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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 2.22, May 2008
NEW DRUG MONOGRAPHS INCLUDE:
- aliskiren; hydrochlorothiazide (Tekturna HCT®) – new FDA-approval; direct renin inhibitor and thiazide diuretic combination for hypertension
- brimonidine; timolol (Combigan™) – new FDA-approval; combination ophthalmic solution for glaucoma and ocular hypertension
- carbetapentane; pyrilamine (Pyrlex™ CB) – cough suppressant and antihistamine combination for the relief of cough
- etravirine (Intellence™) – new FDA approval; non-nucleoside reverse transcriptase inhibitor for HIV
- fosaprepitant (Emend®) – new FDA approval; first dose IV alternative antiemetic in the aprepitant 3-day chemotherapy-induced nausea and vomiting regimen
- hydroxocobalamin (Cyanokit®) – parenteral vitamin B12 preparation for cyanide toxicity and for vitamin B12 deficiencies and related anemias
- methoxy polyethylene glycol-epoetin beta (Mircera™) – synthetic erythropoietin protein for anemia of chronic kidney disease
- metyrapone (Metopirone®) – oral diagnostic agent for testing hypothalamic-pituitary ACTH function
- nebivolol (Bystolic™) – new FDA approval; beta-1 selective adrenergic antagonist for hypertension
- nilotinib (Tasigna™) – new FDA approval; kinase inhibitor for Philadelphia chromosome positive CML
- sapropterin (Kuvan®) – new FDA approval; synthetic tetrahydrobiopterin for lowering phenylalanine concentrations in tetrahydrobiopterin-sensitive phenylketonuria
UPDATED DRUG MONOGRAPHS INCLUDE:
- abatacept (Orencia®) – contraindications updated for recommendation of screening patients for viral hepatitis
- acitretin (Soriatane ®) – precautions updated to reflect non-paraben containing reformulation
- adalimumab (Humira®) – monograph updated for FDA approved uses in juvenile rheumatoid arthritis and chronic plaque psoriasis
- anastrozole (Arimidex®) – indications and dosage updated for off-label uses in uterine leiomyomata and breast cancer
- antihemophilic factor, AHF, factor VIII (Xyntha™) – monograph updated for new FDA approved formulation for treatment and prevention of bleeding in hemophilia A
- aripiprazole (Abilify®) – monograph updated for FDA approval in acute manic or mixed episodes associated with Bipolar I Disorder in 10 to 17 years olds
- bevacizumab (Avastin®) – monograph updated to reflect FDA -approved use for metastatic breast cancer
- bisphosphonates – ADRs updated for all drugs in class for severe joint and muscle pain
- botulinum toxin type A (Botox®) – ADRs and precautions updated for adverse symptoms of systemic botulism
- botulinum toxin type B (Myobloc®) – ADRs and precautions updated for adverse symptoms of systemic botulism
- carbamazepine (Tegretol®) – contraindications updated to suggest genetic testing of Asian patients to identify risk of serious skin reactions
- caspofungin (Cancidas®) – indications and dosage updated to include off-label use for fungal infections in infants and children
- cetirizine (Zyrtec®) – indications and dosage updated for off-label use in atopic dermatitis in children
- chlorpromazine (Thorazine®) – ADRs updated for case report of SIADH
- ciclesonide (Alvesco®) – monograph updated for new, FDA-approved oral inhalation formulation for asthma maintenance
- cilostazol (Pletal®) – ADRs updated for rare reports of aplastic anemia
- cinacalcet (Sensipar™) – monograph updates include off-label use in children on dialysis and adults not on dialysis, and increased risk of hypocalcemia in non-dialysis patients
- clopidogrel (Plavix®) – indications and dosage updated for off-label use in infants and young children with cardiac conditions and risk for arterial thrombosis
- codeine – indications and dosage updated for off-label use in cough
- colesevelam (Welchol™) – monograph updated to reflect FDA-approved use for type 2 diabetes mellitus
- darunavir (Prezista™) – contraindications updated for post-marketing cases of hepatic injury
- deferasirox (Exjade®) – contraindications and ADRs updated for reports of acute liver failure
