CANDID-B Cream

Clotrimazole and Beclometasone Dipropionate Cream are indicated for the symptomatic relief and treatment of superficial fungal infections like dermatophyte infections and candidiasis of skin when accompanied by eczematous/inflammatory symptoms. It can also be used for steroid-responsive inflammatory dermatoses, secondarily complicated by fungal infections.

Posology and Method of Administration

The affected area should be washed with soap and water and dried thoroughly. A thin layer of Clotrimazole and Beclometasone Dipropionate Cream should be applied to cover the affected completely. The frequency of application is 2-3 times daily. Do not use for more than 4 weeks. For some patients, adequate maintenance therapy may be achieved with less frequent application.

Adult

- Clotrimazole and Beclometasone Dipropionate Cream should not be used for longer than 2 weeks for the treatment of tinea cruris and tinea corporis and no longer than 4 weeks for tinea pedis.

- Products containing only tinea cruris and tinea corporis, gently massage cream into the skin of the affected and surrounding area twice daily, morning and evening, for 2 weeks.

- For the treatment of tinea pedis, gentle massage cream into the skin of the affected and surrounding area twice daily, morning and evening, for 4 weeks.

- Clotrimazole and Beclometasone Dipropionate Cream should not be used with occlusive dressings.

- Patients not showing a clinical response within 3-5 days should be re-evaluated.

- The duration of therapy varies with type of infection and extent of the disease; however, treatment of cutaneous candidiasis and most dermatophyte infections usually requires 3-4 weeks.

Pediatric Use

- Clotrimazole and Beclometasone Dipropionate Cream should not be used for longer than 2 weeks for the treatment of tinea cruris and tinea corporis and no longer than 4 weeks for tinea pedis.

- No more than 45g/week is recommended for the cream. In children 12 years and older, for the treatment of tinea cruris and tinea corporis, gently massage cream into the skin of the affected and surrounding area twice daily, morning and evening, for 2 weeks. If improvement is not seen after 1 week, reassess condition. The product should NOT be used longer than 2 weeks.

- In children 12 years and older, for the treatment of tinea pedis, gently massage cream into the skin of the affected and surrounding area twice daily, morning and evening, for 4 weeks. If improvement is not seen after 2 week, reassess condition. The product should NOT be used longer than 4 weeks.

- No uniform guidelines are available with regards to the use of steroid combination formulations in children due to vast individual variability and clinical inconsistency. But although topical Beclometasone has been safety used in some infants and young children, use of the same in children less than 5-6 years of age warrants extreme caution, a clear clinical indication that justifies the potential risk and strict medical supervision due to higher chances of percutaneous absorption and side effects.

- Use in children under 12 years old is not recommended, because of higher risk of percutaneous absorption and side-effects.

- Clotrimazole and Beclometasone Dipropionate Cream should not be used with occlusive dressings.

- The usage must be strictly under medical supervision. Lesser doses and lesser duration of therapy must be preferred in children.

In patients who are sensitive to clotrimazole, Beclometasone Dipropionate, other imidazoles or corticosteroids or to any of the excipients.

Topical corticosteroids are contraindicated in infected skin lesions if no anti-infective agent is used simultaneously; fungal and viral infections of the skin, including herpes simplex, vaccinia and varicella; fungi (e.g. candida, tinea) or bacteria (e.g. impetigo); pregnancy.

Topical corticosteroids are also contraindicated in tuberculous lesions of the skin.

Clotrimazole and Beclometasone Dipropionate Cream is contraindicated in rosacea, acne, perioral dermatitis, varicose ulcers.

Clotrimazole cream

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.

Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticaria).

Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation,, pruritus, rash, stinging/burning.

Beclometasone dipropionate cream

Local burning, irritation, itching, skin atrophy, striae, hypertrichosis and adrenal suppression have been observed following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following the systemic use of corticosteroids.

