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Antibacterial Drugs for Community-Acquired Pneumonia

   
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021  (Issue 1616)
Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) were updated in 2019.1 ...
Treatment of community-acquired pneumonia (CAP) is usually empiric, with selected antibiotic regimens directed against some of the most common causative pathogens. Recommended empiric regimens are listed in Table 2; recommended antibiotic dosages for treatment of CAP are listed in Tables 3 and 4. Joint guidelines for treatment of CAP by the American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) were updated in 2019.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):10-5 |  Show IntroductionHide Introduction

FDA Authorizes Moderna COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021  (Issue 1616)
on December 11, 2020.1 CLINICAL STUDY — Issuance of the EUA was based primarily on the results ...
On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):9-10 |  Show IntroductionHide Introduction

Encorafenib (Braftovi) for Metastatic Colorectal Cancer

   
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021  (Issue 1616)
, and oxaliplatin).1 After failure of initial therapy, subsequent lines of therapy have minimal efficacy ...
The FDA has approved the oral kinase inhibitor encorafenib (Braftovi – Pfizer), in combination with the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux), for treatment of adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. Encorafenib was approved in 2018 for use with the mitogen-activated kinase (MEK) inhibitor binimetinib (Mektovi) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):15-6 |  Show IntroductionHide Introduction

In Brief: Semglee - A New Insulin Glargine for Diabetes

   
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021  (Issue 1616)
), an insulin glargine product similar to Lantus, for treatment of type 1 diabetes in children and adults ...
The FDA has approved Semglee (Mylan), an insulin glargine product similar to Lantus, for treatment of type 1 diabetes in children and adults and type 2 diabetes in adults. Semglee is the second "follow-on" insulin glargine product to become available in the US; Basaglar, which is also similar to Lantus, was the first. Lantus is a recombinant analog of human insulin that forms microprecipitates in subcutaneous tissue, prolonging its duration of action to a mean of about 24 hours with no pronounced peak effect.
Med Lett Drugs Ther. 2021 Jan 25;63(1616):14-5 |  Show IntroductionHide Introduction

In Brief: An Asenapine Patch (Secuado) for Schizophrenia

   
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021  (Issue 1615)
1). Asenapine was also superior to placebo in the Clinical Global Impressions-Severity (CGI ...
A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults. Asenapine is the first antipsychotic to become available in a transdermal formulation in the US. A twice-daily sublingual tablet formulation of asenapine (Saphris) has been available since 2009.
Med Lett Drugs Ther. 2021 Jan 11;63(1615):7-8 |  Show IntroductionHide Introduction

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021  (Issue 1615)
43,548 subjects ≥16 years old were randomized 1:1 to receive 30 mcg of the Pfizer-BioNTech vaccine ...
The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old.
Med Lett Drugs Ther. 2021 Jan 11;63(1615):1-2 |  Show IntroductionHide Introduction

Baloxavir (Xofluza) for Post-Exposure Prophylaxis of Influenza

   
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021  (Issue 1615)
uncomplicated influenza in patients ≥12 years old in 2018.1 Two neuraminidase inhibitors are FDA-approved ...
The oral polymerase acidic endonuclease inhibitor baloxavir marboxil (Xofluza — Genentech) is now FDAapproved for post-exposure prophylaxis of influenza in patients ≥12 years old. Baloxavir was approved for treatment of acute uncomplicated influenza in patients ≥12 years old in 2018.1 Two neuraminidase inhibitors are FDA-approved for prophylaxis of influenza: oseltamivir (Tamiflu, and generics) in patients ≥1 year old, and zanamivir (Relenza) in patients ≥5 years old.2 Unlike oseltamivir and zanamivir, baloxavir is not FDA-approved for pre-exposure prophylaxis of...
Med Lett Drugs Ther. 2021 Jan 11;63(1615):2-3 |  Show IntroductionHide Introduction

Opicapone (Ongentys) - A COMT Inhibitor for Parkinson's Disease

   
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021  (Issue 1615)
clinical trials, opicapone significantly reduced “off” time by about 1 hour, compared to placebo. In one ...
The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in adults with Parkinson’s disease (PD) who experience "off" episodes. It is the third COMT inhibitor to be approved for this indication; tolcapone (Tasmar, and generics) and entacapone (Comtan, and generics) were approved earlier. Opicapone has been available in Europe since 2016.
Med Lett Drugs Ther. 2021 Jan 11;63(1615):3-5 |  Show IntroductionHide Introduction

Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis

   
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021  (Issue 1615)
prolongation and cardiac arrythmias.1,2 The macrolide antibiotics erythromycin and azithromycin ...
The FDA has approved Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D2) receptor antagonist metoclopramide, for relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide (Reglan, and generics) has been available for years in conventional and orally-disintegrating tablets and in an injectable formulation. It is the only drug that is FDA-approved for treatment of diabetic gastroparesis.
Med Lett Drugs Ther. 2021 Jan 11;63(1615):5-7 |  Show IntroductionHide Introduction

IV Amisulpride (Barhemsys) for Postoperative Nausea and Vomiting

   
The Medical Letter on Drugs and Therapeutics • Dec 28, 2020  (Issue 1614)
or motion sickness, female sex, nonsmoking status, age ...
The FDA has approved IV amisulpride (Barhemsys – Acacia), a selective dopamine-2 and -3 (D2/D3) receptor antagonist, for prevention and treatment of postoperative nausea and vomiting (PONV) in adults. It is the first antiemetic to be approved for rescue treatment of PONV in patients who have symptoms despite receiving antiemetic prophylaxis. Oral formulations of amisulpride are available in Europe for treatment of schizophrenia and acute psychotic episodes.
Med Lett Drugs Ther. 2020 Dec 28;62(1614):205-8 |  Show IntroductionHide Introduction