Betamethasone Dipropionate .5 mg/g Lotion, 56.2 g — NDC 45802-021-46 (Billing 45802-0021-46)
This is a package of 56.2 g of Betamethasone Dipropionate .5 mg/g Lotion from Padagis Israel Pharmaceuticals Ltd, marketed since Jun 2006 and currently FDA-listed; retail pharmacies pay about $0.2924 per mL (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007570
- GCN: 31080
- GPI-14 (Medi-Span): 90550020004105
- HICL (First Databank): 003304
- AHFS class code: 68:04.00.00
- RxCUI (RxNorm): 240209
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Betamethasone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Betamethasone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗- It calms inflammation and itching from steroid-responsive skin conditions. The spray is specifically for mild to moderate plaque psoriasis in adults. The valerate foam is for the s...
- Use a thin film or a few drops, as your product directs, once or twice a day. The spray is shaken first and used twice daily. Wash your hands afterward and keep it out of your eyes...
- Not for long. Several products limit use to about 2 weeks and the spray to 4 weeks. Stop when your skin is under control, and call your doctor if you see no improvement within 2 we...
- Mild burning, stinging, itching or dryness where you apply it is the most common. Skin thinning can happen with ongoing use. Call me or your doctor if you notice vision changes or...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Betamethasone Dipropionate — tap one for details:
Betamethasone Dipropionate may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.292 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.4192 | — |
| Medicare drug plans payPart D · Q2 2026 | $0.3793 | — |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 45802-0021-46 You're viewing this Main listing | 56.2 g in 1 BOTTLE, PLASTIC | 2006-06-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Betamethasone Dipropionate .5 mg/g 45802-0376-32 | Padagis | 1 tube | $0.124 | AB | Availability likely | save 57% |
| Betamethasone Dipropionate .5 mg/g 68462-0290-17 | Glenmark | 15 g | $0.200 | — | FDA listed | save 32% |
| Betamethasone Dipropionate .5 mg/g 51672-1310-01 | Sun | 1 tube | $0.209 | AB | Availability likely | save 28% |
| Betamethasone Dipropionate .5 mg/mL 00168-0057-60 | E. | 1 bottle | $0.292 | AB | Availability likely | — |
| Betamethasone Dipropionate .5 mg/mL 00713-0807-53 | Cosette | 1 bottle | $0.292 | AB | Availability likely | — |
| Betamethasone Dipropionate .5 mg/gthis 45802-0021-46 | Padagis | 56.2 g | $0.292 | AB | Availability likely | — |
| Betamethasone Dipropionate .5 mg/g 00472-0381-15 | Actavis | 1 tube | $0.460 | AB | Availability likely | +57% |
| betamethasone dipropionate .5 mg/g 72578-0093-01 | Viona | 1 tube | $0.460 | AB | Availability likely | +57% |
| Betamethasone Dipropionate .5 mg/g 00168-0056-15 | E. | 1 tube | $0.460 | AB | Discontinued | +57% |
| Betamethasone Dipropionate .5 mg/g 45802-0505-14 | Padagis | 1 tube | $0.460 | AB | Availability likely | +57% |
| Betamethasone dipropionate .5 mg/g 70710-1233-01 | Zydus | 1 tube | $0.465 | AB | Availability likely | +59% |
| Betamethasone Dipropionate .5 mg/g 00713-0659-15 | Cosette | 1 tube | $0.465 | AB | Availability likely | +59% |
| Betamethasone Dipropionate .5 mg/g 00472-0380-15 | Actavis | 1 tube | $0.465 | AB | Availability likely | +59% |
| Betamethasone Dipropionate .5 mg/g 00168-0055-15 | E. | 1 tube | $0.465 | AB | Availability likely | +59% |
| Betamethasone dipropionate .5 mg/g 16714-0996-01 | Northstar | 1 tube | $0.465 | AB | Availability likely | +59% |
| Betamethasone Dipropionate .5 mg/g 51672-1274-01 | Sun | 1 tube | $0.465 | AB | Availability likely | +59% |
| Betamethasone Dipropionate .5 mg/g 66993-0897-15 | Prasco | 1 tube | $0.578 | AB | Availability likely | +98% |
| Betamethasone Dipropionate .5 mg/g 00472-0382-15 | Actavis | 1 tube | $0.588 | AB | Discontinued | +101% |
| Betamethasone Dipropionate .5 mg/g 35573-0107-15 | Burel | 1 tube | $0.588 | AB | Availability likely | +101% |
| Betamethasone dipropionate .5 mg/g 68180-0947-01 | Lupin | 1 tube | $0.588 | AB | Availability likely | +101% |
| Betamethasone Dipropionate .5 mg/g 00168-0268-15 | E. | 15 g | $0.588 | AB | Availability likely | +101% |
| Betamethasone Dipropionate .5 mg/g 51672-1309-01 | Sun | 1 tube | $2.740 | AB | Availability likely | +837% |
| betamethasone dipropionate .5 mg/g 70771-1550-01 | Zydus | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 71205-0275-15 | Proficient | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-0235-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-0236-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-2182-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 50090-4680-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 63629-8614-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 59651-0699-14 | Aurobindo | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 70518-4187-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Diprolene .5 mg/g 78206-0124-01 | Organon | 1 tube | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 70771-1380-01 | Zydus | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 71335-2715-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 72162-1415-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 68071-4556-03 | NuCare | 30 g | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 50090-6787-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 59651-0891-14 | Aurobindo | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 76420-0858-15 | Asclemed | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-3276-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 63629-9324-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 68788-7670-05 | Preferred | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-7517-00 | A-S | 50 g | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 68788-9219-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 72162-1405-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 50090-7525-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 51407-0273-15 | Golden | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 63629-8613-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 50090-5232-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 63629-9323-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Betamethasone Dipropionate .5 mg/g 68071-4814-05 | NuCare | 15 g | — | AB | FDA listed | — |
