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Micromedex Assistant

Search Micromedex drug information


Conversational Search:

Micromedex Assistant uses cognitive computing in the IBM cloud to gather search intent through conversation, provide specific clinical answers, and guide clinicians to relevant evidence.

How Micromedex Assistant Works:

Ask questions in a natural way, the way clinicians ask clinicians. The more specific the question, the more specific the answer. Examples:

  • What's the adult dose of lisinopril for hypertension?
  • What are approved uses for pristiq?
  • What are the adverse effects of digoxin?
  • Can cefazolin be given IV push?
  • How fast can Daptomycin be given?

Micromedex Assistant Understands:

Micromedex Assistant is in medical residency and can answer many drug information questions. The system learns from interaction with users and will be able to answer more sophisticated questions over time. For now, answers are limited to:

  • Drug Information (e.g. Drug Classes, Dosing, Administration, Medication Safety, Mechanism of Action, Pharmacokinetics, About)
  • Drug Interactions
  • IV Compatibility

Micromedex Assistant does NOT Understand:

  • In Depth Answers
  • NeoFax/Pediatrics, Toxicology, Disease, Lab, Alternative Medicine, Reproductive Risk
  • Third Party content (e.g. Martindale, Index Nominum)

Disclaimer:

Merative’s statements regarding its plans, directions, and intent are subject to change or withdrawal without notice at Merative’s sole discretion. Information regarding potential future products is intended to outline our general product direction and it should not be relied on in making a purchasing decision. The information mentioned regarding potential future products is not a commitment, promise, or legal obligation to deliver any material, code or functionality. Information about potential future products may not be incorporated into any contract. The development, release, and timing of any future features or functionality described for our products remains at our sole discretion.

Latest News
  • Patient Education (CareNotes) Content...
  • Content Update Highlights
  • Your CLINICAL CHALLENGE for May
  • New/Expanded Indications April/May
  • New Drug Approvals April/May
  • Patient Education (CareNotes) Content...
Latest News Close X

•Content Update Highlights include select content updates including primary literature additions as well as guideline additions and updates.

Content Update Highlights are once a month

All select content updates throughout 2025 can be found in Patient Education (CareNotes) Content Update Highlights 2025

Last Update: 04/01/24

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New CareNotes Titles

•Groin Incisions

•Phlebectomy

•Remote Superficial Femoral Artery Endarterectomy

•Sclerotherapy

•Steal Syndrome

•Subclavian Artery Stenosis

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New Guidelines

* Varicella (Chickenpox) Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/varicella.html

•Chickenpox Vaccine

•Chickenpox Vaccine for Children

* Cholera Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/cholera.html

•Cholera Vaccine

* Tdap (Tetanus, Diphtheria, Pertussis) Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/tdap.html

•Tdap and TD Vaccines for Adults

•Tdap and TD Vaccines for Children

* MMR Vaccine (Measles, Mumps, and Rubella): What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/mmr.html

•MMR Vaccine for Adults

•MMR Vaccine for Children

* MMRV Vaccine (Measles, Mumps, Rubella, and Varicella): What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/mmrv.html

•MMRV Vaccine for Children

* COVID-19 Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/covid-19.html

•COVID-19 Vaccines

* Dengue Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/dengue.html

•Dengue Vaccine

* Ebola Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/ebola.html

•Ebola

* Influenza (Flu) Vaccine (Live, Intranasal): What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/influenza-live-intranasal.html

•Nasal Flu Vaccine for Adults

•Nasal Flu Vaccine for Children

* Influenza (Flu) Vaccine (Inactivated or Recombinant): What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/influenza-inactivated.html

•Flu Shot for Adults

•Flu Shot for Children

* Expanded Recommendations for Use of Pneumococcal Conjugate Vaccines Among Adults Aged greater than or equal50 Years

https://pubmed.ncbi.nlm.nih.gov/39773952/

•Acute Coronary Syndrome

•Acute Pericarditis

•Adenitis

•After CABG (Coronary Artery Bypass Graft)

•After Heart Catheterization

•After Radial Heart Catheterization

•Alpha-1 Antitrypsin Deficiency

•Angina

•Aspiration Pneumonia

•Atrial Septal Defect Repair

•Bacterial Meningitis

•Bacterial Pneumonia

•BK Virus Infection

•CABG (Coronary Artery Bypass Graft)

