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Tramadol Oral Solution (Qdolo) for Pain
The Medical Letter on Drugs and Therapeutics • May 31, 2021 (Issue 1625)
opioid agonist and a weak serotonin and
norepinephrine reuptake inhibitor.1 It is metabolized
by CYP2D6 ...
The opioid agonist tramadol is now available in an oral
solution (Qdolo – Athena Bioscience) for management
of pain severe enough to require an opioid and for
which alternative treatment options are inadequate.
Tramadol has been available for years in immediate-release
tablets and capsules, extended-release
capsules (Ultram, and others), and in a fixed-dose
combination tablet with acetaminophen (Ultracet,
and generics).
Inhaled Mannitol (Bronchitol) for Cystic Fibrosis
The Medical Letter on Drugs and Therapeutics • May 31, 2021 (Issue 1625)
of bronchial
hyperresponsiveness.
Table 1. Pharmacology
Formulation 40 mg dry powder capsules
Route ...
The FDA has approved mannitol powder for oral
inhalation (Bronchitol – Chiesi) as add-on maintenance
treatment to improve pulmonary function in adults with
cystic fibrosis (CF). This product has been available in
Europe for the same indication since 2012. Another
formulation of mannitol inhalation powder (Aridol)
is approved in the US for assessment of bronchial
hyperresponsiveness.
Teprotumumab (Tepezza) for Thyroid Eye Disease
The Medical Letter on Drugs and Therapeutics • May 31, 2021 (Issue 1625)
-like
growth factor-1 receptor (IGF-1R) inhibitor, has
been approved by the FDA for IV treatment ...
Teprotumumab-trbw (Tepezza - Horizon), an insulin-like
growth factor-1 receptor (IGF-1R) inhibitor, has
been approved by the FDA for IV treatment of thyroid
eye disease. It is the first drug to be approved in the US
for this indication.
In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Adolescents 12-15 Years Old
The Medical Letter on Drugs and Therapeutics • May 31, 2021 (Issue 1625)
-19 vaccine to include adolescents 12-15
years old.1 The vaccine has been authorized for use ...
On May 10, 2021, the FDA expanded its Emergency
Use Authorization (EUA) for the Pfizer/BioNTech
mRNA-based COVID-19 vaccine to include adolescents
12-15 years old.1The vaccine has been
authorized for use in persons ≥16 years old since
December 2020.
Plenity for Weight Management
The Medical Letter on Drugs and Therapeutics • May 17, 2021 (Issue 1624)
with a
BMI ≥25 kg/m2 for years.1
THE DEVICE — Taken with water before lunch and
dinner, Plenity capsules ...
Plenity (Gelesis), a nonsystemic oral superabsorbent
hydrogel formulation of cellulose and citric acid is
now available. It was cleared by the FDA in 2019 to
aid in weight management together with diet and
exercise in overweight and obese adults (BMI of
25-40 kg/m2). It is classified by the FDA as a device
because the contents of the capsule are not absorbed
systemically. Plenity is the first ingested, transient,
space-occupying hydrogel to be marketed in the US
and the only weight management treatment available
by prescription for patients with a BMI of 25-30 kg/m2,
regardless of...
Antibacterial Drugs for Lyme Disease
The Medical Letter on Drugs and Therapeutics • May 17, 2021 (Issue 1624)
is also transmitted by I. scapularis, has been shown to
cause a similar illness in the upper Midwest.1-3 ...
Lyme disease in the US is caused by the spirochete
Borrelia burgdorferi, which is transmitted to humans
by Ixodes scapularis (blacklegged [deer] tick) and
I. pacificus (western blacklegged tick). Most cases of
Lyme disease occur in late spring and early summer
in northeastern and mid-Atlantic states, the upper
Midwest, and in northern California. B. mayonii, which
is also transmitted by I. scapularis, has been shown to
cause a similar illness in the upper Midwest.
Loteprednol 0.25% (Eysuvis) for Dry Eye Disease
The Medical Letter on Drugs and Therapeutics • May 17, 2021 (Issue 1624)
inhibitors
(SSRIs). Dry eye disease is most prevalent in women
and older adults.1,2
STANDARD TREATMENT ...
The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis – Kala) for
short-term treatment (≤2 weeks) of dry eye disease.
It is the first ocular corticosteroid to be approved for
this indication. Other formulations of loteprednol are
approved for treatment of steroid-responsive ocular
inflammatory conditions, inflammation after ocular
surgery, and seasonal allergic conjunctivitis.
MenQuadfi - A New Meningococcal (A, C, W, and Y) Vaccine
The Medical Letter on Drugs and Therapeutics • May 17, 2021 (Issue 1624)
impairment. Rates of
meningococcal disease are highest in infants ...
The FDA has licensed MenQuadfi (Sanofi Pasteur),
a quadrivalent polysaccharide conjugate vaccine
that uses tetanus toxoid as a protein carrier, for
prevention of invasive meningococcal disease caused
by Neisseria meningitidis serogroups A, C, W, and Y
(MenACWY) in persons ≥2 years old.
In Brief: Suspension of Johnson & Johnson COVID-19 Vaccine Lifted (online only)
The Medical Letter on Drugs and Therapeutics • May 17, 2021 (Issue 1624)
million doses of the single-dose vaccine had been
administered in the US at the time of the review.1-4 ...
On April 23, 2021, on advice from the Advisory
Committee on Immunization Practices (ACIP), the
FDA and CDC recommended that use of the Johnson
& Johnson adenovirus-based COVID-19 vaccine
resume despite its association with development of
thrombosis with thrombocytopenia syndrome (TTS).
Administration of the vaccine had been paused on April
13 because of 6 reports of TTS, but after completing a
data review that identified a further 9 cases associated
with the formulation, the agencies concluded that the
benefits of the vaccine outweighed its risks. About
7.98 million doses of the...
Vibegron (Gemtesa) for Overactive Bladder
The Medical Letter on Drugs and Therapeutics • May 03, 2021 (Issue 1623)
to
be approved in the US; mirabegron (Myrbetriq) was
the first.1
STANDARD TREATMENT — Overactive bladder (OAB ...
The FDA has approved the selective beta-3 adrenergic
agonist vibegron (Gemtesa – Urovant Sciences)
for treatment of overactive bladder in adults with
symptoms of urge urinary incontinence, urgency, and
urinary frequency. It is the second beta-3 agonist to
be approved in the US; mirabegron (Myrbetriq) was
the first.