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Choose An Archived Content Update

While Clinical Pharmacology OnHand's content is updated daily, we post
content and feature updates to this website for review on a quarterly basis.

Content Updates
Version 2.28, November 2009

WHAT'S NEW:

None at this time.

NEW DRUG MONOGRAPHS INCLUDE:

  • abobotulinumtoxinA (Dysport) – botulinum A toxin for cervical dystonia and glabellar lines in adults

  • acetaminophen; diphenhydramine (Excedrin PM, Tylenol Cold Relief, and others) – combination analgesic and antihistamine for allergy symptoms or pain at bedtime

  • adapalene; benzoyl peroxide (Epiduo) – combination retinoid and benzoyl peroxide product for acne vulgaris

  • asenapine (Saphris) – new FDA-approval; atypical antipsychotic for acute schizophrenia and bipolar I disorder

  • bacitracin; neomycin; polymyxin (Neosporin) – combination anti-infective for ocular infections and prevention of minor skin and skin structure infections

  • bacitracin; polymyxin (Polysporin) – combination anti-infective for ocular infections and prevention of minor skin and skin structure infections

  • dronedarone (Multaq) – new FDA-approval; antiarrhythmic for atrial fibrillation (AF) or atrial flutter (AFL); similar to amiodarone, but with possibly an improved safety profile

  • ferumoxytol (Feraheme) – new FDA-approval; semi-synthetic, IV iron oxide for iron deficiency anemia in adults with chronic kidney disease

  • iloperidone (Fanapt) – new FDA-approval; atypical antipsychotic for the acute treatment of schizophrenia

  • morphine; naltrexone (Embeda) – new FDA approval; sustained release morphine for pain; sequestered with naltrexone to deter tampering

  • pitavastatin (Livalo) – new FDA-approval; HMG-CoA reductase inhibitor for hypercholesterolemia and combined dyslipidemia

  • polyethylene glycol; electrolytes; bisacodyl (HalfLytely and Bisacodyl Bowel Prep Kit) – combination bowel cleansing preparation; administered prior to colonoscopy

  • prasugrel (Effient) – new FDA approval; thienopyridine platelet aggregation inhibitor for the reduction of thrombotic cardiovascular events in patients with ACS managed with PCI

  • saxagliptin (Onglyza) – new FDA approval; oral dipeptidyl-peptidase-IV (DDP-IV) inhibitor for type 2 diabetes mellitus

  • tapentadol (Nucynta) – synthetic mu-opioid receptor agonist and norepinephrine reuptake inhibitor for pain; similar in efficacy to morphine and oxycodone IR but with better GI tolerability

  • tolvaptan (Samsca) – new FDA approval; oral V2 vasopressin receptor antagonist for hyponatremia in patients with heart failure, cirrhosis, or SIADH

  • vigabatrin (Sabril) – new FDA-approval; antiepileptic drug; solution approved for infantile spasms in infants and children; tablets approved for refractory complex partial seizures in adults


UPDATED DRUG MONOGRAPHS INCLUDE:

  • abatacept (Orencia) – monograph updated for FDA-approval for moderate to severe rheumatoid arthritis

  • albuterol; ipratropium (Combivent, Duoneb) – monograph updated for post-marketing reports of myocardial ischemia

  • aliskiren; hydrochlorothiazide, HCTZ (Tekturna HCT) – indications and dosage updated for initial use in patients likely to need multiple antihypertensive medications

  • ambrisentan (Letairis) –ADRs updated for risk of decreased sperm counts

  • anidulafungin (Eraxis) – administration updated for new formulation without dehydrated alcohol diluent

  • atomoxetine (Strattera) – ADRs updated for hypoesthesia, lethargy, and in children, paresthesia, urinary retention, and hesitancy

  • azelastine (Astepro) – monograph updated for FDA-approved higher concentration nasal spray for seasonal and perennial allergic rhinitis

  • benzoyl peroxide (BenzEFoam) – indications and dosage updated for FDA-approved foam for mild or moderate acne vulgaris

  • bevacizumab (Avastin) – monograph updated for new FDA approval for metastatic renal cell carcinoma and treatment recommendations in patients with proteinuria

  • bosentan (Tracleer) – monograph updated for FDA-approval in pulmonary arterial hypertension (WHO Class I) with WHO Class II symptoms

  • bupropion (Wellbutrin) – ADR section updated for QRS prolongation that has been reported in overdose situations

  • bupropion (Zyban) – precautions updated for boxed warning for neuropsychiatric symptoms such as hostility, depressed mood, suicidal thoughts, and attempted suicide

  • ceftriaxone (Rocephin) – ADRs updated for cephalosporin-induced hemolytic anemia

  • colchicine (Colcrys) – monograph updated for first FDA-approved single ingredient formulation

  • dexamethasone (Ozurdex) – monograph updated for new FDA-approved intravitreal implant for macular edema

  • diclofenac (Cambia) – monograph updated to include 2 new FDA-approved formulations: an oral solution for migraine pain and a liquid capsule for pain

  • eculizumab (Soliris) – monograph updated for risk of meningococcal infection; use is contraindicated in unresolved, serious Neisseria meningitidis infection and patients not currently vaccinated against Neisseria meningitidies

  • fenofibric acid (Fibricor) – new FDA-approved tablet formulation for severe hypertriglyceridemia, primary hyperlipidemia, or mixed dyslipidemia

  • fentanyl (Onsolis) – monograph updated for new FDA-approved transmucosal film for breakthrough pain in opioid tolerant patients

