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Candid-B Lotion

Glenmark Pharm
11 Allen Avenue, 4th Floor, Ikeja, Lagos. 24, Sule Abuka St., Off Opebi Rd., Ikeja Lagos
Email: glenmarknigeria@multilinks.com
Tel: Tel: 01-773-8588

Brand Name

Candid-B Lotion

Manufacturer

Glenmark Pharmaceuticals Ltd, Wing-A, B, D Sawant Marg, Chakala, Andheri (E), Mumbai-400 099, India.

Therapeutic Class

Anti-infective/Corticosteroid combinations, Skin

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Lotion (NRN: 04-6849): Clotrimazole USP 1%, Beclometasone Dipropionate BP 0.025%.

Pack size: Bottles of 15 mL.

Pharmacology

Description

Beclomethasone dipropionate is a corticosteroid used topically for its glucocorticoid activity in the treatment of various skin disorders.

Pharmacodynamics: Clotrimazole: Clotrimazole, an imidazole derivative, exerts antifungal effects by inhibition sterol sysnthesis. Clotrimazole appears to inhibit the enzymatic conversion of 2, 4-methylenedihydrolanosterol to demethylsterol, the precursor to ergosterol, which is an essentail building block of the cytoplasmic membrane of the fungi.

At minimum fungicidal concentrations, clotrimazole causes leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and acceralated potassium efflux. Its postulated action has been described as resulting in leakage of essential intracellular components leading to inhibition of synthetic of such macromolecules as protein, lipid, DNA, and polysaccharides.

Other proposed mechanism for antimycotic activity of clotrimazole include alteration of plasma membrane ATPase, alteration of other membrane enzymes, alterations in membrane transport, and fatty acid metabolism.

Antifungal spectrum: Clotrimazole is a broad spectrum antifungal agent that inhibits the growth of most fungi pathogenic to man, including the following: Candida spp., Dermatophytes (Trichophyton, Microsporum, Epidermophyton), Malassezia furfur, Blastomyces dermatitis, Coccidiodes immitis, Cryptococcus neoformans (Toruia histolytic), Histoplasma capsulatum, Naegleria fowleri, Nocardia spp., Paracoccidiodes brasiliensis, and Sporotrichum schenckii.

Beclomethasone: Beclometasone is a halogenated topical corticosteroid which is of moderately potency. Corticosteriods have multiple mechanisms of action including anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions. Anti-inflammatory effects result from decreased formation, release and activity of the mediators of inflammation (e.g. kinins, histamine, liposomal enzymes, prostaglandins, leukotrienes) which reduce the initial manifestations of the inflammatory process. Corticosteroids inhibit margination and subsequent cell migration to the area of injury, and also reverse the dilation and increased vessel permeability in the area, resulting in decreased access of cells to the sites of injury. This vasoconstrictive action decreases serum extravasation, swelling and discomfort. The immunosuppressive properties decrease the response to delayed and immediate hypersensitivity reactions (e.g. type 111 and type IV). This results from inhibition of the toxic effect from antigen and antibody complexes that precipitate in vessel walls creating cutaneous allergic vasculitis, and by inhibiting the action of lymphokines, target cells and macrophages which together produce alleregic contant dermatitis reactions. Additionally, the access of sensitized T lymphocytes and macrophages to target cells may also be prevented by corticosteroids. The antiproliferative effects reduce hyperplastic tissue characteristic of psoriasis.

Pharmacokinetics: The pharmacokinetics of the combination has not been evaluated. The pharmacokinetic profile of the individual ingredients is as follows.

Clotrimazole: Systemic absorption following use of topical clotrimazole populations is low. Estimated bioavailability is less than 0.5%. Following topical application to the skin, clotrimazole was distributed in the stratum corneum, stratum spinosum, stratum papillare, and stratum reticulare. Concentrations of clotrimazole achieved in the epidermal layers exceeded the minimal inhibitory concentrations for almost all pathogenic fungi. The highest levels were in the stratum corneum (50 to 100mcg/mL) and the lowest in the stratum basale papillare (1.53 to 3mcg/mL). Most of absorbed clotrimazole is excreted in the urine as inactive metabolite. Clotrimazole appears to be largely excreted in the feces, primarily via biliary excretion. Renal excretion accounts for 0.05% of drug elimination. The elimination half life of the parent compound 3.5 to 5 hours.

