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Boostrix, Asmanex Twisthaler.


(tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed; GlaxoSmithKline)

The Food and Drug Administration approved Boostrix, the first combination vaccine that provides adolescents with a booster immunization against pertussis (whooping cough) in combination with tetanus and diphtheria.

* Recommended Dosage: Administer a one-time, single 0.5-mL intramuscular injection into the dekoid muscle of the upper arm in patients 10-18 years of age.

* Special Considerations: Pain, redness, and swelling at the injection site were the most commonly reported local adverse events in a large U.S. safety study. Headache and fatigue were the most common general adverse events.

* Comment: The primary U.S. safety study included 3,080 participants aged 10-18 years. Incidence of grade-3 pain at the injection site within 15 days was the main outcome measure. A total of 4.6% of those who received Boostrix reported grade-3 pain, compared with 4.0% of 1,034 who received a control (tetanus and diphtheria toxoids adsorbed for adult use [Td] vaccine, made by Massachusetts Public Health Biologic Laboratories).

"The big thing here is, whooping cough is more common in adolescents and adults than previously believed, possibly from waning immunity after immunization of infants," said Michael Wasserman, M.D., a pediatrician at the Ochsner Clinic Foundation, Metairie, La.

A whole-cell vaccine previously provided protection against pertussis, but many adolescents could not tolerate the side effects, Dr. Wasserman said. Boostrix is an acellular vaccine.

"One would expect common side effects to include redness at the site of injection, elevated temperature, and irritability," Dr. Wasserman said. "'But this new technology may reduce those side effects. We will want to see with postmarketing surveillance." Dr. Wasserman reported no conflict of interest regarding Boostrix or its manufacturer.

Asmanex Twisthaler

(mometasone furoate, Schering-Plough Inc.)

The FDA approved Asmanex Twisthaler 220 mcg (mometasone furoate inhalation powder) for first-line maintenance treatment of asthma as preventive therapy in patients aged 12 years and older. It is also the only inhaled asthma controller therapy approved for once-daily inhalation for management in patients previously treated with bronchodilator monotherapy or inhaled corticosteroids.

* Recommended Dosage: Recommended starting and maximum daily doses vary according to medication history. For example, 200 mcg once daily is the starting dose, and 400 mcg is the highest recommended daily dose, for patients previously taking either bronchodilators alone or inhaled corticosteroids. The recommended starting dose is 440 mcg b.i.d. for patients previously treated with oral corticosteroids, up to a maximum of 880 mcg daily.

* Special Considerations: Patients currently taking oral prednisone should reduce the dosage by no more than 2.5 mg/day, on a weekly basis, after at least 1 week of Asmanex Twisthaler therapy. Monitor these patients for asthma instability.

* Comment: The efficacy of Asmanex Twisthaler was determined in double-blind, placebo-controlled clinical trials involving 1,941 patients 12 years of age and older.

Administer once-daily doses in the evening. Maximum benefit may not be achieved until after 1-2 weeks of regular use. It is desirable to titrate all patients to the lowest effective dose after stability of asthma is achieved. Instruct patients to rinse their mouths after use to avoid the development of thrush.

"There are some potential advantages of Asmanex over other preparations," said James pollowitz, M.D. This is the first once-daily corticosteroid for asthma control, which might improve patient compliance. Mometasone has low bioavailability, which means a low potential for systemic side effects.

In addition, mometasone has been used for years in topical and nasal allergy products, "so we have experience with this medication," said Dr. Pollowitz, a private-practice allergist and immunologist in Scarsdale, N.Y.

"It is very important that appropriate use of the device be demonstrated by the physician or a person in their office, with follow-up to make sure the patient is using it regularly," said Dr. Pollowitz, also of New York Medical College. He owns stock in and is on the speakers' bureau for Schering-Plough.

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Title Annotation:New & Approved
Author:McNamara, Damian
Publication:Family Practice News
Geographic Code:4EUUK
Date:Jun 15, 2005
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