Primovate Cream
Clobetasol Propionate 0.05% topical
0.05%
Beacon Pharmaceuticals Ltd.
| Pack size | 20 gm tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 70.00 AED |
Available as:
Indications
Primovate Cream is used for:
Corticosteroid-responsive Dermatoses, Psoriasis, Scalp Psoriasis, Plaque-type Psoriasis, Vitiligo, Eczema, Alopecia areata, Herpes labialis, Lichen sclerosus, Lichen, Mycosis fungoides, Corticosteroid-responsive dermatoses
Adult Dose
Corticosteroid-responsive Dermatoses
Cream/Oinement:
Apply a thin layer to affected areas twice daily and rub in gently and completely; not to exceed 50 g/week
Scalp Psoriasis
Shampoo:
Apply a thin film to dry scalp once daily; leave in place for 15 min; add water, lather, and then rinse thoroughly
Moderate to Severe Plaque-type Psoriasis
Cream/lotion:
Apply to the affected area on the scalp twice daily for up to 2 weeks if the area is less than 10% of the body surface area; not to exceed 50 g/week
Spray
Moderate-to-severe Plaque-Psoriasis
Indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA)
Apply by spraying onto affected area twice daily; rub into skin; should not be used for more than 4 weeks;
Treatment with spray beyond 2 weeks should be limited to localized lesions that have not improved sufficiently
Child Dose
<12 years
Safety & efficacy not established
>12 years
Corticosteroid-responsive Dermatoses
Cream/Ointment:
Apply a thin layer to affected areas twice daily and rub in gently and completely; not to exceed 50 g/week
Scalp Psoriasis
Shampoo:
Apply a thin film to dry scalp once daily; leave in place for 15 min; add water, lather, and then rinse thoroughly
Moderate to Severe Plaque-type Psoriasis
Cream/lotion:
Apply to the affected area on the scalp twice daily for up to 2 weeks if the area is less than 10% of the body surface area; not to exceed 50 g/week
Renal Dose
Administration
Topical Administration
For topical use only; not for oral, ophthalmic, or intravaginal use
Cream or gel
Apply onto affected skin area
Do not use if atrophy is present at treatment site
Do not bandage, cover, or wrap treated skin area unless directed by a physician
Avoid use on face, scalp, axilla, groin, or other intertriginous areas
Wash hands after each application
Shampoo
Apply onto dry (not wet) scalp qDay in a thin film to affected areas only
Leave in place for 15 minutes before lathering and rinsing
Rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (eg, hands, face, neck and shoulders)
Avoid contact with eyes and lips Minimize contact to nonaffected areas of the body
Although no additional shampoo is necessary to cleanse your hair, you may use a nonmedicated shampoo if desired
Do not cover your head with a shower or bathing cap while shampoo is on the scalp
Spray
Spray to affected area(s); rub in gently and completely
Avoid contact with the eyes
Avoid use on face, scalp, axilla, groin, or other intertriginous areas
Wash hands after each application
Contra Indications
Children <12 yrs.
Long-term treatment of ulcerative conditions, rosacea, and pruritus;
It is contraindicated in rosacea, acne vulgaris, perioral dermatitis, primary cutaneous viral infections (eg. herpes simplex, chickenpox), otitis externa with a perforated eardrum, and hypersensitivity to the preparations.
Scalp application is contraindicated in infection of the scalp.
Viral, fungal, or tubercular skin lesions.
Precautions
Chronic topical corticosteroid therapy may interfere with growth and development in children
May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, especially in younger children or patients receiving high doses for prolonged periods
Use lower potency in children; may absorb proportionally larger amounts after topical application and may cause systemic effects; treatment of children <12 years not recommended; prolonged use may affect growth velocity (routinely monitor growth in pediatric patient); Clobex lotion, Clobex spray, Clobex shampoo, Clodan shampoo not recommended for use in patients <17 years
Allergic contact dermatitis reported with use; diagnosed by failure to heal rather than clinical exacerbation
Kaposi sarcoma reported with prolonged corticosteroid treatment; consider discontinuing therapy if it occurs
Percutaneous absorption of corticosteroids may cause manifestations of Cushing syndrome
Topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract; glaucoma and cataracts reported in postmarketing; avoid contact with eyes; advise patients to report any visual symptoms
Foam dosage form is flammable; avoid fire, flame, or smoking during and immediately following application
Local effects, including perioral dermatitis, acneiform eruptions, folliculitis, hypopigmentation, skin atrophy, miliaria, secondary infection, and telangiectasia may occur; effects may be reversible
Concomitant skin infections may be present or develop during therapy; discontinue if dermatological infection persists after antimicrobial therapy
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
Increased systemic exposure w/ CYP3A4 inhibitors (eg ritonavir & itraconazole).
Adverse Effects
Side effects of Clobetasol Propionate 0.05% topical :
1-10%
Lotion
Skin atrophy (4.2%)
Telangiectasia (3.2%)
Discomfort skin (1.3%)
Dry skin (1%)
Frequency Not Defined
Skin atrophy
Striae
Burning
Cracking/fissuring of the skin
Erythema
Folliculitis
Irritation
Numbness
Pruritus
Stinging
Hypopigmentation (high potency topical steroids)
Intracranial hypertension reported in children with use of topical formulation
Adrenal suppression, Cushing syndrome, hyperglycemia
Acneform lesions
Secondary infection
Pigmentation changes
HPA suppression (with higher potency used >2 weeks); doses as low as 2 g/day can produce HPA suppression
Potentially Fatal: Prolonged usage of large amount of clobetasol propionate can lead to sufficient systemic levels to produce adrenal suppression, Cushing's syndrome, diabetes and hypertension.
Mechanism of Action
Clobetasol is a very potent corticosteroid used in short-term treatment of various inflammatory skin conditions. 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
Primovate 0.05% Cream manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Clobetasol Propionate 0.05% topical. Primovate is availble in Bangladesh.
Farmaco BD drug index information on Primovate Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.