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Mylan Completes Acquisition of Two Limited-Competition Dermatological Products from Valeant
Mylan Chief Executive Officer
Clindamycin Phosphate / Benzoyl Peroxide Gel, 1%/5%, which is indicated for the topical treatment of acne vulgaris,[1] had U.S. sales of approximately
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[1] Clindamycin taken orally or through IV, has been associated with severe colitis, which may result in death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis have been reported with the use of topical and systemic clindamycin. Patients who experience severe diarrhea, severe abdominal cramps, or allergic symptoms, such as severe swelling or shortness of breath, should immediately discontinue use of the product and consult their physician. The product should not be used in patients with a history of Crohn's disease, ulcerative colitis, or antibiotic-associated colitis. It should not be used with other topical acne medication, unless directed by a physician. Common side effects include dry skin, application site reaction, pruritus, peeling, erythema, and sunburn.
[2] Fluorouracil 5% USP cream may cause fetal harm and should not be used in women who are, or may become, pregnant during therapy. It should not be applied to mucous membranes due to the possibility of local inflammation and ulceration. Exposure to UV rays should be minimized during and immediately following treatment. Fluorouracil 5% USP cream should not be used in patients with DPD enzyme deficiency. Common side effects include burning, crusting, allergic contact dermatitis, erosions, erythema, hyperpigmentation, irritation, pain, photosensitivity, pruritus, scarring, rash, soreness and ulceration.
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