RiteMED Betamethasone Dipropionate

Each g contains: Betamethasone (as dipropionate), USP 500 mcg.
Betamethasone is similar to methylprednisolone with a high level of corticosteroid activity and minimal mineralocorticoid effect.

Pharmacology: This product is used externally as a dermatological preparation with anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of phospholipase A2 inhibitory proteins, called lipocortins. These proteins control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, the arachidonic acid. The arachidonic acid is released from membrane phospholipids through phospholipase A2.

This is used to treat inflammatory and pruritic dermatoses that respond to corticosteroids: atopic dermatitis, contact dermatitis, neurodermatitis (lichen simplex chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), intertrigo, dyshidrosis, seborrheic dermatitis, exfoliative dermatitis, solar dermatitis, statis dermatitis, anogenital pruritus and senile pruritus.

Doses for adults: apply sufficient quantity to cover the affected area, once or twice a day.
Pediatric doses: apply sufficient quantity to cover the affected area once a day.

Topical chronic overdose: Since there is no specific antidote available, treatment is symptomatic and supportive. Patients are advised to discontinue its use immediately. Sometimes, gradual withdrawal of use is required.
Acute overdosage: In case of accidental intake, treatment consists of dilution with oral liquids.

Hypersensitivity to any of its components.
If concomitant skin infection is present, an appropriate antimicrobial agent should be used concurrently.
Pre-existing skin atrophy.

Topical corticosteroids are not for ophthalmic use. Corticosteroids may be absorbed percutaneously; for such reason patients with local prolonged therapy are likely to develop systemic effects. In case of irritation, its use should be discontinued immediately.
In case of infection, an antimycotic or antibiotic agent should be administered. If there is no favorable response, patients should discontinue use of corticosteroids until infection has lessened.
Occlusive dressing is not recommended since systemic absorption increases with its use.

FOR EXTERNAL USE ONLY.
In case of significant systemic absorption, measures of 17 hydrocorticosteroids of urine free cortisol may decrease as well as the function of hypothalamic-pituitary-adrenal axis, especially in children.
Eosinophil count may decrease if plasma concentration of cortisol decreases. The glucose concentration in the blood may also increase.
No adequate studies have been conducted to determine the possibility of teratogenicity from topical corticosteroids.
Topical corticosteroids should be used for limited periods of time.
Mutagenicity studies with other corticosteroids have given negative results.
Use in Children: Children have larger skin surface area to body weight ratio compared to adult; therefore, children are likely to absorb higher quantities of corticosteroid than older patients.
Absorption is also higher in premature infants than newborn babies due to incomplete development of the stratus corneum.
Cushing's syndrome, intracranial hypertension and growth retardation due to systemic absorption of corticosteroids have been reported. Caution is needed when topical corticosteroids are applied to children and growing adolescents, especially if there are factors that will increase absorption. In such cases, low potency corticosteroids are recommended.
Use in the Elderly: No studies in topical corticosteroids have been carried out regarding the geriatric population. Elderly-specific problems are not expected to limit their usefulness. However, there is a tendency to have pre-existing skin atrophy related to age. Skin injuries may be consequently more prevalent in elderly people when using topical corticosteroids. Topical corticosteroids should not be used frequently and only for short periods of time under strict medical supervision.

Use during Pregnancy: Teratogenic effects (umbilical hernia, cephalocele, cleft palate) have been observed among rabbits that were administered intramuscularly with betamethasone dipropionate. Safety has not been absolutely determined; therefore it should not be applied extensively or in large amounts or for a prolonged period of time.
Use during Lactation: It is not known whether topical administration of corticosteroids is excreted in breast milk. Studies in human have not been reported. On the other hand, systemic corticosteroids are secreted into breast milk that may cause unwanted effects in the infant such as growth suppression. Topical corticosteroids should not be applied on the breasts of a nursing mother.

Use of topical corticosteroids, especially when occlusive dressings are used, may cause burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruption, perioral dermatitis, allergic dermatitis, maceration, secondary infection, skin atrophy, stretch marks and miliaria.

No interactions have been described in this form of presentation.

Incompatibilities: Not described.

Store in a cool and dry place. Store at temperatures not exceeding 30°C.

Topical Corticosteroids

D07AC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.

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