Stromectol

What is Stromectol used for?

Stromectol is a prescription medicine that is used to treat infections caused by worms.

Description

STROMECTOL® (Ivermectin) is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5-O-demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:

Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol.

STROMECTOL is available in 3-mg tablets containing the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate, butylated hydroxyanisole, and citric acid powder (anhydrous).

Before taking Stromectol, tell your doctor:

• If you are allergic to Stromectol; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Stromectol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Stromectol?

• Tell all of your health care providers that you take Stromectol. This includes your doctors, nurses, pharmacists, and dentists.
• You will need to have a stool exam after taking Stromectol to make sure the infection is gone.
• Some patients may need to take another dose of Stromectol to treat the infection. Talk with the doctor.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Stromectol while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Stromectol best taken?

Use Stromectol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach.
• Take with a full glass of water.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Only 1 dose of Stromectol is needed. If you miss your dose, take it as soon as you think about it.

What are the side effects of Stromectol that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Change in eyesight, eye pain, or very bad eye irritation.
• Very bad skin irritation.
• Joint pain.
• Swelling.
• Fever.
• Swollen gland.
• A very bad and sometimes deadly brain problem has happened in some patients who also have Loa loa infection. This is rare. Tell your doctor if you have been to West Africa or Central Africa where you can get this infection. Tell your doctor right away if you have signs like neck pain, back pain, red eyes, eye bleeding, shortness of breath, seizures, trouble walking or standing, confusion, feeling very tired or weak, or if you are unable to control your bladder or bowels.

What are some other side effects of Stromectol?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Itching.
• Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Stromectol?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

Stromectol® 3 mg (Ivermectin Tablets)

• Manuf. by: Merck Sharp & Dohme BV 2031 BN Haarlem, Netherlands
  Ivermectin (active ingred.) Made in Macao. Formulated in The Netherlands.
• Distributed by: Merck Sharp & Dohme LLC
  Rahway, NJ 07065, USA
• Each tablet contains 3 mg of ivermectin.
  USUAL DOSAGE: See accompanying circular.
  Store at temperatures below 30°C (86°F).
  Rx only
• 20 Tablets
  (2 Foil Strips of 10 tablets each)
• 32
• NDC 0006-0032-20

SRC: NLM .