•Chest Pain

•Chronic Lung Disease and Infection Prevention

•Chronic Pericarditis

•Colitis

•Community Acquired Pneumonia

•Complications of Infection

•COPD (Chronic Obstructive Pulmonary Disease)

•COPD: Prevent Exacerbations

•Coronary Artery Disease

•Coronary Artery Disease in Women

•EVALI (E-Cigarette or Vaping-Associated Lung Injury)

•Hepatitis A

•Hepatitis B

•Hospital Acquired Pneumonia

•nfectious Colitis

•Influenza

•Kaposi's Sarcoma

•Legionnaires Disease

•Liver Abscess

•Lung Abscess

•Malaria

•Mumps

•Myelodysplastic Syndromes

•Myocarditis

•Neutropenia

•Noncardiac Chest Pain

•Pleurisy

•Pneumococcal Vaccine for Adults

•Pneumocystis Jiroveci Pneumonia

•Prevent Infections

•Primary Immune Deficiency Disorder

•Sickle Cell Crisis

•Tonsillitis

•Viral Meningitis

•Viral Pneumonia

•Viral Syndrome

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* Hepatitis A Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/hepatitis-a.html

•Hepatitis A Vaccine

•Hepatitis A Vaccine for Children

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* Hepatitis B Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/hepatitis-b.html

•Hepatitis B Vaccine

•Hepatitis B Vaccine for Children

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* Polio Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/polio.html

•Inactivated Polio Vaccine for Adults

•Inactivated Polio Vaccine for Children

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* RSV (Respiratory Syncytial Virus) Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/rsv.html

•RSV Vaccine for Adults

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* Smallpox/Monkeypox Vaccine (JYNNEOS(TM)): What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/smallpox-monkeypox.html

•Mpox Vaccine

•Smallpox Vaccine

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* Meningococcal B Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/meningococcal-b.html

AND

* Meningococcal ACWY Vaccine: What You Need to Know

https://www.cdc.gov/vaccines/hcp/current-vis/meningococcal-acwy.html

•Meningococcal Vaccine for Adults

•Meningococcal Vaccine for Children

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Last modified: 05/08/2025 12:44:49

Content Update Highlights include select content updates including primary literature additions, guideline additions and updates, and Drug Consult additions and updates.

Content Update Highlights are updated every 2 weeks.

All select content updates throughout 2025 can be found in the Drug Consult titled: Content Highlights 2025

Last Update: 5/08/25

*New Off-Label Indication and Dosing

**New Off-Label Dosing

*Sonidegib: Gorlin syndrome

Verkouteren BJA, Cosgun B, Reinders MGHC, et al: A guideline for the clinical management of basal cell naevus syndrome (Gorlin-Goltz syndrome). Br J Dermatol 2022; 186(2):215-226.

Lear JT, Hauschild A, Stockfleth E, et al: Efficacy and safety of sonidegib in adult patients with nevoid basal cell carcinoma syndrome (Gorlin syndrome): results from a phase 2, double-blind, randomized trial. Clin Cosmet Investig Dermatol 2020; 13:117-121.

Non-FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3170/topicId/nonFdaUsesSection

Adult Dosing

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=931478&contentSetId=100

*Mirtazapine: Insomnia

Karsten J, Hagenauw LA, Kamphuis J, et al: Low doses of mirtazapine or quetiapine for transient insomnia: a randomised, double-blind, cross-over, placebo-controlled trial. J Psychopharmacol 2017; 31(3):327-337.

Savarese M, Carnicelli M, Cardinali V, et al: Subjective hypnotic efficacy of trazodone and mirtazapine in patients with chronic insomnia: a retrospective, comparative study. Arch Ital Biol 2015; 153(2-3):231-238.

Non-FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/1610/topicId/nonFdaUsesSection

Adult Dosing

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=923680&contentSetId=100

*Vedolizumab: Microscopic colitis, steroid-refractory

El Hage Chehade N, Ghoneim S, Shah S, et al: Efficacy and safety of vedolizumab and tumor necrosis factor inhibitors in the treatment of steroid-refractory microscopic colitis: a systematic review and meta-analysis. J Clin Gastroenterol 2024; 58(8):789-799.

