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An EUA for Bamlanivimab - A Monoclonal Antibody for COVID-19
The Medical Letter on Drugs and Therapeutics • Nov 30, 2020 (Issue 1612)
to severe disease and/or hospitalization (see Table 1).1 Monoclonal antibodies, such as bamlanivimab ...
The investigational neutralizing IgG1 monoclonal
antibody bamlanivimab (LY-CoV555; Lilly) has
been granted an FDA Emergency Use Authorization
(EUA) for treatment of recently diagnosed mild
to moderate COVID-19 in patients who are ≥12
years old, weigh at least 40 kg, and are at high
risk for progressing to severe disease and/or
hospitalization (see Table 1).
In Brief: Hydrochlorothiazide and Skin Cancer
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
carcinoma [SCC]) to the labels of products containing
the diuretic hydrochlorothiazide.1
The labeling ...
The FDA has required the addition of information about
an increased risk of nonmelanoma skin cancer (basal
cell carcinoma [BCC] and squamous cell carcinoma
[SCC]) to the labels of products containing the diuretic
hydrochlorothiazide.
Empagliflozin (Jardiance) for Heart Failure
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
diabetes.1 To date, empagliflozin has not been
approved by the FDA for such use. The SGLT2 inhibitor ...
In a randomized, placebo-controlled trial, the
sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly)
reduced the composite risk of cardiovascular death
or hospitalization for worsening heart failure (HF)
in patients with heart failure with reduced ejection
fraction (HFrEF), whether or not they had type 2
diabetes. To date, empagliflozin has not been
approved by the FDA for such use. The SGLT2 inhibitor
dapagliflozin (Farxiga) was approved by the FDA for
this indication earlier this year.
Orphengesic Forte - An Old Analgesic Combination Returns
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
and may be as effective as an opioid/acetaminophen combination for treatment of moderate to severe acute pain.1 MECHANISM ...
A fixed-dose combination of orphenadrine citrate, aspirin,
and caffeine (Orphengesic Forte – Galt; previously
available as Norgesic Forte) has been approved as
a prescription drug by the FDA for treatment of mild
to moderate pain caused by acute musculoskeletal
disorders. Single-ingredient generic orphenadrine
citrate is available by prescription in oral and injectable
formulations and has been used for years as an adjunct
for treatment of acute musculoskeletal pain. Orphengesic
Forte is being marketed as a non-opioid alternative for
pain relief.
Comparison Chart: SGLT2 Inhibitors (online only)
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
2 (SGLT2) INHIBITORS RENAL DOSAGE ADJUSTMENTS CANAGLIFLOZIN eGFR 30 to ...
View the Comparison Chart: SGLT2 Inhibitors
Minocycline Foam (Zilxi) for Rosacea
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
Minocycline Foam (Zilxi) for Rosacea
The FDA has approved a 1.5% topical foam formulation ...
The FDA has approved a 1.5% topical foam formulation
of minocycline (Zilxi – Foamix) for treatment of
inflammatory lesions of rosacea in adults. It is
the only topical minocycline product approved for
this indication. The same manufacturer markets
minocycline foam 4% (Amzeeq) for treatment of acne
in patients ≥9 years old.
Two Drugs for Advanced HER2-Positive Breast Cancer (Enhertu and Tukysa)
The Medical Letter on Drugs and Therapeutics • Nov 16, 2020 (Issue 1611)
secondline treatment.1 FAM-TRASTUZUMAB DERUXTECAN (ENHERTU) Fam-trastuzumab deruxtecan-nxki is FDA-approved ...
The FDA has approved two new drugs for treatment
of previously-treated unresectable or metastatic
human epidermal growth factor receptor 2 (HER2)-positive breast cancer: fam-trastuzumab deruxtecannxki
(Enhertu – Daiichi-Sankyo/AstraZeneca), an IV
HER2-directed monoclonal antibody linked to the
topoisomerase I inhibitor DXd, and tucatinib (Tukysa – Seagen), an oral tyrosine kinase inhibitor.
In Brief: Extended-Release Budesonide (Ortikos) for Crohn's Disease
The Medical Letter on Drugs and Therapeutics • Nov 02, 2020 (Issue 1610)
to be approved for this
indication; Entocort EC, an ileal-release formulation,
was the first.1 A third oral ...
An oral extended-release formulation of the corticosteroid
budesonide (Ortikos – Ferring) is now available
for once-daily treatment of mild to moderate active
Crohn's disease of the ileum and/or ascending colon in
patients ≥8 years old and for maintenance of remission
for up to 3 months in adults. Ortikos is the second oral
formulation of budesonide to be approved for this
indication; Entocort EC, an ileal-release formulation,
was the first. A third oral formulation of budesonide
(Uceris) is approved for induction of remission in
patients with mild to moderate active ulcerative...
In Brief: New Benzodiazepine Warnings
The Medical Letter on Drugs and Therapeutics • Nov 02, 2020 (Issue 1610)
and physical dependence.1 Benzodiazepine
labels have contained a boxed warning about a risk of
serious drug ...
The FDA now requires boxed warnings in the package
inserts of benzodiazepines describing the potential for
these drugs to be abused and misused and to cause
addiction and physical dependence. Benzodiazepine
labels have contained a boxed warning about a risk of
serious drug interactions with opioids since 2016.
Large-Volume, Preservative-Free Albuterol Concentrate
The Medical Letter on Drugs and Therapeutics • Nov 02, 2020 (Issue 1610)
of
severe asthma exacerbations in hospitalized patients,
particularly children.1 Many hospitals ...
The short-acting beta2-agonist albuterol sulfate has
recently become available as a large-volume (20 mL),
preservative-free concentrate (albuterol inhalation
solution 0.5% – Nephron Pharmaceuticals) that
can be used to prepare solutions for administration
of continuous nebulized albuterol (CNA). CNA is
commonly used (off-label) for acute treatment of
severe asthma exacerbations in hospitalized patients,
particularly children. Many hospitals have been
using a 20-mL multidose bottle of 0.5% albuterol that
contains the preservative benzalkonium chloride (BAC)
for this purpose. Until...