DIPROSTENE

Betamethasone dipropionate cream

USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base.

Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity.

Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7, a molecular weight of 504.6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of betamethasone dipropionate cream

USP (augmented), 0.05% contains: 0.64 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a white cream base of carbomer homopolymer type C, ceteareth-30, chlorocresol, cyclomethicone, glyceryl oleate, propylene glycol, purified water, sodium hydroxide, sorbitol solution, white petrolatum and white wax.

Seasonal allergic

Rhinitis after failure of other therapies (general antihistamine, intranasal corticosteroid, or short-dose corticosteroids).

These are those of local corticosteroids, when the condition justifies a high local concentration.

Any local injection prescription must be indicative of the infectious danger, in particular of the risk of promoting bacterial proliferation.

• dermatological: cheloid scars.

• ENT: intra-sinus irrigation in subacute or chronic sinusitis justifying drainage.

• rheumatological: o intra-articular injections: inflammatory arthritis, oarthritis in the burst o peri-articular injections: tendinitis, bursitis o soft injections: talalgia, carpal canal syndrome, Dupuytren's disease.

(Accuracy is attracted to sportsmen, this specialty containing an active ingredient that may induce a positive reaction of tests performed during anti-doping tests.

Rare cases of anaphylactoid/anaphylactic reactions with the possibility of shock occurred in patients treated with parenteral corticosteroids.

Appropriate precautions should be taken in patients who have already experienced allergic reactions to corticosteroids.

A crisis of pheochromocytoma, which may be fatal, has been reported after administration of systemic corticosteroids.

Corticosteroids should not be administered to patients for whom the presence of a pheochromocytoma is suspected or proven only after an appropriate assessment of the benefit/risk ratio.

In case of an agglomerated gastro-duodenal ulcer, agglomerated gastro-resorbetic disorder, agglomerated corticosteroid, agnomical corticosteroid, agglomeration of agglomeration, agglomeration, agglomeration, agglomeration, agglomeration, agitation, agitation of agitation agitation agitation.

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate cream (augmented) in corticosteroid responsive dermatoses is unknown. 12.2 Pharmacodynamics Vasoconstrictor Assay Trials performed with betamethasone dipropionate cream (augmented), 0.05% indicate that it is in the high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids.

However, similar blanching scores do not necessarily imply therapeutic equivalence. 12.3 Pharmacokinetics No pharmacokinetics trials have been conducted with betamethasone dipropionate cream (augmented), 0.05%.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed through normal intact skin.

Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids.

Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys.

Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pharmacotherapeutic group: non-associated systemic corticosteroids, ATC code: H02AB01.

Physiological glucocorticoids (cortisone and hydrocortisone) are essential metabolic hormones.

Synthetic corticosteroids, including betamethasone, are used primarily for their anti-inflammatory effect.

At high doses, they decrease the immune response.

Their metabolic and sodium retention effect is less than that of hydrocortisone.

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.