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  • MDX COVID-19 Resources
  • COVID-19 News
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IBM Micromedex(R) has the following selected resources to provide assistance during the COVID-19 crisis:

COVID-19 Vaccine EUA Drug Monographs

The US FDA has granted Emergency Use Authorization (EUA) for the following vaccines:

  • SARS-COV-2 (COVID-19) Vaccine, Adenovirus 26 Vector (Janssen) for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 18 years of age or older: https://ibm.biz/Bdfie3
  • SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna) for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 18 years of age or older: https://ibm.biz/Bdfxjz
  • SARS-COV-2 (COVID-19) Vaccine, mRNA (Pfizer) for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 16 years of age or older: https://ibm.biz/BdfxjP

Drug Consults

  • COVID-19 Overview - Drug Consult with information on Coronavirus for clinicians: https://ibm.biz/Bdqiw5
  • Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT): http://www.micromedexsolutions.com/micromedex2/librarian/deeplinkaccess?source=deepLink&SearchTerm=Vaccine-Induced+Immune+Thrombotic+Thrombocytopenia (new Apr 23)
  • Heparin-Induced Thrombocytopenia (HIT) Drug Therapy : https://ibm.biz/Bdfqnu
  • COVID-19 Investigational Therapies - Drug Consult with information on COVID-19 investigational therapies for clinicians: https://ibm.biz/BdqZ8m
  • COVID-19 - Select Vaccine Candidates - Drug Consult with information on current vaccine candidates that are under investigation for use in the prevention of COVID-19 caused by the SARS-CoV-2 virus: https://ibm.biz/BdqNhn
  • COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C) - Drug Consult: https://ibm.biz/BdqgTM
  • COVID-19 and Oncology Patients - Drug Consult with information on reducing the risk of COVID-19 in oncology patients: https://ibm.biz/BdqY5U
  • COVID-19: Coagulopathy, Thrombosis, and Antithrombotic Therapy - Drug Consult with evidence related to development of coagulopathy and thrombotic complications in patients with COVID-19 as well as recommendations for antithrombotic therapy and management of coagulopathy associated with COVID-19: https://ibm.biz/BdqSEn
  • COVID-19 - Guidelines for Concomitant Use of Corticosteroids - Drug Consult with recommendations and guidelines on the use of corticosteroids in patients with COVID-19: https://ibm.biz/BdqyNm
  • COVID-19 - Pharmacologic Management of Adults in the ICU - Drug Consult with information on managing critically ill adults with COVID-19: https://ibm.biz/BdqY55
  • Additional Drug Consults relating to COVID-19 are available and can be found under the alphabetical list of Drug Consults starting with the "COVID-19" title or by using the following link and choosing filter by "Drug" https://ibm.biz/BdqNmM.

COVID-19 EUA Drug Monographs

The US FDA has granted Emergency Use Authorization (EUA) for the following:

  • Bamlanivimab and Etesevimab to treat mild to moderate COVID-19 in adults and pediatric patients who are 12 years of age and older weighing at least 40 kg, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization https://ibm.biz/Bdq5Vb and https://ibm.biz/Bdfc62. Note: The FDA revoked the EUA for bamlanivimab monotherapy on April 16, 2021.
  • Casirivimab and Imdevimab to treat mild to moderate COVID-19 in adults and pediatric patients who are 12 years of age and older weighing at least 40 kg, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization https://ibm.biz/Bdfc6K and https://ibm.biz/Bdfc6q.
  • COVID-19 Convalescent Plasma to treat hospitalized patients with COVID-19: https://ibm.biz/BdfcMZ.
  • Fresenius Propoven 2% emulsion (propofol 20 mg/mL) to maintain sedation via continuous infusion in adult and pediatric patients older than 16 years of age with suspected or laboratory confirmed COVID-19 who require mechanical ventilation in an ICU setting: http://www.micromedexsolutions.com/micromedex2/librarian/deeplinkaccess?source=deepLink&SearchTerm=propofol. Note: There is a risk of unintentional overdose with the unapproved Fresenius Propoven 2% emulsion. Important differences in formulation and labeling exist between the current US marketed and FDA-approved Diprivan(R) emulsion USP 10 mg/mL and Fresenius Propoven 2% emulsion (20 mg/mL); the products contain the same active ingredient but Fresenius Propoven 2% has double the concentration.