Miehlke S, Guagnozzi D, Zabana Y, et al: European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations. United European Gastroenterol J 2021; 9(1):13-37.

Non-FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3088/topicId/nonFdaUsesSection

Adult Dosing

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=930961&contentSetId=100

*Minoxidil: Female pattern hair loss (Severe) - Hair graft

Lee WS, Lee HJ, Choi GS, et al: Guidelines for management of androgenetic alopecia based on BASP classification--the Asian Consensus Committee guideline. J Eur Acad Dermatol Venereol 2013; 27(8):1026-1034.

Non-FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/0177/topicId/nonFdaUsesSection

Adult Dosing

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=377498&contentSetId=100

*Minoxidil: Male pattern hair loss (Severe) - Hair graft

Lee WS, Lee HJ, Choi GS, et al: Guidelines for management of androgenetic alopecia based on BASP classification--the Asian Consensus Committee guideline. J Eur Acad Dermatol Venereol 2013; 27(8):1026-1034.

Non-FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/0177/topicId/nonFdaUsesSection

Adult Dosing

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=377498&contentSetId=100

Evolocumab:

Disorder of cardiovascular system, In patients with established cardiovascular disease; Prophylaxis Familial hypercholesterolemia - homozygous, In combination with other LDL-C-lowering therapies Primary heterozygous familial hypercholesterolemia, Alone or in combination with other LDL-C-lowering therapies

Primary hypercholesterolemia, Alone or in combination with other LDL-C-lowering therapies

Patel SB, Wyne KL, Afreen S, et al: American Association of Clinical Endocrinology clinical practice guideline on pharmacologic management of adults with dyslipidemia. Endocr Pract 2025; 31(2):236-262.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3172/topicId/fdaUsesSection

Alirocumab:

Disorder of cardiovascular system, In patients with established cardiovascular disease; Prophylaxis Familial hypercholesterolemia - homozygous, Adjunct to LDL-C-lowering therapies Primary heterozygous familial hypercholesterolemia

Patel SB, Wyne KL, Afreen S, et al: American Association of Clinical Endocrinology clinical practice guideline on pharmacologic management of adults with dyslipidemia. Endocr Pract 2025; 31(2):236-262.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3171/topicId/fdaUsesSection

Inclisiran: Hyperlipidemia, Primary; including heterozygous familial hypercholesterolemia; Adjunct

Patel SB, Wyne KL, Afreen S, et al: American Association of Clinical Endocrinology clinical practice guideline on pharmacologic management of adults with dyslipidemia. Endocr Pract 2025; 31(2):236-262.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3586/topicId/fdaUsesSection

Remdesivir: COVID-19, Hospitalized patients

Bartoletti M, Mozaffari E, Amin AN, et al: A systematic review and meta-analysis of the effectiveness of remdesivir to treat SARS-CoV-2 infection in hospitalized patients: have the guidelines evolved with the evidence. Clin Infect Dis 2025; Epub:Epub.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3456/topicId/fdaUsesSection

Zoster Vaccine Recombinant, Adjuvanted

Jiao X, Zhu J, Ding Y, et al: Effect of herpes zoster vaccine on patients after hematopoietic stem cell transplantation: a systematic review and meta-analysis. Virol J 2025; 22(1):54.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/0804/topicId/fdaUsesSection

Risankizumab-rzaa: Ulcerative colitis, Moderately to severely active

Panaccione R, Louis E, Colombel JF, et al: Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies. J Crohns Colitis 2025; 19(1):jjaf005.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3398/topicId/fdaUsesSection

Risankizumab-rzaa: Crohn disease, Moderately to severely active

Panaccione R, Louis E, Colombel JF, et al: Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies. J Crohns Colitis 2025; 19(1):jjaf005.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3398/topicId/fdaUsesSection

Tralokinumab-ldrm: Atopic dermatitis (Moderate to Severe), in patients not adequately controlled with topical prescription therapies or when those therapies are not advisable

Guttman-Yassky E, Kabashima K, Staumont-Salle D, et al: Targeting IL-13 with tralokinumab normalizes type 2 inflammation in atopic dermatitis both early and at 2 years. Allergy 2024; 79(6):1560-1572.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3588/topicId/fdaUsesSection

