Zuplenz

Generic name: ondansetron (oral)
Brand names: Zofran, Zofran ODT, Zuplenz
Drug class: 5HT3 receptor antagonists

Medically reviewed by  A Ras MD.

What is Zuplenz?

Zuplenz is a prescription medicine that is used in adults to prevent nausea and vomiting that happens with certain cancer chemotherapy medicines, radiation therapy to your stomach-area (abdomen), or radiation therapy to your entire body that may happen after surgery.

In children 4 years of age and older, Zuplenz is only used to prevent nausea and vomiting that happens with certain cancer chemotherapy medicines.

It is not known if Zuplenz is safe and works in children to prevent nausea and vomiting with radiation therapy, nausea and vomiting that may happen after surgery in children, or nausea and vomiting associated with highly emetogenic cancer chemotherapy.

Description

ZUPLENZ (ondansetron) oral soluble film is a white opaque orally dissolving film designed to be applied on top of the tongue where it will dissolve in 4 to 20 seconds and then is swallowed with saliva.

ZUPLENZ does not require water to aid dissolution or swallowing.

The active ingredient in ZUPLENZ is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H -carbazol-4-one.

ZUPLENZ (ondansetron) Structural Formula Illustration

The empirical formula is C 18193O representing a molecular weight of 293.3. Each 4-mg ZUPLENZ oral soluble film for oral administration contains 4 mg ondansetron base. Each 8-mg ZUPLENZ oral soluble film for oral administration contains 8 mg ondansetron base. Each ZUPLENZ oral soluble film also contains the inactive ingredients butylated hydroxytoluene, calcium carbonate, colloidal silicon dioxide, erythritol, hypromellose, monoammonium glycyrrhizinate, peppermint flavor, polyethylene oxide, sodium bicarbonate, sucralose, titanium dioxide and xanthan gum.

 Mechanism of Action

Ondansetron is a selective 5-HT 3 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 3 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-HIAA (5-hydroxyindoleacetic acid) excretion increases after cisplatin administration in parallel with the onset of emesis. The released serotonin may stimulate the vagal afferents through the 5-HT 3 receptors and initiate the vomiting reflex. In animals, the emetic response to cisplatin can be prevented by pretreatment with an inhibitor of serotonin synthesis, bilateral abdominal vagotomy and greater splanchnic nerve section, or pretreatment with a serotonin 5-HT 3 receptor antagonist.

Who should not take Zuplenz?

Do not take Zuplenz if you:

  • have had an allergic reaction to ondansetron, the active ingredient in Zuplenz
  • take apomorphine hydrochloride (Apokyn, Kynmobi)

What should I tell my healthcare professional before taking Zuplenz?

Before you take Zuplenz, tell you doctor about all of your medical conditions, including if you:

  • have any heart problems, including a condition called “congenital long QT syndrome”. •
  • take a medicine that causes heart problems (QT prolongation).
  • have low blood levels of potassium or magnesium.
  • have liver problems.
  • have had recent stomach-area (abdomen) surgery.
  • are pregnant or plan to become pregnant. It is not known if Zuplenz will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Zuplenz passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Zuplenz works, and Zuplenz may affect how other medicines work. Taking Zuplenz with certain other medicines may cause serious side effects.

Especially tell your doctor if you take:

  • medicines called selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors (MAOIs). Ask your doctor if you are not sure if you take these medicines.
  • tramadol hydrochloride (Ultram, Ultram ER, Ryzolt, ConZip, Rybix ODT).
  • any other medicine for nausea and vomiting.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Zuplenz?

  • Read the Instructions for Use at the end of this Patient Information for information about the right way to take Zuplenz.
  • Take Zuplenz exactly as your doctor tells you to take it.
  • If you take too much Zuplenz, call your doctor or go to the nearest hospital emergency room right away.
  • An adult should help a young child use Zuplenz.

What should I avoid while taking Zuplenz?

Zuplenz may cause dizziness. Do not drive, operate machinery, or do other dangerous activities until you know how Zuplenz affects you.

What are the possible side effects of Zuplenz?

