Mepron

What is Mepron used for?

Mepron is a prescription medicine that is used to treat or prevent infections caused by Pneumocystis jirovecii. Mepron may be given to you for other reasons. Talk to your doctor.

Description

MEPRON (atovaquone oral suspension) is a quinone antimicrobial drug. The chemical name of atovaquone is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula:

MEPRON oral suspension is a formulation of micro-fine particles of atovaquone.

Each 5 mL of MEPRON oral suspension contains 750 mg of atovaquone and the inactive ingredients benzyl alcohol, flavor, poloxamer 188, purified water, saccharin sodium, and xanthan gum.

Before taking Mepron, tell your doctor:

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

This is not a list of all drugs or health problems that interact with this medicine.

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 Mepron 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 Mepron?

• Tell all of your health care providers that you take Mepron. This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Mepron best taken?

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

All products:

• Shake well before use.
• Take Mepron with food.
• If you have trouble taking Mepron with food, talk with your doctor.
• Keep taking Mepron as you have been told by your doctor or other health care provider, even if you feel well.

Unit-dose:

• Open pouch. Take contents by mouth. Can be put into a dosing spoon, a cup, or right in the mouth.

Bottle:

• Measure liquid doses carefully. Use the measuring device that comes with Mepron. If there is none, ask the pharmacist for a device to measure Mepron.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, with food.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Mepron 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.
• Low mood (depression).
• Fever.
• White patches in mouth.
• Cough.
• Liver problems have rarely happened with Mepron. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Mepron?

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:

• Headache.
• Upset stomach or throwing up.
• Diarrhea.
• Muscle pain.
• Trouble sleeping.
• Sweating a lot.
• Runny or stuffy nose.
• Flu-like signs.

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 Mepron?

• Store at room temperature. Do not freeze.
• 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

PRINCIPAL DISPLAY PANEL

• NDC 0173-0547-00
• MEPRON
• (atovaquone oral suspension)
• 750 mg/ 5mL
• Each 5 mL sachet (1 teaspoonful) contains 750 mg atovaquone.
• Store at 15o to 25oC (59o to 77oF). DO NOT FREEZE.
• See accompanying prescribing information for Dosage and Administration.
• 5 mL
• Rx only
• Contains 42 sachets of 5 mL each
• ©2020 GSK group of companies or its licensor.

A058473 (62000000058473) Rev. 12/20