Bempedoic acid: Hyperlipidemia, Primary, including heterozygous familial hypercholesterolemia (He FH)

Patel SB, Wyne KL, Afreen S, et al: American Association of Clinical Endocrinology clinical practice guideline on pharmacologic management of adults with dyslipidemia. Endocr Pract 2025; 31(2):236-262

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3451/topicId/fdaUsesSection

Icosapent Ethyl: Hyperlipidemia (Severe), Adjunct to diet

Patel SB, Wyne KL, Afreen S, et al: American Association of Clinical Endocrinology clinical practice guideline on pharmacologic management of adults with dyslipidemia. Endocr Pract 2025; 31(2):236-262.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/2930/topicId/fdaUsesSection

Niacin: Hypertriglyceridemia, severe

Patel SB, Wyne KL, Afreen S, et al: American Association of Clinical Endocrinology clinical practice guideline on pharmacologic management of adults with dyslipidemia. Endocr Pract 2025; 31(2):236-262.

FDA Uses

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3586/topicId/fdaUsesSection

Levetiracetam: Dose Adjustment; Pregnancy

Fallik N, Trakhtenbroit I, Fahoum F, et al: Therapeutic drug monitoring in pregnancy: levetiracetam. Epilepsia 2024; 65(5):1285-1293.

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/2017/topicId/dosageAdjustmentsSection#

Amoxicillin: Adverse Effects; Neurologic Effects; Aseptic meningitis

Banner J, Krulisky K, & Frakes E: Recurrent amoxicillin-induced aseptic meningitis. BMJ Case Rep 2025; 18(3):e262311.

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/0092/topicId/adverseReactionsSection

Tirzepatide: Adverse Effects; Psychiatric Effects; Anorexia nervosa, Relapse

Guerdjikova AI, Dlugosz H, Wolterman R, et al: Relapse in anorexia nervosa associated with tirzepatide: a case report. J Clin Psychopharmacol 2025; Epub:Epub.

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3609/topicId/adverseReactionsSection

Semaglutide: Adverse Effects; Musculoskeletal Effects; Pseudoarthrosis, After posterior cervical fusion

Ng MK, Mastrokostas PG, Mastrokostas LE, et al: Semaglutide use is associated with higher rates of pseudarthrosis and dysphagia in patients undergoing posterior cervical fusion. Spine J 2025; Epub:Epub.

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3304/topicId/adverseReactionsSection

Semaglutide: Adverse Effects; Gastrointestinal Effects; Dysphagia, After posterior cervical fusion

Ng MK, Mastrokostas PG, Mastrokostas LE, et al: Semaglutide use is associated with higher rates of pseudarthrosis and dysphagia in patients undergoing posterior cervical fusion. Spine J 2025; Epub:Epub.

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/3304/topicId/adverseReactionsSection

Fidaxomicin: Adverse Effects; Immunologic Effects; Hypersensitivity Reaction

Chiu CY, Chastain DB, Salam ME, et al: Incidence of fidaxomicin allergy in patients with macrolide allergies: a large database analysis. Antimicrob Agents Chemother 2025; 69(4):e0192424

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/2867/topicId/adverseReactionsSection

Fidaxomicin: Adverse Effects; Immunologic Effects; Anaphylaxis

Chiu CY, Chastain DB, Salam ME, et al: Incidence of fidaxomicin allergy in patients with macrolide allergies: a large database analysis. Antimicrob Agents Chemother 2025; 69(4):e0192424.

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/2867/topicId/adverseReactionsSection

Fidaxomicin: Adverse Effects; Other Effects; Angioedema

Chiu CY, Chastain DB, Salam ME, et al: Incidence of fidaxomicin allergy in patients with macrolide allergies: a large database analysis. Antimicrob Agents Chemother 2025; 69(4):e0192424.

https://www.micromedexsolutions.com/micromedex2/librarian/PFActionId/pf.signInNLink/FwdActionId/hcs.external.RetrieveDocument/ContentSetCode/DRUGDEX-EVALS/DocId/2867/topicId/adverseReactionsSection

Last modified: 05/08/2025 12:23:36

Which of the following treatment modalities is a first-line therapy used to manage symptoms associated with stiff-person syndrome (SPS):

1. Clomipramine: 25mg PO in the morning and 50 mg PO at bedtime every day until spasm resolves.

2. Immune globulin: IV, 2g/kg, divided in 2 daily doses, every month for three months.

3. Baclofen: PO, in increments of 15mg, 30mg, 45mg and 60mg for three days and then 90mg/day.

4. Sufentanil: 1mcg/kg/hr for 24 hours, then 0.5 mcg/kg/hr for 24 hours for the duration of episode.

The correct answer is: 3

Muscle relaxants like Baclofen are prescribed to alleviate muscle stiffness and reduce spasms to help patients regain mobility.

