Stromectol: Things To Know Before You Use It

stromectol ivermectin
BRAND INFORMATION

Brand name: Stromectol
Active ingredient: Ivermectin

Schedule: S4

Consumer Medicine Information (CMI)

Please read this leaflet carefully before you start using Stromectol.

Table of Contents

What it is used for

STROMECTOL (ivermectin) is indicated for the treatment of:

a) Onchocerciasis and intestinal strongyloidiasis (anguillulosis).
b) Crusted scabies in conjunction with topical therapy

c) Human sarcoptic scabies when prior topical treatment has failed or is contraindicated.

Treatment is only justified when the diagnosis of scabies has been established clinically and /or by parasitological examination. Without a formal diagnosis, treatment is not justified in the case of pruritus alone.

Visual appearance

White, round, flat uncoated tablets with a bevelled edge; unscored on one side and engraved with MSD and 32 on the other.

STROMECTOL
stromectol ivermectin 3mg

How do I use STROMECTOL?

How much to take

Your doctor will tell you how many tablets you need to take.

The dose depends on your infection and your weight or height. The dose usually ranges from one tablet to five tablets taken as a single dose.

For river blindness, you may need to take another dose in 6 to 12 months’ time.

Depending on whether you have typical or crusted scabies, your doctor will decide the best treatment for you.

The most common course of treatment is two doses, 8-15 days apart. STROMECTOL can be used alone or in combination with other treatments for scabies.

How to take STROMECTOL

Take STROMECTOL as a single dose with a full glass of water.

Always take STROMECTOL only as prescribed by your doctor.

If you use too much STROMECTOL

If you think that you have used too much STROMECTOL, you may need urgent medical attention.

If you take too many tablets, you may experience some of the following:

  • skin rash, hives;
  • swelling of the legs, ankles or feet;
  • headache, dizziness, feeling sleepy;
  • loss of consciousness;
  • nausea, vomiting, diarrhoea;
  • stomach pain;
  • dilated pupils of your eyes;
  • shortness of breath;
  • walking unsteadily; decreased activity; shaking (or tremors);
  • unusual weakness
  • tingling or numbness of the hands or feet;
  • seizure.
What happens if I overdose?

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 are the dosages of STROMECTOL?

Dosages of Stromectol:

Adult and Pediatric Dosage Forms and Strengths

Tablet

  • 3 g

Dosage Considerations – Should be Given as Follows:

Medical condition

Weight

Recommended dosage

Strongyloidiasis of the Intestinal Tract

Under 15 kg

Safety and efficacy not established

25-35 kg

6 mg orally once

36-50 kg

9 mg orally once

51-65 kg

12 mg orally once

66-79 kg

15 mg orally once

over 80 kg

200 mcg/kg orally once

River Blindness (Onchocerciasis)

Under 15 kg

Safety and efficacy not established

15-25 kg

3 mg orally; may repeat in 3-12 months

26-44 kg

6 mg orally; may repeat in 3-12 months

45-64 kg

9 mg orally; may repeat in 3-12 months

65-84 kg

12 mg orally; may repeat in 3-12 months

85 kg and greater

150 mcg/kg orally; may repeat in 3-12 months

In general repeat doses are not necessary; perform stool examinations to verify eradication of infection

Dosing considerations

  • Note: Does not treat adult worms (must be surgically excised)

Head Lice (Pediculosis capitis; Off-label)

  • 200 mcg/kg orally once; may require 1-2 additional doses repeated after 7 days

Blepharitis (Demodex folliculorum; Off-label)

  • 200 mcg/kg orally once as a single dose, THEN repeat dose once in 7 days

Filariasis Due to Mansonella ozzardi (Off-label)

  • 6 mg orally as a single dose

Filariasis Due to Mansonella streptocera (Off-label)

  • 150 mcg/kg as single dose

Scabies Due to Sarcoptes scabiel

  • Immunocompromised patients: 200 mcg/kg as a single dose; may repeat in 14 days if necessary

Gnathostoma spinigerum

Administration

  • Take on an empty stomach
  • Monitor: Stool exams (Strongyloides)

What happens if I miss a dose?

Since Stromectol is usually given in a single dose, you may not be on a dosing schedule. If you are on a schedule, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.

What other drugs interact with STROMECTOL?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

  • Ivermectin has no known severe interactions with other drugs.
  • Serious Interactions of ivermectin include:
    • ivacaftor
    • quinidine
  • Ivermectin has moderate interactions with at least 47 different drugs.
  • Ivermectin has no known mild interactions with other drugs.

This doesn’t list all interactions or side effects.

Tell your doctor or pharmacist about all your medications before taking this product. Share your drug list with your doctor and pharmacist. If you have health issues, concerns, or want more information about this drug, see your doctor.

What are the warnings and precautions for STROMECTOL?

Warnings

  • This medication contains ivermectin. Do not take Stromectol if you are allergic to ivermectin or any ingredients contained in this drug.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • Hypersensitivity to ivermectin

Effects of Drug Abuse

  • No information available

Short-Term Effects

  • See “What Are Side Effects Associated with Using Stromectol?”

