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Vonvendi - Recombinant von Willebrand Factor (online only)
The Medical Letter on Drugs and Therapeutics • May 22, 2017 (Issue 1521)
(Stimate, and others; 1-deamino-8-
D-arginine vasopressin, DDAVP) stimulates release
of VWF and factor ...
The FDA has approved intravenously administered
recombinant von Willebrand factor (Vonvendi - Shire)
for adults with von Willebrand disease (VWD) who
require on-demand treatment and control of bleeding
episodes. It is the first recombinant von Willebrand
factor (VWF) product to become available in the US.
Comparison Table: Some Topical Corticosteroids (online only)
The Medical Letter on Drugs and Therapeutics • May 08, 2017 (Issue 1520)
% solution Apply bid 36.00 (50 mL)
Fluocinonide – generic 0.1% cream Apply once/d 227.70 (30 g)
Vanos ...
View the Comparison Table: Some Topical Corticosteroids
OTC Fluticasone Furoate Nasal Spray (Flonase Sensimist) for Allergic Rhinitis (online only)
The Medical Letter on Drugs and Therapeutics • Apr 24, 2017 (Issue 1519)
. They are also
Table 1. Some OTC Intranasal Corticosteroids
Drug FDA-Approved Indication Available Formulations ...
The nasal spray formulation of the corticosteroid
fluticasone furoate is now available over the
counter (OTC) as Flonase Sensimist Allergy Relief
(GSK) in the same strength as the prescription
product (Veramyst) for treatment of seasonal or
perennial allergic rhinitis. It is the fourth intranasal
corticosteroid to become available OTC.
In Brief: Pancreatitis with Eluxadoline (Viberzi) in Patients without a Gallbladder
The Medical Letter on Drugs and Therapeutics • Apr 24, 2017 (Issue 1519)
in 2015 for treatment of irritable
bowel syndrome with diarrhea (IBS-D),1 should not be used
in patients ...
The FDA has warned that eluxadoline (Viberzi – Allergan), a mu-opioid receptor agonist and delta-opioid receptor antagonist approved in 2015 for treatment of irritable bowel syndrome with diarrhea (IBS-D),1 should not be used in patients without a gallbladder because of an increased risk of serious pancreatitis.2As of February 2017, the FDA had received reports of 118 cases of serious, nonfatal pancreatitis and 2 deaths associated with use of eluxadoline. Both deaths occurred in patients without a gallbladder who developed severe abdominal pain and vomiting shortly after taking the first...
Plecanatide (Trulance) for Chronic Idiopathic Constipation
The Medical Letter on Drugs and Therapeutics • Apr 24, 2017 (Issue 1519)
, and lubiprostone (Amitiza),
a chloride channel activator, were approved earlier for
treatment of CIC in adults.1 ...
The FDA has approved plecanatide (Trulance –
Synergy), a guanylate cyclase-C receptor agonist,
for treatment of chronic idiopathic constipation (CIC)
in adults. Linaclotide (Linzess), another guanylate
cyclase-C receptor agonist, and lubiprostone (Amitiza),
a chloride channel activator, were approved earlier for
treatment of CIC in adults.
Dupilumab (Dupixent) for Moderate to Severe Atopic Dermatitis
The Medical Letter on Drugs and Therapeutics • Apr 24, 2017 (Issue 1519)
Table 1. Pharmacology
Class Human monoclonal antibody
Formulation 300 mg/2 mL single-dose ...
The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human
monoclonal antibody, for treatment of adults with
moderate to severe atopic dermatitis (eczema) that
has not responded to topical therapies. It can be used
with or without topical corticosteroids.
Reduction of Cardiovascular Risk with Evolocumab (Repatha)
The Medical Letter on Drugs and Therapeutics • Apr 24, 2017 (Issue 1519)
Table 1. Evolocumab Products
Drug Formulations Usual Adult Dosage Cost1
Repatha (Amgen) 140 mg/mL ...
The results of the recently published FOURIER trial
have shown a reduction in cardiovascular events with
addition of the PCSK9 inhibitor evolocumab (Repatha)
to statin therapy in patients with atherosclerotic
cardiovascular disease (ASCVD).
Arymo ER - A New Abuse-Deterrent Morphine Formulation
The Medical Letter on Drugs and Therapeutics • Apr 24, 2017 (Issue 1519)
2018.1
ABUSE-DETERRENT OPIOIDS — Several abusedeterrent
opioid formulations have been approved ...
The FDA has approved Arymo ER (Egalet), a new
extended-release, abuse-deterrent tablet formulation
of morphine sulfate, for management of pain severe
enough to require daily, around-the-clock, long-term
opioid treatment and for which alternative treatment
options are inadequate. Arymo ER can only be
marketed to deter abuse by injection because another
single-entity, extended-release morphine product,
MorphaBond, which has not been marketed to date,
has marketing exclusivity for deterrence of abuse by
the intranasal route through October 2018.
In Brief: New Adult Immunization Recommendations
The Medical Letter on Drugs and Therapeutics • Apr 24, 2017 (Issue 1519)
Practices
(ACIP) includes some new or revised recommendations.1
The complete schedule is available ...
The 2017 adult immunization schedule approved by the CDC's Advisory Committee on Immunization Practices (ACIP) includes some new or revised recommendations.1 The complete schedule is available on the CDC's website (www.cdc.gov/vaccines/schedule). New recommendations for use of influenza vaccine during the 2016-2017 season were included in a previous issue of The Medical Letter.2 Updated recommendations for other vaccines are summarized below. Recommendations for routine use of vaccines in adults were reviewed in an earlier issue.3DK Kim et al. Advisory Committee on Immunization Practices...
Bezlotoxumab (Zinplava) for Prevention of Recurrent Clostridium difficile Infection
The Medical Letter on Drugs and Therapeutics • Mar 27, 2017 (Issue 1517)
with the emergence of an epidemic hypervirulent
strain (NAP1/B1/027).1 The recurrence rate after an
initial episode ...
The FDA has approved the fully human monoclonal
antibody bezlotoxumab (Zinplava – Merck) for use
with antibacterial drug treatment to reduce recurrence
of Clostridium difficile infection (CDI) in adults with
CDI at high risk for recurrence. It is the first drug to be
approved for this indication.