If should be used for short courses only, as prolonged and intensive treatment may cause local atrophic changes in the skin such as thinning, loss of elasticity, dilatation of the superficial blood vessels, telangiectasia and ecchymosis. These changes are particularly likely to occur on the face, where occlusive dressings are used or where skin folds are involved. Prolonged use, use of large amounts, treatment of extensive areas, or application to damaged skin, when Beclometasone dipropionate cream is used and when the occlusive dressing technique is applied can result in sufficient systemic absorption to produce the features of hypercortisonism such as depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland. These effects are most likely to be severe in infants and children. Growth may be retarded and a Cushingoid state may be produced. Benign intracranial hypertension has been reported less frequently.

Treatment of psoriasis with Beclometasone dipropionate cream or its withdrawal may provoke the pustular form of the disease.

A steroid rosacea-like facies may be produced This must be bone in mind when treating such conditions as psoriasis, discold lupus erythematosus, and severe eczema with Beclometasone dipropionate cream.

Application of topical corticosteroid preparations to the eyelids may cause glaucoma.

No information is available on drug interactions with topical Clotrimazole/Beclometasone combination. As systemic absorption is minimal, drug interactions with concomitant systemic medications are unlikely.

For clotrimazole, laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least 5 days after using this product.

Pregnancy

There is a limited amount of data from the use of Clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses. At the low systemic exposure of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore Beclometasone Dipropionate cream should not be used during pregnancy.

Lactation

Available pharmacodynamic/toxicological data in animals have shown excretion of Clotrimazole/metabolites in milk after intravenous administration. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

The use of Beclometasone dipropionate cream is not recommended during breast feeding.

Clotrimazole and Beclometasone Dipropionate Cream should not be used in or near the eyes since this preparation is not formulated for ophthalmic use. Topical corticosteroid preparations should be used with caution near the eyes; application to the eyelids may cause glaucoma.

General:

Topical corticosteroids

Systemic absorption of topical corticosteroid has produced reversible hypothalamic pituitary- adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Systemic absorption of topical corticosteroid agents will be increased with the use more potent corticosteroid agents, with prolonged usage of extensive body surface areas are treated. Therefore, patients receiving large doses of potent topical corticosteroids, applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute with a less potent corticosteroid agent.

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 corticotherapy.

If irritation of hypersensitivity develops with the use of Clotrimazole and Beclometasone Dipropionate Cream, treatment should be discontinued and appropriate therapy instituted.

Suitable precautions should be taken in using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.

Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue, If this occurs, treatment should be discontinued.

Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

Pediatric use:

Safety and effectiveness in children below the age of 12 have not been established. The use of cream in diaper dermatitis 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 greater absorption due to a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (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 again, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical dermatologics containing a corticosteroid to children should be limited to the least amount compatible with an effective therapeutic regimen, Chronic corticosteroid therapy may interfere with the growth and development of children.

In infants the napkin may act as an occlusive dressing, and hence these preparations should not be used in the nappy area for flexural eruptions. Ideally they should not be used in infants and young children at all. Regular review should be made of the necessity for continuing therapy.

When topical anti-inflammatory steroids are used under occlusive absorption may take place to given rise to systemic effects. Such effects have not been reported with Beclometasone Dipropionate Cream. Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

If signs of hypersensitivity appear, application should stop immediately. The least potent corticosteroids should be used with particular caution in facial dermatoses, and only for short periods.

Corticosteroids should never be used in the presence of infection except in conjunction with effective chemotherapy. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.

Excipient

This product contains methylhydroxybenzoate, which may cause allergic reactions (possibly delayed).

Pharmacotherapeutic group: Antifungals for topical use- imidazole and triazole derivatives as well as anti-inflammatory steroid.

Mechanism of Action

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0µg/mL substrate. The mode of action of clotrimazole is primarily fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive. In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci/Staphylococci/Gardenella vaginalis), and gram-negative microorganisms (Bacteroides). In vitro clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci - with the exception of Enterococci - in concentrations of 0.5-10µg/mL substrate. Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

Beclometasone dipropionate is a glucocorticoid which has potent anti-inflammatory, antipruritic and vasoconstrictive properties. In the vasoconstriction test on human skin, Beclometasone dipropionate is 5000 times as potent as hydrocortisone.