TEMOVATE (clobetasol propionate scalp application) Scalp Application contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11B,16B)-21- chioro-9-fluoro-11 -hydroxy-16-methyl-17-(1 -oxo- propoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula:

Clobetasol propionate has the empirical formula C₂₅H₃₂CIFO₅ and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

TEMOVATE Scalp Application contains clobetasol propionate 0.5 mg/g in a base of purified water, iso propyl alcohol (39.3%), carbomer 934P, and sodium hydroxide.

Last updated on RxList: 3/24/2008

TEMOVATE Scalp Application is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis.

This product is not recommended for use in pediatric patients under 12 years of age.

TEMOVATE Scalp Application should be applied to the affected scalp areas twice daily, once in the morning and once at night.

TEMOVATE Scalp Application is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.

TEMOVATE Scalp Application is not to be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients {65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE Scalp Application, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

TEMOVATE Scalp Application, 0.05% is supplied in plastic squeeze bottles, 25 mL {NDC 0173-0432-00) and 50 mL (NDC 0173-0432-01). Store between 4° and 25°C (39° and 77°F). Do not use near an open flame.

Glaxo Wellcome Inc. Research Triangle Park, NC 27709. August 2000. FDA rev date: 4/2/2003

Last updated on RxList: 3/24/2008

TEMOVATE Scalp Application is generally well tolerated when used for 2-week treatment periods.

The most frequent adverse events reported for TEMOVATE Scalp Application have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended.

No information provided.

Last updated on RxList: 3/24/2008

No information provided.

General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g (of ointment) per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions that augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free Cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw trie drug, to reduce the frequency of application, or to substitute a less potent steroid Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. Irritation is possible if TEMOVATE Scalp Application contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended.

If the inflammatory lesion becomes infected, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Although TEMOVATE Scalp Application is intended for the treatment of inflammatory conditions of the scalp, it should be noted that certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important if these areas are to be treated.

As with other potent topical corticosteroids, TEMOVATE Scalp Application should not be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis.

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

Urinary free Cortisol test
ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of TEMOVATE Scalp Application. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of TEMOVATE Scalp Application. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. TEMOVATE Scalp Application should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 excreted in human milk, caution should be exercised when TEMOVATE Scalp Application is administered to a nursing woman.

Pediatric Use: Use of TEMOVATE Scalp Application in pediatric patients under 12 years of age is not recommended.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

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

Geriatric Use: A limited number of patients at or above 65 years of age (n = 65) have been treated with TEMOVATE Scalp Application in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of TEMOVATE Scalp Application in geriatric patients is warranted

Last updated on RxList: 3/24/2008

Topically applied TEMOVATE Scalp Application can be absorbed in sufficient amounts to produce systemic effects {see PRECAUTIONS).

TEMOVATE Scalp Application is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

Last updated on RxList: 3/24/2008

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain.

Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (See DOSAGE AND ADMINISTRATION).

As with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the fiver and are then excreted by the kidneys. Some of the topical corticosteroids, including clobetasol propionate and its metabolites, are also excreted into the bile.

Following repeated nonocclusive application in the treatment of scalp psoriasis, there is some evidence that TEMOVATE Scalp Application has the potential to depress plasma Cortisol levels in some patients. However, hypothatamic-pituitary-adrenal (HPA) axis effects produced by systemically absorbed clobetasol propionate have been shown to be transient and reversible upon completion of a 2-week course of treatment.

Last updated on RxList: 3/24/2008

Patients using TEMOVATE Scalp Application should receive the following information and instructions:

1.  This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.
2.  This medication should not be used for any disorder other than that for which it was prescribed.
3.  The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.
4.  Patients should report any signs of local adverse reactions to the physician.

Last updated on RxList: 3/24/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CLOBETASOL SCALP SOLUTION - TOPICAL

(kloh-BAY-tuh-sol)

COMMON BRAND NAME(S): Cormax, Temovate

USES: Clobetasol is used to treat certain scalp and skin conditions (e.g., psoriasis, dermatitis, rash). Clobetasol reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a very strong (super-high-potency) corticosteroid.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for certain skin conditions (e.g., eczema, psoriasis) on other parts of the body.

HOW TO USE: Apply this medication to the affected area, usually twice daily in the morning and evening or as directed by your doctor.

Use this medication only on the skin. However, do not use it on the face, groin or underarms unless directed to do so by your doctor.

Wash and dry your hands before applying. Apply the prescribed amount of medication to the affected area and gently rub in. Do not bandage, wrap or cover the area.

After applying the medication, wash your hands, unless you are using this medication to treat the hands. If applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting the medication in your nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water.

Use this medication exactly as prescribed. Do not increase your dose, take it more frequently, or use it for longer than 2 weeks in a row. Do not apply more than 50 milliliters of medication in a given week unless directed by your doctor. Doing so could increase your risk of side effects.

Inform your doctor if your condition persists or worsens after 2 weeks.

SIDE EFFECTS: Burning, stinging, itching, irritation, dryness, or redness may occur when this medication is first applied to the scalp/skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks (striae), skin thinning/discoloration, excessive hair growth, acne, hair bumps (folliculitis).

Skin infections can become worse when using this medication. Notify your doctor if redness, swelling or irritation does not improve.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using clobetasol, tell your doctor or pharmacist if you are allergic to it; or to any other steroids (e.g., hydrocortisone, dexamethasone); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, other skin/scalp conditions (e.g., rosacea, perioral dermatitis), immune system problems.

Do not use if there is an infection or sore in the area to be treated.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children and for those who have used this drug for an extended period of time, especially if they also have serious medical problems such as serious infections, injuries, or surgeries. This precaution applies for up to one year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst or urination, unusual weakness, unusual weight loss, dizziness.

Consult your doctor or pharmacist for more details, and inform them that you use or have used this medication.

This drug is not recommended for use in children under 12 years of age. Children may be more sensitive to the effects of steroid excess. Though it is unlikely to occur with topical corticosteroids, this medication may affect growth in infants and children if used for long periods. Monitor your child's height and rate of growth from time to time.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the scalp/skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professional (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral corticosteroids (e.g., prednisone), other topical corticosteroids (e.g., hydrocortisone), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (e.g., adrenal gland function tests, morning cortisol blood tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for more than 2 weeks or apply it over large areas of the body. Consult your doctor for more details.

Inform all your doctors you use or have used this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product at room temperature between 39-77 degrees F (4-25 degrees C) away from heat and open flame.

Store the Canadian product at room temperature 59 to 86 degrees F (15 to 30 degrees C) away from heat and open flame.

Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.