  • gemcitabine (Gemzar) – indications and dosage updated for new trial results in pancreatic cancer

  • glimepiride (Amaryl) – ADRs updated for allergic vasculitis

  • haemophilus influenza type b conjugate vaccine (Hiberix) – new FDA approved formulation; a booster dose to be given after receipt of primary vaccination series

  • human papilloma virus vaccine (Gardasil) – monograph updated for off-label use in women 27-45 years of age; ADRs updated for syncope, seizure-like activity, and falls

  • hydrochlorothiazide, HCTZ; losartan (Hyzaar) – ADRs updated for rare occurrence of thrombocytopenia and post-marketing reports of general malaise

  • hydrocortisone (Cortalo) – monograph updated for new FDA-approved gel for corticosteroid-responsive dermatoses

  • ibritumomab (Zevalin) – monograph updated for FDA-approved indication for newly diagnosed follicular non-Hodgkin’s lymphoma

  • insulin aspart (NovoLog) – administration updated for insulin pump recommendations including reservoir dwell times and frequency of infusion set and injection site changes

  • interferon beta-1b (Extavia) – monograph updated for new FDA-approved formulation for relapsing-remitting multiple sclerosis

  • ketorolac (Acuvail) – monographs updated for new FDA-approved ophthalmic formulation

  • leuprolide (Lupron Depot) – monograph updated for post-marketing reports of seizures

  • levocetirizine (Xyzal) – monograph updated for FDA-approval in children for idiopathic urticaria, perennial allergic rhinitis, and seasonal allergic rhinitis

  • levonorgestrel (Plan B One-Step) – monograph updated for new 1.5 mg formulation with OTC approval in patients 17 years and older

  • lisdexamfetamine (Vyvanse) – ADRs updated for post-marketing reports of blurred vision, mydriasis, diplopia, psychosis, mania, hallucinations, aggression, and logorrhea

  • losartan (Cozaar) – ADRs updated for rare occurrence of thrombocytopenia and post-marketing reports of general malaise

  • methylene blue – indications and dosage updated for off-label use in sentinel lymph node mapping and parathyroid gland localization

  • olopatadine (Patanase) – ADRs and precautions updated for post-marketing reports of nasal perforation and probable drug-induced depression; FDA safety review ongoing

  • onabotulinumtoxinA (Botox) – precautions updated for risk of systemic botulism

  • orlistat (Xenical, Alli) – monograph updated for FDA early communication regarding possible liver injury

  • oxaliplatin (Eloxatin) – indications and dosage updated for gastric cancer and new trial results in pancreatic cancer.

  • paliperidone (Invega) – monograph updated for FDA-approval of oral formulation for schizoaffective disorder and extended-release injection for schizophrenia

  • pancrelipase (Zenpep) – monograph updated for second FDA-approved formulation

  • pemetrexed (Alimta) – indications and dosage updated for FDA-approved indication for advanced or metastatic non-small cell lung cancer

  • poliovirus vaccine, inactivated, IPV (IPOL) – indications and dosing updated for revised ACIP recommendations for routine poliovirus vaccination

  • rimabotulinumtoxinB (Myobloc) – precautions updated for risk of systemic botulism

  • sevelamer (Renvela) – monograph updated for new FDA-approved powder for oral suspension

  • sibutramine (Meridia) – monograph updated for reports of serotonin syndrome or neuroleptic malignant syndrome-like symptoms

  • sorafenib (Nexavar) – indications and dosage updated with for renal cell carcinoma and recent study results for malignant melanoma

  • sotalol – monograph updated for new FDA-approved intravenous formulation

  • sumatriptan (Sumavel DosePro) – monograph updated for new FDA-approved single use, needle-free SC formulation for acute migraine and cluster headaches

  • sunitinib (Sutent) – indications and dosage updated for recently study results for metastatic renal cell carcinoma

  • tacrolimus (Prograf) – indications and dosage updated for liver and heart transplant rejection prophylaxis

  • teriparatide (Forteo) – monograph updated for new FDA approval in glucocorticoid-induced osteoporosis and for rare post-market reports of osteosarcoma

  • trastuzumab (Herceptin) – indications and dosage updated for recently reported study results in gastric cancer

  • treprostinil (Tyvaso) – monograph updated for FDA-approved oral inhalation formulation for pulmonary arterial hypertension

  • triamcinolone (Aristospan) – precautions updated for head trauma

  • tumor necrosis factor (TNF) modifiers – precautions updated for the increased risk of lymphoma and other cancers in children and adolescents

  • urea (Kerol AD) – monograph updated for new FDA-approved topical emulsion

  • valganciclovir (Valcyte) – monograph updated for new FDA-approved oral solution and for CMV prophylaxis in pediatric patients older than 4 months

  • valsartan (Diovan) – ADRs updated for post-marketing reports of vasculitis

  • zoledronic acid (Reclast) – ADRs and contraindications updated for post-marketing reports of renal damage

  • zolpidem (Edluar, Zolpimist) – monograph updated for FDA-approved sublingual tablet for insomnia and to avoid administration of the sublingual spray with or after a meal
IV COMPATIBILITY:
None at this time.
SPECIFIC CONTENT ISSUES:
Selected content issues include, but are not limited to:
  • New indication terms for anal cancer and biliary tract cancer added to select monographs

  • The more specific indication terms of small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) were added to select monographs

  • FDA MedWatch: Drug Safety Alerts and Label Changes
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