Rx Product News

Published Online: Monday, June 13, 2011
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Tradjenta

Marketed by:

Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, CT) and Eli Lilly and Co (Indianapolis, IN)

Indication:

Tradjenta (linagliptin) was approved by the FDA as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Tradjenta is available in 5-mg tablets and is the first and only dipeptidyl peptidase-4 inhibitor approved with 1 dosage strength. Tradjenta is not to be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, and has not been studied in combination with insulin. The recommended dose is 5 mg once daily, taken with or without food. No dosing adjustments are necessary for patients with renal or hepatic impairment.

Dosage Form:

Tablets: 5 mg

For More Information:

www.tradjenta.com

Duexis

Marketed by:

Horizon Pharma (Northbrook, IL)

Indication:

The FDA approved Duexis (ibuprofen and famotidine) tablets for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of the development of an upper gastrointestinal ulcer in patients taking ibuprofen for those indications. Duexis is a fixed-dose combination of the nonsteroidal anti-inflammatory drug ibuprofen and the histamine 2 -receptor antagonist famotidine. The recommended dose is 1 tablet taken 3 times daily. Duexis carries a boxed warning for the risk of serious cardiovascular and gastrointestinal events.

Dosage Form:

Tablets: ibuprofen 800 mg and famotidine 26.6 mg

For More Information:

www.duexis.com

Sylatron

Marketed by:

Merck & Co Inc (Whitehouse Station, NJ)

Indication:

Merck announced the FDA approval of Sylatron (peginterferon alfa-2b) for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. It is a once-weekly subcutaneous injection that can be self-administered. Patients should premedicate with 500 to 1000 mg of acetaminophen orally 30 min prior to the first dose and as needed for subsequent doses. Sylatron is administered at 6 mcg/kg/week subcutaneously for 8 weeks followed by 3 mcg/kg/week subcutaneously for up to 5 years.

Dosage Form:

Subcutaneous injection: 296, 444, and 888 mcg lyophilized powder per single-use vial

For More Information:

www.merck.com

Horizant

Marketed by:

GlaxoSmithKline (Research Triangle Park, NC) and XenoPort, Inc (Santa Clara, CA)

Indication:

The FDA approved Horizant (gabapentin enacarbil) extended-release tablets for the treatment of moderate-to-severe primary restless legs syndrome in adults. Horizant is not recommended for patients whose schedules require them to sleep during the day and remain awake at night. Horizant is not interchangeable with other gabapentin products. The recommended dose of Horizant is 600 mg once daily taken at about 5 pm with food. Patients should swallow the tablets whole and not chew, cut, or crush them.

Dosage Form:

Extended-release tablets: 600 mg

For More Information:

www.horizant.com

Cuvposa

Marketed by:

Shionogi Inc (Florham Park, NJ)

Indication:

The FDA approved Cuvposa (glycopyrrolate) oral solution, an anticholinergic agent indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling, such as cerebral palsy. Dosing should begin at 0.02 mg/ kg 3 times daily and be titrated in increments of 0.02 mg/kg every 5 to 7 days, depending on therapeutic response and adverse reactions. The maximum recommended dose is 0.1 mg/kg 3 times daily. Cuvposa is available as a clear, cherry-flavored oral solution that should be administered 1 hour before or 2 hours after meals.

Dosage Form:

Oral solution: 16-oz bottles containing 1 mg/5 mL

For More Information:

www.cuvposa.com

Xifaxan

Marketed by:

Salix Pharmaceuticals Inc (Morrisville, NC)

Indication:

Xifaxan (rifaximin) tablets have been approved by the FDA for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years and older. It was previously approved for patients 12 years and older with travelers’ diarrhea caused by noninvasive strains of Escherichia coli. HE is a worsening of brain function that can occur in patients with livers that can no longer remove toxins, such as ammonia, from the blood. The dosage of Xifaxan for HE is one 550-mg tablet taken orally 2 times daily, with or without food.

Dosage Form:

Tablets: 200 and 550 mg

For More Information:

www.xifaxan550.com

Afinitor

Marketed by:

Novartis Pharmaceuticals (East Hanover, NJ)

Indication:

Novartis announced the FDA approval of Afinitor (everolimus) tablets for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced, or metastatic. Afinitor is the first drug approved for this patient population in 30 years. The drug was previously approved for advanced renal cell carcinoma after failure of sunitinib or sorafenib therapy and subependymal giant cell astrocystoma associated with tuberous sclerosis. The recommended dose for PNET is 10 mg once daily with or without food.

Dosage Form:

Tablets: 2.5, 5, and 10 mg

For More Information:

www.afinitor.com

Invega

Marketed by:

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals Inc (Titusville, NJ)

Indication:

The FDA has approved Invega (paliperidone) extended-release tablets for the treatment of schizophrenia in adolescents aged 12 to 17 years. Invega was previously approved for the treatment of schizophrenia in adults and as monotherapy or an adjunct to mood stabilizers and/or antidepressants for the treatment of schizoaffective disorder. The recommended dose for adolescents is 3 to 6 mg/day for those weighing less than 51 kg and 3 to 12 mg/day for those weighing more than 51 kg. Tablets should be swallowed whole and should not be chewed, divided, or crushed.

Dosage Form:

Extended-release tablets: 1.5, 3, 6, and 9 mg

For More Information:

www.invega.com



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