean weight for adolescents was 61.4 kg for sertraline and 62.5 kg for placebo. There was a bigger difference between sertraline and placebo in the proportion of outliers for clinically important weight loss in children than in adolescents. For children, about 7% had a weight loss > 7% of body weight compared to none of the placebo patients; for adolescents, about 2% had a weight loss > 7% of body weight compared to about 1% of the placebo patients. A subset of these patients who completed the randomized controlled trials (sertraline n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study. A mean weight loss of approximately 0.5 kg was seen during the first eight weeks of treatment for subjects with first exposure to sertraline during the open-label extension study, similar to mean weight loss observed among sertraline treated subjects during the first eight weeks of the randomized controlled trials. The subjects continuing in the open label study began gaining weight compared to baseline by week 12 of sertraline treatment. Those subjects who completed 34 weeks of sertraline treatment (10 weeks in a placebo controlled trial + 24 weeks open label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers. Regular monitoring of weight and growth is recommended if treatment of a pediatric patient with an SSRI is to be continued long term. Safety and effectiveness in pediatric patients below the age of 6 have not been established.
The risks, if any, that may be associated with Sertraline hydrochloride’s use beyond 1 year in children and adolescents with OCD or major depressive disorder have not been systematically assessed. The prescriber should be mindful that the evidence relied upon to conclude that sertraline is safe for use in children and adolescents derives from clinical studies that were 10 to 52 weeks in duration and from the extrapolation of experience gained with adult patients. In particular, there are no studies that directly evaluate the effects of long-term sertraline use on the growth, development, and maturation of children and adolescents. Although there is no affirmative finding to suggest that sertraline possesses a capacity to adversely affect growth, development or maturation, the absence of such findings is not compelling evidence of the absence of the potential of sertraline to have adverse effects in chronic use (see – ).
Geriatric Use
Other Adverse Events in Geriatric Patients. In 354 geriatric subjects treated with Sertraline hydrochloride in placebo-controlled trials, the overall profile of adverse events was generally similar to that shown in Tables 2 and 3. Urinary tract infection was the only adverse event not appearing in Tables 2 and 3 and reported at an incidence of at least 2% and at a rate greater than placebo in placebo-controlled trials.
SSRIS and SNRIs, including Sertraline hydrochloride, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see , ).
Granisetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of granisetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention.
QT prolongation has been reported with granisetron [see and )].
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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