Clobex

Each ml contains: Clobetasol propionate, Ph. Eur. 500 mcg.
Vehicle (ethanol, citric acid monohydrate, coco-betaine, polyquarternium-10 dihydrated sodium citrate, sodium laureth sulfate, and purified water) 1 mL.
Excipient with known effect: One gram of Clobetasol propionate (Clobex) shampoo contains 100 milligrams of alcohol (ethanol 96 per cent) which is equivalent to 10% w/w.

Treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Maintenance treatment for prevention of recurrence. Treatment of seborrheic dermatitis, moderate to severe of the scalp, when associated with the use of ketoconazole shampoo.

For cutaneous use. One application per day. A half tablespoon (around 7.5 ml) per application is sufficient to cover all the scalp. Should be applied directly on dry scalp. Hands should be washed carefully after application. Should be then kept in place without covering for 15 minutes before rinsing with water. Therapy should be discontinued when control has been achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. The treatment is limited to maximum 4 weeks. The total dosage should not exceed 50 g per week.
Treatment of seborrheic dermatitis, in the acute phase (in flares): use the Clobetasol propionate (Clobex) shampoo twice a week, alternating with ketoconazole shampoo, twice a week, for 4 weeks.
Maintenance treatment for prevention of recurrence in case of psoriasis: two applications per week, for maximally 6 months. Clobetasol propionate belongs to the most potent class of topical corticosteroids (class IV/class I) and prolonged use may result in serious undesirable effects (see Precautions). If treatment with a local corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations.

In the case of chronic overdose or misuse, the features of hypercortisolism may appear and in this situation, treatment should be discontinued gradually.
However, because of the risk of acute adrenal suppression, this should be done under medical supervision.

Clobetasol propionate is contraindicated in patients who are hypersensitive to Clobetasol propionate or to any ingredient in this preparation. Skin areas affected by bacterial and mycobacterial, viral, fungal, parasitic infections or ulcerous wounds. Must not be used in Children under 2 years of age. Must not be applied to the eyes and eyelids (risk of glaucoma, risk of cataract).

Hypersensitivity to corticosteroids can be observed.
Clobetasol propionate is not recommended in patients who are hypersensitive to other corticosteroids.
Topical corticosteroids are known to potentially induce: post treatment rebound, relapses, development of tolerance (tachyphylaxis) and development of local or systemic toxicity such as skin atrophy, infection (including isolated cases of systemic infections), telangiectasia of the skin or hypothalamic-pituitary-adrenal axis suppression.
In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked generalized pustular psoriasis in case of intensive and prolonged topical use.
Clobetasol propionate is not recommended in patients with Acne vulgaris, rosacea or perioral dermatitis.
Treatment of large surface areas, long-term continuous therapy with corticosteroids, or use of occlusive dressings can enhance absorption and lead to a higher risk of systemic effects. In such cases, medical supervision should be increased and patients may be evaluated periodically for evidence of hypothalamic-pituitary- adrenal axis suppression.
Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for gluco corticosteroid insufficiency, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients. Such systemic effects resolve when treatment is stopped.
Abrupt discontinuation can lead to acute adrenal insufficiency, especially in children.
Clobetasol propionate must not be applied on intertriginous areas (axillae and genitoanal regions) and on other erosive skin surfaces as this could increase the risk of topical adverse events such as atrophic changes, telangiectasia or cortico-induced dermatitis.
If Clobetasol propionate does enter the eye, the affected eye should be rinsed with copious amounts of water.
The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids.
Patients should be instructed to use Clobetasol propionate for the minimum amount of time necessary to achieve the desired results.
Cases of osteonecrosis, serious infections (including necrotizing fasciitis), and systemic immunosuppression (sometimes resulting in reversible Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol propionate beyond the recommended doses (see Dosage & Administration). In some cases, patients used other potent oral/topical corticosteroids or immunosuppressors concomitantly (e.g. methotrexate, mycophenolate mofetil). If treatment with local corticosteroids is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered.
Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
This medicine contains alcohol (ethanol) that may cause burning sensation on damaged skin.
Effects on ability to drive and use machines: As Clobetasol propionate is a topical corticosteroid no influence on the ability to drive and use machines is expected.
Use in Renally Impaired: No clinical data available. No preclinical data.
Use in Hepatically Impaired: Patients with severe liver dysfunction and severe diabetes mellitus should be treated with special caution and closely monitored for side-effects.
Use in Children: Use in patients between 2 and 18 years of age is not recommended and is contraindicated in children below 2 years of age. Growth retardation may be observed in case of systemic absorption of topical corticosteroids.
Use in the Elderly: Clinical Studies of Clobetasol propionate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

Pregnancy: There are no adequate data from the use of topical Clobetasol propionate in pregnant women. Studies in animals have shown reproductive toxicity.
Use during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation: Systemically administered corticosteroids pass into breast milk. Damage to the infant is not reported to date. Nevertheless, as there are no adequate data on the possible milk transfer of topical clobetasol propionate and its biological or clinical repercussions.
Clobetasol propionate should not be prescribed to breastfeeding women unless clearly indicated.
Fertility: No clinical data available.

Tabulated list of adverse reactions: The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data including post market experience). (See Table.)

Click on icon to see table/diagram/image

There are no known drug interactions for Clobetasol propionate (Clobex) Shampoo.

Instruction for Use and Handling: In order to avoid interaction with hair colour dying product, such as hair colour changes, clobetasol propionate shampoo should be thoroughly rinsed.
Not for ophthalmic use.
Step-By-Step Usage Guide for Optimal Results*: 1. On a dry scalp, apply the medication directly to the psoriasis lesions once a day. Do not wet hair first. Spread the product over the lesion to cover it with a thin film and then, gently massage Clobex Shampoo onto the lesion.
2. Leave Clobex Shampoo in place for 15 minutes. Do NOT cover.
3. Add water and lather, avoiding contact with eyes, lips, face, and other erosive skin surfaces.
4. Rinse thoroughly.
*Read product insert/patient information before using the product. Up to 7.5 mL/day may be applied (1 teaspoon = 5 mL).
To be used once daily for up to 4 weeks as required. Non-medicated shampoo can be used after treatment, if desired.

Store at temperatures not exceeding 30°C. Store in the original container.

Topical Corticosteroids

D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.

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