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.
ZUPLENZ
Overview
What is ZUPLENZ?
ZUPLENZ (ondansetron) oral soluble film is a white opaque orally dissolving film designed to be applied on top of the tongue where it will dissolve in 4 to 20 seconds and then is swallowed with saliva.
ZUPLENZ does not require water to aid dissolution or swallowing.
The active ingredient in ZUPLENZ is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H carbazol-4-one.
The empirical formula is CHNO representing a molecular weight of 293.3. Each 4-mg ZUPLENZ oral soluble film for oral administration contains 4 mg ondansetron base. Each 8-mg ZUPLENZ oral soluble film for oral administration contains 8 mg ondansetron base. Each ZUPLENZ oral soluble film also contains the inactive ingredients butylated hydroxytoluene, calcium carbonate, colloidal silicon dioxide, erythritol, hypromellose, monoammonium glycyrrhizinate, peppermint flavor, polyethylene oxide, sodium bicarbonate, sucralose, titanium dioxide and xanthan gum.
What does ZUPLENZ look like?
What are the available doses of ZUPLENZ?
ZUPLENZ (ondansetron) oral soluble film is available in 4 mg and 8 mg strengths. The thin white opaque films are rectangularly shaped strips with a printed identifier in black ink of "4 mg" for ZUPLENZ 4 mg or "8 mg" for ZUPLENZ 8 mg.
What should I talk to my health care provider before I take ZUPLENZ?
How should I use ZUPLENZ?
ZUPLENZ (ondansetron) oral soluble film is indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m
.
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy
Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:
Prevention of nausea and vomiting associated with radiotherapy:
Postoperative nausea and vomiting
See dosage adjustment for patients with impaired hepatic function. ()
What interacts with ZUPLENZ?
Sorry No Records found
What are the warnings of ZUPLENZ?
Sorry No Records found
What are the precautions of ZUPLENZ?
Sorry No Records found
What are the side effects of ZUPLENZ?
Sorry No records found
What should I look out for while using ZUPLENZ?
The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
ZUPLENZ (ondansetron) oral soluble film is contraindicated for patients known to have hypersensitivity to the drug. Anaphylactic reactions have been reported in patients taking ondansetron.
What might happen if I take too much ZUPLENZ?
There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy. Individual intravenous doses as large as 150 mg and total daily intravenous doses as large as 252 mg have been inadvertently administered without significant adverse events. These doses are more than 10 times the recommended daily dose.
In addition to the adverse events listed above, the following events have been described in the setting of ondansetron overdose: "Sudden blindness" (amaurosis) of 2 to 3 minutes' duration plus severe constipation occurred in 1 patient that was administered 72 mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in a patient that took 48 mg of ondansetron HCl tablets. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. In all instances, the events resolved completely.
Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg/kg) in young children. Reported symptoms included somnolence, agitation, tachycardia, tachypnea, hypertension, flushing, mydriasis, diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and seizure. Patients required supportive care, including intubation in some cases, with complete recovery without sequelae within 1 to 2 days.
How should I store and handle ZUPLENZ?
STORE ZUPLENZ (ondansetron) oral soluble film 4 mg and ZUPLENZ (ondansetron) oral soluble film 8 mg, are supplied as thin rectangular white opaque films in individual foil-foil sealed child resistant pouches. Individual films are identified by "4 mg" or "8 mg", according to the respective strengths, which is printed using pharmaceutical grade edible ink.Individual pouches of ZUPLENZ 4 mg oral soluble film are packaged in boxes of 30 (NDC 89141-444-30) and packaged in boxes of 1 (NDC 89141-444-01).Individual pouches of ZUPLENZ 8 mg oral soluble film are packaged in boxes of 30 (NDC 89141-448-30) and packaged in boxes of 1 (NDC 89141-448-01).ZUPLENZ (ondansetron) oral soluble film 4 mg and ZUPLENZ (ondansetron) oral soluble film 8 mg, are supplied as thin rectangular white opaque films in individual foil-foil sealed child resistant pouches. Individual films are identified by "4 mg" or "8 mg", according to the respective strengths, which is printed using pharmaceutical grade edible ink.Individual pouches of ZUPLENZ 4 mg oral soluble film are packaged in boxes of 30 (NDC 89141-444-30) and packaged in boxes of 1 (NDC 89141-444-01).Individual pouches of ZUPLENZ 8 mg oral soluble film are packaged in boxes of 30 (NDC 89141-448-30) and packaged in boxes of 1 (NDC 89141-448-01).ZUPLENZ (ondansetron) oral soluble film 4 mg and ZUPLENZ (ondansetron) oral soluble film 8 mg, are supplied as thin rectangular white opaque films in individual foil-foil sealed child resistant pouches. Individual films are identified by "4 mg" or "8 mg", according to the respective strengths, which is printed using pharmaceutical grade edible ink.Individual pouches of ZUPLENZ 4 mg oral soluble film are packaged in boxes of 30 (NDC 89141-444-30) and packaged in boxes of 1 (NDC 89141-444-01).Individual pouches of ZUPLENZ 8 mg oral soluble film are packaged in boxes of 30 (NDC 89141-448-30) and packaged in boxes of 1 (NDC 89141-448-01).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ondansetron is a selective 5-HT receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether ondansetron' s antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. In humans, urinary 5-HIAA (5-hydroxyindoleacetic acid) excretion increases after cisplatin administration in parallel with the onset of emesis. The released serotonin may stimulate the vagal afferents through the 5 HT receptors and initiate the vomiting reflex. In animals, the emetic response to cisplatin can be prevented by pretreatment with an inhibitor of serotonin synthesis, bilateral abdominal vagotomy and greater splanchnic nerve section, or pretreatment with a serotonin 5-HT receptor antagonist.
Non-Clinical Toxicology
The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.ZUPLENZ (ondansetron) oral soluble film is contraindicated for patients known to have hypersensitivity to the drug. Anaphylactic reactions have been reported in patients taking ondansetron.
Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided.
Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin.
Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT receptor antagonists. ZUPLENZ (ondansetron) oral soluble film should be discontinued immediately at the first sign of hypersensitivity.
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
516Total 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).