General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticoid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS-Pediatric Use).

If irritation develops, Capex® Shampoo should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Capex® Shampoo should be discontinued until the infection has been adequately controlled.

Information for Patients:

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. In case of contact, wash eyes liberally with water.

2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.

4. Patients should report to their physician any signs of local adverse reactions.

5. Discard contents after two (2) months.

Laboratory Tests:

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, mutagenesis, and impairment of fertility:

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Capex® Shampoo.

Pregnancy:

Nursing Mothers:

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are secreted in human milk, caution should be exercised when Capex® Shampoo is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children and infants have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at a greater risk of glucocorticoid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

Important:

Capex Shampoo is for use on the skin only. Do not get Capex Shampoo in your eyes.

What is Capex Shampoo?

Capex Shampoo is a prescription medicine used on the scalp to treat a skin condition called seborrheic dermatitis. It is not known if Capex Shampoo is safe and effective in children and infants.

Who should not use Capex Shampoo?

Do not use Capex Shampoo if you are allergic to any of its ingredients. See the end of this leaflet for a complete list of ingredients in Capex Shampoo.

Before using Capex Shampoo, tell your doctor about all of your medical conditions, including if you:

• have a scalp infection. You may need medicine to treat the scalp infection before you use Capex Shampoo.
• are pregnant or plan to become pregnant. It is not known if Capex shampoo can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Capex Shampoo passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed you baby if you use Capex Shampoo.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Do not use other products containing a corticosteroid medicine with Capex Shampoo without talking to your doctor first.

How should I use Capex Shampoo?

• When you receive your Capex Shampoo, it will already be mixed in a bottle by your pharmacist.
• Use Capex Shampoo exactly as your doctor tells you to use it.
• Your doctor should tell you how much Capex Shampoo to use and where to apply it.
• Capex Shampoo is for use on your scalp only (topical).
• Shake the Capex Shampoo bottle well before using.
• Do not apply more than 1 ounce of Capex Shampoo to your scalp, 1 time each day.
• Work Capex Shampoo into a lather.
• Leave Capex Shampoo on your scalp for at least 5 minutes.
• Rinse your hair and scalp well with water.
• Avoid getting Capex Shampoo in your eyes. If you get Capex Shampoo in your eyes, rinse your eyes well with water.
• Do not bandage or cover your head after using Capex Shampoo unless your doctor tells you to.
• Tell your doctor if you develop irritation where you apply Capex Shampoo, or if your seborrheic dermatitis is not getting better with Capex Shampoo.

What are the possible side effects of Capex Shampoo?

Capex Shampoo can pass through your skin.

The side effects of corticosteroids medicines used on the skin (topical) include:

• dry, itchy, and reddened skin

• burning or stinging at application site

• inflamed hair follicle

• acne

• thinning of skin

• loss of skin color

These are not all the possible side effects of Capex Shampoo. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Capex Shampoo?

• Store Capex Shampoo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the Capex Shampoo bottle tightly closed.
• Throw away (discard) your Capex Shampoo bottle after 2 months, even if there is still medicine left in the bottle.

Keep Capex Shampoo and all medicines out of the reach of children.

General information about the safe and effective use of Capex Shampoo.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Capex Shampoo for a condition for which it was not prescribed. Do not give Capex Shampoo to other people, even if they have the same symptoms you have. It may harm them. You can also ask your doctor or pharmacist for information about Capex Shampoo that is written for health professionals.

What are the ingredients in Capex Shampoo?

Active ingredient: fluocinolone acetonide
Inactive ingredients: aluminum acetate dibasic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether-sulfate complex, cocoamine oxide, dibasic calcium phosphate dihydrate, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water, talc, fragrances, D&C Yellow 10, and FD&C Blue 1 as coloring.

Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177, USA
GALDERMA is a registered trademark.

Made in Canada
P52306-3

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 12/2015