Betamethasone Valerate (Page 2 of 3)

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1.
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2.
This medication should not be used for any disorder other than that for which it was prescribed.
3.
The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4.
Patients should report to their physician any signs of local adverse reactions.
5.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test
A.M. plasma cortisol testUrinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of betamethasone valerate.

Betamethasone was genotoxic in the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation and in the in vivo mouse bone marrow micronucleus assay.

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women. Therefore, betamethasone valerate foam 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 on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when betamethasone valerate foam is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, 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 an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS

The most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows:

Incidence and severity of burning/itching/stinging

Maximum severity

Product

Total incidence

Mild

Moderate

Severe

Betamethasone valerate foam n = 63

34 (54%)

28 (44%)

5 (8%)

1 (2%)

Betamethasone valerate lotion n = 63

33 (52%)

26 (41%)

6 (10%)

1 (2%)

Placebo Foam n = 32

24 (75%)

13 (41%)

7 (22%)

4 (12%)

Placebo Lotion n = 30

20 (67%)

12 (40%)

5 (17%)

3 (10%)

Other adverse events which were considered to be possibly, probably, or definitely related to betamethasone valerate foam occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

OVERDOSAGE

Topically applied betamethasone valerate foam can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

DOSAGE AND ADMINISTRATION

Note: For proper dispensing of foam, can must be inverted.

For application to the scalp invert can and dispense a small amount of betamethasone valerate foam onto a saucer or other cool surface. Do not dispense directly onto hands as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Betamethasone valerate foam should not be used with occlusive dressings unless directed by a physician.

HOW SUPPLIED

Betamethasone Valerate Foam, 0.12% contains 1.2 mg of betamethasone valerate, USP per gram. It is available as follows:

NDC 0378-8180-50
50 g aluminum can

NDC 0378-8180-99
100 g aluminum can

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

WARNING

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Questions: Call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX). Side effects should be reported to this number.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, TX 78215

140880-0317

Revised: 3/2017
DPT:BETA:R1p

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