Availability: Welchol is available by prescription.
Product: Repaglinide and metformin (PrandiMet)
Manufacturer: Novo Nordisk Inc.
(800) 727-6500
www.prandimet.com
What it does: PrandiMet combines the diabetes drugs repaglinide and metformin into a single tablet to be used, in addition to a healthful diet and exercise, for blood glucose control in people with Type 2 diabetes. Repaglinide is sold under the brand name Prandin and works by stimulating the pancreas to release insulin in response to a meal. Metformin is sold as Glucophage, Glucophage XR, Riomet, and Glumetza, as well as in generic forms, and works by increasing insulin sensitivity in the body and decreasing the amount of glucose produced by the liver.
PrandiMet tablets are available in strengths of 1 milligram/500 milligrams and 2 milligrams/500 milligrams of Prandin and metformin, respectively. Tablets should be taken two to three times daily with meals, up to a maximum dose of 4 milligrams/1,000 milligrams per meal or 10 milligrams/2,500 milligrams per day.
Kidney function should be assessed before starting the medicine and at least annually thereafter. People with kidney impairment or metabolic acidosis (a condition in which the blood becomes excessively acidic), as well as those taking gemfibrozil (Lopid) and itraconazole (Sporanox), should not take PrandiMet. The most common side effects reported with use of this medicine are hypoglycemia (low blood glucose) and headache.
Availability: PrandiMet was approved by the U.S. Food and Drug Administration in June and is currently scheduled for release in the latter half of 2008.
New drug indications
Product: Insulin aspart (NovoLog)
Manufacturer: Novo Nordisk Inc.
(800) 727-6500
www.novolog.com
New indications: Rapid-acting NovoLog insulin mimics the body’s first-phase insulin secretion, the burst of insulin released from the pancreas after glucose from a meal or snack hits the bloodstream. NovoLog is delivered by pump or injection, typically before the start of a meal or snack. In March 2008, the FDA approved this insulin for use in insulin pumps by children ages 4–18.
Product: Tadalafil (Cialis)
Manufacturer: Eli Lilly and Company
(877) CIALIS-1 (242-5471)
www.cialis.com
New indications: Cialis, an oral drug used to treat erectile dysfunction, was originally approved in doses of 5 milligrams, 10 milligrams, or 20 milligrams, to be taken up to 36 hours before sexual activity. Cialis is now approved for once-daily use in doses of 2.5 milligrams or 5 milligrams. Men should discuss with their doctor which dosing regimen is more appropriate.
Discontinuations
Product: Insulin human (rDNA origin) inhalation powder (Exubera)
Manufacturer: Pfizer Inc.
(800) 438-1985
www.pfizer.com
Reason for discontinuation: Exubera, a rapid-acting, inhalable insulin, was designed to be administered via the handheld Exubera Inhaler. According to Pfizer Inc., because Exubera did not meet customers’ needs or the company’s financial expectations, sales of the product were discontinued in September 2008.
