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Zofran & Zuplenz Risks Anti-Nausea Drug Used During Pregnancy


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3.3.2017 | Jessica MacAdam
Zofran
Zofran & Zuplenz Risks Anti-Nausea Drug Used During Pregnancy

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The Zuplenz package insert also notes that for patients with severely impaired liver function, the total daily dose of Zuplenz should not exceed 8 mg.

Other Zofran generic equivalent products have been approved by the FDA and have been available in the U.S. 3. since 2006.

As stated in the package insert, the recommended adult oral dosage of Zofran for the prevention of nausea and vomiting associated with chemotherapy ranges from one 8 mg tablet or 10 mL of oral solution twice daily to three 8 mg tablets administered 30 minutes before the start of single-day chemotherapy, depending on the emetogenic potential (moderate or high, respectively) of the chemotherapy.

You should provide your physician a complete list of the medications you currently take or plan to begin taking; this list should include all of your prescription drugs plus all of your over-the-counter drugs, including vitamins and nutritional supplements. Your physician can l you about the risks and should therefore be consulted before you start taking more than one medication at a time.

Taking more than one medication at a time is sometimes necessary, however, there may be an elevated risk of certain side effects.

Zofran and Zuplenz have been used “off-label” for the treatment of nausea and vomiting associated with pregnancy, although the U.S. Food and Drug Administration (FDA) has not approved these drugs for this indication.

The package insert-recommended adult oral dosage of Zofran for the prevention of nausea and vomiting associated with cancer radiation therapy of a limited body area is one 8 mg tablet or 10 mL of oral solution thrice daily. For total body irradiation, the dosage is the same, except it should be administered one to two hours prior to each fraction of radiation therapy administered each day or – for single high-dose fraction radiotherapy to the abdomen – every eight hours after the first dose for one to two days, post-treatment.

According to its package insert, Zofran is indicated for the prevention of nausea and vomiting associated with surgery, chemotherapy, or cancer radiotherapy. 4 Zuplenz is approved for similar indications.

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Zofran and Zuplenz are prescription drugs used to treat nausea related to surgeries, cancer treatment and pregnancy. The drug has been prescribed for off-label uses despite the fact that there is a risk of side effects like serotonin syndrome and pregnancy risks.

These other medications include:. Certain medications used in combination with Zofran or Zuplenz can cause serotonin syndrome.

5. A separate dosing schedule is recommended for the intravenous formulation of Zofran for the prevention of nausea and vomiting associated with emetogenic chemotherapy.

For moderay emetogenic chemotherapy, one 8 mg film should be taken 30 minutes before, followed by an 8 mg film eight hours later and an additional film every 12 hours for a day or two after the conclusion of chemotherapy is recommended. 6. The Zuplenz package insert states that for highly emetogenic chemotherapy, the appropriate adult dose of Zuplenz are three 8 mg films taken 30 minutes before the commencement of chemotherapy.

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Zuplenz package insert, Galena Biopharma, http://zuplenz.com/pdf/Zuplenz-PI-long-version.pdf (accessed April 1, 2015). ↩.

Zofran package insert, GlaxoSmithKline, https://www.gsksource.com/gskprm/en/US/adirect/gskprm?cmd=ProductDetailPage&product_id= &featureKey=600624 (accessed April 1, 2015). ↩.

For postoperative nausea and vomiting, the appropriate Zuplenz dose is 16 mg, given as two 8 mg films 1 hour before the administration of anesthesia. For the prevention of nausea and vomiting associated with radiotherapy, the appropriate Zuplenz dose is one 8 mg film, taken three times a day.

Zuplenz is another formulation of ondansetron, manufactured by Galena Biopharma Inc. Zofran (ondansetron) is a prescription antiemetic medication taken orally or by injection to treat nausea and/or vomiting resulting from surgery, cancer chemotherapy, or cancer radiation therapy.

The package insert-recommended adult oral dosage of Zofran for the prevention of nausea and vomiting following surgery is 16 mg given as two 8 mg tablets or 20 mL of oral solution one hour before induction of anesthesia.

Zofran and Zuplenz have also been used “off-label” to prevent or treat symptoms of nausea and vomiting associated with pregnancy, commonly called morning sickness, although the U.S. Food and Drug Administration (FDA) has not approved these drugs for this indication.

“Generic Zofran Availability,” available at https://www.drugs.com/availability/generic-zofran.html (accessed April 1, 2015). ↩.

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The Zofran and Zuplenz package inserts contain several contraindications and warnings, summarized as follows:

Oregon State University College of Pharmacy (2003). ↩. “5-Hydroxytryptamine3 (5-HT3) Receptor Antagonists”.

Sanger GJ (September 2008). “5-hydroxytryptamine and the gastrointestinal tract: where next?” Trends in Pharmacological Sciences, Vol. 29:9, 465–71 (2008) (accessed April 1, 2015). ↩.

under the brand names Zofran and Zuplenz. The 5-HT3 receptor antagonist ondansetron is sold in the U.S. Zuplenz is available through prescription as an oral film that dissolves on the tongue. Zofran is available through prescription as an injection, oral tablet, orally disintegrating tablet and oral solution.

5-HT3 receptor antagonists such as Zofran and Zuplenz quell this emesis reflex by preventing serotonin from binding to the 5-HT3 receptors. 1 2. When serotonin binds to these receptors, the emesis reflex may be activated, resulting in feelings of nausea and the urge to vomit.

Zofran injection for intravenous use package insert, GlaxoSmithKline, https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Zofran_Injection/pdf/ZOFRAN-INJECTION.PDF (accessed April 1, 2015). ↩.

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These 5-HT3 receptors attract serotonin produced by the body in response to, for example, chemotherapy drugs. Zofran and Zuplenz are antiemetics known as 5-HT3 receptor antagonists that exhibit a strong affinity for only certain 5-HT3 receptors, such as those of the central nervous system’s afferent branches of the vagus nerve.

You should seek medical attention immediay if you experience serotonin syndrome symptoms, such as:. The package inserts that accompany Zofran and Zuplenz advises doctors to monitor patients for signs of serotonin syndrome.

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