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In Brief: New Recommendations for Use of Metformin in Renal Impairment
The Medical Letter on Drugs and Therapeutics • Apr 25, 2016 (Issue 1493)
was previously contraindicated in women with
a SCr level ≥1.4 mg/dL and in men with a SCr level ≥1.5
mg/dL ...
The FDA has required labeling changes that replace serum creatinine (SCr) with estimated glomerular filtration rate (eGFR) as the parameter used to determine the appropriateness of treatment with the biguanide metformin (Glucophage, and others) in patients with renal impairment. These changes will allow more patients with mild to moderate renal impairment to receive metformin, which is generally the first drug prescribed for treatment of type 2 diabetes.Metformin was previously contraindicated in women with a SCr level ≥1.4 mg/dL and in men with a SCr level ≥1.5 mg/dL, but use of SCr as a...
In Brief: Cholic Acid (Cholbam) for Bile Acid Synthesis Disorders
The Medical Letter on Drugs and Therapeutics • Apr 25, 2016 (Issue 1493)
trials survived for more
than 3 years.1 Some of these survivors have been treated
successfully for more ...
The FDA has approved oral cholic acid (Cholbam – Retrophin) for treatment of children and adults with bile acid synthesis disorders caused by single enzyme defects and for adjunctive treatment of peroxisomal disorders such as Zellweger spectrum disorders in patients who have liver disease, steatorrhea, or complications from fat-soluble vitamin malabsorption. Patients with these rare inborn errors of bile acid metabolism cannot synthesize primary bile acids such as cholic acid, resulting in reduced bile flow, decreased absorption of fat and fat-soluble vitamins, and development of liver...
In Brief: Jadenu - A New Formulation of Deferasirox for Iron Overload (online only)
The Medical Letter on Drugs and Therapeutics • Apr 25, 2016 (Issue 1493)
of
deferasirox (Exjade) was approved in 2005 for the same
indications.1 Jadenu and Exjade are the only once ...
The FDA has approved an oral tablet formulation of deferasirox (Jadenu [ jade' new] – Novartis) for once-daily treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients ≥2 years old or chronic iron overload in patients ≥10 years old with non-transfusion-dependent thalassemia syndromes. A once-daily, oral tablet for suspension formulation of deferasirox (Exjade) was approved in 2005 for the same indications.1 Jadenu and Exjade are the only once-daily oral formulations for iron chelation available in the US.No new clinical trials were required...
Buprenorphine Buccal Film (Belbuca) for Chronic Pain
The Medical Letter on Drugs and Therapeutics • Apr 11, 2016 (Issue 1492)
to
methadone for treatment of opioid dependence.1,2
were randomized to continue taking buprenorphine ...
Belbuca (Endo), a buccal formulation of the partial
opioid agonist buprenorphine, has been approved by the
FDA for management of pain severe enough to require
daily, around-the-clock, long-term opioid treatment.
Buprenorphine is also available as a transdermal patch
(Butrans) and in a parenteral formulation (Buprenex, and
generics) for treatment of pain. A sublingual formulation
of buprenorphine and buccal and sublingual formulations
containing buprenorphine and the opioid antagonist
naloxone are approved for use as alternatives to
methadone for treatment of opioid...
Calcipotriene/Betamethasone Foam (Enstilar) for Psoriasis
The Medical Letter on Drugs and Therapeutics • Apr 11, 2016 (Issue 1492)
tolerated
than either component alone.1,2 Phototherapy and
systemic therapy, including biologic agents ...
The FDA has approved Enstilar (Leo), an aerosol
foam formulation of the synthetic vitamin D3 analog
calcipotriene and the high-potency corticosteroid
betamethasone dipropionate, for topical treatment
of plaque psoriasis in adults. Topical ointment and
suspension formulations of the same combination
have been available for many years.
Which Oral Anticoagulant for Atrial Fibrillation?
The Medical Letter on Drugs and Therapeutics • Apr 11, 2016 (Issue 1492)
stroke by about 60%.1 If necessary, vitamin K,
prothrombin complex concentrate, or fresh frozen
plasma ...
Direct-to-consumer advertisements continue to
urge patients who take warfarin (Coumadin, and
others) for atrial fibrillation to ask their doctors
about the benefits of one or another of the newer
oral anticoagulants.
Dichlorphenamide (Keveyis) for Periodic Paralysis
The Medical Letter on Drugs and Therapeutics • Apr 11, 2016 (Issue 1492)
%) benefited
from acetazolamide therapy.1
MECHANISM OF ACTION — Carbonic anhydrase
inhibitors are thought ...
Dichlorphenamide (Keveyis – Taro), an oral carbonic
anhydrase inhibitor, has been approved by the
FDA for treatment of primary hypokalemic and
hyperkalemic periodic paralysis and related variants.
Dichlorphenamide is the first drug to be approved in
the US for this indication. It was approved as Daranide
in 1958 for treatment of glaucoma, but had not been
marketed since 2002.
Seebri Neohaler and Utibron Neohaler for COPD
The Medical Letter on Drugs and Therapeutics • Mar 28, 2016 (Issue 1491)
and a LABA to become
available in the US; umeclidinium/vilanterol (Anoro
Ellipta)1 and tiotropium ...
The FDA has approved two new inhalers for long-term
maintenance treatment of chronic obstructive
pulmonary disease (COPD). Seebri Neohaler
(Novartis) contains the long-acting anticholinergic
glycopyrrolate. Utibron Neohaler (Novartis) contains
both glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) indacaterol. Glycopyrrolate/indacaterol is the third fixed-dose combination of a
long-acting anticholinergic and a LABA to become
available in the US; umeclidinium/vilanterol (Anoro
Ellipta) and tiotropium/olodaterol (Stiolto Respimat)
were approved...
Lumacaftor/Ivacaftor (Orkambi) for Cystic Fibrosis
The Medical Letter on Drugs and Therapeutics • Mar 28, 2016 (Issue 1491)
in patients
≥2 years old with other mutations.1 Orkambi is the
first drug to be approved ...
The FDA has approved a fixed-dose combination
of lumacaftor and ivacaftor (Orkambi – Vertex) for
oral treatment of cystic fibrosis (CF) in patients
≥12 years old who are homozygous for the F508del
mutation. About 50% of patients in the US with
CF are homozygous for the F508del (also called
Phe508del) mutation. This is the first approved
indication for lumacaftor; ivacaftor is available
alone as Kalydeco for treatment of CF in patients
≥2 years old with other mutations. Orkambi is the
first drug to be approved in the US for treatment of
patients with the F508del...
Cobimetinib (Cotellic) for Metastatic Melanoma
The Medical Letter on Drugs and Therapeutics • Mar 28, 2016 (Issue 1491)
mutation-positive unresectable or metastatic
melanoma.1,2 Adding the MEK inhibitor trametinib
(Mekinist ...
The FDA has approved the mitogen-activated
extracellular signal-regulated kinase (MEK) inhibitor
cobimetinib (Cotellic – Genentech) for use in combination
with the BRAF kinase inhibitor vemurafenib
(Zelboraf) for treatment of unresectable or metastatic
melanoma with a BRAF V600E or V600K mutation.