Each mL of Klaron® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite; methylparaben; xanthan gum; EDTA and simethicone.

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

Last updated on RxList: 9/15/2008

Klaron Lotion is indicated in the topical treatment of acne vulgaris.

Apply a thin film to affected areas twice daily.

4 FL OZ (118mL) bottles (NDC 0066-7500-04).

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. Shake well before using. Keep tightly closed.

Prescribing information as of June 2006. Dermik Laboratories. A business of sanofi-aventis U.S. LLC Brigdewater, NJ 08807. FDA Rev date: 2/21/2003

Last updated on RxList: 9/15/2008

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Klaron Lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Klaron Lotion had adverse reactions of erythema, itching and edema. It has been reported that sodium sulfacetamide may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.

No information provided.

Last updated on RxList: 9/15/2008

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.

Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

Klaron Lotion contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).

General: For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sodium sulfacetamide can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Keep out of the reach of children.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy - Category C: Animal reproduction studies have not been conducted with Klaron® Lotion. It is also not known whether Klaron Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Klaron Lotion should be given to a pregnant woman only if clearly needed. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Klaron Lotion in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Klaron Lotion. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Last updated on RxList: 9/15/2008

No information provided.

Klaron Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Last updated on RxList: 9/15/2008

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

Last updated on RxList: 9/15/2008

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 9/15/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

SODIUM SULFACETAMIDE SUSPENSION - TOPICAL (ACNE ONLY)

(sull-fuh-SEET-uh-mide)

COMMON BRAND NAME(S): Klaron

USES: This medication is used to treat acne. Sodium sulfacetamide belongs to a class of drugs known as sulfa antibiotics. It works by killing certain bacteria on the skin that can lead to acne.

HOW TO USE: Shake the container well before each use. Apply a thin film of the lotion to the areas of skin with acne, usually twice daily or as directed by your doctor. Wash your hands with soap and water after each application.

Dosage is based on your medical condition and response to therapy.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not use more of this medication, use it more frequently, or keep using it for longer than prescribed. Your acne will not improve any faster, and your risk of side effects may be increased. Inform your doctor if your acne does not improve or worsens.

SIDE EFFECTS: Skin redness/itching/swelling at the site of application may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Although this effect is unlikely with sulfa medications that are applied to the skin, some rare but serious side effects have occurred with other sulfa antibiotics when taken by mouth. Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea, vomiting, weakness, tiredness, stomach/abdominal pain, yellowing eyes/skin, loss of appetite, dark urine, painful/swollen joints, fever, new cough, easy bleeding/bruising, sudden weakness, pale skin, fast breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using sulfacetamide lotion, tell your doctor or pharmacist if you are allergic to it; or to other sulfa antibiotics (e.g., sulfamethoxazole, sulfisoxazole); or to sulfites; or if you have any other allergies.

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

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used on the same skin area with the following medications: skin preparations containing silver.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

Keep all medical appointments.

MISSED DOSE: 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 and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.