COVID-19 Drug Monograph

Remdesivir is now FDA-approved to treat COVID-19 requiring hospitalization in adult and pediatric patients (12 years of age or older and weighing at least 40 kg). The drug monograph can be found at: http://www.micromedexsolutions.com/micromedex2/librarian/deeplinkaccess?source=deepLink&SearchTerm=remdesivir.

COVID-19 Investigational Drug Monographs

The following is a selected investigational drug monograph for a drug that is being researched for COVID-19:

Last modified: 04/28/2021 11:45:54

FDA COVID-19 Update: EUA Revoked for Bamlanivimab Monotherapy

On April 16, 2021, the US FDA revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on ongoing data analysis, specifically the increase in SARS-CoV-2 viral variants that are resistant to bamlanivimab resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab monotherapy no longer outweigh the known and potential risks for its authorized use. Therefore it was determined that the criteria for issuance of an EUA are no longer being met. Please note that the EUA for bamlanivimab and etesevimab to be used together was NOT revoked. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab.

FDA COVID-19 Update: Moderna COVID-19 Vaccine EUA Revisions for Increased Doses Per Vial

On April 1, 2021, the US FDA announced 2 revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10 to 11 doses. The second revision authorizes the availability of an additional multidose vial in which each vial contains a maximum of 15 doses, with a range of 13 to 15 doses that can potentially be extracted. Please note that the dosing regimen remains unchanged. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-makes-two-revisions-moderna-covid-19-vaccine-emergency-use.

FDA COVID-19 Update: EUA Issued for the Janssen COVID-19 Vaccine

On February 27, 2021, the US FDA issued an emergency use authorization (EUA) to Janssen for a vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 18 years of age or older. This is the third COVID-19 vaccine to gain EUA status after meeting the statutory criteria for issuance. The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 and is administered as a single dose. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine.

FDA COVID-19 Update: More Flexible Storage for Pfizer-BioNTech Vaccine

On February 25, 2021, the US FDA announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to 2 weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80 and -60 degrees C (-112 and -76 degrees F). Pfizer submitted data to the FDA to demonstrate that their COVID-19 vaccine remains stable after storage of the undiluted vials for up to 2 weeks at standard freezer temperature. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer. And for the updated Fact Sheet for Healthcare Providers, visit the following link: https://www.fda.gov/media/144413/download.

FDA COVID-19 Update: EUA Issued for Monoclonal Antibodies

On February 9, 2021, the US FDA issued an Emergency Use Authorization (EUA) for bamlanivimab IV solution and etesevimab IV solution to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are 12 years of age and older weighing at least 40 kg (about 88 lbs) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This EUA includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. In clinical trials, treatment with bamlanivimab and etesevimab significantly reduced COVID-19-related hospitalization and death compared with placebo. Safety and effectiveness of bamlanivimab and etesevimab for use in the treatment of COVID-19 continue to be evaluated. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0?utm_medium=email&source=govdelivery.

FDA Statement on Following Authorized COVID-19 Vaccines Dosing Schedules

On January 4, 2021, the US FDA issued a statement regarding the importance of following the authorized dosing schedules for COVID-19 vaccines. Although there are discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19, changes to dose or dosing schedule are not supported by adequate scientific evidence and may ultimately be counterproductive to public health. Therefore, until vaccine manufacturers have data and science supporting a change, the FDA continues to strongly recommend that healthcare providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-statement-following-authorized-dosing-schedules-covid-19-vaccines.

FDA COVID-19 Update: EUA Issued for the Moderna COVID-19 Vaccine

On December 18, 2020, the US FDA issued an emergency use authorization (EUA) to Moderna for a vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 18 years of age or older. This is the second COVID-19 vaccine to gain EUA status after meeting the statutory criteria for issuance. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid.

