Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Palonosetron
Overview
What is Palonosetron?
Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo- 1benz[de]isoquinoline hydrochloride. The empirical formula is CHNO.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula:
Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water and soluble in methanol.
Palonosetron hydrochloride injection is a sterile, clear, colorless, non pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron hydrochloride injection is available as 5 mL single use vial or 1.5 mL single use vial.
Each 5 mL vial contains 0.25 mg palonosetron base as hydrochloride, 207.5 mg mannitol, disodium edetate and sodium acetate trihydrate in water for intravenous administration.
Each 1.5 mL vial contains 0.075 mg palonosetron base as hydrochloride, 62.25 mg mannitol, disodium edetate and sodium acetate trihydrate in water for intravenous administration.
The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5, Hydrochloric acid or sodium hydroxide may have been added to adjust pH.
What does Palonosetron look like?
What are the available doses of Palonosetron?
0.25 mg/5mL (free base) single-use vial
0.075 mg/1.5mL (free base) single-use vial
What should I talk to my health care provider before I take Palonosetron?
How should I use Palonosetron?
What interacts with Palonosetron?
Sorry No Records found
What are the warnings of Palonosetron?
Sorry No Records found
What are the precautions of Palonosetron?
Sorry No Records found
What are the side effects of Palonosetron?
Sorry No records found
What should I look out for while using Palonosetron?
Palonosetron hydrochloride injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [see Adverse Reactions )]
What might happen if I take too much Palonosetron?
There is no known antidote to palonosetron hydrochloride injection. Overdose should be managed with supportive care.
Fifty adult cancer patients were administered palonosetron at a dose of 90 mcg/kg (equivalent to 6 mg fixed dose) as part of a dose ranging study. This is approximately 25 times the recommended dose of 0.25 mg. This dose group had a similar incidence of adverse events compared to the other dose groups and no dose response effects were observed.
Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose. A single intravenous dose of palonosetron at 30 mg/kg (947 and 474 times the human dose for rats and mice, respectively, based on body surface area) was lethal to rats and mice. The major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse.
How should I store and handle Palonosetron?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.Palonosetron Hydrochloride Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. NDC 55111-694-19 Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial packaged in a carton containing 1 vial. NDC 55111-694-07Storage• Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. • Protect from freez ing. • Protect from light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Palonosetron is a 5-HT receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors.
Cancer chemotherapy may be associated with a high incidence of nausea and vomiting, particularly when certain agents, such as cisplatin, are used. 5-HT receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex.
Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factors and is triggered by release of 5-HT in a cascade of neuronal events involving both the central nervous system and the gastrointestinal tract. The 5-HT receptor has been demonstrated to selectively participate in the emetic response.
Non-Clinical Toxicology
Palonosetron hydrochloride injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [see Adverse Reactions )]Metabolism of a number of medications, including antipsychotics, antidepressants, β-blockers, and antiarrhythmics, occurs through the cytochrome P450 2D6 isoenzyme (debrisoquine hydroxylase). Approximately 10% of the Caucasian population has reduced activity of this enzyme, so-called “poor” metabolizers. Among other populations the prevalence is not known. Poor metabolizers demonstrate higher plasma concentrations of antipsychotic drugs at usual doses, which may correlate with emergence of side effects. In one study of 45 elderly patients suffering from dementia treated with perphenazine, the 5 patients who were prospectively identified as poor P450 2D6 metabolizers had reported significantly greater side effects during the first 10 days of treatment than the 40 extensive metabolizers, following which the groups tended to converge. Prospective phenotyping of elderly patients prior to antipsychotic treatment may identify those at risk for adverse events.
The concomitant administration of other drugs that inhibit the activity of P450 2D6 may acutely increase plasma concentrations of antipsychotics. Among these are tricyclic antidepressants and selective serotonin reuptake inhibitors, e.g., fluoxetine, sertraline and paroxetine. When prescribing these drugs to patients already receiving antipsychotic therapy, close monitoring is essential and dose reduction may become necessary to avoid toxicity. Lower doses than usually prescribed for either the antipsychotic or the other drug may be required.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
515Total User Reviews
User Reviews
Learn about
User Reviews
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).