- diclofenac (Flector®) – monograph updated for new FDA-approved topical patch for acute, mild or moderate pain
- diphenhydramine (Benadryl®) – indications and dosage updated for allergic reactions, allergic rhinitis, nocturnal cough, and insomnia in children
- duloxetine (Cymbalta®) – contraindications and precautions updated for use in patients with glaucoma or increased intraocular pressure
- dutasteride (Avodart®) – ADRs updated for post-marketing reports of serious skin reactions
- enfuvirtide (Fuzeon™) – dosage and indications updated for off-label use in HIV prophylaxis
- esomeprazole (Nexium®) – monograph updated for FDA approval for GERD and erosive esophagitis in children
- estradiol (Climara®) – ADRs updated for post-marketing reports of throat swelling and eyelid edema
- etanercept (Enbrel®) – indications and dosage updated for off-label use in plaque psoriasis in adolescents and children at least 4 years old
- ethinyl estradiol; norelgestromin (Ortho Evra®) – precautions and ADRs updated with new study information regarding the risk of VTE
- ezetimibe (Zetia®) – description updated for preliminary results from ENHANCE trial
- ezetimibe; simvastatin (Vytorin®) – description updated for preliminary results from ENHANCE trial
- famotidine (Pepcid®) – ADRs updated for rare reports of seizures in patients with renal impairment, toxic epidermal necrolysis, and Stevens-Johnson Syndrome
- fludarabine (Fludara®) – ADRs updated to include progressive multifocal leukoencephalopathy
- fluocinolone (Derma-Smoothe/FS®) – indications and dosage updated for off-label use of oil in moderate to severe atopic dermatitis in infants and children 3 months or older
- haemophilus influenzae type b conjugate vaccine (PedvaxHIB®, Comvax®) – monograph updated for temporary booster dose deferral recommendations secondary to vaccine recall
- human papillomavirus vaccine, quadrivalent (Gardasil®) – ADRs updated for post-marketing reports of anaphylaxis and Guillan-Barre syndrome
- ibandronate (Boniva®) – indications and dosage updated for off-label treatment or prevention of osteoporosis in patients taking anastrozole
- idursulfase (Elaprase®) – ADRs updated to include reports of biphasic anaphylactoid reactions occurring after infusion
- iloprost (Ventavis™) – ADRs updated for post-marketing reports of gingival bleeding and epistaxis within 1 month of treatment initiation
- influenza virus vaccine (Afluria®, Fluarix®, Fluzone®) – indications and dosage updated for new recommendations in children
- lamivudine (Epivir®) – dosage and indications updated for new FDA-approved half-strength tablets for pediatric patients
- letrozole (Femara®) – indications and dosage updated for off-label use in males with idiopathic short stature or constitutional delayed puberty
- levocetirizine (Xyzal®) – monograph updated for new FDA-approved oral solution for allergic rhinitis or urticaria
- lidocaine (Xylocaine®) – indications and dosage updated for off-label use of nebulized lidocaine in corticosteroid-dependent asthma
- measles virus; mumps virus; rubella virus; varicella virus vaccine, live (ProQuad®) – ADRs updated for risk of febrile seizures
- meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra®) – monograph updated for preferred use in children at increased risk of infection and to control outbreaks
- metformin; sitagliptin (Janumet®) – ADRs updated for reports of hypersensitivity reactions
- methadone – contraindications updated for use in breast-feeding
- methotrexate (Trexall®) – ADRs updated for ocular adverse reactions such as blurred vision and optic neuropathy
- mycophenolate (Myfortic®) – ADRs updated for reports of pure red cell aplasia
- natalizumab (Tysabri®) – monograph updated for new FDA-approved indication for moderate to severe Crohn's disease; ADRs updated for severe hepatic injury
- nisoldipine (Sular®) – monograph updated for new, lower-strength bioequivalent tablets using Geomatrix™ technology
- nonoxynol-9 – monograph updated for FDA ruling of no increase in protection against STDs or HIV and possible increase in the risk of HIV transmission
