Pharmacy & Therapeutics - June 2008 - (Page 328)

NEW DRUGS NEW DRUGS Methylnaltrexone (Relistor) For Opioid-Induced Constipation The U.S. Food and Drug Administration (FDA) has approved methylnaltrexone bromide (Relistor, Wyeth, Progenics) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to alleviate pain. Opioids can interfere with normal bowel elimination by relaxing the intestinal smooth muscles and preventing them from contracting. Relistor blocks opioid entrance into the cells and enables the bowels to continue to function normally. An injectable medication, Relistor can be administered as needed, but only one dose should be given in a 24-hour period. The recommended starting schedule is one dose every other day as needed. Relistor is not recommended for those patients with intestinal obstr uction. Patients experiencing severe diarrhea, vomiting, nausea, or abdominal pain during therapy should stop taking this medication and should consult with their health care providers. (Source: FDA, April 28, 2008.) DRUG NEWS normal sensation in the lower and upper lip. Within one hour, 41% of the patients reported normal lower-lip sensation, compared with 7% of controls, and 59% of the patients reported normal upper lip sensation, compared with 12% of controls. No serious events were reported except temporary injection-site pain. OraVerse is not intended for children younger than six years of age, children who weigh less than 33 pounds (15 kg), or patients undergoing root canals or tooth extractions. Novalar plans to launch OraVerse at this year’s American Dental Association meeting in October 2008. (Sources: FDA; The New York Times, May 12, 2008.) safety warnings as Requip, such as cautions about falling asleep while engaged in activities of daily living and driving. (Source: FDA, May 9, 2008.) Once-Daily Taclonex For Scalp Psoriasis Warner Chilcott and LEO Pharma have announced the FDA’s approval of their New Drug Application (NDA) for calcipotriene 0.005%/betamethasone dipropionate 0.064% (Taclonex Scalp Topical Suspension) for the topical treatment of moderate to severe psoriasis vulgaris of the scalp in adults. Known as Xamiol outside the U. S., it is scheduled to be launched in the second half of 2008. (Source: Warner Chilcott/LEO, May 12, 2008.) Phentolamine (OraVerse) After Dental Anesthesia The FDA has approved phentolamine mesylate (OraVerse, Novalar) for the reversal of soft-tissue anesthesia and the associated deficits resulting from local anesthetics used by dentists. This is the only local anesthetic-reversal agent that accelerates the return to normal sensation and function after restorative and periodontal procedures. Phentoloamine has also been used to treat hypertension. Lidocaine is usually combined with epinephrine to constrict the blood vessels. OraVerse dilates the blood vessels and speeds up blood flow so that the anesthetic can be carried away; the injection reverses epinephrine, not lidocaine or the anesthetic. Local dental anesthetics frequently result in unnecessary and lingering numbness. OraVerse reverses numbness of the lip and tongue and deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. In clinical studies, OraVerse reduced the median time needed for recovery of Alvimopan (Entereg) For Postoperative Ileus The FDA has approved alvimopan (Entereg, Adolor/GlaxoSmithKline) to accelerate the restoration of bowel function in patients 18 years of age and older after partial large-bowel or small-bowel surgery. Alvimopan is indicated for hospitalized patients who can receive no more than 15 doses. The FDA is approving alvimopan with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the drug’s benefits outweigh its risks. The product is restricted to inpatient use only. After abdominal surgery, patients may experience temporar y impairment of gastrointestinal (GI) tract motility. Some pain relievers, such as morphine, can slow or inhibit normal motility. Alvimopan blocks opioid effects in the bowel. The recommended dose is one 12-mg capsule given just before surgery and another 12-mg dose twice daily for up to seven days, not to exceed 15 doses. The product is not approved for use in children. (Source: FDA, May 20, 2008.) Generic Requip (Ropinirole) The first generic versions of GlaxoSmithKline’s Requip (ropinirole HCl) tablets have been approved for the treatment of moderate to severe restless legs syndrome in dosage strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Roxane, Teva, Par, and Mylan have received approval to market the tablets. The labeling for the generic versions may differ from that of Requip, because some uses are protected by patents. Requip is also approved to treat symptoms of Parkinson’s disease (PD). The generic product was scheduled to be eligible for treating PD after late May. The generic tablets will carry the same 328 P&T® • June 2008 • Vol. 33 No. 6

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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