Dermazene

• Stratus Pharamceuticals, Inc

• Stratus Pharmaceuticals, Inc.

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.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Irritation where this medicine is used.
• Change in color of skin.
• Thinning of the skin.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Hydrocortisone has anti-inflammatory, antipruritic and vasoconstrictor properties. The mechanism of anti-inflammatory activity is unclear. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Iodoquinol has both antifungal and antibacterial properties.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Hydrocortisone can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, hydrocortisone is metabolized in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

There are no data available regarding the percutaneous absorption of Iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as a glucuronide.

NDC 58980-811-10
NET WT 1.0 OZ (28.4 grams)

Dermazene™ CREAM
(hydrocortisone 1% - iodoquinol 1%)

Rx only

Distributed by STRATUS PHARMACEUTICALS INC. 14377 Southwest 142nd Street, Miami, Florida 33186-6727

Dermazene

1 OZ TUBE