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Qbrexza - A Glycopyrronium Cloth for Axillary Hyperhidrosis
The Medical Letter on Drugs and Therapeutics • Jan 28, 2019 (Issue 1564)
-week, randomized,
double-blind trials (ATMOS-1 and -2) in a total
of 697 patients ≥9 years old ...
Qbrexza (Dermira), a premoistened cloth containing
the long-acting anticholinergic drug glycopyrronium,
has been approved by the FDA for once-daily topical
treatment of excessive underarm sweating (primary
axillary hyperhidrosis) in patients ≥9 years old.
Glycopyrronium bromide (glycopyrrolate) has been
available for years in parenteral, inhalation, and oral
formulations for treatment of multiple conditions.
Revefenacin (Yupelri) for COPD
The Medical Letter on Drugs and Therapeutics • Jan 28, 2019 (Issue 1564)
twice daily with a portable handheld
nebulizer, was the first.1
MAINTENANCE TREATMENT OF COPD ...
The FDA has approved revefenacin (Yupelri – Mylan/Theravance Biopharma), a long-acting antimuscarinic
agent (LAMA) administered once daily by standard
jet nebulizer, for maintenance treatment of chronic
obstructive pulmonary disease (COPD). Revefenacin
is the second nebulized LAMA to be approved for this
indication; glycopyrrolate (Lonhala Magnair), which
is administered twice daily with a portable handheld
nebulizer, was the first.
OTC Primatene Mist Returns
The Medical Letter on Drugs and Therapeutics • Jan 28, 2019 (Issue 1564)
have been diagnosed with
mild intermittent asthma by a healthcare professional.1
The original version of Primatene ...
The FDA has approved over-the-counter (OTC) sale
of inhaled epinephrine (Primatene Mist – Amphastar),
a nonselective alpha and beta agonist, for temporary
relief of mild symptoms of intermittent asthma in
patients ≥12 years old who have been diagnosed with
mild intermittent asthma by a healthcare professional.
The original version of Primatene Mist, which was
approved by the FDA in 1967, was removed from the
market in 2011 because the metered-dose inhaler (MDI)
contained ozone-depleting chlorofluorocarbon (CFC)
propellants; the new MDI contains hydrofluoroalkane
(HFA)...
Aripiprazole with Digital Ingestion Tracking (Abilify MyCite)
The Medical Letter on Drugs and Therapeutics • Jan 28, 2019 (Issue 1564)
for maintenance treatment of nonadherent
patients (Abilify Maintena, Aristada).1
INGESTION TRACKING — Cuprous ...
Monitoring adherence of psychiatric patients to
oral medication may be especially difficult. The
FDA has approved Abilify MyCite (Otsuka/Proteus),
an aripiprazole tablet with an embedded sensor
that tracks when patients take the medication. It is
indicated for treatment of adults with schizophrenia,
bipolar disorder, or major depressive disorder. Abilify MyCite is the first drug with a digital ingestion tracking
system to be approved in the US.
Tildrakizumab (Ilumya) - Another IL-23 Antagonist for Psoriasis
The Medical Letter on Drugs and Therapeutics • Jan 14, 2019 (Issue 1563)
selective
IL-23 antagonist to be approved for this indication;
guselkumab (Tremfya) was the first.1 ...
Tildrakizumab-asmn (Ilumya – Sun), an interleukin
(IL)-23 antagonist, has been approved by the FDA for
treatment of adults with moderate to severe plaque
psoriasis who are candidates for systemic therapy or
phototherapy. Tildrakizumab is the second selective
IL-23 antagonist to be approved for this indication;
guselkumab (Tremfya) was the first.
Dupilumab (Dupixent) for Asthma
The Medical Letter on Drugs and Therapeutics • Jan 14, 2019 (Issue 1563)
inadequately controlled with
topical therapies.1
Pronunciation Key
Dupilumab: doo pil’ ue mab Dupixent: du ...
The FDA has approved the subcutaneously injected
monoclonal antibody dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of
patients ≥12 years old with moderate to severe
asthma with an eosinophilic phenotype or with oral
corticosteroid-dependent asthma. Dupilumab was
approved earlier to treat adults with moderate to
severe atopic dermatitis inadequately controlled with
topical therapies.
Symfi, Symfi Lo, and Cimduo for HIV (online only)
The Medical Letter on Drugs and Therapeutics • Jan 14, 2019 (Issue 1563)
for treatment of HIV-
1 infection. Symfiand SymfiLo (Mylan) contain the
non-nucleoside reverse transcriptase ...
The FDA has approved three new once-daily fixed-dose
antiretroviral drug combinations for treatment of HIV-1 infection. Symfi and Symfi Lo (Mylan) contain the
non-nucleoside reverse transcriptase inhibitor (NNRTI)
efavirenz and the nucleoside reverse transcriptase
inhibitors (NRTIs) lamivudine and tenofovir disoproxil
fumarate (TDF) and were approved as complete
antiretroviral regimens. Symfi Lo contains a lower
dose of efavirenz than both Symfi and Atripla, a fixed-dose
combination of efavirenz, TDF, and the NRTI
emtricitabine that was approved in 2006. Cimduo
(Mylan), which...
Drugs for Cough
The Medical Letter on Drugs and Therapeutics • Dec 17, 2018 (Issue 1562)
treatment, especially in
children. Suppression of productive cough may be
harmful.1 Management of patients ...
Acute cough (<3 weeks in duration) generally does
not require pharmacologic treatment, especially in
children. Suppression of productive cough may be
harmful. Management of patients with cough should
include elimination of any precipitating factor (e.g.,
cigarette smoking) and treatment of any underlying
cause such as upper airway cough syndrome,
gastroesophageal reflux disease, asthma, or other
pulmonary disease.
Rivaroxaban (Xarelto) plus Aspirin for Secondary Prevention of Cardiovascular Events
The Medical Letter on Drugs and Therapeutics • Dec 03, 2018 (Issue 1561)
) and for prevention of stroke
and systemic embolism in patients with nonvalvular
atrial fibrillation.1 ...
The FDA has approved a new 2.5-mg formulation of
the direct factor Xa inhibitor rivaroxaban (Xarelto –
Janssen) for use in combination with low-dose aspirin
to reduce the risk of major cardiovascular events in
patients with chronic coronary artery disease (CAD)
or peripheral artery disease (PAD). Rivaroxaban is
the first direct oral anticoagulant to be approved for
this indication. It was approved earlier for prevention
and treatment of deep vein thrombosis (DVT) or
pulmonary embolism (PE) and for prevention of stroke
and systemic embolism in patients with nonvalvular
atrial...
Baloxavir Marboxil (Xofluza) for Treatment of Influenza
The Medical Letter on Drugs and Therapeutics • Dec 03, 2018 (Issue 1561)
-controlled trial (CAPSTONE-1), 1436
otherwise healthy outpatients 12-64 years old with
uncomplicated ...
The FDA has approved baloxavir marboxil (Xofluza –
Shionogi/Genentech), the first polymerase acidic (PA)
endonuclease inhibitor, for single-dose, oral treatment
of acute uncomplicated influenza in patients ≥12 years
old. Baloxavir is the first drug with a new mechanism
of action to be approved for treatment of influenza in
almost 20 years.