sulfacetamide sodium-sulfur 10 %-5 % topical suspension

Generic name:
Sodium sulfacetamide/sulfur - topical

Pronunciation
(SOE-dee-um SUL-fa-SEET-a-mide/SUL-fur)

Brand name(s)
Plexion TS , Rosula

This medication is used to treat several skin problems (acne, acne rosacea, seborrheic dermatitis). Sodium sulfacetamide works by stopping the growth of certain bacteria on the skin that can lead to acne and worsen these other skin conditions. It belongs to a class of drugs known as sulfa antibiotics. Sulfur works by helping remove the top layer of dead skin. It belongs to a class of drugs known as keratolytics. It may also help kill acne-causing bacteria and unclog pores.

This medication may also contain other ingredients (for example, other keratolytics such as urea).

This medication is for use on the skin only.

Clean and dry the affected skin area and your hands. Some products need to be shaken before use. If so directed on the product label, shake the container well before each use. Apply a thin layer of the product to the areas of skin with acne, rosacea, or seborrhea as directed by your doctor, usually 1 to 3 times daily. Dosage is based on your medical condition and response to treatment. Follow your doctor's directions. Wash your hands with soap and water after each use.

Do not apply this product to skin that is cracked, broken, or raw because this may increase your risk of side effects.

Avoid getting this medication on your eyelids or lips, or in your eyes, nose, or mouth. If you do get medication in these areas, rinse with plenty of water.

Use this medication regularly to get the most benefit from it. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.

Tell your doctor if your condition does not get better after a few weeks or if it worsens.

Mild peeling of the top layer of skin is expected. Skin irritation, redness, and scaling may also occur. If any of these effects last or get worse, stop using this medication and tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, sodium sulfacetamide products applied to the skin may be absorbed and may cause serious side effects. Stop using this product and tell your doctor right away if you have any serious side effects, including:

• aching/swollen joints
• rash on nose and cheeks
• signs of infection (such as sore throat that doesn't go away, fever)
• signs of anemia (such as unusual tiredness/weakness, rapid breathing, fast heartbeat)
• unusual bleeding/bruising
• signs of liver problems (such as nausea that doesn't stop, dark urine, yellowing eyes/skin, stomach/abdominal pain, vomiting)
• mouth sores

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to sodium sulfacetamide or sulfur; or to sulfa antibiotics (such as sulfamethoxazole); or to other ingredients listed on the product package; 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:

• kidney problems

Tell your doctor if there are areas of skin near where this product will be applied that are cracked, broken, or raw. Injured skin may absorb more of this product, and the chance of serious side effects may increase.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• skin products containing silver (such as silver sulfadiazine)

This medicine may be harmful if swallowed. 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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Protect from freezing. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.