Mission Pharmacal Expands Its Prescription Dermatology Offerings

Ovace for seborrheic dermatitis and seborrhea siccaItch. Scratch. Repeat. Irritating skin conditions, such as seborrheic dermatitis (SD), can create a distracting, uncomfortable vicious circle for those affected.

In teens and adults, this common skin disease tends to be a chronic condition with no cure. Scaly, reddish, or flaking patches may form on the scalp, face, and ears. These symptoms can come and go throughout a person’s life.

The encouraging news is appropriate treatment can reduce flare-ups of SD and provide relief.2 Based on a patient’s symptoms and other health factors, a dermatologist or primary care physician can design a treatment plan that may combine two or more high-quality medications, such as prescription-strength dandruff shampoos, washes, topicals, and barrier repair creams.

To help bring a treatment option to people afflicted with common skin disorders including SD, Mission Pharmacal Company is adding Ovace® Plus Lotion (sodium sulfacetamide 9.8%) to its popular family of Ovace® product offerings.

Ovace Plus Lotion joins Ovace® Plus Wash (sodium sulfacetamide 10%) Cleansing Gel and Ovace® Plus Shampoo (sodium sulfacetamide 10%) formulated with the proven action of sodium sulfacetamide for SD, seborrhea sicca (dandruff), and infections of the skin caused by sulfonamide-susceptible bacteria.

Ovace products help manage flares and control the symptoms of SD and dandruff.

“Ovace Plus Lotion is a new formulation to help manage the itching and flaking often associated with SD and dandruff,” says Rusty Nolen, Dermatology Marketing Director, Mission Pharmacal. “In addition, the lotion formulation is designed to cover larger affected areas of the body.”

Ovace products are free of steroids and sulfurs. These features make them suitable for this chronic condition and give physicians more flexibility in treating patients who are allergic or sensitive to sulfur.

In addition, Ovace products provide physicians and their patients with the added assurance of being manufactured in the U.S. using high-quality raw ingredients in compliance with the highest manufacturing standards.

Complete information about Ovace products, including full prescribing information, is available at ovace.com. This fact-packed website also provides information about common skin conditions.

INDICATIONS: OVACE® Plus Lotion (sodium sulfacetamide) is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).

OVACE® Plus Lotion is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Sodium sulfacetamide is a sulfonamide with antibacterial activity.

Important Safety Information

CONTRAINDICATIONS:

OVACE® Plus Lotion is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of this product. OVACE® Plus Lotion should not be used by patients with kidney disease.

WARNINGS:

Serious hypersensitivity reactions, such as Stevens-Johnson syndrome, have been reported with sulfonamides, including topical sodium sulfacetamide. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide, including one case with a fatal outcome, have been reported. OVACE® Plus Lotion should be discontinued at the first signs of hypersensitivity, skin rash, or other reactions.

Topical sodium sulfacetamide should be kept out of the reach of children.

PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Non-susceptible organisms, including fungi, may proliferate with use of this preparation.

Although rare, sensitivity to sulfacetamide may occur. Patients who may be prone to hypersensitivity to topical sulfonamides should be carefully monitored. If the condition under treatment becomes worse, or irritation, signs of hypersensitivity, or other untoward reactions occur, this product should be discontinued and appropriate therapy instituted. Patients should be instructed to discontinue this product immediately and notify a physician if any arthritis, fever, or sores in the mouth occur.

Patients should be carefully monitored for local irritation or sensitization during long-term therapy. Systemic toxic reactions (e.g., agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis) indicate sensitivity to sulfonamides. Hypersensitivity reactions may occur when a sulfonamide is readministered, regardless of the route of administration, and cross-reactivity between different sulfonamides may occur.

Particular caution should be employed if topical sulfacetamide is applied to large, infected, abraded, denuded or severely burned areas. As with systemic administration of sulfonamides, appropriate observations and laboratory determinations should be performed.

OVACE® Plus Lotion is for external use only. Patients should be instructed to avoid contact with eyes, lips, and mucous membranes.

Long-term animal studies to assess carcinogenic potential of this product have not been performed.

There are no adequate and well controlled studies of topical sodium sulfacetamide in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be given to a pregnant woman only if clearly needed, or when potential benefits outweigh potential hazards to the fetus.

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

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

ADVERSE REACTIONS:

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported.

For additional information, see ovace.com for full Prescribing Information.

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