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Rosula gel

Generic Name: sulfacetamide/sulfur (SUL-fa-SEET-a-mide/SUL-fur/UE-REE-a)
Brand Name: Examples include Rosula and Sulfatol

Rosula gel is used for:

Treating acne, rosacea, and seborrhea. It may also be used for other conditions as determined by your doctor.

Rosula gel is a sulfonamide antibiotic and keratolytic combination. It works by killing bacteria and shedding the top layer of skin.

Do NOT use Rosula gel if:

  • you are allergic to any ingredient in Rosula gel or sulfur
  • you have had an allergic reaction to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
  • you have kidney disease

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rosula gel:

Some medical conditions may interact with Rosula gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have eczema or a history of lupus

Some MEDICINES MAY INTERACT with Rosula gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Silver-containing products (eg, silver sulfadiazine) because they may decrease Rosula gel's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rosula gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rosula gel:

Use Rosula gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Rosula gel is for use on the skin only. Rosula gel may stain clothing and the skin if too much is used.
  • Wash your hands before and after using Rosula gel, unless your hands are part of the treated area.
  • Gently wash and dry the affected areas. Apply a thin film of Rosula gel to the affected areas, as directed by your doctor.
  • Continue to use Rosula gel even if your condition improves. Do not miss any doses.
  • If you miss a dose of Rosula gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Rosula gel.

Important safety information:

  • It may take several days for Rosula gel to work fully.
  • Rosula gel is for external use only. Avoid getting it in your eyes, nose, or mouth. If you get it in your eyes, rinse immediately with cool water.
  • Talk with your doctor before you use any other medicines or cleansers on your skin.
  • Do not apply Rosula gel to open wounds or to damaged or burned skin without first checking with your doctor.
  • If you use topical products too often, your condition may become worse.
  • Long-term or repeated use of Rosula gel may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Rosula gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rosula gel while you are pregnant. It is not known if this medicine is found in breast milk after topical use. If you are or will be breast-feeding while you use Rosula gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Rosula gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild irritation, stinging, or burning of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cracked or extremely dry skin; fever; joint pain; red, swollen, scaling, or blistered skin; severe diarrhea; severe skin irritation; sores in the mouth; unusual bruising; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Rosula gel may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Rosula gel:

Store Rosula gel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not freeze. Keep Rosula gel out of the reach of children and away from pets.

General information:

  • If you have any questions about Rosula gel, please talk with your doctor, pharmacist, or other health care provider.
  • Rosula gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Rosula gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Rosula gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rosula gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Rosula gel.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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