Klaron

What is Klaron?

Klaron is a prescription mrdicine thatis used to treat pimples (acne).

Description

Each mL of Klaron® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of edetic acid, hydroxyethyl cellulose, lauramide DEA, methylparaben, PEG-400 monolaurate, propylene glycol, purified water, silicone emulsion, sodium chloride, sodium metabisulfite, and xanthan gum.

Sodium sulfacetamide is a sulfonamide with antibacterial activity. Chemically, sodium sulfacetamide is N’ -[(4-amino phenyl) sulfonyl] – acetamide, monosodium salt, monohydrate. The structural formula is:

Before taking Klaron, tell your doctor:

• If you have a sulfa allergy.
• If you are allergic to Klaron; 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 using drugs that have silver in them.
• If you have kidney disease.

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 Klaron 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 Klaron?

• Tell all of your health care providers that you take Klaron. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may stain clothing or fabric.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not use longer than you have been told. A second infection may happen.
• If you use Klaron too often, your skin problem may become worse.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• 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 Klaron best taken?

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

• Do not take Klaron by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Use as you have been told, even if your signs get better.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Shake well before use.

What do I do if I miss a dose?

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

What are the side effects of Klaron 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.
• Rarely, very bad effects have happened with sulfa drugs. Sometimes, these have been deadly. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or 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.
• A health problem called lupus has happened with drugs like this one. One death has been reported. Tell your doctor right away if you have signs of lupus like a rash on your cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.

What are some other side effects of Klaron?

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:

• 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 Klaron?

• Store at room temperature. Do not freeze.
• Protect from heat.
• Keep lid tightly closed.
• 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 – 118 ML BOTTLE CARTON