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New Drugs of 2007 by Amy P CONTINUING EDUCATION New Drugs of 2007 By Amy P. Witte, PharmD; Jodie V. Mahlhotra, PharmD; and Trevor McKibbin, PharmD, MSc, BCPS pon successful completion of this There have been no reported contraindications with article, the pharmacist should be the use of retapamulin. A thin layer should be applied to able to: the affected area (up to 100 cm2 in total area in adults or 1. Identify the new molecular entities 2 percent total body surface area in pediatric patients) approved by the Food and Drug twice daily for five days. Administration (FDA) in 2007. The most common adverse effect seen with re- U2. Review approved indications, mechanism of tapamulin use was application site irritation. Patients action, and pharmacokinetic profile for each should discontinue the use of retapamulin in the event agent. of severe local irritation or sensitization. It is not intend- 3. List the available dosage forms and ed for ingestion or for intraoral, intranasal, ophthalmic, strengths, dosing schedules, and routes of or intravaginal use. Patients should also be aware of administration for the new agents. the potential for microbial overgrowth while using reta- 4. Describe the potential adverse effects, drug pamulin. If a superinfection is suspected during treat- interactions, precautions, and contraindica- ment, the patient should contact their physician. The tions associated with routine use. effect of retapamulin in combination with other topical 5. Identify medications that have been with- agents to the same area of skin has not been studied. drawn from the market in 2007. Retapamulin is a pregnancy category B agent. How- ever, it is not known whether retapamulin is excreted In 2007, the FDA approved 15 new molecular in breast milk. Dosage adjustments are unnecessary entities (13 of which are discussed in this article) as when co-administered with a CYP3A4 inhibitor, such well as numerous new dosage forms (see Tables 2 as ketoconazole, due to the low incidence of systemic and 4, pages 37 and 39). While this is not a com- exposure to retapamulin. prehensive review of the new drugs, it highlights Retapamulin is available by prescription as an oint- important information on agents approved in 2007. ment. It is supplied in a 5 gram, 10 gram, or 15 gram Additionally, six medications were withdrawn from tube. Patients should only use retapamulin as directed the market (see Table 3, page 38 ). by a physician. Both patients and caregivers should wash their hands after each application. The patient ALTABAX™ (RETAPAMULIN) should notify their physician if there is no improvement Manufactured by GlaxoSmithKline, retapamu- in symptoms within three to four days after starting use lin 1 percent is first in a new class of topical of retapamulin. antibacterials used for the treatment of impe- tigo due to Staphylococcus aureus (methicil- BYSTOLIC™ (NEBIVOLOL) lin-susceptible) or Streptococcus pyogenes in Bystolic, manufactured by Forest Pharmaceuticals, is patients nine months of age or older. It works by an orally active inhibitor of beta ß adrenergic receptors. selectively inhibiting bacterial protein synthesis. Nebivolol is primary a ß1 selective inhibitor, however Retapamulin demonstrates both bacteriostatic at higher doses it inhibits both ß1 and ß2 adrenergic and bactericidal activity. receptors. This new drug is indicated for the treatment of www.americaspharmacist.net June 2008 | america’s PHARMACIST 35 Table 1: Lisdexamfetamine Drug Interactions Drug/Class Interaction Urinary acidifying agents Decrease serum amphetamine level Adrenergic blockers Inhibited by amphetamine Tricyclic antidepressants Enhanced activity of both agents MAO inhibitors Slowed amphetamine metabolism Antihistamines Blocked sedative effects of antihistamines Antihypertensives Antagonism of antihypertensive Chlorpromazine, haloperidol, lithium carbonate Inhibition of stimulant effects Ethosuximide Delayed intestinal absorption of ethosuximide Meperidine Potentiation of analgesic effects of meperidine Methenamine therapy Increased urinary excretion of stimulant Norepinephrine Enhanced adrenergic effects of norepinephrine Phenobarbital Delayed intestinal absorption of Phenobarbital Phenytoin Delayed intestinal absorption of phenytoin Veratrum alkaloids Inhibition of hypotensive effects of veratrum alkaloid hypertension. It may be used alone or in combination with bradycardia. Nebivolol should be used with other antihypertensive agents. caution when myocardial depressants, inhibi- Nebivolol is contraindicated in patients with se- tors of AV conduction, or antiarrhythmic agents vere bradycardia, heart block greater than first degree, are used concurrently. It is metabolized by gluc- cardiogenic shock, decompensated cardiac failure, uronidation and