FDA COVID-19 Update: EUA Issued for the Pfizer-BioNTech COVID-19 Vaccine

On December 11, 2020, the US FDA issued the first emergency use authorization (EUA) to Pfizer-BioNTech for a vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 16 years of age or older. This is the first COVID-19 vaccine to gain EUA status after meeting the statutory criteria for issuance. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.

FDA COVID-19 Update: EUA Issued for Monoclonal Antibody Cocktail

On November 21, 2020, the US FDA issued an Emergency Use Authorization (EUA) for casirivimab intravenous solution and imdevimab intravenous solution to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are 12 years of age and older weighing at least 40 kg (about 88 lbs) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. In clinical trials, patients treated with casirivimab and imdevimab were shown to have a larger viral load reduction (primary endpoint) compared with those treated with placebo. Additionally, patients at high risk for disease progression who were treated with casirivimab and imdevimab had fewer hospitalizations and emergency room visits (secondary endpoint) compared with those treated with placebo. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19.

FDA COVID-19 Update: EUA Issued for Baricitinib in Combination with Remdesivir

On November 19, 2020, the US FDA issued an Emergency Use Authorization (EUA) for baricitinib oral tablets, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib, which is sold under the brand name of Olumiant(R), is FDA-approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis. While the safety and effectiveness continue to be evaluated for use in COVID-19 treatment, baricitinib in combination with remdesivir was shown in clinical trials to reduce time to recovery within 29 days after initiating treatment compared with placebo plus remdesivir. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19, For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19.

FDA COVID-19 Update: EUA Issued for Monoclonal Antibody Bamlanivimab

On November 9, 2020, the US FDA issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients who are 12 years of age and older weighing at least 40 kg (about 88 lbs). Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. While the safety and effectiveness continue to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment compared with placebo. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19.

FDA COVID-19 Update: First COVID-19 Treatment

On October 22, 2020, the US FDA approved Veklury(R) (remdesivir) IV injection for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kg (about 88 lbs) for the treatment of COVID-19 requiring hospitalization. Veklury, which is the first COVID-19 treatment to gain FDA approval, was approved based on the ACTT-1 clinical trial in which the median time to recovery was fewer days for patients treated with remdesivir plus standard of care compared with those treated with placebo plus standard of care which was a significant difference. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19.

FDA COVID-19 Update: EUA Issued for Convalescent Plasma

On August 23, 2020, the US FDA issued an Emergency Use Authorization (EUA) for convalescent plasma for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Based on scientific evidence available, the FDA concluded that convalescent plasma may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment.

FDA Guidance for Extending COVID-19 Drugs "In-Use Time"

On August 4, 2020, the US FDA issued information regarding extending "in-use time" for drugs needed to treat patients with COVID-19 in response to challenges faced by health care facilities and providers in maintaining adequate supplies of these drugs. In particular, health care facilities and providers have reported that care of ventilated patients can be complicated by the need to discard containers and unused portions before drugs are fully administered because of the in-use time specified on the FDA-approved label. The "in-use time" is the maximum amount of time that can be allowed to elapse between penetration of a a sterile drug product container or after a lyophilized drug product has been reconstituted, and before patient administration. Some facilities and providers are considering use of certain drugs, for which supplies may not be consistently available, beyond the labeled "in-use times." As a result, the FDA is providing extended "in-use time" guidance to ensure necessary access to these drugs and at the same time minimize the likelihood of physicochemical degradation or microbial proliferation in these scenarios. Further information regarding the FDA's guidance for extended "in-use time" can be found at the following link: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/information-health-care-facilities-and-providers-use-time-covid-19.

FDA Guidance

The US FDA is working with US Government partners, including Centers for Disease Control and Prevention (CDC), and international partners to address the COVID-19 outbreak. The FDA plays a critical role in protecting the US from threats including emerging infectious diseases. For continual updates and press releases, visit the following FDA website: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19.

Last modified: 04/19/2021 12:29:18

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