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Palonosetron Hydrochloride

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Overview

What is Palonosetron Hydrochloride?

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: (3a-2-[()-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1benz[]isoquinoline hydrochloride. The molecular 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, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol.

Palonosetron HCl injection is a sterile, clear, colorless, non pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron HCl injection is available as a 5 mL single-dose vial. Each 5 mL vial contains 0.25 mg palonosetron base as 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. Hydrochloric acid or sodium hydroxide may have been added to adjust pH.

The pH of the solution in the 5 mL vial is 4.5 to 5.5.



What does Palonosetron Hydrochloride look like?



What are the available doses of Palonosetron Hydrochloride?

0.25 mg/5 mL (free base) single-dose vial ()

What should I talk to my health care provider before I take Palonosetron Hydrochloride?

Chemotherapy-Induced Nausea and Vomiting

Pediatric use: Safety and effectiveness in neonates (less than 1 month of age) have not been established ()

Postoperative Nausea and Vomiting

Safety and Effectiveness in patients below the age of 18 years have not been established ()

How should I use Palonosetron Hydrochloride?

Palonosetron HCl injection is indicated for:

•


What interacts with Palonosetron Hydrochloride?

Sorry No Records found


What are the warnings of Palonosetron Hydrochloride?

Sorry No Records found


What are the precautions of Palonosetron Hydrochloride?

Sorry No Records found


What are the side effects of Palonosetron Hydrochloride?

Sorry No records found


What should I look out for while using Palonosetron Hydrochloride?

Palonosetron HCl Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components.


What might happen if I take too much Palonosetron Hydrochloride?

There is no known antidote to palonosetron. 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 Hydrochloride?

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].Palonosetron HCl injection is supplied as:NDC 0781-3312-75, 0.25 mg (free base)/5 mL single-dose vial individually packaged in a carton.StoragePalonosetron HCl injection is supplied as:NDC 0781-3312-75, 0.25 mg (free base)/5 mL single-dose vial individually packaged in a carton.StoragePalonosetron HCl injection is supplied as:NDC 0781-3312-75, 0.25 mg (free base)/5 mL single-dose vial individually packaged in a carton.Storage


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Clinical Information

Chemical Structure

No Image found
Clinical 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-HT 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 HCl Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components.

Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT receptor antagonists.

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.

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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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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. 315.72
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Tips

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Interactions

Interactions

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