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Betamethasone Dipropionate Cream and Ross Ru Skin Discontinuities
Overview
What is RRB Pak?
Betamethasone Dipropionate Cream (Augmented), 0.05%:
Contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient 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
H
FO
, 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 (Augmented), 0.05% contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an emollient cream base of carbomer homopolymer type C, ceteareth-30, chlorocresol, cyclomethicone, glyceryl oleate/propylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol solution, white petrolatum, and white wax.
Ross Ru SD® Wound Care Hydrogel:
May be used for managing partial and full thickness wounds, pressure related ulcerations, diabetic related ulcerations, surgical wounds and virtually all types of lacerations, abrasions, and first aid applications including 1st and 2nd degree burns. Ross Ru SD® is for external use only and can be used on any part of the body except for oral or ophthalmic use.
What does RRB Pak look like?
What are the available doses of RRB Pak?
Sorry No records found.
What should I talk to my health care provider before I take RRB Pak?
Sorry No records found
How should I use RRB Pak?
Betamethasone Dipropionate Cream USP 0.05%:
Betamethasone Dipropionate Cream (Augmented), 0.05% is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
Betamethasone Dipropionate Cream USP 0.05%:
Apply a thin film of Betamethasone Dipropionate Cream (Augmented), 0.05% to the affected skin areas once or twice daily.
Betamethasone
Dipropionate
Cream (Augmented), 0.05% is not to be used with occlusive dressings.
What interacts with RRB Pak?
Betamethasone Dipropionate Cream USP 0.05%:
Betamethasone Dipropionate Cream (Augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
What are the warnings of RRB Pak?
Sorry No Records found
What are the precautions of RRB Pak?
General
Array
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure (see
).
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 60 evaluable patients, of the 19 who showed evidence of suppression, 4 patients were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), 0.05%, and 3 of the 4 (75%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see
).
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Array
1. Consult with a heath care professional if you have any concerns or questions about the wound.
2. Always be alert for signs of wound infection or worsening conditions. These can include:
- Pus or cloudy fluid draining from the wound
- Increased redness around the wound
- Wound has become extremely tender
- Increased pain or swelling 48 hours after the wound occurred
- Onset of fever
3. If wound has not healed within 10 days from the date of the treatment please consult a health care professional. Do not use beyond the recommended 10-day treatment period.
4. The Gel is designed for use on any part of the body except for oral and ophthalmic use. Do not use the gel in any other manner.
Array
Information for Patients
Array
Patients using topical corticosteroids should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
1. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive (see
).
4. Patients should report any signs of local adverse reactions.
5. Other corticosteroid-containing products should not be used with Betamethasone Dipropionate Cream (Augmented), 0.05% without first talking to your physician.
Laboratory Tests
Array
The following tests may be helpful in evaluating HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, Impairment of Fertility
Array
Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
Betamethasone was negative in the bacterial mutagenicity assay (
and
), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the
human lymphocyte chromosome aberration assay, and equivocal in the
mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.
Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the human dose based on a mg/m
comparison, respectively.
Pregnancy
Nursing Mothers
Array
It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Array
Use of Betamethasone Dipropionate Cream (Augmented), 0.05% in pediatric patients 12 years of age and younger is not recommended (see
and
). In an open-label study, 19 of 60 (32%) evaluable pediatric patients (aged 3 months-12 years old) using betamethasone dipropionate cream (augmented), 0.05% for treatment of atopic dermatitis demonstrated HPA axis suppression. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group (see
-
).
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with the growth and development of children.
Geriatric Use
Array
Clinical studies of betamethasone dipropionate cream (augmented), 0.05% 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.
What are the side effects of RRB Pak?
Betamethasone Dipropionate Cream USP 0.05%:
The only local adverse reaction reported to be possibly or probably related to treatment with betamethasone dipropionate cream (augmented), 0.05% during adult controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.
Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream (augmented), 0.05% during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months-12 years of age.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, 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.
What should I look out for while using RRB Pak?
Betamethasone Dipropionate Cream USP 0.05%:
Betamethasone Dipropionate Cream (Augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
What might happen if I take too much RRB Pak?
Betamethasone Dipropionate Cream USP 0.05%:
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see
).
How should I store and handle RRB Pak?
Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.Betamethasone Dipropionate Cream (Augmented), 0.05% is available as follows:50 g tube (NDC 45802- 376-32)Ross Ru SD® Wound Care Hydrogel:45 mL squeezable tube, with screw-top flip-cap.Betamethasone Dipropionate Cream (Augmented), 0.05% is available as follows:50 g tube (NDC 45802- 376-32)Ross Ru SD® Wound Care Hydrogel:45 mL squeezable tube, with screw-top flip-cap.Betamethasone Dipropionate Cream (Augmented), 0.05% is available as follows:50 g tube (NDC 45802- 376-32)Ross Ru SD® Wound Care Hydrogel:45 mL squeezable tube, with screw-top flip-cap.Betamethasone Dipropionate Cream (Augmented), 0.05% is available as follows:50 g tube (NDC 45802- 376-32)Ross Ru SD® Wound Care Hydrogel:45 mL squeezable tube, with screw-top flip-cap.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Betamethasone Dipropionate Cream USP 0.05%:
The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.
Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, anti-pruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
Ross Ru SD® Wound Care Hydrogel:
Uses proprietary silver nano-particle technology to ensure maximum anti-microbial effect from small quantities of silver. The silver is in elemental form, and not mixed with alginates or sulfa compounds that can cause allergies. This hydrogel follows all guidelines of the World Health Organization and U.S. Centers for Disease Control on managing clean wounds.
Non-Clinical Toxicology
Betamethasone Dipropionate Cream USP 0.05%:Betamethasone Dipropionate Cream (Augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
Drug Interactions:
Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition
Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, doetilide) have not been performed, but caution is advised (see WARNINGS).
Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.
Betamethasone Dipropionae Cream USP 0.05%:
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure (see ).
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 60 evaluable patients, of the 19 who showed evidence of suppression, 4 patients were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), 0.05%, and 3 of the 4 (75%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see ).
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Ross Ru SD® Wound Care Hydrogel:
1. Consult with a heath care professional if you have any concerns or questions about the wound. 2. Always be alert for signs of wound infection or worsening conditions. These can include: - Pus or cloudy fluid draining from the wound - Increased redness around the wound - Wound has become extremely tender - Increased pain or swelling 48 hours after the wound occurred - Onset of fever 3. If wound has not healed within 10 days from the date of the treatment please consult a health care professional. Do not use beyond the recommended 10-day treatment period. 4. The Gel is designed for use on any part of the body except for oral and ophthalmic use. Do not use the gel in any other manner.
Betamethasone Dipropionate Cream USP 0.05%:
The only local adverse reaction reported to be possibly or probably related to treatment with betamethasone dipropionate cream (augmented), 0.05% during adult controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.
Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream (augmented), 0.05% during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months-12 years of age.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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