AHFS Drug Information: What's New in December, 2008

AHFS Drug Information
by Gerald K. McEvoy, PharmD and Elaine K. Snow, BS Pharm
American Society of Health-System Pharmacists (2008)

New Monographs:

• Clevidipine: Clevidipine is a 1,4-dihydropyridine-derivative calcium-channel blocking agent.
• Difluprednate: Difluprednate is a difluorinated corticosteroid.
• Protein C Concentrate: Protein C, a naturally occurring precursor of a vitamin K-dependent serine protease, is an anticoagulant.
• Romiplostim: Romiplostim, a biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein, is a thrombopoietin receptor agonist.

Revised Monographs:

• Adefovir: Adefovir dipivoxil is a prodrug of adefovir, an acyclic nucleotide analog antiviral agent that is active against human hepatitis B virus (HBV) and certain other viruses.
• Aldesleukin: Aldesleukin, a human interleukin-2 derivative, is a biosynthetic (recombinant DNA origin) cytokine (i.e., lymphokine) with antineoplastic and immunomodulating activities.
• Alemtuzumab: Alemtuzumab, a recombinant DNA-derived humanized anti-CD52 monoclonal antibody (Campath-1H), is an antineoplastic agent.
• Alteplase: Alteplase, a biosynthetic (recombinant DNA origin) form of the enzyme human tissue-type plasminogen activator (t-PA), is a thrombolytic agent.

