Sodium Sulfacetamide and Sulfur Lotion

What is Sodium Sulfacetamide and Sulfur Lotion?

Sodium Sulfacetamide and Sulfur Lotion is a prescription medicine used to treat the symptoms of Acne and Seborrheic Dermatitis. Sodium Sulfacetamide and Sulfur Lotion may be used alone or with other medications.

Sodium Sulfacetamide and Sulfur Lotion belongs to a class of drugs called Acne Agents, Topical Combos; Antipsoriatics, Topical; Antiseborrheic Agents, Topical.

It is not known if Sodium Sulfacetamide and Sulfur Lotion is safe and effective in children.

What are the possible side effects of Sodium Sulfacetamide and Sulfur Lotion?

Sodium Sulfacetamide and Sulfur Lotion may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• aching or swelling joints,
• rash on nose and cheeks,
• fever,
• sore throat,
• unusual tiredness or weakness,
• rapid breathing,
• fast heartbeat,
• unusual bruising or bleeding,
• dark urine,
• yellowing of the skin or eyes (jaundice),
• stomach pain,
• persistent nausea,
• vomiting,
• mouth sores, and
• severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Sodium Sulfacetamide and Sulfur Lotion include:

• skin redness,
• irritation, and
• stinging and burning at the application site

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Sodium Sulfacetamide and Sulfur Lotion. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Each mL of Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) as dispensed contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a lotion of 2-bromo-2-nitropropane-1,3-diol, butylparaben, colloidal activated attapulgite, diethanolamine, hydroxyethyl cellulose, iron oxides, lauramide DEA, methylparaben, polyethylene glycol 400 monolaurate, propylene glycol, purified water, simethicone emulsion, sodium chloride, sodium metabisulfite, sodium polynaphthalenesulfonate, talc, xanthan gum, and zinc oxide.

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N'-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.

The structural formula is:

INDICATIONS

Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION

Shake well before using. Apply a thin film to affected areas with light massaging, 1 to 3 times daily, or as directed by a physician.

(Important to the Pharmacist: At the time of dispensing, add contents of sodium sulfacetamide vial* to the bottle. Shake well and/or stir with a glass rod to insure uniform dispersion. Place expiration date of four (4) months on bottle label.)

*Sodium Sulfacetamide vial contains 2.1 g of sodium sulfacetamide.

HOW SUPPLIED

Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is available as follows:

25 g bottle (NDC 45802-950-01)

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Manufactured by Stiefel Laboratories, Inc. Coral Gables, Fl 33134. Distributed by, Perrigo, Allegan, MI 49010. FDA rev date: n/a

SIDE EFFECTS

Although rare, sodium sulfacetamide may cause local irritation.

DRUG INTERACTIONS

No information provided.

WARNINGS

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep bottle tightly closed.

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 nonasthmatic people.

PRECAUTIONS

General

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. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Teratogenic Effects

Pregnancy Category C-Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free). It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether sodium sulfacetamide is excreted in human milk following topical use of Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free). However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing woman.

Pediatric Use

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

OVERDOSE

No information provided.

CONTRAINDICATIONS

Sodium Sulfacetamide 10% and Sulfur 5% Lotion (Tint Free) is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur, or any other component of this preparation. This drug is not to be used by patients with kidney disease.

CLINICAL PHARMACOLOGY

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.

The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

PATIENT INFORMATION

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