Long-Term Effects

  • See “What Are Side Effects Associated with Using Stromectol?”

Cautions

  • May cause cutaneous and/or systemic reactions
  • Does not kill adult Onchocerca volvulus, only microfilariae
  • Not active against disseminated Strongyloides, only intestinal
  • The potential risk of Mazzotti reactions (cutaneous and systemic adverse effects)
  • May be required to repeat treatments in immunocompromised patients
  • Suppressive therapy (monthly) may be necessary to control extraintestinal strongyloidiasis
  • Perform pretreatment assessment for Loa loa infection in any patient with significant exposure to endemic areas; serious and/or fatal encephalopathy reported during treatment in patients with loiasis

Pregnancy and Lactation

  • Use ivermectin with caution during pregnancy if benefits outweigh risks
  • Animal studies show risk and human studies are not available, or neither animal nor human studies were done
  • Ivermectin enters breast milk
  • The American Academy of Pediatrics (AAP) Committee states ivermectin is compatible with nursing

Are there any side effects?

Inform your doctor or pharmacist if you feel ill while taking STROMECTOL.

Although it may have negative effects, STROMECTOL helps most with river blindness, threadworm, or scabies. All drugs have adverse effects. Some are serious; most are not. If you have adverse effects, get medical help. Ask your doctor or pharmacist if you have concerns regarding side effects.

Less serious side effects for patients being treated for river blindness

Less serious side effects 

What to do

Muscles and joint related
  • painful joints or muscles
Skin related
  • skin rash, itching or swelling
Lung related
  • worsening asthma
Eye related
  • swelling of the eyelids, conjunctivitis, a gritty or painful eye, redness of the eye, visual impairment
Heart related
  • fast heartbeat
Other
  • painful and tender glands in the neck, armpits or groin
  • fever
  • lightheadedness or dizziness, especially when standing up
  • headache
  • swelling of the face, legs, ankles or feet
Some of these are symptoms of an allergic reaction which may occur as a result of the death of the worms after taking STROMECTOL for river blindness. They are usually not serious side effects.
Speak to your doctor if you have any of these less serious side effects, and they worry you.

Less serious side effects for patients being treated for threadworm

Less serious side effects

What to do

Gastrointestinal related

  • nausea, vomiting, diarrhoea, constipation
  • lack or loss of appetite
  • stomach pain

Skin related

  • skin rash, itching or hives

Lung related

  • worsening asthma

Other

  • unusual tiredness or weakness
  • sleepiness
  • dizziness
  • spinning sensation, also called vertigo
  • shaking or tremors
  • lightheadedness or dizziness, especially when standing up

These are usually not serious side effects.

Speak to your doctor if you have any of these less serious side effects, and they worry you.

Less serious side effects for patients being treated for scabies

Less serious side effects

What to do

Gastrointestinal related

  • stomach discomfort

Skin related

  • rash

Other

  • tiredness
  • dizziness

The most common side effects reported are due to the death of the mites and include:

  • headache
  • joint pain
  • loss of appetite
  • worsening of the itching.

Speak to your doctor if you have any of these less serious side effects, and they worry you.

Serious side effects for patients being treated for river blindness, threadworm or scabies

Serious side effects

What to do

Allergic reaction related

  • severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell.
  • skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals

These are serious side effects. You may need urgent medical attention. These side effects are rare.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

If the patient has intestinal worms, ivermectin may kill the worms, and patients may notice them being expelled during defaecation.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who distributes STROMECTOL

Location

Australia

Company

Merck Sharp & Dohme (Australia) Pty Limited

Address

Level 1, Building A 26 Talavera Road

Macquarie Park NSW 2113

 

S-IPC-MK-0933-T-032021

RCN000019992-AU

Copyright © (2021) Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All rights reserved.

References

  1. Stromectol. Ivermectin, Brand Information. nps.org.au. Updated: by MIMS April 2022. Available from: [URL_Link]
  2. Stromectol – Uses, Side Effects, and More. webmd.com. Available from: [URL_Link]
  3. Brand name: Stromectol. healthdirect.gov.au. Available from: [URL_Link]
  4. New Zealand consumer medicine information. medsafe.govt.nz. Available from: [URL_Link]
  5. Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases. Reviewed By: Charles Patrick Davis, MD, PhD on 8/12/2020. Available from: [URL_Link]

  6. Ivermectin (Stromectol) Basics, Side Effects, Reviews & More. goodrx.com. Available from: [URL_Link]
  7. Stromectol. drugs.com. Available from: [URL_Link]
Disclaimer

Never Give Up Team info isn’t for emergencies. Call triple zero (000) if you have an acute sickness, overdose, or emergency.

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6 thoughts on “Stromectol: Things To Know Before You Use It”

  1. I’ve read this AFTER my treatment, and I’m shocked by the side effects. I didn’t have any of these. I guess I’m lucky.

    Reply

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