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5.5.2017 | Jessica MacAdam
Zofran
Zofran (Ondansetron Hydrochloride Tablets and Solution) Side

The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.

ZOFRAN ODT Orally Disintegrating Tablets: Manufactured for : GlaxoSmithKline, Research Triangle Park, NC 27709. September 2014. GlaxoSmithKline, Research Triangle Park, NC 27709. ZOFRAN Tablets and Oral Solution: GlaxoSmithKline, Research Triangle Park, NC 27709. by Catalent UK Swindon Zydis Ltd., Blagrove, Swindon, Wiltshire, UK SN5 8RU.

The empirical formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.9.

For daily fractionated radiotherapy to the abdomen, one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

The recommended oral dosage is one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given 3 times a day.

Pediatric Use : There is no experience with the use of ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN Oral Solution in the prevention of radiation -induced nausea and vomiting in pediatric patients.

ZOFRAN Tablets, 8 mg (ondansetron HCl dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets engraved with “Zofran” on one side and “8” on the other in daily unit dose packs of 3 tablets ( NDC, and bottles of 30 tablets ( NDC.

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). On the basis of available data, no dosage adjustment is recommended for patients on these drugs. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron.

ZOFRAN ODT Orally Disintegrating Tablets, 8 mg (as 8 mg ondansetron base) are white, round and plano-convex tablets debossed with a “Z8” on one side in unit dose packs of 30 tablets ( NDC.

The most frequently reported adverse events were headache, constipation, and diarrhea. The adverse events reported in patients receiving ZOFRAN Tablets and concurrent radiotherapy were similar to those reported in patients receiving ZOFRAN Tablets and concurrent chemotherapy.

Skin: Urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, concomitant use of apomorphine with ondansetron is contraindicated (see CONTRAINDICATIONS ).

Special Senses: Eye Disorders: Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.

Neurology: Oculogyric crisis, appearing alone, as well as with other dystonic reactions.

Pediatric Use : There is no experience with the use of ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN Oral Solution in the prevention of postoperative nausea and vomiting in pediatric patients.

Unit Dose Packs: Store between 2° and 30°C (36° and 86°F).

However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs.1,3. In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased.

Protect from light. Store upright between 15° and 30°C (59° and 86°F). Store bottles upright in cartons.

For total body irradiation, one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ZOFRAN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of oral formulations of ZOFRAN.

Each 5 mL of ZOFRAN Oral Solution contains 5 mg of ondansetron HCl 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.

One 4-mg ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN Oral Solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. Pediatric Use : For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN Oral Solution given 3 times a day.

Table 5: Principal Adverse Events in US Trials: Single Day Therapy With 24-mg ZOFRAN Tablets (Highly Emetogenic Chemotherapy) Event Ondansetron 24 mg q.d. n = 117 Headache 33 (11%) 16 (13%) 17 (15%) Diarrhea 13 (4%) 9 (7%) 3 (3%). n = 300 Ondansetron 8 mg b.i.d. n = 124 Ondansetron 32 mg q.d.

The recommended dosage is 16 mg given as two 8-mg ZOFRAN Tablets or two 8-mg ZOFRAN ODT Tablets or 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ZOFRAN Oral Solution 1 hour before induction of anesthesia.

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

The empirical formula is C 18 H 19 N 3 O representing a molecular weight of 293.4.

ECG changes including QT interval prolongation has been seen in patients receiving ondansetron. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia ), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation. Avoid ZOFRAN in patients with congenital long QT syndrome. In addition, post-marketing cases of Torsade de Pointes have been reported in patients using ondansetron.

ZOFRAN (ondansetron hydrochloride) Oral Solution.

Geriatric Use : The dosage recommendation is the same as for the general population.

The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. It has the following structural formula:. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3- -4H-carbazol-4-one, monohydrochloride, dihydrate.

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Do not attempt to push ZOFRAN ODT Tablets through the foil backing. Administration with liquid is not necessary. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIAY place the ZOFRAN ODT Tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva.

Geriatric Use : The dosage recommendation is the same as for the general population.

Store between 2° and 30°C (36° and 86°F).

The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of ZOFRAN. A causal relationship to therapy with ZOFRAN has been unclear in many cases.

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 rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. 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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Dispense in tight, lightresistant container as defined in the USP. Store between 2° and 30°C (36° and 86°F). Protect from light.

Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol.4,5.

Call your doctor at once if you have a serious side effect such as:

Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported. General: Flushing.

Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline.

In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. Tumor response to chemotherapy in the P-388 mouse leukemia model is not affected by ondansetron.

There is no experience beyond first-day administration of ondansetron. The dosage recommendation is the same as for the general population.

These patients were receiving concurrent moderay emetogenic chemotherapy, primarily cyclophosphamide-based regimens. The adverse events in Table 6 have been reported in ≥ 5% of adults receiving either 8 mg of ZOFRAN Tablets 2 or 3 times a day for 3 days or placebo in 4 trials.

The recommended adult oral dosage is one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given twice a day. One 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose.

Cardiovascular: Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported.

ZOFRAN ODT (ondansetron) Orally Disintegrating Tablets.

