Prascion RA with Sunscreens Cream

Rx only
DESCRIPTION: Each gram of Prascion® RA Cream With Sunscreens contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a cream containing avobenzone, benzyl alcohol NF, cetyl alcohol NF, cocoglycerides, dimethicone 200/100, edetate disodium USP, fragrance, glyceryl stearate/Peg-100 stearate, isopropyl myristate NF, light mineral oil NF, octinoxate USP, polysorbate 60 NF, propylene glycol USP, purified water USP, sodium thiosulfate USP, sorbitan monostearate NF, stearyl alcohol NF, xanthan gum NF.

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:

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.

INDICATIONS AND USAGE: Prascion RA Cream With Sunscreens is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Prascion RA Cream With Sunscreens 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.

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 sulfacetamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicated hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

PRECAUTIONS: General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. For external use only. Keep away from eyes. 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.
Keep out of 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 Prascion® RA Cream With Sunscreens. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It 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 Prascion® RA Cream With Sunscreens. 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 children under the age of 12 have not been established.

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION: Apply a thin film of Prascion RA Cream With Sunscreens to affected areas 1 to 3 times daily.

HOW SUPPLIED: NDC 66993-904-45 in 45 g tubes.

Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured for: Prasco Laboratories
                           Mason, OH 45040 USA
Manufactured by: Groupe Parima, Inc.
                           Montreal, QC H4S 1X6 CANADA

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.
• Very bad and rarely deadly effects have happened with sulfa (sulfonamide) drugs like this one. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

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:

• Dry skin.
• Itching.
• 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 Prascion RA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.