Palonosetron hydrochloride is the generic equivalent of the brand-name drug Palonosetron. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Palonosetron hydrochloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in: Adults for prevention of : acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). ( 1 ) acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). ( 1 ) postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1 ) Pediatric patients aged 1 month to less than 17 years for prevention of : acute nausea and vomiting associated with initial and repeat courses of emetoge…
Adverse Reactions
6 ADVERSE REACTIONS Serious or otherwise clinically significant adverse reactions reported in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions ( 5.2 ) ] Most common adverse reactions in chemotherapy-induced nausea and vomiting in adults (≥5%) are: headache and constipation ( 6.1 ) postoperative nausea and vomiting (≥ 2%) are: QT prolongation, bradycardia, headache, and constipation. ( 6.1 ) To report SUS…
Drug Interactions
7 DRUG INTERACTIONS Serotonergic Drugs : Monitor for serotonin syndrome; if symptoms occur, discontinue Palonosetron Hydrochloride Injection and initiate supportive treatment. ( 7.1 ) 7.1 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and nor…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Chemotherapy-Induced Nausea and Vomiting ( 2.1 ) Age Dose Note different dosing units in pediatrics Infusion Time Adults 0.25 mg as a single dose Infuse over 30 seconds beginning approximately 30 minutes before the start of chemotherapy Pediatrics (1 month to less than 17 years) 2 0 micrograms per k ilo g ra m (maximum 1.5 mg) as a single dose Infuse over 15 minutes beginning approximately 30 minutes before the start of chemotherapy Postoperative Nausea and Vomiting (…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling ( Patient Information ). Hypersensitivity Reactions Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients with or without known hypersensitivity to other 5-HT 3 receptor antagonists. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of Palonosetron Hydrochloride Injection [see Warnings and Precautions ( 5.1 )] . Serotonin Syndrome Adv…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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