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Vuity - Pilocarpine Ophthalmic Solution for Presbyopia

   
The Medical Letter on Drugs and Therapeutics • Feb 07, 2022  (Issue 1643)
Vuity - Pilocarpine Ophthalmic Solution for Presbyopia The FDA has approved Vuity (Abbvie), a 1 ...
The FDA has approved Vuity (Abbvie), a 1.25% ophthalmic solution of the muscarinic receptor agonist pilocarpine hydrochloride, for treatment of presbyopia in adults. Pilocarpine 1%, 2%, and 4% ophthalmic solutions (Isopto Carpine, and others) have been available for years for treatment of glaucoma, but local and systemic adverse effects have limited their use.
Med Lett Drugs Ther. 2022 Feb 7;64(1643):17-8 | Show Introduction Hide Introduction

Difelikefalin (Korsuva) for Chronic Kidney Disease-Associated Pruritus

   
The Medical Letter on Drugs and Therapeutics • Feb 07, 2022  (Issue 1643)
skin lesions.1 STANDARD TREATMENT — The first-line treatment for all patients with CKD ...
Difelikefalin (Korsuva – Vifor), an IV kappa opioid receptor (KOR) agonist, has been approved by the FDA for treatment of moderate to severe pruritus associated with chronic kidney disease (CKD) in adults on hemodialysis. It is the first drug to be approved for this indication and the first KOR agonist to become available in the US. Difelikefalin has not been studied in patients on peritoneal dialysis.
Med Lett Drugs Ther. 2022 Feb 7;64(1643):18-9 | Show Introduction Hide Introduction

Lonapegsomatropin (Skytrofa) for Growth Hormone Deficiency

   
The Medical Letter on Drugs and Therapeutics • Feb 07, 2022  (Issue 1643)
their biosimilars. Table 1. Pharmacology Class Recombinant human growth hormone Formulation 3, 3.6, 4.3, 5.2, 6 ...
Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due to inadequate secretion of endogenous growth hormone in children ≥1 year old who weigh ≥11.5 kg. It is the first once-weekly rhGH product to be approved in the US; other available rhGH formulations are administered more frequently.
Med Lett Drugs Ther. 2022 Feb 7;64(1643):20-2 | Show Introduction Hide Introduction

Drugs for Acute Otitis Media in Children

   
The Medical Letter on Drugs and Therapeutics • Feb 07, 2022  (Issue 1643)
children with AOM produced beta-lactamase and were resistant to amoxicillin.1 Moraxella catarrhalis ...
More antibiotics are prescribed for treatment of acute otitis media (AOM) than for any other infection in young children. Children with AOM typically present with otalgia, fever, and bulging and erythema of the tympanic membrane.
Med Lett Drugs Ther. 2022 Feb 7;64(1643):22-3 | Show Introduction Hide Introduction

Glycopyrrolate (Dartisla ODT) for Peptic Ulcer Symptoms

   
The Medical Letter on Drugs and Therapeutics • Feb 07, 2022  (Issue 1643)
Glycopyrrolate (Dartisla ODT) for Peptic Ulcer Symptoms 1. KJ Ivey. Anticholinergics: do they work ...
The FDA has approved adjunctive treatment with Dartisla ODT (Edenbridge), a new orally disintegrating tablet (ODT) formulation of the anticholinergic drug glycopyrrolate, to reduce symptoms of a peptic ulcer. Glycopyrrolate oral tablets (Robinul, Robinul Forte, and generics) were approved for the same indication in 1961.
Med Lett Drugs Ther. 2022 Feb 7;64(1643):24 | Show Introduction Hide Introduction

Paxlovid for Treatment of COVID-19

   
The Medical Letter on Drugs and Therapeutics • Jan 24, 2022  (Issue 1642)
Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease ...
On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease inhibitor ritonavir (Paxlovid – Pfizer) for oral treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh at least 40 kg and are at high risk of progressing to severe disease, including hospitalization or death. Paxlovid was the first oral antiviral drug to be authorized in the US for treatment of COVID-19; Merck's oral antiviral drug molnupiravir was granted an EUA for treatment of COVID-19 on December 23,...
Med Lett Drugs Ther. 2022 Jan 24;64(1642):9-10 | Show Introduction Hide Introduction

Molnupiravir for Treatment of COVID-19

   
The Medical Letter on Drugs and Therapeutics • Jan 24, 2022  (Issue 1642)
of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative ...
The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the FDA in...
Med Lett Drugs Ther. 2022 Jan 24;64(1642):10-1 | Show Introduction Hide Introduction

In Brief: Mifepristone by Mail for Pregnancy Termination

   
The Medical Letter on Drugs and Therapeutics • Jan 24, 2022  (Issue 1642)
be dispensed in person to the patient.1 Removal of the longstanding in-person dispensing requirement under ...
The FDA has removed the requirement that mifepristone (Mifeprex, and generics), a progestin receptor antagonist approved for use in a regimen with the prostaglandin E1 analog misoprostol (Cytotec, and generics) for medical termination of pregnancy, must be dispensed in person to the patient.
Med Lett Drugs Ther. 2022 Jan 24;64(1642):11 | Show Introduction Hide Introduction

Ruxolitinib (Opzelura) for Atopic Dermatitis

   
The Medical Letter on Drugs and Therapeutics • Jan 24, 2022  (Issue 1642)
Ruxolitinib (Opzelura) for Atopic Dermatitis The FDA has approved a 1.5% topical cream ...
The FDA has approved a 1.5% topical cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) for short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients ≥12 years old whose disease has not been adequately controlled with other topical prescription drugs. Ruxolitinib is the first JAK inhibitor to be approved for topical use and the first to be approved in the US for treatment of AD. An oral formulation of ruxolitinib (Jakafi) is approved for treatment of myelofibrosis, polycythemia vera, and...
Med Lett Drugs Ther. 2022 Jan 24;64(1642):12-3 | Show Introduction Hide Introduction

Bupivacaine/Meloxicam (Zynrelef) for Postsurgical Pain

   
The Medical Letter on Drugs and Therapeutics • Jan 24, 2022  (Issue 1642)
anesthetics.1,2 Table 1. Zynrelef Clinical Trial Results Regimen1 Pain Intensity Score2 Opioid Consumption3 ...
The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef – Heron) for single-dose, intraoperative, soft-tissue or periarticular instillation to provide postsurgical analgesia for up to 72 hours in adults undergoing foot and ankle, small-to-medium open abdominal, or lower extremity total joint arthroplasty surgical procedures.
Med Lett Drugs Ther. 2022 Jan 24;64(1642):13-5 | Show Introduction Hide Introduction