Extended-Release Pain Reliever Now Available

Ultram ER (tramadol) extended-release tablets by Ortho-McNeil and Biovail Corp. are available by prescription in the United States, according to a company press release.

Ultram ER is the first extended-release tramadol product approved in the United States for adult patients with moderate to moderately severe chronic pain who need around-the-clock treatment for extended periods.

Ultram ER is available in once-daily dosage strengths of 100 mg, 200 mg and 300 mg.

The FDA based its approval of Ultram ER on the results of four controlled clinical trials of more than 3,000 patients. Tramadol is a nonscheduled centrally-acting opioid analgesic that has been used in the United States since 1995, according to the press release.

The most commonly reported adverse events associated with tramadol in clinical trials were dizziness, nausea, constipation, somnolence and flushing.

Seizures have been reported in patients receiving tramadol, and the risk of seizure is increased with doses of tramadol higher than the recommended range and in patients who also are taking tricyclic antidepressants, selective serotonin-reuptake inhibitors and opioids, according to the press release.

Ultram ER extended-release tablets are intended for oral use only. They should be swallowed whole and not split, crushed or chewed.

Prenatal Vitamin With DHA Available by Prescription

Mission Pharmacal has introduced Citracal Prenatal + DHA to improve the nutritional status of women before conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers, according to a company press release.

The Citracal Prenatal + DHA prenatal pack contains a balanced daily dose of prescription-strength vitamins and minerals in a tablet and a 250 mg tablet of Martek DHA, a plant-derived essential omega-3 fatty acid.

DHA is a relatively new ingredient recommended for optimal maternal and fetal nutrition, according to the release. Research indicates that supplementing the diets of pregnant women with DHA could have significant developmental benefits to mothers and their children. DHA improves the development of brain, nerve and eye tissue in infants and is found naturally in breast milk.

HIV Drugs Receive Traditional FDA Approval

The FDA granted traditional approval status to the HIV drugs Viread (tenofovir) and Truvada (emtricitabine and tenofovir) by Gilead Sciences.

Viread is a once-daily antiretroviral medication. Truvada is a combination of Viread and Emtriva (emtricitabine).

The FDA previously granted accelerated approval for Viread in October 2001 and Truvada in August 2004. The FDA granted traditional approval status based on a review of a 48-week study for Viread.

Colon-Cleansing Drug Cleared by FDA

OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Tablets by Salix Pharmaceuticals received marketing clearance from the FDA on March 17 for the cleansing of the colon in preparation for colonoscopy in adults 18 years of age or older, according to a company press release.

OsmoPrep "provides a more desirable alternative for physicians and patients who would prefer a virtually tasteless tablet cleansing agent over difficult-to-tolerate liquid cleansing agents," according to the release.

Bowel cleansing agents were prescribed more than 10 million times in the United States in 2005, according to the company.

Caution is advised before prescribing OsmoPrep Tablets to patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute obstruction or pseudo-obstruction if the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling surgery or hypomotility syndrome.

Clinicians should use OsmoPrep with caution in patients with impaired renal function, a history of acute phosphate nephropathy or known or suspected electrolyte disturbances and in patients taking drugs that affect electrolyte levels.

OA Product Helps Meet Nutritional Requirements

Primus Pharmaceuticals has introduced Limbrel (flavocoxid) for osteoarthritis. Limbrel is the first prescription product developed to safely meet the nutritional requirements of patients with OA, according to a company news release.

Limbrel represents a new approach to managing OA and a breakthrough in patient safety, according to the release. Limbrel is regulated as a medical food, and its ingredients meet strict regulatory safety guidelines.

In clinical studies and patient use, Limbrel has "consistently demonstrated significant improvements in the validated OA measures of discomfort, stiffness and mobility," according to the release.

Flavocoxid is a blend of natural ingredients comprised primarily of the concentrated flavonoids baicalin and catechin. Flavonoids are found in colored vegetables, fruits, cocoa, red wine and green tea.