Insulin Injection Manages Sugar Spikes
Insulin glulisine (rDNA origin) injection (Apidra) was approved by the FDA for the treatment of adults with type 1 and type 2 diabetes mellitus and for the control of hyper-glycemia. Insulin glulisine is a product of Aventis.
Insulin glulisine is a new recombinant DNA human insulin analog that has a more rapid onset and shorter duration of action than regular human insulin after subcutaneous administration. Aventis states that the new drug is designed to take care of mealtime blood sugar spikes. When used in combination with insulin glargine (Lantus), it offers a synergistic approach to total glucose control.
The new insulin is injected within 15 minutes before a meal or within 20 minutes after starting a meal. In addition to administration by subcutaneous injection, insulin glulisine can be administered by continuous subcutaneous pump infusion.
Etanercept Now Indicated for Psoriasis
The FDA has approved etanercept (Enbrel) for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The new approval for etanercept is the fifth indication for the drug, an anti-tumor necrosis factor (TNF) therapy. Etanercept is also approved to treat psoriatic arthritis, rheumatoid arthritis, polyarticular-course juvenile rheumatoid arthritis, and ankylosing spondylitis.
Etanercept was approved with a step-down dosing regimen of 50 mg administered twice weekly for 3 months, followed by a maintenance dose of 50 mg weekly thereafter.
New Drug Treats Menopause Symptoms
A plant-derived synthetic conjugated estrogen product, (synthetic conjugated estrogens, B (Enjuvia), has been approved by the FDA. In addition to estrogen, the new product also contains the active estrogenic compound delta 8,9-dehydroesterone sulfate.
Enjuvia, a product of Barr Pharmaceuticals, is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, including hot flashes, night sweats, and vaginal dryness.
Enjuvia is available in 0.625-mg and 1.25-mg doses. Barr plans to eventually provide Enjuvia in 0.3-mg, 0.45-mg, and 0.9-mg tablets.
Estrogens should not be used in women with undiagnosed abnormal genital bleeding, known or suspected breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis, thromboembolic disorders, active or recent arterial thromboembolic disease, or pregnancy.
Children's Motrin Grape Chewables Alert
McNeil Consumer and Specialty Pharmaceuticals alerted customers nationwide that one lot of Children's Motrin (ibuprofen) Grape Chewable Tablets may mistakenly contain Tylenol 8-hour extended release (acetaminophen) Geltabs. The lot (JAM108, expiration date 1/06) was distributed nationally to wholesale and retail customers between February 5, 2004, and April 1, 2004. The bottles involved in the alert are labeled as containing 24 tablets.
The Tylenol 8-hour product contains an adult dose of acetaminophen. Use of this adult product could cause children to overdose. The mislabeled bottles are probably the result of a packaging error for the lot.
The two medications are visually different. Children's Motrin Grape Chewable Tablets are round, purple-colored, scored tablets with the letters "MO" and the number 50 on the tablet surface. The tablets have a non-glossy finish and smell like grape. The Tylenol 8-Hour Geltabs are hard, round, gelatin-coated, and shiny. They are white on one side, red on the other, and have "8-Hour" printed in blue on either the red or the white side.
For more information on this alert, call McNeil's Consumer Relationship Center at 1-800-962-5357.