- orphenadrine (Norflex®) – ADRs updated to include euphoria
- palonosetron (Aloxi™) – monograph updated for FDA-approval in post-operative nausea/vomiting and changes in warnings for risk of QTc interval elevation
- pioglitazone (Actos®) – contraindications and ADRs updated for possible increased risk of myocardial infarction, heart failure, and death in elderly patients
- pneumococcal vaccine, polyvalent (Prevnar®) – pharmacokinetics updated to include immunogenicity data in infants with sickle cell disease
- rosiglitazone (Avandia®) – contraindications and ADRs updated for possible increased risk of myocardial infarction, heart failure, and death in elderly patients
- sargramostim, GM-CSF (Leukine®) – monograph updated for recall of liquid Leukine® formulation, which contains EDTA, due to increased ADRs such as syncope
- selegiline (Emsam®) – monograph updated for risk of suicidality or unusual changes in behavior and to not use in children due to risk of hypertensive crisis
- sirolimus (Rapamune®) – indications and dosage updated for new recommendations in renal/hepatic impairment and to check trough concentrations after formulation changes
- somatropin (Accretropin™) – monograph updated for new FDA-approved formulation for children with growth failure due to growth hormone deficiency or Turner’s Syndrome
- temozolomide (Temodar®) – contraindications updated to include gelatin hypersensitivity in patients taking capsule
- teriparatide (Forteo™) – ADRs updated for post-marketing reports of leg and back muscle spasms
- thrombin (Recothrom™) – monograph updated for new FDA-approved recombinant, plasma-free formulation for control of surgical bleeding
- thyrotropin alfa (Thyrogen®) – monograph updated for new FDA-approved indication for radioiodide ablation post-thyroidectomy in nonmetastatic thyroid cancer
- tramadol (Ultram®) – indications and dosage updated for recommendations for switching from immediate-release to extended-release formulation
- treprostinil (Remodulin®) – monograph updated for risks associated with continuous IV infusion and abrupt discontinuation of therapy
- varenicline (Chantix®) – monograph updated for risk of neuropsychiatric symptoms
- venlafaxine (Effexor XR®) – monograph updates include risk of abnormal bleeding and new FDA approval for the long-term treatment of social anxiety disorder
- voriconazole (VFEND®) – indications and dosage updated for off-label use for fungal infections in infants and children
- yellow fever vaccine (YF-Vax®) – contraindications updated to postpone vaccine in patients with acute febrile disease and for use in pregnancy and breast-feeding
- zanamivir (Relenza®) – monograph updated for post-marketing reports of self-injury and delirium, particularly in pediatric patients
- zileuton (Zyflo®) – monograph updated for discontinuation of the immediate-release formulation and to recommend conversion to the controlled-release formulation
- zoledronic acid (Reclast®, Zometa®) – indications and dosage updated for off-label use in osteoporosis prophylaxis
- zolpidem (Ambien CR®) – indications and dosage updated for 24-week efficacy data in adults with primary insomnia
IV COMPATIBILITY:
New/Revised pairs:
- caspofungin compatibility with 31 drugs
- oxaliplatin stability in D5W injection
- palonosetron compatibility with cisatracurium, rocuronium, succinylcholine, vecuronium
- tramadol stability in sterile water for injection
- vecuronium stability in sterile water for injection
SPECIFIC CONTENT ISSUES:
Selected content issues include, but are not limited to:
Since the last quarter, more than 2,165 content changes were performed, including:
- Drug interactions: Over 510 revised and new entries
- Increased risk of suicidal behavior and ideation added to ADRs and precautions in all anticonvulsant monographs
- Summary of FDA recommendations against the use of non-prescription cough and cold products in children less than 2 years of age
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