"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
Chemotherapy-Induced Nausea And Vomiting
ALOXI is indicated for
- Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
- Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses
Postoperative Nausea And Vomiting
ALOXI is indicated for
- Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, ALOXI is recommended even where the incidence of postoperative nausea and/or vomiting is low.
DOSAGE AND ADMINISTRATION
Chemotherapy-Induced Nausea and Vomiting
Dosage for Adults – a single 0.25 mg I.V. dose administered over 30 seconds. Dosing should occur approximately 30 minutes before the start of chemotherapy.
Postoperative Nausea and Vomiting
Dosage for Adults - a single 0.075 mg I.V. dose administered over 10 seconds immediately before the induction of anesthesia.
Instructions For I.V. Administration
ALOXI is supplied ready for intravenous injection. ALOXI should not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of ALOXI.
Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.
Dosage Form And Strengths
ALOXI is supplied as a single-use sterile, clear, colorless solution in glass vials that provide:
- 0.25 mg (free base) per 5 mL
- 0.075 mg (free base) per 1.5 mL
Storage And Handling
NDC # 62856-797-01, ALOXI Injection 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton.
NDC # 62856-798-01, ALOXI Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials.
- Store at controlled temperature of 20–25°C (68°F–77°F).
- Excursions permitted to 15–30°C (59-86°F).
- Protect from freezing.
- Protect from light.
Mfd by: OSO Biopharmaceuticals, LLC, Albuquerque, NM, USA or Pierre Fabre, Médicament Production, Idron, Aquitaine, France and Helsinn Birex Pharmaceuticals, Dublin, Ireland, HELSINN, Mfd for Helsinn Healthcare SA, Switzerland Eisai Inc., Distributed and marketed by Eisai Inc., Woodcliff Lake, NJ 07677 under license of Helsinn Healthcare SA, SwitzerlandThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/18/2014
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