Ivermectin: What you need to know before using the medication

what is ivermectin used for
BRAND INFORMATION
Active ingredients: Ivermectin (EYE-vər-MEK-tin)
Trade name: Stromectol, Soolantra, Sklice

Other names: MK-933

Molecular Formula: C48H74O14

Modify: 2022-07-30

Create: 2005-11-20

Consumer Medicine Information (CMI)

Please read this leaflet carefully before you start using Ivermectin.

Table of Contents

What is Ivermectin and How is it Used?

Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea.

Some forms of animal ivermectin are approved to prevent heartworm disease and treat certain internal and external parasites. It’s important to note that these products are different from the ones for people and safe only when used in animals as prescribed.

Ivermectin is a U.S. Food and Drug Administration (FDA)-approved prescription medication used to treat certain infections caused by internal and external parasites. When used as prescribed for approved indications, it is generally safe and well tolerated.

During the COVID-19 pandemic, ivermectin dispensing by retail pharmacies has increased, as has the use of veterinary formulations available over the counter but not intended for human use. FDA has cautioned about the potential risks of use for the prevention or treatment of COVID-19.

Ivermectin is not authorized or approved by FDA for the prevention or treatment of COVID-19. The National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines Panel has also determined that there are currently insufficient data to recommend ivermectin for treatment of COVID-19. ClinicalTrials.gov has listings of ongoing clinical trials that might provide more information about these hypothesized uses in the future.

Adverse effects associated with ivermectin misuse and overdose are increasing, as shown by a rise in calls to poison control centres reporting overdoses and more people experiencing adverse effects.

You may need urgent medical attention if you think you have taken too much Ivermectin.

You should immediately:
phone the Poisons Information Centre 

(by calling 13 11 26 in Australia or 0800 764 766 [0800 POISON] in New Zealand), or contact your doctor, or go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

What does this have to do with COVID-19?

In April 2020, Australian researchers published results from a laboratory experiment showing ivermectin could stop the SARS-CoV-2 virus from multiplying in animal cells under a microscope. [5] This discovery was exciting. However, even the researchers themselves have cautioned that this one study is not enough to prove the medicine will work against COVID-19 in humans. [6] The experiment was performed on monkey cells in test tubes, and the dose of ivermectin used was a lot higher than has ever been given to a human. [57]

More work needs to be done; first, to see if ivermectin works on the SARs-CoV-2 virus in humans, and second, to see if there is an effective dose that is also safe. This type of research will involve clinical trials to study medicine in human subjects.

Clinical trial evidence is important because people with COVID-19 may already be very unwell and should not take a medicine that might make them sicker.

Has it already been used for people with COVID-19?

There are some media reports about health professionals in Australia and overseas having ‘success’ using ivermectin as part of COVID-19 treatment. [8,9] There are also preliminary trial results that suggest no benefit from this medicine, [10] or possibly a shorter hospital stay. [11]

At the moment, publicly available details about these cases and trials are limited or have not been peer-reviewed (looked at carefully by experts to ensure the data has been analysed correctly and completely).

So, currently, no clear information confirms whether ivermectin works as a COVID-19 treatment. Instead, plenty of questions need to be answered by well-run and correctly planned clinical trials. These questions include:

  • what are meaningful results that show benefits with this medicine?
  • what is a safe dose to use?
  • should other medicines be given as well?
  • are there side effects that are harmful?
  • can it be given to all patients with COVID-19?

Human clinical trials that include ivermectin as a treatment for COVID-19 are now underway.

Ivermectin is approved in Australia but not for COVID-19

Before a medicine can be sold in Australia, it must be approved by the Therapeutic Goods Administration (TGA), a division of the Australian Government Department of Health. The TGA looks at clinical evidence to assess: 

  • how effective the medicine is for specific uses;
  • how safe the medicine is. 

This information helps the TGA decide who can use the medicine, what doses can be made available, and also what conditions the medicine is approved to treat (these are called indications).

In Australia, ivermectin is approved as a treatment for scabies, the tropical diseases onchocerciasis and strongyloidiasis, and a skin condition called rosacea. [13,14] It is considered a safe treatment when used at the correct doses for these conditions.

Ivermectin is only available on prescription.

Ivermectin is not approved to prevent or treat COVID-19. The safety and effectiveness of this medicine for non-approved conditions is unknown.

Read more about clinical trials and how medicines are approved in Australia.

Medical uses

Ivermectin is used to treat human diseases caused by roundworms and ectoparasites.

Worm infections

Ivermectin is used in mass medication administration programs for river blindness (onchocerciasis) and lymphatic filariasis. A single oral dosage of ivermectin (150 micrograms per kilogram of body weight) kills larval Onchocerca volvulus worms for many months, blocking transmission and disease development Adult worms live in the skin and develop larvae again; ivermectin is taken once a year for 10–15 years to keep them at bay. Oral ivermectin (200 micrograms per kilogram) is administered yearly to treat lymphatic filariasis. ivermectin, diethylcarbamazine citrate and albendazole in places without onchocerciasis; and ivermectin and albendazole in places with onchocerciasis.

The World Health Organization (WHO) considers ivermectin the drug of choice for strongyloidiasis. Most cases are treated with two daily doses of oral ivermectin (200 g per kilogram), whereas severe infections need five to seven days. Ivermectin treats Mansonella ozzardi and cutaneous larva migrans. The U.S. Centers for Disease Control and Prevention (CDC) recommends ivermectin, albendazole, or mebendazole as treatments for ascariasis. Ivermectin is occasionally used with albendazole or mebendazole to treat whipworm and gnathostomiasis.

