Click here to see IMPORTANT SAFETY INFORMATION for CORDRAN® Tape (Flurandrenolide Tape, USP), ACZONE® (dapsone) Gel 7.5%, and RHOFADE® (oxymetazoline HCl) cream 1%

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Dr. Jeanine Downie Discusses CORDRAN® Tape (Flurandrenolide Tape, USP)

CORDRAN® Tape is back just in time. In this video, Jeanine B. Downie, MD, explains what differentiates CORDRAN® Tape, describes her experience using it, and discusses considerations about its use.

CORDRAN® Tape Important Information

INDICATIONS AND USAGE

CORDRAN® Tape (Flurandrenolide Tape, USP) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestation of corticosteroid responsive dermatoses, particularly dry, scaling localized lesions.

IMPORTANT SAFETY INFORMATION

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of the product. Use of CORDRAN® Tape is not recommended for lesions exuding serum or in intertriginous areas.

Systemic absorption of potent topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Use over large surface areas, prolonged use, and the addition of occlusive dressings augment systemic absorption. Pediatric patients may absorb proportionately larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Patients receiving a large dose to a large surface area should be evaluated periodically for evidence of HPA axis suppression, and therapy should be modified or discontinued as appropriate.

Local adverse reactions may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. Reactions that may occur more frequently with occlusive dressings include: maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Please see CORDRAN® Tape full Prescribing Information.


ACZONE® (dapsone) Gel 7.5% Important Information

INDICATIONS AND USAGE

ACZONE® (dapsone) Gel 7.5% is indicated for the topical treatment of acne vulgaris in patients aged 12 years and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hematological Effects

Methemoglobinemia: Cases of methemoglobinemia with resultant hospitalization have been reported post marketing in association with twice-daily dapsone gel 5% treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Avoid use of ACZONE® Gel 7.5% in patients with congenital or idiopathic methemoglobinemia.

Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and symptoms of methemoglobinemia are characterized by a slate-gray cyanosis seen in, eg, buccal mucous membranes, lips, and nail beds. Advise patients to discontinue ACZONE® Gel 7.5% and seek immediate medical attention in the event of cyanosis.

Dapsone can cause elevated methemoglobin levels, particularly in conjunction with methemoglobin-inducing agents.

Hemolysis: Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.

In clinical trials, there was no evidence of clinically relevant hemolysis or hemolytic anemia in subjects treated with topical dapsone. Some subjects with G6PD deficiency using dapsone gel 5% twice daily developed laboratory changes suggestive of hemolysis.

Discontinue ACZONE® Gel 7.5% if signs and symptoms suggestive of hemolytic anemia occur. Avoid use of ACZONE® Gel 7.5% in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE® Gel 7.5% with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency.

Peripheral Neuropathy

Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical dapsone treatment.

Skin Reactions

Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical dapsone treatment.

ADVERSE REACTIONS

The most common adverse reactions of ACZONE® Gel 7.5% are dryness and pruritus at the application site.

Methemoglobinemia has been identified during postmarketing use of topical dapsone.

DRUG INTERACTIONS

Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair.

Please see ACZONE® Gel 7.5% full Prescribing Information.


RHOFADE® (oxymetazoline HCl) cream 1%

Indication

RHOFADE® (oxymetazoline HCl) cream 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential Impacts on Cardiovascular Disease

Alpha-adrenergic agonists may impact blood pressure. RHOFADE® cream should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.

Potentiation of Vascular Insufficiency

RHOFADE® cream should be used with caution in patients with cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.

Risk of Angle Closure Glaucoma

RHOFADE® cream may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop

ADVERSE REACTIONS

The most common adverse reactions for RHOFADE® cream were: application-site dermatitis 2%, worsening inflammatory lesions of rosacea 1%, application-site pruritus 1%, application-site erythema 1%, and application-site pain 1%.

Click here for full Prescribing Information for RHOFADE® cream.