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What is ivermectin approved for in the U.S.?
A: Ivermectin tablets are approved for use in humans for the treatment of some parasitic worms (intestinal strongyloidiasis and onchocerciasis) and ivermectin topical formulations are approved for human use by prescription only for the treatment of external parasites such as headlice and for skin conditions such as rosacea.
Ivermectin is FDA-approved for use in animals for prevention of heartworm disease in some small animal species, and for treatment of certain internal and external parasites in various animal species. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular species for which they are labeled. Using these products in humans could cause serious harm.
Q: Is there any danger to humans taking ivermectin?A: There are approved uses for ivermectin in people and animals but it is not approved for the prevention or treatment of COVID-19. You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.
Some of the side-effects that may be associated with ivermectin include skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalization and liver injury (hepatitis). Laboratory test abnormalities include decrease in white cell count and elevated liver tests. Any use of ivermectin for the prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established. Data from clinical trials are necessary for us to determine whether ivermectin is safe and effective in treating or preventing COVID-19.
Q: What should I do if the ivermectin products I purchase for use in my animals are not available at my typical retailer?A: Ivermectin is an important part of a parasite control program for certain species and should only be given to animals for approved uses or as prescribed by a veterinarian in compliance with the requirements for extra-label drug use. Due to potentially elevated interest in ivermectin following the new research, some products may not be available. If you are having difficulty locating a particular ivermectin product for your animal(s), the FDA recommends that you consult with your veterinarian.
Q: What is the FDA doing to protect people from fraudulent COVID-19 products?A: We have established a cross-agency task force dedicated to closely monitoring for fraudulent COVID-19 products. We have reached out to major retailers to ask for their help in monitoring online marketplaces for fraudulent COVID-19 products. Products sold are subject to FDA investigation and potential enforcement action if they claim to prevent, diagnose, treat, or cure COVID-19 and have not demonstrated safety and effectiveness for that intended use. The task force has already worked with retailers to remove dozens of these types of product listings online.
The FDA and the Federal Trade Commission (FTC) issue warning letters to companies that violate federal law and pose significant risks to patient health by selling unapproved products with fraudulent claims to treat or prevent COVID-19. View the warning letters for more information.
Before taking this medicineYou should not use ivermectin if you are allergic to it.
To make sure ivermectin is safe for you, tell your doctor if you have:
liver or kidney disease; or
cancer, HIVor AIDS, or other conditions that can weaken your immune system.
It is not known whether ivermectin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Ivermectin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Ivermectin should not be given to a child who weighs less than 33 pounds (15 kg).
How should I take ivermectin?Never take ivermectin in larger amounts, or for longer than recommended by your doctor. Follow all directions on your prescription label.
Here’s What You Need to Know about IvermectinFDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Ivermectin is not an anti-viral (a drug for treating viruses).
Taking large doses of this drug is dangerous and can cause serious harm.
If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed.
Never use medications intended for animals on yourself. Ivermectin preparations for animals are very different from those approved for humans.
Uses
This medicationis used to treat certain parasitic roundworm infections. Curing parasitic infections helps to improve your quality of life. In people with weakened defense (immune) systems, curing roundworm infections can reduce the risk of developing a severe or life-threatening infection. Ivermectinbelongs to a class of drugs known as antihelmintics. It works by paralyzing and killing parasites.Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdosemay include: numbness, tingling, trouble breathing, loss of coordination, seizures.
How to use Ivermectin
Take this medicationby mouthwith a full glass of water (8 ounces or 240 milliliters) on an empty stomachat least 1 hour before a meal. Ivermectinis usually taken as a single dose or series of doses, or as directed by your doctor.
Dosage is based on your weight, medical condition, and response to treatment.
Tell your doctor if your condition persists or worsens.
Precautions
Before taking ivermectin, tell your doctor or pharmacistif 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 traveled 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 more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholicbeverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentistabout all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
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