hydroxylation by CYP2D6 and sick sinus syndrome (unless a permanent pacemaker should be used with caution when co-adminis- is in place), or severe hepatic impairment (Child-Pugh tered with CYP2D6 inhibitors such as quinidine, >B), and in patients who are hypersensitive to any fluoxetine, or paroxetine. component of this product. Caution should be advised The recommended starting dose is 5 mg in patients with diabetes, cardiac failure, peripheral vas- orally once daily with or without food. For cular disease, and in patients concomitantly treated with those patients requiring further reduction in a non-dihydropyridine calcium channel blocker, such blood pressure, the dose can be increased at as diltiazem. Nebivolol has not been studied in patients two week intervals to a maximum dose of 40 with angina pectoris or who had a recent myocardial mg. In patients with severe renal or moderate infarction. In addition, patients with bronchospastic dis- hepatic impairment, the recommended dose eases should not receive beta blockers. is 2.5 mg once daily. Nebivolol is available Nebivolol is a pregnancy category C agent. However, by prescription as 2.5 mg, 5 mg, or 10 mg it is not known whether this drug had been excreted in tablets. All three strengths are supplied as a human breast milk. Nebivolol should be used with caution 30 or 100 bottle. in patients with severe renal impairment and moderate hepatic impairment. Furthermore, it has not been studied DORIBAX™ (DORIPENEM) in patients receiving dialysis. Doribax is manufactured by Shionogi & Co., The most common adverse reactions reported with and distributed by Ortho-McNeil Pharma- nebivolol use were headache, dizziness, nausea, and ceuticals. It is indicated as a single agent for 36 america’s PHARMACIST | June 2008 www.americaspharmacist.net Table 2: New Drug Approvals of 2007 Brand Name Generic Name Manufacturer Approved Indication Altabax Retapamulin GlaxoSmithKline Topical treatment of impetigo Bystolic Nebivolol Forest/Mylan Treatment of hypertension Treatment of complicated intra-abdominal infections (cIAI)† and Doribax Doripenem Ortho-McNeil complicated urinary tract infections Isentress Raltegravir Merck Treatment of HIV-1 infection Bristol-Meyers Ixempra Ixabepilone Treatment of metastatic or locally advanced breast cancer Squibb Kuvan Sapropterin BioMarin Treatment of phenylketonuria (PKU) Letairis Ambrisentan Gilead Sciences Treatment of pulmonary arterial hypertension Treatment of the signs and symptoms of early-stage idiopathic Neupro Rotigotine Schwarz Pharma Parkinson’s disease Selzentry Maraviroc Pfizer Treatment of HIV-1 infection Somatuline Lanreotide Beaufour Ipsen Treatment of acromegaly Tasigna Nilotinib Novartis Treatment of chronic myelogenous leukemia (CML) Tekturna Aliskiren Novartis Treatment of hypertension Torisel Temsirolimus Wyeth Treatment of advanced renal cell carcinoma Treatment of advanced or metastatic breast cancer in combination Tykerb Lapatinib GlaxoSmithKline with capecitabine Vyvanse Lisdexamfetamine Shire Treatment of attention-deficit/hyperactivity disorder (ADHD) the treatment of complicated intra-abdomi- other drugs in the carbapenem class. Use of doripenem nal infections and complicated urinary tract is also contraindicated in patients who have demonstrat- infections (including pyelonephritis) that are ed anaphylactic reactions to beta-lactams. Doripenem is caused by designated susceptible bacteria. a pregnancy category B. It is not know whether doripe- Doripenem belongs to the carbapenem class nem is excreted in human milk, so it should be used with of antimicrobials. It works by inhibiting bacte- caution in nursing women. rial cell wall biosynthesis. The most common adverse effects (≥5%) associ- The recommended dose of doripenem for ated with doripenem are headache, nausea, diarrhea, patients 18 or older is 500 mg every eight hours rash, and phlebitis. Additionally, Clostridium difficile- administered by intravenous infusion over an associated diarrhea has been associated with nearly hour. For patients with moderately impaired re- all antibacterial agents. Only two drug interactions nal function (estimated creatinine clearance ≥30 have been reported with doripenem use. Carbapen- ml/min to ≤50 ml/min) the recommended dose ems may reduce the serum valproic acid concentra- is 250 mg intravenously (over an hour) every tions, resulting in a loss of seizure control. Frequent eight hours. For patients with severely impaired monitoring of serum valproic acid concentrations renal function (estimated creatinine clearance is recommended following initiation of doripenem >10 ml/min to <30 ml/min), the recommended therapy. Probenicid has been shown to reduce the dose is 250 mg intravenously (over an hour) renal clearance of doripenem, which results in in-
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