Clobecort Ointment
Clobetasone butyrate 0.05% Topical
0.05%
Opsonin Pharma Limited
| Pack size | 25 gm Tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 75.00 AED |
Available as:
Indications
Clobecort Ointment is used for:
Inflammatory skin disorders, eczema, dermatitis, atopic eczema, photodermatitis, otitis externa, primary irritant & allergic dermatitis (napkin rash), prurigo nodularis, seborrhoeic dermatitis, insect bite reactions
Adult Dose
Topical/Cutaneous
Corticosteroid-responsive dermatoses
Adult: Use as 0.05% cream or ointment to be applied thinly once or twice daily on affected areas.
Continuous daily treatment for longer than four weeks is not recommended. If the condition worsens or does not improve within four weeks, treatment and diagnosis should be re-evaluated.
Child Dose
Topical/Cutaneous
Corticosteroid-responsive dermatoses
Children 12 years and over: Use as 0.05% cream or ointment to be applied thinly once or twice daily on affected areas.
When clobetasone is used in the treatment of dermatoses in children, extreme caution is required and treatment should not normally exceed 7 days.
If the condition worsens or does not improve within 7 days, treatment should be reviewed.
Once the condition has been controlled, the frequency of application should be reduced to the lowest effective dose for the shortest time possible.
Renal Dose
Renal Impairment
In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Administration
Wash hands and dry them
Squeeze out the correct amount of cream onto index finger.
Half a fingertip will cover a patchnof skin the same size as the palm of hand.
Gently rub the cream into the skin area that are treating.
Wash hands again (unless it is your hands you are treating).
Contra Indications
Hypersensitivity to the active substance or to any of the excipients.
The following conditions should not be treated with Clobetasone butyrate:
Rosacea, acne, pruritus without rash, perioral dermatitis.
Untreated bacterial infections such as cellulitis, folliculitis, furunculosis or impetigo.
Fungal infections such as those associated with tinea (eg athletes foot, jock itch).
Viral infections including cold sores (herpes simplex), chicken pox or shingles (Varicella zoster) or vaccinia.
Parasitic infestations such as scabies.
Do not use on broken or infected skin or on inflamed skin near chronic ulcers.
Topical corticosteroids inhibit wound healing processes and are contraindicated in skin ulcers, cuts and abrasions
Precautions
Manifestations of hypercortolism (Cushing’s syndrome) can occur in some individuals, due to prolonged duration of use, extensive application to the skin, or because of increased systemic absorption due to use of occlusive dressings or application to broken or thin skin.
Visual disturbances have been reported with the use of systemic and topical corticosteroids as a result of increased systemic availability and direct contact with the eyes.
Consequently, 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 as possible causes may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR)
Clobetasone butyrate cream should not be used for the treatment of psoriasis as this condition needs to be managed by a doctor.
Clobetasone butyrate cream should not be used concomitantly with other corticosteroids (by systemic or topical routes), as this may increase the risk of unwanted effects.
For external use only. This and all medications should be kept out of the reach of children.
Pregnancy-Lactation
Pregnancy
Safety data on clobetasol in pregnant woman is not available
Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy
Advise pregnant women of the potential risk to a fetus and to use clobetasol on the smallest area of skin and for the shortest duration possible
In animal reproduction studies, increased malformations (eg, cleft palate and skeletal abnormalities), were observed after SC administration of clobetasol to pregnant mice and rabbits
Lactation
No information is available regarding the presence of clobetasol in breast milk or its effects on the breastfed infant or on milk production
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
Unknown whether topical administration of clobetasol could result in sufficient systemic absorption to produce detectable quantities in human milk
To minimize potential exposure to the breastfed infant via breast milk, use clobetasol on the smallest area of skin and for the shortest duration possible while breastfeeding
Advise breastfeeding women to avoid applying clobetasol directly to the nipple and areola to prevent direct infant exposure
Interactions
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
Adverse Effects
Side effects of Clobetasone butyrate 0.05% Topical :
Systemic side effects are more likely in children, if large areas of the skin are treated or if large amounts are used, if treatment is prolonged or if treated areas are occluded.
The use of corticosteroids by multiple routes of administration (eg topical and oral or inhaled) may increase the likelihood of adverse reactions occurring.
Very rare
Infections and Infestations
Opportunistic infection
Immune System Disorders
Hypersensitivity, generalised rash
Endocrine Disorders
Hypothalamic-pituitary adrenal (HPA) axis suppression:
Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels
Skin and Subcutaneous Tissue Disorders
Allergic contact dermatitis, urticaria, skin atrophy*, pigmentation changes*, exacerbation of underlying symptoms, local skin burning, hypertrichosis, rash, pruritus, erythema
Not known
Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules.
Eye disorders
Vision, blurred
Local atrophic changes; pigmentation changes & hypertrichosis. Increased liability to infection. Infections may be masked. Acute adrenal insufficiency. Growth retardation in child. Cushingoid symptoms. Amenorrhoea, hyperhidrosis, skin thinning,
Mechanism of Action
Clobetasone butyrate is classed as a moderately potent topical corticosteroid. Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; and reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.
Note
Clobecort 0.05% Ointment manufactured by Opsonin Pharma Limited. Its generic name is Clobetasone butyrate 0.05% Topical. Clobecort is availble in Bangladesh.
Farmaco BD drug index information on Clobecort Ointment is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.