These patients were receiving multiple concomitant perioperative and postoperative medications. The adverse events in Table 7 have been reported in ≥ 5% of patients receiving ZOFRAN Tablets at a dosage of 16 mg orally in clinical trials. With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups.

ZOFRAN (ondansetron hydrochloride) Tablets.

Hepatobiliary: Liver enzyme abnormalities Lower Respiratory: Hiccups.

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post- anesthesia care unit or an infusion center. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of ZOFRAN alone has also been reported.

Integumentary: Rash has occurred in approximay 1% of patients receiving ondansetron.

Table 7: Frequency of Adverse Events From Controlled Studies With ZOFRAN Tablets (Postoperative Nausea and Vomiting) Adverse Event Ondansetron 16 mg (n = 550) Placebo (n = 531) Wound problem 152 (28%) 162 (31%) Drowsiness/sedation 112 (20%) 122 (23%) Headache 49 (9%) 27 (5%) Hypoxia 49 (9%) 35 (7%) Pyrexia 45 (8%) 34 (6%) Dizziness 36 (7%) 34 (6%) Gynecological disorder 36 (7%) 33 (6%) Anxiety/agitation 33 (6%) 29 (5%) Bradycardia 32 (6%) 30 (6%) Shiver(s) 28 (5%) 30 (6%) Urinary retention 28 (5%) 18 (3%) Hypotension 27 (5%) 32 (6%) Pruritus 27 (5%) 20 (4%).

Central Nervous System: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron.

Each 4-mg ZOFRAN Tablet for oral administration contains ondansetron HCl dehydrate equivalent to 4 mg of ondansetron. Each 8-mg ZOFRAN Tablet for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains theinactive ingredients lactose, microcrystalline cellulose, pregelatinized starch, hypromellose, magnesium stearate, titanium dioxide, triacetin, and iron oxide yellow (8-mg tablet only).

ZOFRAN Tablets, 4 mg (ondansetron HCl dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with “Zofran” on one side and “4” on the other in bottles of 30 tablets ( NDC.

Preliminary observations in a small number of subjects suggest a higher incidence of headache when ZOFRAN ODT Orally Disintegrating Tablets are taken with water, when compared to without water.

Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) (see WARNINGS ).

It should not be used instead of nasogastric suction. The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy -induced nausea and vomiting may mask a progressive ileus and/or gastric distension. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis.

Table 6: Principal Adverse Events in US Trials: 3 Days of Therapy With 8-mg ZOFRAN Tablets (Moderay Emetogenic Chemotherapy) Event Ondansetron 8 mg b.i.d. n = 415 Placebo n = 262 Headache 58 (24%) 113 (27%) 34 (13%) Malaise/fatigue 32 (13%) 37 (9%) 6 (2%) Constipation 22 (9%) 26 (6%) 1 ( < 1%) Diarrhea 15 (6%) 16 (4%) 10 (4%) Dizziness 13 (5%) 18 (4%) 12 (5%). n = 242 Ondansetron 8 mg t.i.d.

The etiology of the liver failure is unclear. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics.

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Multiday, single-dose administration of a 24 mg dosage has not been studied. The recommended adult oral dosage of ZOFRAN is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m.

Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

The role of cancer chemotherapy in these biochemical changes cannot be clearly determined. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. The increases were transient and did not appear to be related to dose or duration of therapy. Hepatic: In 723 patients receiving cyclophosphamide-based chemotherapy in US clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximay 1% to 2% of patients receiving ZOFRAN Tablets.

The adverse events in Table 5 have been reported in ≥ 5% of adult patients receiving a single 24-mg ZOFRAN Tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin -based chemotherapy regimens (cisplatin dose ≥ 50 mg/m ).

If symptoms of serotonin syndrome occur, discontinue ZOFRAN and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ZOFRAN is used concomitantly with other serotonergic drugs (see PRECAUTIONS and OVERDOSAGE ). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ZOFRAN and other serotonergic drugs. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia ), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

It has the following structural formula:. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3--4Hcarbazol- 4-one. 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-HT3 receptor type.

Geriatric Use : The dosage is the same as for the general population.

Except for bronchospasm and anaphylaxis, the relationship to ZOFRAN was unclear. Other: Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported.

Bottles: Store between 2° and 30°C (36° and 86°F). Dispense in tight container as defined in the USP.

ZOFRAN Oral Solution, a clear, colorless to light yellow liquid with a characteristic strawberry odor, contains 5 mg of ondansetron HCl dihydrate equivalent to 4 mg of ondansetron per 5 mL in amber glass bottles of 50 mL with child-resistant closures ( NDC.

ZOFRAN ODT Orally Disintegrating Tablets, 4 mg (as 4 mg ondansetron base) are white, round and plano-convex tablets debossed with a“Z4” on one side in unit dose packs of 30 tablets ( NDC.

Geriatric Use : The dosage is the same as for the general population.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Pediatric Use : There is no experience with the use of a 24 mg dosage in pediatric patients.

In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate.

For single high-dose fraction radiotherapy to the abdomen, one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

Zofran