Download Express Scripts Drug Information & Wellness Center Drug Information Updates

March 2011
Volume 3 Issue 2
Express Scripts Drug Information & Wellness Center
Drug Information Updates
In the News:
FDA removes hundreds of unapproved cough, cold, and allergy products from the market
These products have never been tested for safety, effectiveness, and quality
♦ FDA approved prescription and over the counter products provide patients many alternative choices of therapy
♦ Manufacturers are expected to stop manufacturing within 90 days and to stop shipment of removed products within 180 days
♦ A full list of products can be found on the Food and Drug Administration website
(www.fda.gov)
♦
Long term use of Proton Pump Inhibitors (PPI) is associated with low magnesium levels
♦ Most cases involved PPI use over one year
♦ Low magnesium levels may cause muscle spasms, irregular heartbeat, and convulsions but some patients may experience no symptoms at all
♦ In one quarter of the cases, supplementation was not enough and the PPI needed to
be discontinued
Special points of interest:
> In the News
> New Formulations and Indications
> New Generic Approvals
> Newly Approved Drugs
> Drug Information Question
> Apps of the Month
New Formulations and Indications:
Intuniv (guanfacine) extended-release tablets by Shire US Inc.
Class: Attention Deficit Hyperactivity Disorder (ADHD) medication
New Indication: Now approved as adjunct therapy to stimulant medications for the treatment of
ADHD in children and adolescents ages 6-17 years
MOA: Selective alpha2A-adrenergic receptor agonist; mechanism in ADHD not fully understood
Dosing: Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week.
Maintain the dose within the range of 1-4 mg once daily, depending on clinical response and
tolerability.
Abilify (aripiprazole) tablets by Bristol-Meyers Squibb
Class: Antipsychotics
New Indication: Now approved as adjunct therapy to the mood stabilizers lithium and valproate
for treatment of patients with bipolar I disorder
MOA: Proposed efficacy is mediated through a combination of partial agonist activity at D2 and
5-HT1A receptors and antagonist activity at 5-HT2A receptors. The exact mechanism in bipolar
disorder is unknown.
Dosing: Adults: 10-15 mg once a day. Children (10-17 years): 10 mg once a day
New Generic Approvals:
GENERIC
Abacavir oral tablets—Tentative Approval (2/15/11)
Abacavir oral solution – Tentative Approval (2/16
BRAND
Ziagen
/11)
Irbesartan/HCTZ oral tablets – Tentative Approval (2/16/11)
Ziagen
Avalide
March is
Red Cross Month.
Make a
difference...help
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Page 2
Express Scripts Drug Information & Wellness Center
Volume 3 Issue 2
Newly Approved Drugs
Makena (hydroxyprogesterone caproate) IM injection by K-V Pharmaceuticals (approved 2/3/11)
Class: Hormone (progestin)
Indication: Reduce the risk of preterm birth in women with a history of singleton spontaneous preterm delivery
MOA: Mechanism by hydroxyprogesterone caproate reduces risk of preterm birth is unknown
Interactions: Metabolism of drugs metabolized by CYP1A2, CYP2A6, and CYP2B6 may be increased during treatment with Makena.
Dosing: 250 mg (1 mL) IM injection once weekly (administered by a healthcare professional)
Corifact (human factor XIII concentrate) IV injection by CSL Behring (approved 2/15/11)
Class: Clotting factor adjunct
Indication: Factor XIII deficiency
MOA: Is a transglutaminase enzyme that catalyzes the cross-linking of fibrin chains for stabilization and resistance to fibrinolysis
Dosing: Initial: 40 International Units (units) per kg body weight slow IV injection at a rate not exceeding 4 mL/min. Subsequent: Should be
guided by the most recent factor XIII trough levels. Specific recommendations can be found in the package insert.
Edarbi (azilsartan medoxomil) oral tablet by Takeda Pharms North America (approved 2/25/11)
Class: Antihypertensive agent
Indication: Hypertension
MOA: Blocks angiotensin II from binding to receptors and causing vasoconstriction
Interactions: Co-administration with NSAIDs, including selective COX-2 inhibitors, may result in deterioration of renal function, including possible
acute renal failure, as well as attenuation of the antihypertensive effect of Edarbi
Dosing: 80 mg by mouth once daily (consider starting at 40 mg by mouth once daily in patients on high doses of diuretics)
Daliresp (roflumilast) oral tablet by Forest Laboratories (approved 2/28/11)
Class: Respiratory agent
Indication: Reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
MOA: Selectively inhibits phosphodiesterase IV in neutrophils, eosinophils, and monocytes, resulting in accumulation of cyclic AMP in lung cells
Interactions: CYP3A4 & 1A2 substrate. Co-administration with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.
Dosing: One 500 mcg tablet by mouth once daily
Recent Guideline Updates
American College of Physicians (ACP) - Intensive insulin therapy in hospitalized patients
Clinical Guidelines Committee of the American College of Physicians. Use of Intensive Insulin Therapy for the Management of Glycemic Control in Hospitalized Patients: A Clinical Practice Guideline From the American College of
Physicians. Ann Intern Med. 2011 Feb 15;154(4):260-267.
