Zofran (Ondansetron Hydrochloride) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Zofran

Nausea and Vomiting »

Nausea and vomiting facts

Nausea and vomiting are symptoms of a disease or condition. The underlying cause of the illness causing nausea and vomiting should be identified and treated.
Nausea and vomiting symptom control is important both for comfort's sake and to prevent dehydration.
Dehydration can worsen nausea and vomiting.
Medication may be available to control symptoms of nausea and vomiting.

Introduction to nausea and vomiting

Nausea and vomiting are symptoms of an underlying illness and not a specific disease. Nausea is the sensation that the stomach wants to empty itself, while vomiting (emesis) or throwing up, is the act of forcible emptying of the stomach. The term "dry heaves" refers to an episode of vomiting where there is no food in the stomach to vomit, and only clear secretions are vomited.

Vomiting is a violent act in which the stomach almost...

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ZOFRAN®
(ondansetron hydrochloride) Tablets

ZOFRAN ODT®
(ondansetron) Orally Disintegrating Tablets

ZOFRAN®
(ondansetron hydrochloride) Oral Solution

DRUG DESCRIPTION

The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HC1) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT₃ receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-lH-imidazol-l-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:

ZOFRAN®
(ondansetron hydrochloride) Structural Formula Illustration

The empirical formula is C₁₈H₁₉N₃O•HCl•2H₂O, representing a molecular weight of 365.9.

Ondansetron HC1 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-HT₃ receptor type. Chemically it is (+) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-lH-imidazol-l-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:

ZOFRAN®
(ondansetron) Structural Formula Illustration

The empirical formula is C₁₈H₁₉N₃O representing a molecular weight of 293.4.

Each 4-mg ZOFRAN Tablet for oral administration contains ondansetron HC1 dihydrate equivalent to 4 mg of ondansetron. Each 8-mg ZOFRAN Tablet for oral administration contains ondansetron HC1 dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients lactose, microcrystalline cellulose, pregelatinized starch, hypromellose, magnesium stearate, titanium dioxide, triacetin, and iron oxide yellow (8-mg tablet only).

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 rapidly 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 HC1 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 are the possible side effects of ondansetron (Zofran, Zofran ODT)?

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.

Call your doctor at once if you have any of these serious side effects:

blurred vision or temporary blindness;
fever;
slow heart rate, trouble breathing;
anxiety, agitation, shivering;
feeling light-headed, fainting; or
urinating less than usual or not at all.

Less serious side...

Read All Potential Side Effects and See Pictures of Zofran »

What are the precautions when taking ondansetron hydrochloride (Zofran)?

Before taking ondansetron, tell your doctor or pharmacist if you are allergic to it; or to other serotonin blockers (e.g., granisetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, stomach/intestinal problems (e.g., recent abdominal surgery, ileus, swelling).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising...

Read All Potential Precautions of Zofran »

Last reviewed on RxList: 9/26/2011
This monograph has been modified to include the generic and brand name in many instances.