Atrovent HFA Inhalation Aerosol, Evoclin Foam.
(ipratropium bromide HFA, Boehringer Ingelheim Pharmaceuticals)
The Food and Drug Administration approved ipratropium bromide HFA (Atrovent HFA Inhalation Aerosol), a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema in patients 12 years and older.
* Recommended Dosage: The usual starting dose of ipratropium bromide inhalation aerosol is two inhalations (36 meg) four times a day. Patients may take additional inhalations as needed, but should not exceed a total of 12 inhalations in a 24-hour period.
* Special Considerations: Atrovent HFA is not indicated for initial treatment of acute bronchospasm where a rapid response is required. In trials, the most common adverse events related to Atrovent HFA were dry mouth and taste perversion (bitter taste), each in fewer than 2% of participants. Rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur as immediate hypersensitivity reactions after administration of ipratropium bromide.
* Comment: In response to concerns about chlorofluorocarbons (CFCs) depleting the ozone layer, the new formulation of Atrovent contains the propellant hydrofluoroalkane (HFA). Researchers compared the CFC and HFA formulations in a 12-week, double-blind, placebo- and active-controlled trial. No statistically significant differences were found between the two formulations. Each product significantly improved lung function in patients with chronic obstructive pulmonary disease, according to a company release.
"Atrovent is very good for very sick children. It helps with really tight bronchospasm, especially in the hospital or emergency room," said Erin Kelleher, M.D., a pediatrician at Children's Medical Practice in Bronxville, N.Y. Dr. Kelleher has no financial affiliation with Atrovent HFA or Boehringer Ingelheim.
Albuterol (Xopenex, Sepracor), however, is generally Dr. Kelleher's first-line choice for control of bronchospasm. She cited cost considerations. "Pretty much all insurance companies will pay for albuterol."
"I would tend to use Atrovent HFA for severe reactions. You need close follow-up, especially for children with asthma," Dr. Kelleher advised. "'Children with asthma tend to deteriorate very quickly."
(clindamycin phosphate foam, 1%, Connetics Corp.)
The FDA approved Evoclin (clindamycin) Foam, 1% for topical treatment of acne vulgaris in patients 12 years and older.
* Recommended Dosage: Wash affected areas with mild soap and allow to fully dry. Apply Evoclin once daily for 12 weeks.
* Special Considerations: Clindamycin is contraindicated in patients with a history of regional enteritis, ulcerative colitis, antibiotic-associated colitis, or hypersensitivity to preparations containing clindamycin or lincomycin. Mild to moderate adverse reactions included headache, and application site reactions (burning, itching, and dryness) in a randomized, double-blind, multicenter clinical trial of more than 1,000 patients.
* Comment: In a noninferiority study that compared 386 patients using Evoclin Foam with 385 using clindamycin phosphate gel 1%, Evoclin reduced total acne lesions by 43%, compared with the reference drug's 36% reduction. There were also 127 patients using vehicle-only foam who had a 31% reduction in total lesions.
"I think it's very helpful to have a once-a-day formulation of a topical antibiotic," said Lawrence Eichenfield, M.D. Although clindamycin can be used as monotherapy for mild to moderate cases, combination with benzoyl peroxide or a retinoid are alternatives. For severe acne, stronger combination therapies may be warranted.
"Having a once-a-day clindamycin is useful for patients with moderate disease where we can pair clindamycin with another once-a-day retinoid," said Dr. Eichenfield, clinical professor of pediatrics and dermatology at the University of California San Diego, and chief of pediatric and adolescent dermatology at Children's Hospital of San Diego.
The hospital was one of the investigational sites for clinical studies. Dr. Eichenfield serves on a Connetics advisory board, but he has no current financial interest in the company.
Evoclin is novel because of its proprietary VersaFoam vehicle. The foam spreads easily on all body surfaces, Dr. Eichenfield said.
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|Title Annotation:||New & Approved|
|Date:||Jan 1, 2005|
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