Zuplenz

What is Zuplenz?

Zuplenz (Ondansetron) is a 5-HT3 receptor antagonist medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.

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What are the uses of this medicine?

Zuplenz (Ondansetron) 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, or nausea and vomiting that may happen after surgery in children.

How does this medicine work?

• 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.
• 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 Use this medicine ?

This medicine cannot be used in patients who:

• take apomorphine hydrochloride (Apokyn)
• have had an allergic reaction to ZUPLENZ or are allergic to any of its ingredients

What drug interactions can this medicine cause?

• The concomitant use of apomorphine with ondansetron is contraindicated.

Is this medicine FDA approved?

• Initial U.S. Approval: 1991

How should this medicine be used?

Recommended dosage: Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy: The adult oral dosage is 24 mg given successively as three 8 mg films administered 30 minutes before the start of chemotherapy.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

• Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

Pediatric patients 4 through 11 years of age:

• One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

Prevention of nausea and vomiting associated with radiotherapy:

• The adult dosage is one 8 mg film three times a day.

Postoperative nausea and vomiting:

• The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

Administration:

• 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 4 mg and 8 mg oral soluble film.

This medicine is available in fallowing brand namesː

• ZUPLENZ

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• tiredness and body discomfort
• constipation
• diarrhea

ZUPLENZ may cause serious side effects, including:

• severe allergic reactions
• heart rhythm changes

What special precautions should I follow?

• ZUPLENZ may cause dizziness. Do not drive, operate machinery, or do other dangerous activities until you know how ZUPLENZ affects you.
• Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
• Avoid ZUPLENZ in patients with congenital long QT syndrome. Monitor ECG 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.
• 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.
• Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue Zuplenz and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if Zuplenz is used concomitantly with other serotonergic drugs.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Sudden blindness (amaurosis)
• severe constipation
• Hypotension
• serotonin syndrome
• somnolence
• agitation
• tachycardia
• tachypnea
• hypertension
• flushing
• mydriasis
• diaphoresis
• myoclonic movements
• horizontal nystagmus
• hyperreflexia
• seizure

Management of overdosage:

• There is no specific antidote for ondansetron overdose.
• Patients should be managed with appropriate supportive therapy.

Can this medicine be used in pregnancy?

• ZUPLENZ (ondansetron) oral soluble film should be used during pregnancy only if clearly needed.
• There are, however, no adequate and well- controlled studies in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness in pediatric patients have not been established for the following indications: prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, prevention of nausea and vomiting associated with radiotherapy, and prevention of postoperative nausea and/or vomiting.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

• Manufactured by:

Aquestive Therapeutics Warren, NJ

• Distributed by:

Fortovia Therapeutics Inc. Raleigh, NC

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Zuplenz
• FDA Zuplenz

Zuplenz Resources
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