Rx Product News

ZIOPTAN

Marketed by: Merck & Co, Inc (Whitehouse Station, NJ

Indication: The FDA recently approved Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free analogue ophthalmic solution. Zioptan is indicated for the reduction of intraocular eye pressure in patients with open-angle glaucoma or ocular hypertension. One drop of Zioptan should be instilled in the affected eye(s) once daily in the evening. Some patients may experience pigmentation of the iris, periorbital tissue, or eyelashes, as well as gradual changes to the eyelashes, including increased thickness, length, and number of lashes. Changes in iris pigmentation may be permanent.

Dosage Form: Ophthalmic solution: tafluprost 0.015 mg/mL

For More Information: http://zioptan.com

Nascobal

Marketed by: Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc (Woodcliff Lake, NJ)

Indication: Nascobal (Cyanocobalamin, USP) Nasal Spray has an updated National Drug Code (NDC). Pharmacists are encouraged to update their systems with the new NDC, which is now 49884-270-86. Nascobal Nasal Spray is indicated for the maintenance of normal hematologic status in patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement, as well as other vitamin B12 deficiencies. It is currently available in a 4-dose, 3-mL bottle.

Dosage Form: Nasal spray: 3-mL bottle (1.3 mL of solution)

For More Information: www.nascobal.com

VitaMedMD One Rx

Marketed by: TherapeuticsMD, Inc (Boca Raton, FL)

Indication: TherapeuticsMD, Inc announced the launch of vitaMedMD One Rx, a once-daily prescription prenatal vitamin for adult women who are pregnant or nursing. The dietary supplement contains 14 vitamins and minerals, including 30 mg of iron and 200 mg of plant-based docosahexaenoic acid. Each vitaMedMD One Rx softgel also contains 600 mcg of the patent-protected fourth-generation folate Quatrefolic, along with 400 mcg of folic acid. Patients should take one softgel daily with a meal.

How Supplied: Softgels: 30-count box

For More Information: www.vitamedmdrx.com

QNASL

Marketed by: Teva Respiratory, LLC, a subsidiary of Teva Pharmaceutical Industries Ltd (Horsham, PA)

Indication: The FDA approved QNASL (beclomethasone dipropionate) Nasal Aerosol, the first nonaqueous corticosteroid nasal aerosol for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years and older. The recommended dose of QNASL Nasal Aerosol is 320 mcg per day, which is administered as 2 intranasal sprays in each nostril once daily. QNASL Nasal Aerosol has a built-in dose counter.

Dosage Form: Nasal aerosol: 80 mcg beclomethasone dipropionate per actuation; 120 actuations per 8.7-g canister

For More Information: http://qnasl.com

Binosto

Marketed by: Mission Pharmacal (San Antonio, TX)

Indication: Mission Pharmacal announced that it entered into a patent and technology licensing agreement with EffRx Pharmacueticals SA to manufacture and commercialize Binosto (alendronate sodium) Effervescent Tablets in the United States and Canada. Binosto is FDA-approved for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. Binosto is a once-weekly, strawberry flavored effervescent tablet that can be dissolved in 4 oz of plain water. It is available in packages of 4 and 12 tablets.

Dosage Form: Effervescent tablets: alendronate 70 mg

For More Information: www.missionpharmacal.com

Sklice

Marketed by: Sanofi Pasteur Inc (Swiftwater, PA)

Indication: Sanofi announced that the FDA approved Sklice (ivermectin) Lotion, 0.5% for the topical treatment of head lice in patients 6 months and older. Patients should apply enough Sklice Lotion to dry hair to thoroughly coat the hair and scalp. After 10 minutes, the product should be rinsed off with water. Sklice is supplied in a 4-oz, single-use laminate tube and any unused portion should be discarded. In pediatric patients, Sklice should be administered only under direct adult supervision to reduce the risk of accidental ingestion.

Dosage Form: Lotion: 0.5%

For More Information: www.sanofipasteur.us

Afinitor

Marketed by: Novartis Pharmaceuticals (East Hanover, NJ)

Indication: The FDA approved Afinitor (everolimus) tablets for the treatment of adult patients with renal angiomyolipomas and tuberous sclerosis complex who do not require immediate surgery. This is the first medication approval for this population. For the new indication, the dosage is 10 mg once daily with or without food. Dosage reductions are required in patients with hepatic impairment and for patients taking moderate inhibitors of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein. For concomitant use with strong CYP3A4 inducers, dosage increases are required.

Dosage Form: Tablets: 2.5, 5, 7.5, and 10 mg

For More Information: www.afinitor.com/index.jsp

Dutoprol

Marketed by: AstraZeneca Pharmaceuticals LP (Wilmington, DE)

Indication: AstraZeneca announced the availability of Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) tablets, a combination product that is FDA approved for the treatment of hypertension. Dutoprol, which combines the beta-blocker metroprolol succinate with the diuretic hydrochlorothiazide, can be administered with other antihypertensive agents, and is taken once daily with or without food. Dosing should be individualized and take into account baseline and target blood pressure measurements, as well as experience with the product’s individual components.

Dosage Form: Tablets (metoprolol succinate extended release/hydrochlorothiazide): 25/12.5, 50/12.5, and 100/12.5 mg

For More Information: www.dutoprol.com