Mites and insects

Ivermectin treats arthropod parasites. Scabies is treated with permethrin or ivermectin. An initial dosage of ivermectin kills active mites but not their eggs. A second treatment kills newly born mites a week later. For severe “crusted scabies”, the U.S. Centers for Disease Control and Prevention (CDC) recommends up to seven doses of ivermectin over the course of a month, along with a topical antiparasitic. Head lice and pubic lice may be treated with ivermectin or other pesticides. Ivermectin treats rosacea and blepharitis, which Demodex folliculorum mites may cause or worsen.

Side Effects

Side effects 

What to do

  • Headache, dizziness, muscle pain, nausea, or diarrhea may occur. If you are being treated for “river blindness” (onchocerciasis), you may experience reactions to the dying parasites during the first 4 days of treatment, including joint pain, tender/swollen lymph nodes, eye swelling/redness/pain, weakness, vision changes, itching, rash, and fever.
  • If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
  • To reduce dizziness upon standing, get up slowly when rising from a sitting or lying position.
  • neck/back pain, swelling face/arms/hands/feet, chest pain, fast heartbeat, confusion, seizures, loss of consciousness.
  • Tell your doctor right away
  • symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
  • A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms.
  • painful joints or muscles
  • unusual tiredness or weakness
  • skin rash or itch
  • headache
  • nausea, vomiting, stomach discomfort
  • dizziness
  • swelling of the face or the legs
  • worsening asthma.
  • Some of these side effects are likely a reaction to the parasite (worm or mite) dying. The side effects are usually temporary.
  • Consult your doctor if you feel unwell.

 Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This is not a complete list of possible side effects. Contact your doctor or pharmacist if you notice other effects not listed above.

Precautions

  • Before taking ivermectin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
  • Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.
  • If you have travelled or lived in West or Central Africa, you may be infected with certain parasites (such as Loa loa, African trypanosomiasis) that could cause problems with ivermectin treatment. These effects could rarely result in serious (possibly fatal) effects on the brain (such as encephalopathy). Consult your doctor for more information.
  • This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you dizzier. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
  • Before surgery, tell your doctor or dentist about all the products you use (including prescription, nonprescription, and herbal products).
  • If you have a weakened immune system (such as due to HIV infection), you may need repeat treatments with this medicine. Talk to your doctor for more details.
  • During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
  • Ivermectin passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breastfeeding.
  • Consult your pharmacist or physician.

Interactions

  • Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
  • Some of the products that may interact with this drug include barbiturates (such as phenobarbital, butalbital), benzodiazepines (such as clonazepam, lorazepam), sodium oxybate (GHB), valproic acid.

References

  1. Potential medicines to treat COVID-19. Australian Commission on Safety and Quality in Health Care. Available from [URL_Link]
  2. Discovery of SARS-CoV-2 antiviral drugs through large-scale compound repurposing. Nature 2020. National Library of Medicine. Available from [URL_Link]
  3. Ivermectin (Stromectol) for typical and crusted scabies. RADAR. Sydney: NPS MedicineWise, 2014 (accessed 14 August 2020). Available from [URL_Link]
  4. FDA Letter to stakeholders: Do not use ivermectin intended for animals as treatment for COVID-19 in humans. USA: FDA, 2020 (accessed 26 August 2020). Available from [URL_Link]
  5. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res 2020;178:104787. Available from [URL_Link]
  6. Ivermectin and COVID-19: A report in Antiviral Research, widespread interest, an FDA warning, two letters to the editor and the authors’ responses. National Library of Medicine. Available from [URL_Link]
  7. Ivermectin as a potential COVID-19 treatment from the pharmacokinetic point of view: antiviral levels are not likely attainable with known dosing regimens. Biotechnology & Biotechnological Equipment 2020;34:469-74. Taylor & Francis Online. Available from [URL_Link]
  8. Well-respected Australian researcher: Consider triple therapy (ivermectin, zinc, doxycycline) for COVID-19. Utah, USA: TrialSite News, 2020 (accessed 14 August 2020). TS News. Available from [URL_Link]
  9. Broward County doctor using ivermectin off-label combo on COVID-19 patients—it is working & secures county health protocol approval. Utah, USA: TrialSite News, 2020 (accessed 14 August 2020). TS News. Available from [URL_Link]
  10. A randomized trial of ivermectin-doxycycline and hydroxychloroquine-azithromycin therapy on COVID19 patients. Bangladesh, 2020 (accessed 20 August 2020). ResearchGate. Available from [URL_Link]
  11. Effectiveness of ivermectin as add-on therapy in COVID-19 management (pilot trial). medRxiv 2020:2020.07.07.20145979 (accessed 20 August 2020). Available from [URL_Link]
  12. Ivermectin (Stromectol) product information. South Granville, NSW: MSD (Australia) Pty Ltd, 2013 (accessed 20 August 2020). Available from [URL_Link]
  13. Ivermectin (Soolantra) cream product information. Belrose, NSW: Galderma Australia Pty Ltd, 2020 (accessed 26 August 2020). Available from [URL_Link]
  14. Why You Should Not Use Ivermectin to Treat or Prevent COVID-19. U.S. Food & Drug Administration. Available from [URL_Link]
  15. Ivermectin – Uses, Side Effects, and More. WebMD. Available from [URL_Link]
  16. WHO advises that ivermectin only be used to treat COVID-19 within clinical trials. World Health Organization. Available from [URL_Link]

Disclaimer

Our drug info isn’t for emergencies. Call triple zero (000) if you have an acute sickness, overdose, or emergency. When created, correct information was provided. This material shouldn’t be used to replace medical advice, diagnosis, or treatment. Please see our T&Cs.

5 thoughts on “Ivermectin: What you need to know before using the medication”

  1. Every time I read the info about medicines, I’m interested in the people who can use such strong drugs while pregnant. It seems so dumb to me.

    Reply

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