Seb-Prev

Sulfacetamide sodium is an antibiotic that fights bacteria on the skin.

Sulfacetamide sodium topical (for the skin) is used to treat acne, dandruff, seborrheic dermatitis (red, flaking skin rash), and certain skin infections.

Sulfacetamide sodium topical may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may need to shake the medicine before each use. Follow the directions on your medicine label.

Make sure the treatment area is clean and dry before using sulfacetamide sodium topical cream, gel, lotion, or solution. Apply the medicine in a thin layer and rub in gently.

To use sulfacetamide sodium soap, wet the skin and apply enough of the medicine to work into a lather. Massage the lather on the skin gently and then rinse thoroughly with plain water. Pat the skin dry with a clean towel.

Apply the foam to dry hair when treating your scalp. Massage gently into the scalp until all the foam dissolves. Allow the foam to dry completely on the treated area.

Do not apply sulfacetamide sodium topical over large skin areas.

Wash your hands after applying this medicine.

If you are using this medicine on your scalp, wash your hair with a non-medicated shampoo at least once per week during treatment.

Sulfacetamide sodium topical is usually applied 2 times per day for 8 to 10 days. Space your doses evenly by applying the medicine at the same times each day.

You may need to keep using the medicine once or twice per week, or once every other week. Follow your doctor's instructions. Call your doctor if your condition comes back after you stop using sulfacetamide sodium topical.

Call your doctor if your symptoms do not improve, or if they get worse while using this medicine.

Store at room temperature away from moisture and heat. Do not freeze.

Store the foam canister upright and keep away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use this medicine for any skin infection that has not been checked by a doctor.

Avoid getting this medicine in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use the medicine on sunburned, windburned, dry, chapped, irritated, or broken skin. Avoid getting sulfacetamide sodium topical soap on your eyelids or lips while washing with it.

Avoid getting this medicine on your clothing. Sulfacetamide sodium topical may leave a slight yellow color on light fabrics.

Avoid exposure to sunlight or tanning beds. Sulfacetamide sodium topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using other medications on the areas you treat with sulfacetamide sodium topical unless your doctor tells you to.

• Tell all of your health care providers that you take this medicine. 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 Seb-Prev 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 or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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.

Seb-Prev™ Gel is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

General

Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Seb-Prev™ Gel produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.

Information For Patients

Patients should discontinue Seb-Prev™ Gel if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Seb-Prev™ Gel also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop. For external use only. Avoid contact with eyes and mucous membranes. Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or poison control center immediately (see OVERDOSAGE).

Drug Interactions

Seb-Prev™ Gel is incompatible with silver preparations.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies for carcinogenic potential have not been performed on Seb-Prev™ Gel to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Seb-Prev™ Gel. It also is not known whether Seb-Prev™ Gel can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Seb-Prev™ Gel should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Seb-Prev™ Gel is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under the age of 12 years have not been established.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Seb-Prev may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.