Zuplenz may cause serious side effects, including:

  • severe allergic reactions. Stop taking Zuplenz and get medical help right away if you have any of these signs or symptoms of an allergic reaction to Zuplenz:
    • fever
    • rash
    • hives
    • chills
    • itching
    • trouble breathing
    • chest tightness or chest pain
    • swelling of your mouth, face, lips, or tongue
  • heart rhythm changes. Zuplenz can cause a change in the electrical activity in your heart called QT prolongation, which can cause irregular heartbeats. Tell your doctor right away if you get any symptoms of heart rhythm changes such as feeling as if your heart is beating fast, irregular or slow, if you feel lightheaded or you faint.
  • serotonin syndrome. A possible life-threatening problem called serotonin syndrome can happen with medicines called 5-HT3 receptor antagonists, including Zuplenz, especially when used with medicines to treat migraine headaches and depression called selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and certain other medicines. Get medical help right away if you have any of these signs or symptoms of serotonin syndrome:
    • agitation
    • coma
    • dizziness
    • fever
    • muscle twitching
    • nausea
    • seeing things that are not there
    • rapid pulse
    • sweating
    • tremors
    • become unstable
    • vomiting
    • confusion
    • high or low blood pressure
    • flushing
    • stiff muscles
    • seizures
    • diarrhea
  • Zuplenz may make it more difficult to recognize the signs and symptoms of a blockage in the intestine (bowel obstruction) in people who have had stomach-area (abdomen) surgery or nausea and vomiting after chemotherapy. Tell your doctor right away if you have had stomach-area (abdomen) surgery or nausea and vomiting after chemotherapy and you have any signs or symptoms of a blockage in your intestine while taking Zuplenz, including: stomach pain or swelling of your stomach-area (abdomen).

The most common side effects of Zuplenz in adults include:

  • headache
  • tiredness and body discomfort
  • constipation
  • diarrhea
  • low oxygen in the blood (hypoxia)

These are not all the possible side effects of Zuplenz. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Zuplenz

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Zuplenz for a condition for which it was not prescribed. Do not give Zuplenz to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about Zuplenz that is written for health professionals.

How should I store Zuplenz?

  • Store Zuplenz at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Zuplenz in the foil pouch until ready to use. Keep foil pouches in the carton.
  • Use Zuplenz right after you take it out of the pouch.

Keep Zuplenz and all medicines out of the reach of children.

What are the ingredients in Zuplenz?

Active ingredient: ondansetron

Inactive ingredients: butylated hydroxytoluene, calcium carbonate, colloidal silicon dioxide, erythritol, hypromellose, monoammonium glycyrrhizinate, peppermint flavor, polyethylene oxide, sodium bicarbonate, sucralose, titanium dioxide and xanthan gum.

For more information call 1-877-394-5045.

Instructions for use for Zuplenz

ZUPLENZ®
(ZOO-plenz)
(ondansetron) Oral Soluble Film

Step 1. Keep the ZUPLENZ film in the foil pouch until ready to use. Use ZUPLENZ film right away after you take it out of the pouch.

Step 2. Make sure your hands are dry.

Step 3. Fold the pouch along the dotted line to expose the tear notch. See Figure A.

Figure A

Expose the tear notch - Illustration

 

Step 4. While still folded, tear the pouch carefully along the edge. See Figure B.

Figure B

Tear the pouch carefully along the edge - Illustration

 

Step 5. Take the ZUPLENZ film out of the pouch. See Figure C.

Figure C

Take the ZUPLENZ film out - Illustration

 

Step 6. Put the ZUPLENZ film on top of your tongue. It will dissolve in 4 to 20 seconds. See Figure D

Figure D

Put the ZUPLENZ film on top of your tongue - Illustration

 

Step 7. Do not chew or swallow the film whole.

Step 8. Swallow after the ZUPLENZ film dissolves. You may swallow the dissolved film with or without liquid.

Step 9. Wash your hands after taking ZUPLENZ.

How should I store ZUPLENZ?

  • Store ZUPLENZ at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep ZUPLENZ in the foil pouch until ready to use. Keep foil pouches in the carton.
  • Use ZUPLENZ right after you take it out of the pouch.

How should I store Zuplenz?

  • Store Zuplenz at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Zuplenz in the foil pouch until ready to use. Keep foil pouches in the carton.
  • Use Zuplenz right after you take it out of the pouch.

Keep Zuplenz and all medicines out of the reach of children.

Label

PRINCIPAL DISPLAY PANEL – 4 MG FILM POUCH BOX

 

  • NDC 89141-444-30
  • Zuplenz ®
    (ondansetron) oral soluble film
  • 4 mg
  • Rx only
  • 30 Films
PRINCIPAL DISPLAY PANEL - 4 mg Film Pouch Box

PRINCIPAL DISPLAY PANEL – 8 MG FILM POUCH BOX

 

  • NDC 89141-448-30
  • Zuplenz ®
    (ondansetron) oral soluble film
  • 8 mg
  • Rx only
  • 30 Films
PRINCIPAL DISPLAY PANEL - 8 mg Film Pouch Box

SRC: NLM .