Rx Product News (November 2015)

Sunovion Pharmaceuticals, Inc

Indication: The FDA has expanded the use of Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures. Aptiom is also indicated for the treatment of partial-onset seizures as adjunctive therapy. For dosing guidelines, see the full prescribing information.

Dosage Form: Tablets: 200, 400, 600, and 800 mg

For More Information: aptiom.com

BrilintaMarketed by: AstraZeneca

Indication: The FDA has expanded the use of Brilinta (ticagrelor) in a 60-mg dose for patients with a history of heart attack. Brilinta is a P2Y12 platelet inhibitor indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. Treatment should be initiated with a 180-mg oral loading dose following an ACS event. Treatment should be continued with 90 mg twice daily during the first year after an ACS event. After 1 year, 60 mg should be administered twice daily. Brilinta should be used with a daily maintenance dose of aspirin of 75 to 100 mg.

Dosage Form: Tablets: 60 and 90 mg

For More Information: brilinta.com

TeflaroMarketed by: Actavis, Inc

Indication: The FDA has updated the label of Teflaro (ceftaroline fosamil) to show that the drug can now be administered by intravenous (IV) infusion in 5 minutes to 1 hour—a shorter infusion time than what was previously approved. Teflaro is approved by the FDA for the treatment of acute bacterial skin and skin structure infections, as well as community-acquired bacterial pneumonia requiring a shorter infusion time. The recommended dosage is 600 mg every 12 hours by IV infusion over a period of 5 to 60 minutes in adults 18 years and older.

Dosage Form: Injection: 600 mg or 400 mg of sterile ceftaroline fosamil powder in single-use 20-mL vials. The powder is constituted and further diluted for IV injection.

For More Information: teflaro.com

AddyiMarketed by: Valeant

Indication: The FDA has approved Addyi (flibanserin) for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to (1) a coexisting medical or psychiatric condition, (2) problems within the relationship, or (3) the effects of a medication or other drug substance. The recommended dosage is 100 mg taken once daily at bedtime.

Dosage Form: Tablets: 100 mg

For More Information: addyi.com