Beclomethasone: Topical corticosteriods can be absorbed from normal intact skin. Inflammation, use of occlusive dressings may increase percutaneous absorption. Any beclomethasone that is absorbed is then metabolised by the liver and excreted by the kidney.

Indications

Candid B lotion is indicated for the treatment of superficial fungal infections like dermatophyte infections, candidiasis of skin and tinea versicolor particularly when accompanied by eczematous symptoms. Candid B lotion will be useful in large lesions and for hairy and intertriginous skin areas.

Contra-indications

Hypersensitivity to clotrimazole, beclomethasone dipropionate or any other component of the formulation.

Precautions/Warnings

Candid-B lotion is not for ophthalmic or intravaginal use. It is for external use only. Avoid using large amounts and over larger areas of the body. Keep the drug out of the reach of children.

Avoid contact with the face, axillae, perianal region, genitalis, eyes and mucous membranes

Discontinue the treatment if irritation develops. Certain areas such as face, groin and axilla are more prone to atrophic changes. Frequent observations is important

Discontinue the treatment if irritation develops. This preparation should not be used in patients with tuberculosis of the kin, herpes simplex, chicken pox, measles, vaccinia, syphilitic skin lesions.

Candid-B lotion should be used with caution in the following group of patients: Patients with a history of allergic-type responses to other topical or oral corticosteriods because of the enhanced risk of sensitivity.

Children may absorb proportionally larger amounts of topical corticosteroids and be more susceptible to systemic toxicity.

Patients with a history of pre-existing skin atrophy, peripheral vascular disease at site.

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression occurs following systemic absorption of topical corticosteroids. Clinical symptoms include Cushing's syndrome, hyperglycemia and glucosuria. An increased incidence may be observed with use of the more potent steroids, use of medication over a large surface area, prolonged use, the addition of occlusive dressings, and coexisting hepatic failure. Following discontinuation of the drug, recovery of the HPA axis is prompt and complete. Rarely, steroid withdrawal symptoms occur and require supplemental systemic corticosteroids.

Patients receiving large doses of a potent topical corticosteroid applied to extensive areas or under an occlusive dressing should be evaluated periodically for evidence of HPA-axis suppression.

Patients receiving topical corticosteroids should be instructed to use the preparations as directed by the physician, only for the disorder it was prescribed and for no longer than the time period prescribed.

This preparation should be used cautiously in patients taking concomitant systemic antifungal treatment, diabetic patients, patients with history of immunosuppression and immunocompromised patients.

Interactions

 

 

Adverse Effects

Clotrimazole: Topical preparations of clotrimazole are generally well tolerated. Adverse events that may occur with use of topical clotrimazole preparations include: erythema, stinging, burning, pruritus, urticaria and edema. Contact dermatitis may occur rarely.

Beclometasone: As with other corticosteroids, the incidence and severity of local or systemic side effects increase with factors that increase percutaneous absorption. Percutaneous absorption of topical corticosteroids or using the steroids in occlusive dressings or using excessive quantities of steroids has resulted in systemic side effects such as hyperglycemia, glycosuria and hypothalamic-pituitary-adrenal axis (HPA axis) suppression.

Some of the side effects seen with topical steroids are: Local: allergic contact dermatitis, folliculitis, skin atrophy, acneform eruptions, perioral dermatitis, hypopigmentation, milliaria rubra, striae, subcutaneous tissue atrophy, unusual los of hair.

Systemic side effects like cataracts, Cushings's syndrome, hirsutism, hypertension, oedema, gastric ulcer, etc.

Dosage & Administration

Adults: The affected area should be washed and dried thoroughly. Sufficient quantity of candid B lotion is applied 2-3 times daily to the affected area. In hairly sites, the hair should be parted before application to allow direct contact with the lesions.

Children should be supervised during the use of Candid-B lotion. The use of Candid-B lotion for longer than 4 weeks is not recommended. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive.

Pediatric: Use of Candid-B lotion is not recommended in patients less than 12 years of age.

Overdosage

No information is available on overdose with Candid-B lotion.

Clotrimazole: Overdose with topical clotrimazole preparations is unlikely. If overdosage is suspected, medical assistance should be sought immediately.

Beclomethasone: Excessive prolonged use of topical corticosteriods can suppress the pituitary-adrenal function resulting in secondary adrenal insufficiency.

Treatment: Appropriate symptomatic treatment is indicated in the event of overdosage. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.

Storage/Handling Recommendations

Store below 25oC. Protect from light

Review Date

2016-04-05 07:54:41