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ZOFRAN
Overview
What is ZOFRAN?
The active ingredient in ZOFRAN tablets and ZOFRAN oral solution is ondansetron hydrochloride as the dihydrate, 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, monohydrochloride, dihydrate. It has the following structural formula:
The empirical formula is CHNO•HCl•2HO, representing a molecular weight of 365.9.
Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline.
The active ingredient in ZOFRAN ODT orally disintegrating tablets 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. It has the following structural formula:
The empirical formula is CHNO representing a molecular weight of 293.4.
Each 4-mg ZOFRAN tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8-mg ZOFRAN tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients hypromellose, iron oxide yellow (8-mg tablet only), lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, triacetin, and titanium dioxide.
Each 4-mg ZOFRAN ODT orally disintegrating tablet for oral administration contains 4 mg ondansetron base. Each 8-mg ZOFRAN ODT orally disintegrating tablet for oral administration contains 8 mg ondansetron base. Each ZOFRAN ODT tablet also contains the inactive ingredients aspartame, gelatin, mannitol, methylparaben sodium, propylparaben sodium, and strawberry flavor. ZOFRAN ODT tablets are a freeze-dried, orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing.
Each 5 mL of ZOFRAN oral solution contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. ZOFRAN oral solution contains the inactive ingredients citric acid anhydrous, purified water, sodium benzoate, sodium citrate, sorbitol, and strawberry flavor.
What does ZOFRAN look like?
What are the available doses of ZOFRAN?
ZOFRAN tablets are oval, film-coated tablets engraved with “Zofran” on one side and are available in the following strengths:
ZOFRAN ODT orally disintegrating tablets are white, round, and plano-convex tablets available in the following strengths:
ZOFRAN oral solution, 4 mg/5 mL, is a clear, colorless to light yellow liquid with a characteristic strawberry odor available in a 50-mL bottle.
What should I talk to my health care provider before I take ZOFRAN?
How should I use ZOFRAN?
ZOFRAN is indicated for the prevention of nausea and vomiting associated with:
ZOFRAN is also indicated for the prevention of postoperative nausea and/or vomiting.
The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively.
Corresponding doses of ZOFRAN tablets, ZOFRAN ODT orally disintegrating tablets and ZOFRAN oral solution may be used interchangeably.
What interacts with ZOFRAN?
Sorry No Records found
What are the warnings of ZOFRAN?
Sorry No Records found
What are the precautions of ZOFRAN?
Sorry No Records found
What are the side effects of ZOFRAN?
Sorry No records found
What should I look out for while using ZOFRAN?
ZOFRAN is contraindicated in patients:
What might happen if I take too much ZOFRAN?
There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy.
In addition to the adverse reactions listed above, the following adverse reactions have been described in the setting of ondansetron overdose: “Sudden blindness” (amaurosis) of 2 to 3 minutes’ duration plus severe constipation occurred in one 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 ZOFRAN 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 adverse reactions resolved completely.
Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg per 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 ZOFRAN?
ZOFRAN TabletsZOFRAN ODT Orally Disintegrating TabletsZOFRAN Oral SolutionStore upright between 15°C and 30°C (59°F and 86°F). Protect from light. Store bottles upright in cartons.ZOFRAN TabletsZOFRAN ODT Orally Disintegrating TabletsZOFRAN Oral SolutionStore upright between 15°C and 30°C (59°F and 86°F). Protect from light. Store bottles upright in cartons.ZOFRAN TabletsZOFRAN ODT Orally Disintegrating TabletsZOFRAN Oral SolutionStore upright between 15°C and 30°C (59°F and 86°F). Protect from light. Store bottles upright in cartons.ZOFRAN TabletsZOFRAN ODT Orally Disintegrating TabletsZOFRAN Oral SolutionStore upright between 15°C and 30°C (59°F and 86°F). Protect from light. Store bottles upright in cartons.
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-hydroxyindoleacetic acid (5-HIAA) 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.
Non-Clinical Toxicology
ZOFRAN is contraindicated in patients:Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism , particularly when bactericidal activity is desired, this drug combination should be avoided.
In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT receptor antagonists. If hypersensitivity reactions occur, discontinue use of ZOFRAN; treat promptly per standard of care and monitor until signs and symptoms resolve
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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