Rx Product News (August 2015)

Pernix Therapeutics

Indication: The FDA has approved Treximet, a combination of sumatriptan (a serotonin receptor agonist) and naproxen sodium (a nonsteroidal antiinflammatory drug) for the acute treatment of migraine with or without aura in pediatric patients aged 12 to 17 years. The drug was previously indicated exclusively for adults. The recommended dose for patients aged 12 to 17 years is one 10/60-mg tablet, and the maximum dose in a 24-hour period is one 85/500-mg tablet.

Dosage Form: Tablets: 10/60 and 85/500 mg

For More Information: www.treximet.com

PromactaMarketed by: Novartis

Indication: The FDA has approved Promacta (eltrombopag), a thrombopoietin receptor agonist, for the treatment of chronic immune thrombocytopenia (ITP) in pediatric patients 6 years and older who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The drug was previously indicated for this purpose exclusively in adults. The recommended starting dose for pediatric patients with ITP is 50 mg orally once daily on an empty stomach.

Dosage Form: Tablets: 12.5, 25, 50, 75, and 100 mg

For More Information: www.promacta.com

NamzaricMarketed by: Actavis, Inc

Indication: The FDA has approved Namzaric, a combination of memantine hydrochloride extended-release (an NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor) for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on:

• Memantine hydrochloride 10 mg twice daily or 28-mg extendedrelease once daily and donepezil hydrochloride 10 mg; or

• Memantine hydrochloride 5 mg twice daily or 14-mg extendedrelease once daily and donepezil hydrochloride 10 mg.

Dosage Form: Capsules: 14/10 and 28/10 mg

For More Information: www.namzaric.com

Invega TrinzaMarketed by: Janssen Pharmaceuticals

Indication: The FDA has approved Invega Trinza (paliperidone palmitate), an atypical antipsychotic, for the treatment of schizophrenia. The drug should be administered by a health care professional as an intramuscular injection once every 3 months. Invega Trinza should only be used by patients who have been adequately treated with 1-month paliperidone palmitate (Invega Sustenna) for at least 4 months.

Dosage Form: Extended-release injectable suspension: 273, 410, 546, and 819 mg

For More Information: www.invegatrinza.com