• Altretamine: Altretamine, an s-triazine derivative, is a synthetic antineoplastic agent.
• Amiodarone: Amiodarone hydrochloride is considered to be predominantly a class III antiarrhythmic agent, but the drug also appears to exhibit activity in each of the 4 Vaughn-Williams antiarrhythmic classes, including some class I (membrane-stabilizing) antiarrhythmic action.
• Anastrozole: Anastrozole, an aromatase inhibitor, is an antineoplastic agent.
• Anticonvulsants General Statement: The International Classification of Epileptic Seizures currently classifies seizure disorders into 4 major categories: partial seizures (seizures beginning locally); generalized seizures (bilaterally symmetrical and without local onset); unilateral seizures (seizures that are predominantly unilateral); and unclassified epileptic seizures (seizures that are unclassifiable because of incomplete data). Partial seizures are subdivided into those with elementary symptomatology, those with complex symptomatology, and those that are secondarily generalized. Partial seizures with elementary symptomatology include those with motor symptoms (e.g., Jacksonian seizures) or with autonomic symptoms. Partial seizures with complex symptomatology are also known as temporal lobe or psychomotor seizures. Generalized seizures include tonic-clonic (grand mal) seizures, absence (petit mal) seizures, myoclonic seizures, and akinetic seizures. Specialized references should be consulted for a more complete seizure classification and specific information. Seizures which recur at a frequency which does not allow consciousness to be regained in the interval between seizures are known as status epilepticus.
• Asparaginase: Asparaginase (type EC-2), an enzyme derived from Escherichia coli, is an antineoplastic agent.
• Bevacizumab: Bevacizumab, a recombinant humanized monoclonal antibody, is an antineoplastic agent.
• Clonazepam: Clonazepam is a benzodiazepine derivative that is used both as an anticonvulsant and for the treatment of panic disorder with or without agoraphobia.
• Ephedrine: Ephedrine is a sympathomimetic agent that occurs naturally in plants of the genus Ephedra; ephedrine stimulates both α- and β-adrenergic receptors.
• Epinephrine: Epinephrine is an endogenous catecholamine that is the active principle of the adrenal medulla; epinephrine acts directly on both α- and β-adrenergic receptors.
• Estrogen-Progestin Combinations: Oral, intravaginal, and transdermal estrogen-progestin combinations are used for prevention of conception in women who elect to use one of these preparations as a method of contraception. When taken according to the prescribed regimen, these contraceptives provide almost completely effective contraception.
• Etidronate: Etidronate disodium is a synthetic bisphosphonate analog of pyrophosphate, a naturally occurring inhibitor of bone metabolism.
• Extended-Spectrum Penicillins General Statement: Extended-spectrum penicillins are a group of semisynthetic penicillin antibiotics that, because of their chemical structures, have wider spectra of activity than natural penicillins, penicillinase-resistant penicillins, and aminopenicillins.
• Felbamate: Felbamate, a dicarbamate, is an anticonvulsant.
• Fosphenytoin: Fosphenytoin sodium, a prodrug of phenytoin, is a hydantoin-derivative anticonvulsant.
• Gemifloxacin: Gemifloxacin, a naphthyridine derivative, is a fluoroquinolone anti-infective agent.
• Ibandronate: Ibandronate sodium, a synthetic bisphosphonate analog of pyrophosphate, is a bone resorption inhibitor.
• Isradipine: Isradipine is a 1,4-dihydropyridine-derivative calcium-channel blocking agent.
• Lamotrigine: Lamotrigine is a phenyltriazine anticonvulsant.
• Lapatinib: Lapatinib, an inhibitor of human epidermal growth factor receptor type 2 (HER2/ERBB2) and epidermal growth factor receptor (HER1/EGFR/ERBB1) tyrosine kinases, is an antineoplastic agent.
• Levofloxacin: Levofloxacin is a fluoroquinolone anti-infective agent.
• Methsuximide: Methsuximide is a succinimide-derivative anticonvulsant.
• Mitomycin: Mitomycin is an antineoplastic antibiotic produced by Streptomyces caespitosus.
• Mitoxantrone: Mitoxantrone hydrochloride, a synthetic anthracenedione, is an antineoplastic agent.
• Nebivolol Hydrochloride: Nebivolol is a β-adrenergic blocking agent.
• Nilotinib: Nilotinib, an inhibitor of Bcr-Abl tyrosine kinase, is an antineoplastic agent.
• Norfloxacin: Norfloxacin is a fluoroquinolone anti-infective agent.
• Ofloxacin: Ofloxacin is a synthetic fluoroquinolone anti-infective agent.
• Pamidronate: Pamidronate disodium, a synthetic bisphosphonate analog of pyrophosphate, is a bone resorption inhibitor.
• Papaverine: Papaverine hydrochloride is a vasodilating agent.
• Pegaspargase: Pegaspargase, a polyethylene-glycol (PEG) conjugated L-asparaginase, is an antineoplastic agent.
• Phenobarbital: Phenobarbital is a barbiturate-derivative anticonvulsant.
• Phenylephrine: Phenylephrine is a sympathomimetic amine that predominantly acts by a direct effect on α-adrenergic receptors.
• Phenytoin: Phenytoin is a hydantoin-derivative anticonvulsant.
• Piperacillin and Tazobactam: Piperacillin sodium and tazobactam sodium is a fixed combination of the sodium salts of piperacillin (an extended-spectrum penicillin antibiotic) and tazobactam (a β-lactamase inhibitor); tazobactam synergistically expands piperacillin's spectrum of activity against many strains of β-lactamase-producing bacteria.
• Protamine: Protamine sulfate, which is prepared from the sperm or mature testes of salmon or related species and is composed of arginine, proline, serine, and valine, acts as a heparin antagonist.
• Reteplase: Reteplase is used as a thrombolytic agent in selected cases of acute evolving transmural myocardial infarction (MI).
• Risedronate: Risedronate sodium, a synthetic pyridinyl bisphosphonate analog, is a bone resorption inhibitor.
• Rivastigmine: Rivastigmine is a centrally active, reversible cholinesterase inhibitor.
• Tiagabine: Tiagabine, a nipecotic acid derivative, is an anticonvulsant.
• Tirofiban: Tirofiban hydrochloride, a selective, competitive platelet-aggregation inhibitor, has been referred to as a platelet glycoprotein (GP IIb/IIIa)-receptor inhibitor.
• Varenicline: Varenicline is a selective α4β2 nicotinic acetylcholine receptor partial agonist.
• Zoledronic Acid: Zoledronic acid, a synthetic imidazole bisphosphonate analog of pyrophosphate, is a bone resorption inhibitor.
• Zonisamide: Zonisamide is used in combination with other anticonvulsants in the management of partial seizures in adults with epilepsy.