Clarinex Syrup Available In New Bottle Size

Clarinex (desloratadine) Syrup by Schering-Plough will be available in a 4 oz. bottle to make it easier for pharmacists to dispense the usual course of treatment, according to a company press release. Clarinex is indicated for the treatment of symptoms associated with seasonal allergic rhinitis in children aged 2 years and older and for perennial allergic rhinitis and chronic idiopathic urticaria in children as young as 6 months.

Clarinex Syrup, which is also available in a 16 oz. bottle, was approved by the U.S. Food and Drug Administration in 2004. It is the only prescription nonsedating antihistamine syrup approved for patients as young as 6 months, according to the press release.

The FDA based its approval of Clarinex Syrup on results from three safety studies involving 246 patients between 6 months and 11 years of age with a history of allergic rhinitis and chronic idiopathic urticaria.

Side effects in children aged 6 to 11 years are similar to placebo. Side effects for children between the ages of 6 months and 5 years vary by age and include fever, diarrhea, upper respiratory infection, irritability and coughing.

New 5-Day Regimen Approved for Antibiotic

The U.S. Food and Drug Administration in August approved a new five-day, 750 mg once daily regimen for Levaquin (levofloxacin) tablets by Ortho-McNeil to treat acute bacterial sinusitis. The regimen is the first and only short-course fluoroquinolone regimen approved for the treatment of acute bacterial sinusitis, according to a company press release.

The FDA based the approval on a study that found that this treatment regimen is as effective as a traditional regimen of Levaquin 500 mg for 10 days. The study involved 780 adult outpatients diagnosed with acute bacterial sinusitis.

Levaquin is indicated for the treatment of adults with acute bacterial sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, the most common causes of acute bacterial sinusitis.

Clinical success rates in the study were seen for 91.4% of patients in the five-day group and 88.6% of patients in the 10-day group.

The five-day, 750 mg once daily regimen of Levaquin also is approved for adults with community-acquired pneumonia caused by penicillin-susceptible Streptococcus pneumoniae (excluding drug-resistant strains), Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae or Mycoplasma pneumoniae.

The most common adverse events in clinical trials were nausea and diarrhea.

Drug Approved for High-Risk MI Survivors

Diovan (valsartan) by Novartis Pharmaceuticals in August received approval from the U.S. Food and Drug Administration to reduce cardiovascular death in patients at high risk following a heart attack. The FDA also expanded the drug's heart failure labeling to include a broader range of heart failure patients, including patients intolerant of angiotensin-converting enzyme inhibitors.

Diovan's approval to reduce cardiovascular death in high-risk heart attack survivors is based on the results of the Valsartan in Acute Myocardial Infarction (VALIANT) study of 14,703 patients.

Diovan is also indicated for the first-line treatment of hypertension and may be used over a dose range of 80 mg to 320 mg daily. Diovan is available in 40 mg, 80 mg and 160 mg tablets.

The most common side effects in heart failure patients include dizziness, hypotension and diarrhea. The most common side effects to cause post-myocardial infarction patients to stop taking the drug are hypotension, cough, rash and an increase in serum creatinine levels.

FDA Approves Actonel With Calcium Carbonate

Actonel with Calcium (risedronate with calcium carbonate) by Sanofi-Aventis received approval from the U.S. Food and Drug Administration in August. Actonel with Calcium is the first prescription osteoporosis therapy to include calcium, according to a company press release.

Actonel with Calcium is indicated for the prevention and treatment of postmenopausal osteoporosis and includes four weeks of therapy. Patients take one 35 mg Actonel tablet each week along with six tablets that provide 500 mg of calcium.

Actonel with Calcium is contraindicated in patients with known hypersensitivity to any component of the product or in patients who are unable to stand or sit upright for at least 30 minutes.

In a one-year study comparing Actonel 35 mg taken once a week and Actonel 5 mg taken daily, the side effects associated with the two dosing regimens were similar. Actonel generally was well tolerated in clinical trials, according to the release. Side effects observed with Actonel 5 mg daily were similar to placebo. The most commonly reported adverse events reported regardless of causality were infection, back pain and arthralgia.

Single-Dose Oral Antibiotic Now in Pharmacies

Zmax (azithromycin extended release) for oral suspension, a one-dose treatment for mild to moderate acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP) in adults, is available in pharmacies, according to a company press release.

Zmax, by Pfizer, which was approved by the FDA in June, 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 like 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.