Zofran ODT

Name: Zofran ODT

Zofran ODT Drug Class

Zofran ODT is part of the drug class:

  • Serotonin 5HT3 antagonists

Inform MD

Before taking Zofran ODT, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • or anyone in your family has or has ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death)
  • have heart disease
  • have liver disease
  • have an electrolyte imbalance
  • have phenylketonuria (PKU). PKU is an inherited condition in which a special diet must be followed to prevent mental retardation. The orally disintegrating tablets (Zofran ODT) contain aspartame that forms phenylalanine.
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Zofran ODT and Lactation

It is not known if Zofran ODT crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Zofran ODT.

Zofran ODT Overdose

If you take too much Zofran, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Other Requirements

Keep this and all medications out of the reach of children.

How is this medicine (Zofran ODT) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • If the tablets come in a foil blister, do not push the tablet out of the foil when opening. Use dry hands to take it from the foil.
  • Open right before use.
  • Place on your tongue and let it melt. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.

What do I do if I miss a dose?

  • If you take Zofran ODT on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some other side effects of Zofran ODT?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Feeling sleepy.
  • Anxiety.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Patient Counseling Information

QT Prolongation

Inform patients that ZOFRAN may cause serious cardiac arrhythmias such as QT prolongation. Instruct patients to tell their healthcare provider right away if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode.

Hypersensitivity Reactions

Inform patients that ZOFRAN may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. Instruct patients to immediately report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems to their healthcare provider.

Masking of Progressive Ileus and Gastric Distension

Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that ZOFRAN may mask signs and symptoms of bowel obstruction. Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider.

Drug Interactions

• Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider. Concomitant use of apomorphine and ZOFRAN may cause a significant drop in blood pressure and loss of consciousness. • Advise patients of the possibility of serotonin syndrome with concomitant use of ZOFRAN and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.

Administration of Zofran ODT Orally Disintegrating Tablets

Instruct patients not to remove Zofran ODT tablets from the blister until just prior to dosing.

• Do not attempt to push Zofran ODT tablets through the foil backing. • With dry hands, peel back the foil backing of 1 blister and gently remove the tablet. • Immediately place the Zofran ODT tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. • Administration with liquid is not necessary. • Peelable illustrated stickers are affixed to the product carton that can be provided with the prescription to ensure proper use and handling of the product.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

T2017-90
August 2017

PRINCIPAL DISPLAY PANEL

NDC 0078-0679-19

Zofran ODT®

(ondansetron)

Orally Disintegrating Tablets

4 mg

Each tablet contains 4 mg ondansetron base.

Store between 2o and 30oC (36o and 86oF).

Do not use if blisters are torn, broken, or missing.

Phenylketonurics: Contains phenylalanine.

See package insert for Dosage and Administration.

Rx only

30 Tablets (3 blistercards each containing 10 tablets)

Novartis

PRINCIPAL DISPLAY PANEL

NDC 0078-0680-19

Zofran ODT®

(ondansetron)

Orally Disintegrating Tablets

8 mg

Each tablet contains 8 mg ondansetron base.

Store between 2o and 30oC (36o and 86oF).

Do not use if blisters are torn, broken, or missing.

Phenylketonurics: Contains phenylalanine.

See package insert for Dosage and Administration.

Rx only

30 Tablets (3 blistercards each containing 10 tablets)

Novartis

ZOFRAN  ODT
ondansetron hydrochloride tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0679
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON (ONDANSETRON) ONDANSETRON 4 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME  
GELATIN  
MANNITOL  
METHYLPARABEN SODIUM  
PROPYLPARABEN SODIUM  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 14mm
Flavor STRAWBERRY Imprint Code Z4
Contains     
Packaging
# Item Code Package Description
1 NDC:0078-0679-19 30 BLISTER PACK in 1 BOX, UNIT-DOSE
1 NDC:0078-0679-61 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020781 08/23/2017
ZOFRAN  ODT
ondansetron hydrochloride tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0680
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON (ONDANSETRON) ONDANSETRON 8 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME  
GELATIN  
MANNITOL  
METHYLPARABEN SODIUM  
PROPYLPARABEN SODIUM  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 14mm
Flavor STRAWBERRY Imprint Code Z8
Contains     
Packaging
# Item Code Package Description
1 NDC:0078-0680-19 30 BLISTER PACK in 1 BOX, UNIT-DOSE
1 NDC:0078-0680-61 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020781 08/23/2017
Labeler - Novartis Pharmaceuticals Corporation (002147023)
Revised: 08/2017   Novartis Pharmaceuticals Corporation
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