Cloroid^® (Ointment) Instructions for Use

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

ATC Code

D07AD01 (Clobetasol)

Active Substance

Clobetasol (Rec.INN registered by WHO)

Dosage Form

Cloroid®

Ointment for external use 0.05%: 25 g tube

Dosage Form, Packaging, and Composition

Ointment for external use is homogeneous, from white to almost white in color.

Excipients: white soft paraffin – 939.5 mg, sorbitan sesquioleate – 30 mg, propylene glycol – 30 mg.

25 g – tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids; corticosteroids with very high activity (group IV)

Pharmacological Action

Topical glucocorticosteroid. Prevents marginal accumulation of neutrophils, reduces inflammatory exudation and lymphokine production, inhibits macrophage migration, reduces the intensity of infiltration and granulation processes, and has local anti-inflammatory, antipruritic, antiallergic, and anti-exudative effects.

Pharmacokinetics

After application of clobetasol in topical dosage forms to healthy skin, the mean C_max of the active substance is about 0.63 ng/ml and is reached in plasma approximately 8-13 hours later. In patients with psoriasis and eczema, the mean C_max is reached approximately 3 hours after application and is 2.3-4.6 ng/ml.

When applied to large areas of the skin, absorption is possible (damage to the integrity or inflammation of the skin enhances absorption) and systemic effects may occur.

It is metabolized mainly in the liver, and a small part – in the kidneys. It is excreted in the urine.

Indications

Psoriasis (except for extensive plaque psoriasis), prevention and treatment of relapses of scalp psoriasis (except for extensive plaque psoriasis); eczema, lichen planus, discoid lupus erythematosus; skin diseases resistant to therapy with less active topical glucocorticosteroids.

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin areas once or twice daily.

Gently rub in until absorbed. Limit application to the smallest area necessary.

The maximum treatment duration is two weeks. Do not exceed 50 grams per week.

Use for the shortest period required to achieve control of symptoms.

Avoid use under occlusive dressings unless specifically directed by a physician.

Do not apply to the face, axillae, or groin due to high risk of skin atrophy.

Discontinue treatment once control is achieved. If no improvement is seen within two weeks, reassess the diagnosis.

For scalp psoriasis, apply a thin layer to affected areas of the scalp once daily.

In pediatric patients, use the minimal effective amount and monitor closely; avoid prolonged use.

If chronic use is necessary, employ an intermittent dosing regimen to minimize risk of adverse effects.

Wash hands thoroughly after application unless the hands are the treatment site.

Adverse Reactions

Dermatological reactions: burning, skin itching, steroid acne, dry skin, folliculitis, skin soreness, psoriasis (exacerbation), alopecia, allergic contact dermatitis, erythema; with long-term use – weakening of the skin barrier function; with long-term use in high doses – atrophic changes in the skin, in particular, its thinning, appearance of atrophic striae (stretch marks), dilation of superficial blood vessels, especially when applying occlusive dressings and when applying the product to skin folds (the risk of this complication is increased in young children, in which case a diaper can act as an occlusive dressing); skin pigmentation and hypertrichosis may develop.

From the digestive system: when applied to large surfaces, gastritis, ulceration of the gastrointestinal mucosa are possible.

From the endocrine system: when applied to large surfaces, symptoms of hypercortisolism, suppression of adrenal function, Cushing’s syndrome are possible.

From the organ of vision: eye pain/burning, eye irritation, eye strain, glaucoma are possible.

From the nervous system: headache.

Other: in rare cases – exacerbation of disease symptoms.

Contraindications

Hypersensitivity to clobetasol; rosacea, acne vulgaris, skin cancer, Hyde’s nodular prurigo, perioral dermatitis, perianal and genital pruritus, skin manifestations of syphilis, diaper rash, bacterial, viral and fungal skin diseases (including herpes simplex, chickenpox, skin tuberculosis, actinomycosis), extensive plaque and pustular psoriasis; application of the product to the eyes and eyelids (risk of glaucoma, cataract); pregnancy, lactation (breastfeeding); children’s age – depending on the dosage form.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the clobetasol drug labels regarding contraindications for the use of specific clobetasol dosage forms in children of different ages.

Special Precautions

In rare cases, treatment of psoriasis with topical glucocorticosteroids (or their withdrawal) provokes the development of pustular psoriasis.

Long-term prescription of topical glucocorticosteroids in large doses or their application to extensive areas of the skin may be accompanied by systemic absorption with the subsequent development of symptoms of hypercortisolism. The risk of this complication is increased in children, especially when using an occlusive dressing, in which case a diaper can act as such a dressing. In such cases, it is necessary to enhance medical supervision and regularly examine the patient for suppression of the hypothalamic-pituitary-adrenal system. Provided that clobetasol is used in adults at a dose of no more than 50 g per week, suppression of pituitary and adrenal function is transient with rapid recovery immediately after the end of the course of treatment.

Clobetasol is preferably used for short-term treatment.

The use of topical glucocorticosteroids for a prolonged period should be avoided, as this may lead to suppression of adrenal function.

Atrophic skin changes may appear on the face more often than on other parts of the body as a result of long-term use of topical glucocorticosteroids.

Clobetasol should not be applied to the periorbital area, as this may cause the development of glaucoma.

Treatment of psoriasis with topical glucocorticosteroids may be accompanied by the development of disease relapses, tolerance, generalized pustular form of the disease, local or systemic toxic reactions due to impaired skin barrier function, therefore patient monitoring is especially important.

In case of secondary infection, appropriate antibacterial therapy should be administered. If any signs of infection generalization appear, topical use of glucocorticosteroids should be discontinued and appropriate treatment with antibacterial drugs should be carried out. The warm, moist conditions created by an occlusive dressing promote the occurrence of bacterial infection, so the skin should be thoroughly cleaned before applying a new dressing.

Clobetasol in the form of a shampoo is indicated only for the treatment of scalp psoriasis; it should not be applied to other parts of the body and skin areas prone to chafing (armpits, genital and anal areas) and to erosive areas of the skin, as this increases the risk of local adverse reactions, such as atrophic skin changes, telangiectasias, or glucocorticosteroid-induced dermatitis. If shampoo gets into the eyes, they should be rinsed immediately with plenty of water.

Use in pediatrics

The use of clobetasol in children requires medical supervision at least once a week. The use of topical glucocorticosteroids for a prolonged period in young children should be avoided, as this may lead to suppression of adrenal function.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.