Clomipramine is a tricyclic antidepressant. Though antidepressants may be used to address underlying anxiety or depression, they are not primarily aimed at treating the core symptoms of SPS.

Immunotherapy has been found to be quite effective if response to standard treatment (Baclofen) was poor.

Sufentanil is an analgesic of which spasms are adverse effects.

Last modified: 05/05/2025 11:39:23

Dupixent(R) (dupilumab): First New Targeted Therapy For Chronic Spontaneous Urticaria

On April 18, 2025, the US FDA approved a new indication for Dupixent(R) (dupilumab) intravenous injection indicated for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. This is the first new targeted therapy in over a decade for chronic spontaneous urticaria.

The prescribing information can be found at: https://www.regeneron.com/downloads/dupixent_fpi.pdf.

The press release can be found at: https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131.

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Valtoco(R) (diazepam): Now for Immediate Seizure Medication

On April 16, 2025, the US FDA approved a revised indication for Valtoco(R) (diazepam) nasal spray now indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older. The intranasal formulation of diazepam was previously recognized by the FDA as clinically superior to the rectal gel formulation resulting in its orphan drug exclusivity designation.

The prescribing information can be found at: https://valtoco.com/VALTOCO_Prescribing_Information.pdf.

The press release can be found at: https://www.neurelis.com/neurelis-announces-fda-approval-for-immediate-use-seizure-medication-valtoco-diazepam-nasal-spray-in-ages-2-to-5/.

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Opdivo(R) (nivolumab) plus Yervoy(R) (ipilimumab): For Previously Untreated Microsatellite Instability-High or Mismatch Repair Deficient Unresectable or Metastatic Colorectal Cancer

On April 8, 2025, the US FDA approved a revised indication for Opdivo(R) (nivolumab) plus Yervoy(R) (ipilimumab) intravenous injection now indicated as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). This is the first-ever dual immune checkpoint inhibitor combination to demonstrate significant efficacy benefit compared to ipilimumab monotherapy and chemotherapy in MSI-H/dMMR mCRC patients.

The prescribing information can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s132lbl.pdf.

The press release can be found at: https://news.bms.com/news/corporate-financial/2025/U-S--Food-and-Drug-Administration-Approves-Opdivo-nivolumab-plus-Yervoy-ipilimumab-as-a-Treatment-for-Patients-with-Previously-Untreated-Microsatellite-Instability-High-or-Mismatch-Repair-Deficient-Unresectable-or-Metastatic-Colorectal-Cancer1/default.aspx.

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Uolizna(R) (inebilizumab-cdon): First and Only Treatment For IGG4-RD

On April 3, 2025, the US FDA approved a new indication for Uolizna(R) (inebilizumab-cdon) intravenous injection indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients. The FDA granted Breakthrough Therapy Designation to inebilizumab-cdon for this indication given the high unmet medical need for this condition and the medicine's potential to benefits.

The prescribing information can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761142s003lbl.pdf.

The press release can be found at: https://www.amgen.com/newsroom/press-releases/2025/04/uplizna-inebilizumabcdon-is-now-the-first-and-only-fdaapproved-treatment-for-igg4related-disease.

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Last modified: 04/29/2025 11:23:17

Vanrafia(TM) (atrasentan): For Proteinuria Reduction in Primary IgAN

On April 3, 2025, the US FDA approved Vanrafia(TM) (atrasentan) oral tablets indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g. This indication is approved under accelerated approval based on a reduction of proteinuria and it has not been established whether atrasentan slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

The prescribing information can be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219208s000lbl.pdf.

The press release can be found at: https://www.novartis.com/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan

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Last modified: 04/08/2025 12:32:58

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