Category: Uncategorized

INDICATIONS:
Texacort^® (hydrocortisone) topical solution 2.5% is a prescription corticosteroid (steroid hormone) used on the skin (topical) to treat people with certain skin conditions that cause red, flaky, and itchy skin.

Important Safety Information

Texacort is not for everyone. You should not use Texacort if you are allergic to hydrocortisone or any of the ingredients in the medication. Ask your doctor if you are not sure.

Corticosteroids can cause serious side effects in some people:

• Increased levels of sugar in the blood or urine may occur.
• Irritation – if irritation develops discontinue treatment and call your doctor.
• Symptoms of Cushing ́s syndrome, a disorder which occurs when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. Symptoms can include: weight gain, especially around your upper back and midsection; slow healing of cuts, insect bites, and infections; tiredness and muscle weakness; depression; anxiety, and irritability; roundness of your face (moon face); new or worsening high blood pressure.
• Symptoms of adrenal insufficiency, a disorder where the adrenal gland does not make enough of certain hormones, may occur during or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency. Tell your doctor if you have any of these symptoms of adrenal insufficiency: tiredness that worsens and does not go away, nausea or vomiting, dizziness or fainting, muscle weakness, irritability and depression, loss of appetite or weight loss.
• Children are more susceptible to the symptoms of Cushing’s syndrome or adrenal insufficiency, so do not use more medicine than your doctor instructed you to use.
• Children can develop increased pressure within the skull. Symptoms may include headaches, changes in vision, or bulging fontanelle (outward swelling on an infant’s soft spot on the head).
• Long-term treatment with corticosteroids can impair growth or development in children.

Tell your doctor about all the medicines you take, especially if you take a corticosteroid by mouth or use other products on your skin that contain corticosteroids. Before using Texacort topical solution, tell your doctor if you: have had irritation or other skin reaction to a steroid medicine in the past, adrenal gland problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Texacort has not been studied in pregnant or breastfeeding women. It is not known if Texacort topical solution will harm your unborn baby or if it passes into your breast milk.

The most common side effects of topical corticosteroids are: burning, itching, irritation, dryness, infection of the hair follicles, increased body hair, acne, lightening of skin, rash around the mouth, allergic skin rash, softening and whitening of skin, infection, thinning of skin, stretch marks, heat rash.

These are not all the possible side effects with Texacort topical solution. Tell your doctor about any side effect that bothers you or does not go away, including skin infections, or side effects that occur under a bandaged area.

The treated skin area should not be bandaged or covered or wrapped unless directed by your doctor. For infants and small children, do not use tight-fitting diapers or plastic pants if the child is being treated in the diaper area.

Texacort topical solution should be used as directed by your doctor. Do not use for other conditions. This medicine is for external use only. Avoid contact with the eyes.

Call your doctor for medical advice about side effects. You may report negative side effects to Mission Pharmacal Company at 1-800-298-1087, or to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch

Please click here for full Prescribing Information.