Treatment Effective for Irritant Contact Dermatitis

Cloderm (clocortolone) Cream 0.1%, by Coria Laboratories, in combination with TheraSeal skin protectant is highly effective for the long-term treatment of irritant contact dermatitis of the hands, according to a study recently presented at the American Academy of Dermatology annual meeting.

Cloderm Cream, a mid-potency steroid, is available for the treatment of inflammation and pruritus associated with dermatoses. The most common side effects associated with Cloderm include dryness, irritation, folliculitis, acneiform eruptions and burning.

FDA Approves Single-Dose Oral Antibiotic

The FDA in June approved Zmax (azithromycin extended release) by Pfizer for oral suspension, a one-dose treatment for mild to moderate acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP) in adults, according to a company news release.

Zmax delivers a complete course of therapy in a single two-gram dose. During the first 24 hours after a dose of Zmax, three times as much drug reaches patients' tissues than with a standard dose of immediate-release azithromycin, according to the release. This "front loading" of Zmax provides high drug levels earlier in the course of infection when the bacterial burden is likely to be highest, according to the release.

Zmax's technology allows for the release of the medicine in the small intestine instead of the stomach, which results in fewer side effects, according to the release.

Side effects from Zmax were generally mild to moderate. In the pivotal clinical studies, the most common treatment-related adverse reactions in adults were diarrhea/loose stools, nausea, abdominal pain, headache and vomiting.

Expanded Indication for Once Daily ADHD Drug

Adderall XR (mixed salts of a single-entity amphetamine product) by Shire Pharmaceuticals received FDA approval as a once-daily treatment for adolescents aged 13 to 17 with attention deficit hyperactivity disorder in July, according to a company news release.

Adderall XR has been approved for children between 6 and 12 since October 2001 and for adults 18 and older since August 2004. Adderall XR is the most prescribed brand of ADHD medication in the United States, according to the release.

The most common adverse events in adolescent trials of Adderall XR included loss of appetite, insomnia, abdominal pain and weight loss.

New Insomnia Medication Receives FDA Approval

Rozerem (ramelteon) by Takeda Pharmaceuticals North America in July received FDA approval for the treatment of insomnia characterized by difficulty with sleep onset, according to a company news release. Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years. It will be available to patients by late September.

Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence. It has not been designated as a controlled substance. All other prescription medications indicated for insomnia are classified as schedule IV controlled substances, according to the release.

Rozerem should be taken within 30 minutes before going to bed, and activities should be confined to those necessary to prepare for bed, according to the release. Patients should not take Rozerem with or immediately after a high-fat meal. Patients should not engage in hazardous activities that require concentration after taking Rozerem.

The most common adverse events associated with Rozerem were somnolence, dizziness and fatigue.

Extended-Release Drug Treats Type 2 Diabetes

Glumetza (extended-release metformin) by Depomed and Biovail Corp. received approval from the FDA in June for the treatment of type 2 diabetes, according to a company news release. Glumetza is a once-daily extended-release formulation of metformin hydrochloride.

Glumetza may offer potential advantages such as less-frequent dosing and proven effectiveness in combination with other diabetes drugs, according to the release. Glumetza also offers excellent tolerability so that health care providers can more quickly administer a dose high enough to provide glycemic control without significantly increasing the incidence of side effects such as diarrhea and nausea, according to the release.

Patients with kidney problems, metabolic acidosis or heart failure that is treated with medicine should not take Glumetza. Because Glumetza can cause lactic acidosis, patients should stop taking Glumetza and call their health care providers immediately if they feel very weak or tired, or have unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, or diarrhea. Other signs of lactic acidosis are feeling cold, especially in the arms or legs, dizziness and lightheadedness.