♦ Available from: http://www.annals.org/content/154/4/260.full.pdf
American Heart Association (AHA) - Prevention of cardiovascular disease in women
Effectiveness-Based Guidelines for the Prevention of Cardiovascular Disease in Women- 2011 Update: A Guideline
From the American Heart Association. Circulation. 2011 Feb 16.
♦ Available from: http://circ.ahajournals.org/cgi/reprint/CIR.0b013e31820faaf8v2
American Society of Clinical Oncology (ASCO) - Bone-modifying agents in metastatic breast cancer
American Society of Clinical Oncology Executive Summary of the Clinical Practice Guideline Update on the Role of
Bone-Modifying Agents in Metastatic Breast Cancer. J Clin Oncol. 2011 Feb 22.
♦ Available from: http://jco.ascopubs.org/content/early/2011/02/16/JCO.2010.32.5209.full.pdf
American Academy of Pediatrics (AAP) - Children’s fever and antipyretic use
The Section on Clinical Pharmacology and Therapeutics; Committee on Drugs. Fever and Antipyretic Use in Children. Pediatrics. 2011 Mar;127(3):580-587.
♦ Available from: http://pediatrics.aappublications.org/cgi/reprint/peds.2010-3852v1
Infectious Diseases Society of America (IDSA) - Acute uncomplicated cystitis and pyelonephritis in women
Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International
clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women. Clin Infect
Dis. 2011 Mar;52(5):e103-20.
♦ Available from: http://cid.oxfordjournals.org/content/52/5/e103.full.pdf+html
Volume 3 Issue 2
Page 3
Drug Information Question
What are bath salts and how do you treat someone who has taken them?
A search was conducted that led to the U.S. Department of Justice website. On that
site, we found that preliminary findings show that the active ingredients of “bath salts”
are usually synthetic cathinone derivatives such as MDPV (3, 4- methylenedioxypyrovalerone) or mephedrone. These products are commonly sold as bath salts, plant
food and herbal incense. Some common names include: Blue Silk, Ivory Snow, Ocean
Burst and White Dove. In each case, it is a designer drug being marketed as a harmless consumer product.
However, these products are far from harmless. Users can inject, smoke
or snort the products to gain a sensation similar to using methamphetamine or
cocaine. While the effects and duration of methamphetamine and cocaine are
well documented, the side effects and half lives of these designer drugs have not
been fully studied. Currently, the synthetic methamphetamine and cocaine are
not regulated by the DEA. The process to restrict and schedule these types of
drugs can be a very time consuming process at the federal level. Banning the
products at the state and local level is a much faster proposition. Recent news
reports on the use and abuse of these “legal highs” across the country has led to
many local governments banning the products from their municipalities. In 2010
the state of Louisiana issued an emergency ban on the sale of these bath salts
after receiving 125 poison center calls in 3 months related to these products. Recently, the city of Marion, IL voted to ban the sale, possession and distribution of
bath salts. Law makers were spurred to action by the increase in emergency department visits and poison center calls. According to the American Association of
Poison Control Centers, there were 373 calls concerning bath salts in the first
few weeks of 2011. In contrast, there were only 234 for the entire year of 2010.
A search of Poisindex in Micromedex stated that in cases of mild to moderate poisoning, patients may exhibit
Parkinsonian- like qualities, tachycardia, hypertension, mydriasis and agitation. The toxicity of these synthetic cathinones
is a result of excess sympathetic activity. Treatment is based on patient symptoms and centers on supportive care.
Mephedrone
Methamphetamine
Page 4
Express Scripts
Drug Information & Wellness Center
Southern Illinois University Edwardsville
Volume 3 Issue 2
Monday — Friday
8 a.m. — 4 p.m.
(618) 650-5142
Apps of the Month
The following applications for smartphones have been reviewed and critiqued by students and pharmacists:
Name
Cost
Content
Micromedex
Free
• Contains drug monographs by brand, generic,
and drug class
Eponyms
Free
Opioids
Free
• Opioid analgesic dosage
conversion calculator
Shots 2010
Free
*Shots 2011 coming soon
• Contains the immunization schedules for the
United States for 2010
STAT ICD-9
LITE
Free
*Updated version is available for $29.99
• Contains ICD-9 codes
from 2008
SparkPeople
Free
Medscape
Free
• The #1 downloaded free
medical app in 2010!
Cardio Calc
Free
• Medical calculator for all
things cardiology
Pharmacist’s
Letter
Free
• The unbiased advice of
Pharmacist’s Letter on
your mobile device
PPA
Free
• Helps find prescription
assistance programs
• Werdnig-Hoffman syndrome - not sure what this
means? Download this
app!
• A mobile nutrition and
fitness tracker to help you
reach your goals for a
healthy lifestyle
Rating (1-5)