BETSOL

Betamethasone is a long-acting corticosteroid with immunosuppressive and antiinflammatory properties.

It can be used topically to manage inflammatory skin conditions such as eczema, and parenterally to manage several disease states including autoimmune disorders.

Betamethasone has potent glucocorticoid activity and negligible mineralocorticoid activity.

As a member of the corticosteroid family, betamethasone is indicated for the treatment of several inflammatory conditions.

As topical monotherapy, betamethasone is indicated to relieve pruritic and inflammatory symptoms of corticosteroid-responsive-dermatoses. 12, 14, 15 Betamethasone can be used topically in combination with a vitamin D analog such as calcipotriene to treat plaque psoriasis.

The corticosteroid is also available as an injectable suspension and can be used to manage a range of inflammatory conditions including endocrine disorders, gastrointestinal disorders, and rheumatic disorders among other conditions.

Corticosteroids bind to the glucocorticoid receptor inhibiting pro-inflammatory signals, while promoting anti-inflammatory signals.

Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces.

Patients who require long-term treatment with a corticosteroid should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

The absorption and potency of any topical corticosteroid including betamethasone depends on the vehicle in which the steroid is delivered.

For example, betamethasone dipropionate 0.05% ointment is classified as a highly potent topical steroid, while betamethasone dipropionate 0.05% cream or lotion is considered to be moderately potent.

There are several structural modifications that can determine the potency of a topical corticosteroid.

For example, corticosteroids containing a halogen at specific carbons, or that contain esters are more potent due to enhanced lipophilicity.

As such, there is a marked difference between topical products containing betamethasone dipropionate vs. betamethasone valerate.

Betamethasone dipropionate contains 2 esters which enhances its potency, while betamethasone valerate has only one ester and is less potent.

It should be noted that the use of occlusive dressings with topical steroids significantly increases the absorption, increasing the risk for adverse effects.

In a study that included

Indian women of reproductive age, the volume of distribution following a single intramuscular dose of betamethasone phosphate was 94,584±23,539 mL(s).

The metabolism of betamethasone yields 6 metabolites.

The metabolic processes include 6β hydroxylation, 11β-hydroxyl oxidation, and reduction of the C-20 carbonyl group followed by removal of the side chain.

In a study that included

Indian women of reproductive age, the half-life following a single intramuscular dose of betamethasone phosphate was 10.2 ± 2.5 hours.

In a study that included

Indian women of reproductive age, the CL/F following a single intramuscular dose of betamethasone phosphate was 6,466 ± 805 mL/hour.

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Chronic high doses of glucocorticoids can lead to the development of cataracts, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency.

Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.

Betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Hypersensitivity to any component of this medicine.

Apply a thin film of betamethasone dipropionate cream (augmented) to the affected skin areas once or twice daily.

Therapy should be discontinued when control is achieved.

Betamethasone dipropionate cream (augmented) is a high-potency corticosteroid.

Treatment with betamethasone dipropionate cream (augmented) should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Betamethasone dipropionate cream (augmented) should not be used with occlusive dressings unless directed by a physician.

Avoid contact with eyes.

Wash hands after each application.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

Betamethasone dipropionate cream (augmented) is for topical use only.

It is not for oral, ophthalmic, or intravaginal use.

Apply a thin film to the affected skin areas once or twice daily.

Discontinue therapy when control is achieved.

Use no more than 50 g per week.

Do not use with occlusive dressings unless directed by a physician.

Not for oral, ophthalmic, or intravaginal use.

Betamethasone dipropionate cream

USP (augmented), 0.05% is a white cream supplied in 15 g (NDC 51672-1310-1), 30 g (NDC 51672-1310-2) and 50 g (NDC 51672-1310-3) tubes.

Store at 20° to 25°C (68° to 77°F) .

Protect from freezing.

Store at 20° to 25°C (68° to 77°F) .

Protect from freezing.

There are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy.

Advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible.

In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits.

The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate cream (augmented) .

The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the

U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and to 20%, respectively.

Betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

Use of betamethasone dipropionate cream (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression.

In an open-label

HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream (augmented), 0.05% was applied twice daily for to 3 weeks over a mean body surface area of 58% (range 35% to 95%).

In of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol.

Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), and of the 4 (75%) had complete recovery of HPA axis function.

The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs.

They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic effects such as

Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of betamethasone dipropionate cream (augmented) in the treatment of diaper dermatitis.

Clinical trials of betamethasone dipropionate cream (augmented) included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.

However, greater sensitivity of some older individuals cannot be ruled out.