DESCRIPTION: DEFOSALIC Lotion contains in each gram:0.64 mg of betamethasone dipropionate, equivalent to 0.5 mg (0.05%) of betamethasone, and 20 mg (2%) of Salicylic acid… DEFOSALIC Lotion FOR DERMATOLOGIC USE ONLY
How does DEFOSALIC solution work?
Betamethasone dipropionate, a synthetic fluorinated corticosteroid, has:
Anti-inflammatory action( to control eczema/dermatitis and many other skin conditions.).
antipruritic action(relieve itching).
vasoconstrictive action (narrowing of the blood vessels resulting from contraction of the muscular wall of the vessels).
Topical salicylic acid has keratolytic properties(Keratolytic is a type of medical treatment to remove warts, calluses and other lesions in which the epidermis produces excess skin). as well as bacteriostatic( stop bacteria growth and multiplication) and fungicidal actions( kill fungi).
DEFOSALIC Lotion demonstrates these actions in a sustained manner, thereby permitting twice a day application.
DEFOSALIC LOTION- betamethasone dipropionate and salicylic acid
INDICATIONS AND USAGE
DEFOSALIC Lotion is indicated for the relief of the inflammatory manifestations of psoriasis ( Psoriasis is skin disorder that causes skin cells to multiply up to 10 times faster than normal. This makes the skin build up into bumpy red patches covered with white scales. They can grow anywhere, but most appear on the scalp, elbows, knees, and lower back).
DEFOSALIC Lotion is indicated for the relief of the inflammatory manifestations of seborrhea of the scalp(Seborrheic dermatitis is a common skin condition that mainly affects your scalp. It causes scaly patches, red skin and stubborn dandruff. Seborrheic dermatitis can also affect oily areas of the body, such as the face, sides of the nose, eyebrows, ears, eyelids and chest.).
DEFOSALIC Lotion is also indicated for the relief of inflammatory manifestations of non-scalp lesions of psoriasis and other corticosteroid-responsive dermatoses.
DOSAGE AND ADMINISTRATION
Apply a few drops of DEFOSALIC Lotion to the affected areas and massage gently and thoroughly into the scalp or the skin.
The usual frequency of application is twice daily, in the morning and at night.
For some patients adequate maintenance therapy may be achieved with less frequent application.
ADVERSE REACTIONS
Adverse reactions that have been reported with the use of topical corticosteroids include:
burning.
Itching.
Irritation.
Dryness.
Folliculitis( inflammation of one or more follicles especially of the hair).
Hypertrichosis( is a condition characterized by excessive hair growth anywhere on a person’s body).
acneiform eruptions( are a group of dermatoses including acne vulgaris, rosacea, folliculitis, and perioral dermatitis).
Hypopigmentation( A condition in which the skin is lighter in color than normal. It occurs when special cells in the skin do not make enough of the pigment called melanin).
perioral dermatitis( an inflammatory rash involving the skin around the mouth. The rash may spread up to the nose or even the eyes.).
allergic contact dermatitis( A red, itchy, weepy reaction where the skin has come into contact with a substance that the immune system recognizes as foreign, such as poison ivy, poison oak or poison sumac or certain preservatives in creams and lotions.).
maceration of the skin( Maceration occurs when skin is in contact with moisture for too long. Macerated skin looks lighter in color and wrinkly. It may feel soft, wet, or soggy to the touch).
secondary infections( an infection that occurs during or after treatment for another infection. It may be caused by the first treatment or by changes in the immune system).
skin atrophy( thinning of the skin as a result of prolonged exposure to steroids. In people with psoriasis using topical steroids it occurs in up to 5% of people after a year of use).
Striae (medical term for stretch marks, which are irregular areas of skin that look a lot like bands or streaks).
Miliaria ( also called “sweat rash”, is a skin disease marked by small and itchy rashes due to sweat trapped under the skin by clogged sweat gland ducts).
sensation of pain.
rhagades( fissures, cracks, or linear scars in the skin, especially at the angles of the mouth and nose. They tend to form at areas of motion).
Salicylic acid preparations may cause dermatitis(skin irritation).
CONTRA-INDICATIONS: DEFOSALIC Lotion is contraindicated in those patients with a history of sensitivity reactions to any of its components.
PRECAUTIONS
If irritation or sensitization develops with the use of DEFOSALIC Lotion, treatment should be discontinued.
In the presence of an infection, appropriate therapy is indicated.
Any of the side effects that are reported following systemic use of corticosteroids. including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children. Systemic absorption of topical corticosteroids or salicylic acid will be increased if extensive body surface areas are treated… Adrenal suppression is a decrease of the normal cortisol secretion from the adrenal gland, which is a small gland over your kidneys.
Application of salicylic acid to open wounds or damaged skin should be avoided.Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
Occlusive dressing should not be used with DEFOSALIC Lotion.
If excess dryness or increased skin irritation develops, discontinue use of this preparation.
DEFOSALIC Lotion is not for ophthalmic use, avoid contact with eyes and mucous membranes.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body-weight ratio. HPA axis expression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelle( brain swelling or fluid buildup in the brain), headaches and bilateral papilledema( optic disc swelling that is caused by increased intracranial pressure).
DEFOSALIC Lotion alternative(similar to) Diprosalic Lotion
Pregnancy and breastfeeding
Since safety of topical corticosteroid use in pregnant women has not been established. drugs of this class(Topical synthetic fluorinated corticosteroid) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce delectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
OVERDOSAGE
Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism. including Cushing’s disease(a condition in which the pituitary gland releases too much adrenocorticotropic hormone (ACTH). ).
Excessive or prolonged use of topical preparations containing salicylic acid may cause symptoms of salicylism( a toxic condition produced by the excessive intake of salicylic acid or salicylates and marked by ringing in the ears, nausea, and vomiting).
OVERDOSAGE Treatment
Appropriate symptomatic treatment is indicated.
Acute hyper corticoid symptoms are usually reversible.
Treat electrolyte imbalance, if necessary in case of chronic toxicity, slow withdrawal of corticosteroids is advised.
Treatment of salicylism is symptomatic.
Measures should be taken to rid the body rapidly of salicylate.
Administer oral sodium bicarbonate to alkalinize the urine and force diuresis.
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Categories and Tags: #D07XC01/N02BA01, #Betamethasone dipropionate/Salicylic acid Topical Lotion, #DEEF PHARMACEUTICAL INDUSTRIES, #KSA, #D_letter, #حرف_د.
