Anti-inflammatory, antibacterial, antifungal, anti-pruritic, anti-itch.

For temporary relief of:

• minor skin irritations associated with redness, itching, dryness and scaling
• minor skin irritations, rashes, itching and redness due to eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis (e.g. caused by soaps, detergents, cosmetics and/or jewellery), seborrheic dermatitis, psoriasis.

Apply Cliocort (clioquinol/hydrocortisone) to the affected area in a thin layer 3 to 4 times daily.

Use of Cliocort under occlusive dressings is not recommended as the resulting humid conditions may promote secondary infections with non-sensitive organisms and also may increase the possibility of elevated PBI.

 

• Hypersensitivity to Cliocort or any of its components . • Hypersensitivity to iodine. • Lesions of the eye. • Tuberculosis of the skin and other primary bacterial or fungal infections of the skin. • Viral skin lesions (including herpes simplex, vaccinia and varicella). • Cutaneous infections caused bv Pseudomonas species. • Rosacea. • Acne vulgaris. • Pruritis without inflammation. • Use in children. Cliocort should not be used in children or infants because of the risk of irreversible optic atrophy and peripheral neuropathy.

The use over extensive skin areas may result in systemic absorption of both hydrocortisone and clioquinol - particularly with occlusive skin dressings. Therefore, use in large amounts or for long periods of time should be avoided.

Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamicpituitary- adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. If either of the above are observed, withdraw the treatment gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see ADVERSE REACTIONS).

Risk factors for increased corticosteroidal systemic effects are:

• Potency and formulation of topical corticosteroid

• Duration of exposure

• Application to a large surface area

• Use on occluded areas of skin e.g. on intertriginous areas or under occlusive dressings (nappies may act as an occlusive dressing)

• Increasing hydration of the stratum corneum

• Use on thin skin areas such as the face

• Use on broken skin or other conditions where the skin barrier may be impaired

 

Recovery of HPA-axis function is generally prompt and complete following discontinuation of the drug. In some patients, signs and symptoms of steroid withdrawal may occur, necessitating supplemental systemic corticosteroid therapy.

Patients receiving large doses of a topical corticosteroid, applied to extensive areas or under an occlusive dressing, should be evaluated periodically for evidence of HPAaxis suppression by using the urinary free cortisol test or the corticotropin stimulation test.

Therapy with topical corticosteroids should be discontinued gradually as rebound of pre-existing dermatoses can occur if stopped abruptly.

Contact Sensitisation

Extended or recurrent application of hydrocortisone with clioquinol may increase the risk of contact sensitisation. If local irritation, rash and sensitivity reactions occur the product should be discontinued.

Cross sensitivity with other hydroquinolone and quinoline derivatives, and occasionally to iodides, can occur.

Infection risk with occlusion

Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.

Infection

Extension of the infection may occur due to the masking effect of the steroid. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.

Application to the face

Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.

Application to the eyelids

If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataracts and glaucoma might result from repeated exposure.

Chronic leg ulcers

Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.

Diabetes Mellitus

Use cautiously in patients with diabetes mellitus. These patients may require adjustments in diet, insulin or hypoglycaemic agents.

Staining

This medicine may turn yellow in colour when exposed to air. It may cause yellow staining of skin, hair, nails and fabrics, including clothing and bed linen.

A light, permeable dressing may be used as a protective measure.

Dilution

Products which contain antimicrobial agents should not be diluted.

Paediatric use

Not to be used on infants and children under 12 years of age (see CONTRAINDICATIONS).

Elderly

The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Renal / Hepatic Impairment

The minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Effects on Laboratory Tests

Clioquinol may be absorbed through the skin and interfere with thyroid function tests.

If such tests are contemplated, wait at least one month between discontinuation of therapy and performance of these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if clioquinol is present in the urine.

There are no generally recognised drug interactions attributable to topical hydrocortisone or clioquinol.

Topical use of clioquinol, as well as other iodine-containing compounds, may increase the amount of protein-bound iodine (PBI) in patients with normal thyroid function and therefore may interfere with some thyroid function tests (such as PBI, radioactive iodine and butanolextractable iodine). These tests should not be performed within a period shorter than 1 month following the use of cliocort. Other thyroid function tests, such as the T3 resin sponge test or the T4 determination, are unaffected by clioquinol.

The ferric chloride test for phenylketonuria may yield a false-positive result when clioquinol is present in the urine.

Pregnancy

Topical corticosteroids should be used during pregnancy only when the potential benefits justify the possible risks to the foetus. Use over extensive areas, in large amounts or for a prolonged period is not recommended. The minimum quantity should be used for the minimum duration.

The risk to the foetus born after exposure to clioquinol has not been determined.

Breast-feeding

Because of possible percutaneous absorption of both hydrocortisone and clioquinol, and therefore secretion in breast milk, administration should only be considered if the expected benefit to the mother outweighs the risk to the infant.

If used during lactation, the ointment should not be applied to the breasts to avoid accidental ingestion by the infant.

Not applicable

Occasionally: signs of irritation such as burning sensation, itching or skin rash at the site of

application; hypersensitivity reactions.

If an exacerbation or an allergic type reaction occurs, treatment with

Cliocort  (clioquinol/hydrocortisone) should be discontinued.

Local adverse reactions reported during topical treatment with glucocorticoids (predominantly with glucocorticoids more potent than hydrocortisone) include contact allergy, changes in skin pigmentation, secondary infections. Topically applied glucocorticoids may give rise to striae rubrae distensae, telangiectasia, purpura, skin atrophy, or steroid acne, especially if applied for prolonged periods of time, under occlusive dressings, to large areas or to permeable areas (e.g., face, axillae). However, serious side effects caused by topically applied hydrocortisone are rare unless it is used excessively.

 

National Pharmacovigilance and Drug Safety Center (NPC)

o Fax: +966-11-205-7662

o To call the executive management of vigilance and crisis management: +966-11-2038222 ext.: 2353 – 2356 – 2317 – 2354 – 2334 – 2340

o Toll-free: 8002490000

o E-mail: npc.drug@sfda.gov.sa

o Website: www.sfda.gov.sa/npc

Application to extensive and/or eroded areas of skin may lead to increased PBI values within 1 week. Elevated PBI values may also occur where relatively small areas of skin are treated for more than 1 week. If signs and symptoms resembling those of thyrotoxicosis occur, the preparation should be withdrawn at once.

Cliocort ointment contains hydrocortisone clioquinol in a base containing: White soft paraffin

Cliocort is a topical compound for dermatological use, combining the antifungal and antibacterial actions of clioquinol and the anti-inflammatory and antipruritic effects of hydrocortisone to provide broad control of acute and chronic dermatoses.

Percutaneous absorption of both hydrocortisone and clioquinol has been demonstrated and is determined by many factors including use of occlusive dressings and the integrity of the epidermal barrier. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Percutaneous absorption of up to 40% of the dose of clioquinol has been reported following application under occlusive dressings.

 

In vitro studies have demonstrated that Cliocort effectively inhibits the growth of various mycotic organisms such as Microsporons, Trichophytons and Candida albicans and Gram-positive cocci such as Staphylococci and Enterococci. The role of steroids in alleviating the inflammation and pruritus associated with many dermatoses

has been well established.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

White soft Paraffin

Not applicable.

Three years

Store below 30° C

10 gram Aluminum tube with plastic screw cap .

-        Store in the original pack to protect from light.

-        Once the pack has been opened , the contents should be used within 28 days.