EM·DRUGS

COMING SOON

EM-Drugs is an ongoing project aiming to provide a unique tool about Emergency Medicine Drugs, delivering answers about critical care medications and their indications, doses, preparations, literature evidence reviews and more.

Excited to contribute to Emergency Medicine Education and diffusion of practical and relevant clinical pharmacology!

Cristóbal Sáa, MD
Emergency Medicine
Santiago, Chile

CORE CONTENT ABOUT COMMON CRITICAL CARE DRUGS

SNEAK·PEEK 1: Fibrinolytic Therapy

Tenecteplase (TNK)
e.g. Metalyse®
50mg lyophilized powder

Acute Coronary Syndrome w/ST elevation <12hrs

FDA approved

Studies: 2003 ASSENT-2 Trial

Dose:

<60 kg 30 mg

60 - 69 kg 35mg

70 - 79 kg 40 mg

80 - 89 kg 45 mg

≥90 kg 50 mg


Pulmonary Embolism

FDA not approved (visited June 2021)

Dose:

60 kg 30 mg

60 - 69 kg 35 mg

70 - 79 kg 40 mg

80 - 89 kg 45 mg

≥90 kg 50 mg


Ischemic Stroke (<4.5hrs)

FDA not approved (visited June 2021)

Studies: 2018 EXTEND-IA TNK + part 2 2020

Dose:

0.25mg/kg bolus (max 25mg)

Alteplase (tPA)
e.g. Actilyse®
50mg lyophilized powder

Acute Coronary Syndrome with ST elevation (<12 hours)

FDA approved.

Studies: 1993 GUSTO trial.

Dose, accelerated scheme:

≤67kg: 15mg 1-2 min + 0.75mg/kg 30 min

(max 50mg) + 0.5mg/kg 60min (max 35mg).

>67kg (100 mg in 1.5 hr): 15 mg in 1-2 min + 50 mg in 30 min + 35 mg in 60 min.

Pulmonary Embolism

FDA approved only for high risk, but cardiac arrest not included.

Studies: 2014 metaanalysis, JAMA.

Dose:

Intermediate: 50mg in 2hrs

High risk: 100mg in 2 hrs

Cardiac arrest: 50mg in 2 min

+ 50mg if no ROSC in 15 min

Isquemic Stroke (<4.5 hours)

FDA approved for <3 hours, Universally accepted use in <4.5 hours. Studies: 2008 ECASS III Trial.

Dose:

Total dose 0.9mg/kg (max 90mg)

<100kg 0.09mg/kg 1 min + 0.81mg/kg 60min

>100kg 9mg 1min + 81mg 60min

Fibrinolysis

SNEAK·PEEK 2: Tetanus Immune Globulin (human)

Tetanus Immune Globulin (human): full description

Usage

Tetanus Immune Globulin (TIG) consists of human antibodies derived from healthy donors used for the treatment of tetanus disease and tetanus post-exposure prophylaxis. Provides passive immunity towards tetanus by neutralizing unbound toxins produced by Clostridium tetani (tetanus toxin or tetanospasmin). It improves survival and is considered to be standard treatment.

Indications

Tetanus treatment

Tetanus prophylaxis based on patient’s history of tetanus immunization and wound characteristics:

  • Unknown or <3 previous doses

    • Dirty, tetanus-prone wound*:

      • Give Tetanus and diphtheria (Td) toxoids adsorbed

      • Give Tetanus immune globulin

    • Clean, not tetanus-prone wound:

      • Give Tetanus and diphtheria (Td) toxoids adsorbed, no TIG.

  • 3 or more previous doses

    • Dirty, tetanus-prone wound*:

      • Give Td only if >5 years since last booster, no TIG

    • Clean, not tetanus-prone wound:

      • Give Td only if >10 years since last booster, no TIG

*Tetanus-prone wounds: >6 hours, >1cm depth, high risk of contamination mechanism of injury (missile, crush, burn, frostbite, agriculture-related injuries), presence of devitalized tissue, presence of contaminants (dirt, saliva, etc)

Adult dose

Tetanus treatment: The actual recommended dose is 500 IU IM with part of the dose infiltrated around the source wound (1; CDC 2020). Classically the sugested dose of 3000-6000 Units IM, with part of the dose infiltrated around the wound, derived from limited data from 1960-1980s studies (3; Nation 1965). HyperTET™ 2020 label for active tetanus refers that the “dosage should be adjusted according to the severity of the infection”.

Tetanus prophylaxis: 250 Units IM*.

*FDA Approved in 1957

Pediatric dose

Tetanus Prophylaxis:

<7 years: 4 IU/kg.

>7 years: 250 IU IM.

Tetanus Treatment: 500 IU IM recommended (1; CDC 2020). Very limited data.

Renal, hepatic, geriatric or other adjustments

No adjustments needed.

Dosage Forms: US

HyperTET™ S/D: 250 units/mL (1ml), injectable, only intramuscular administration.

Adverse effects

Frequency not defined:

Central nervous system: increased body temperature.

Local: Local soreness at injection site, pain at injection site, tenderness at injection site

<1%, postmarketing, and/or case reports: Anaphylactic shock, angioedema, nephrotic syndrome.

Product of human plasma, may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

Contraindications

Use with caution in individuals who have experienced allergic or other adverse effects secondary to other immunoglobulin-containing products.

Pregnancy Risk Factor and Lactation

Pregnancy Risk Factor Category C.

Animal reproduction and human pregnancy studies have not been conducted. The CDC recommends Tetanus Immune Globulin and tetanus toxoid containing vaccine as part of the standard wound management to prevent tetanus in pregnant women.

Lactation: very low risk, safe. Minimal risk for breastfeeding and infant. The secretion of immunoglobulin into breast milk may help to transfer passive immunization to the child.

Pharmacology

Half-life elimination: individuals with normal IgG concentration: ~23 days

Time to peak, plasma: IgG concentration: IM: ~2 days

Major drug interactions

Monitor closely the administration of live vaccines: adenovirus type 4 and 7, BCG, measles (rubeola), measles-mumps-rubella, measles-mumps-rubella-varicella, varicella virus, rubella, smallpox. As tetanus immune globulin decreases their effect. Separate any by 3 months (NIH 2020).

References

  1. Centers for Disease Control and Prevention (CDC), Epidemiology and Prevention of Vaccine-Preventable Diseases. Tejpratap S.P. Tiwari, MD; Pedro L. Moro, MD, MPH; and Anna M. Acosta, MD. Chapter 21: Tetanus. Updated December 2020. Visited in June 2021.
    https://www.cdc.gov/vaccines/pubs/pinkbook/tetanus.html#medical

  2. Yen LMM, Thwaites CLU. Tetanus. Lancet. 2019 Apr 20;393(10181):1657-68. doi:10.1016/S0140-6736(18)33131-3.
    https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)33131-3/fulltext#articleInformation

  3. Nation NS, Pierce NF, Adler SJ, Chinnock RF, Wehrle PF: Tetanus: the use of human hyperimmune globulin in treatment. Calif Med 1963; 98: pp. 305-307.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1575749/

  1. NIH (National Institutes of Health). DailyMed. Label: HyperTET™ (Tetanus Immune Globuline - human injection), updated December 2020.
    https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=393fa198-7e07-4162-bd0a-9d873f1544a9&version=17

  2. WHO/UNICEF. Breastfeeding and Maternal Medication Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development, 2002.
    http://apps.who.int/iris/bitstream/handle/10665/62435/55732.pdf;jsessionid=6A78FBE9088BBFA2D9F8B66066747332?sequence=1

Updates coming, enjoy!

EM·DRUGS

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EM-Drugs Team