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FDA Approves Third Drug In BD Simplist™ Prefilled Injectable Line Of Products

Stocks in this article: BDX

BD Rx plans to launch 20 to 30 drugs in its BD Simplist line of products during the next few years and is targeting generic injectables in doses most commonly relied on by clinicians in both the hospital and surgical center settings.

About Ondansetron Injection, USP 4mg/2mL (2mg/mL) INDICATIONS Ondansetron Injection is a 5-HT 3 receptor antagonist indicated for: Prevention of nausea and/or vomiting postoperatively and with initial and repeat courses of emetogenic cancer chemotherapy.

IMPORTANT SAFETY INFORMATION Ondansetron Injection is contraindicated in patients know to have hypersensitivity (e.g. anaphylaxis) to this product or any of its components and in the concomitant use of apomorphine.

Hypersensitivity reactions including anaphylaxis and bronchospasm have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.  QT prolongation occurs in a dose-dependent manner.  Torsades de Pointes have been reported.  Avoid Ondansetron in patients with congenital long QT syndrome.  Use in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention.

The most common adverse reactions in adults are headache, diarrhea and fever.  In pediatric patients (ages 1 to 24 months), the most common adverse reaction is diarrhea.

For additional important safety information, please see the Ondansetron full prescribing information.

About Metoclopramide Injection, USP INDICATIONS AND USAGE Metoclopramide Injection, USP is indicated for:

  • the relief of symptoms associated with acute and recurrent diabetic gastric stasis
  • prophylaxis of vomiting associated with emetogenic cancer chemotherapy
  • the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.

Metoclopramide Injection, USP also may be used to:

  • facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers
  • stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.

IMPORTANT SAFETY INFORMATION

  • Metoclopramide treatment can cause tardive dyskinesia, a serious movement disorder that is often irreversible. Therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. Treatment for longer than 12 weeks should be avoided in all but rare cases.
  • Metoclopramide is contraindicated whenever stimulation of gastrointestinal motility might be dangerous; in patients with pheochromocytoma; in patients with epilepsy or taking drugs which are likely to cause extrapyramidal reactions; or patients with known sensitivity or intolerance to the drug.
  • Metoclopramide can cause serious side effects including abnormal muscle movements, uncontrolled spasms of the face and neck muscles, or muscles of the body, arms, and legs, depression, thoughts of suicide, and suicide, and rarely but serious Neuroleptic Malignant Syndrome and Parkinsonism.
  • The most common side effects of Metoclopramide Injection include feeling restless, sleepy, tired, dizzy, or exhausted, headache, confusion and trouble sleeping.

For additional Important Safety Information, please see the metoclopramide full prescribing information including BOXED WARNINGS and Medication Guide.

About Diphenhydramine Hydrochloride Injection, USP INDICATIONS AND USAGE Diphenhydramine Hydrochloride Injection, USP is effective in adults and pediatric patients, other than premature infants and neonates, when diphenhydramine hydrochloride in the oral form is impractical.

For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For active treatment of motion sickness and for use in parkinsonism, when oral therapy is impossible or contraindicated in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

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