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Zofran

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Zofran

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 (HCl) 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-1H-imidazol-1-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 HCl 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-1H-imidazol-1-yl)methyl]-4Hcarbazol- 4-one. It has the following structural formula:

ZOFRAN® (ondansetron hydrochloride) 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 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).

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 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.

What are the possible side effects of ondansetron (Zofran, Zofran ODT, Zuplenz)?

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 a serious side effect such as:

  • blurred vision or temporary vision loss (lasting from only a few minutes to several hours);
  • severe dizziness, feeling short of breath, fainting, fast or pounding heartbeats;
  • slow heart rate, trouble breathing;
  • anxiety, agitation, shivering;
  • feeling like you might pass out; or
  • urinating...

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: irregular heartbeat, liver disease, stomach/intestinal problems (e.g., recent abdominal surgery, ileus, swelling).

Ondansetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical...

Read All Potential Precautions of Zofran »

Last reviewed on RxList: 11/7/2014
This monograph has been modified to include the generic and brand name in many instances.

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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.


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