| Betamethasone dipropionate .5 mg/g 67296-2275-01 | Redpharm | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII HHT01ZNK31
Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Betamethasone Dipropionate Lotion USP, 0.05% is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply a few drops of Betamethasone Dipropionate Lotion USP, 0.05% to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Betamethasone Dipropionate Lotion USP, 0.05% is not to be used with occlusive dressings.
⛔ Contraindications ▾
CONTRAINDICATIONS Betamethasone Dipropionate Lotion USP, 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following local adverse reactions are reported infrequently when betamethasone dipropionate lotion 0.05% is used as recommended in the DOSAGE AND ADMINISTRATION section. 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, miliaria. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate lotion 0.05% during a pediatric study include: paresthesia (burning), erythema, erythematous rash, and dry skin.
These adverse reactions each occurred in a different patient; 4% of the 25 patient population, respectively. An adverse reaction reported to be possibly or probably related to treatment in 2 different patients, 8%, of the 25 patients is puritis. 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.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects: Pregnancy Category C- Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 0.03 fold the estimated maximum human dose based on a mg/m 2 comparison.
The abnormalities observed included umbilical hernias, cephalocele and cleft palates. 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 on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids 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.
🧒 Pediatric Use ▾
Pediatric Use - Use of Betamethasone Dipropionate Lotion USP, 0.05% in pediatric patients 12 years of age and younger is not recommended (see CLINICAL PHARMACOLOGY and ADVERSE REACTIONS sections). In an open-label study, 11 of 15 (73%) evaluable pediatric patients (aged 6 years-12 years old) using betamethasone dipropionate lotion 0.05% for treatment of atopic dermatitis for 2-3 weeks demonstrated adrenal suppression (see CLINICAL PHARMACOLOGY - Pharmacokinetics ). 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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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.
Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.
🆘 Overdosage ▾
OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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, antipruritic, 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. Pharmacokinetics - 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 (see DOSAGE AND ADMINISTRATION ).
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into the bile. Twenty-five pediatric patients ages 6 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Betamethasone dipropionate lotion 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 45% (range 35% to 72%).
In 11 of 15 (73%) evaluable patients, adrenal suppression was indicated by either a < 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol < 18 mcg/dL and an increase of < 7 mcg/dL from the baseline cortisol. Studies performed with betamethasone dipropionate lotion 0.05% indicate that it is in the medium range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Betamethasone Dipropionate Lotion USP, 0.05% is available as follows: 60 mL bottle (NDC 45802- 021 -46) Shake well before using.
📦 Storage and Handling ▾
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Store in carton until contents are used.
📋 Description ▾
DESCRIPTION Betamethasone Dipropionate Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight 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 Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water.
Sodium hydroxide is used to adjust pH. Image 1
💬 Information for Patients ▾
Information for Patients - 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. 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. 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 DOSAGE AND ADMINISTRATION ). 4. Patients should report any signs of local adverse reactions.
5. Other corticosteroid-containing products should not be used with Betamethasone Dipropionate Lotion USP, 0.05% without first talking to your physician.
⚠️ Precautions ▾
PRECAUTIONS General - 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. Conditions which augment systemic absorption include the application of the more potent steroids, 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 DOSAGE AND ADMINISTRATION ).
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 15 evaluable patients, of the 11 subjects who showed evidence of suppression, 6 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate lotion 0.05%, and 4 of the 6 (67%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS - Pediatric Use ).
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.
Information for Patients - 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. 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. 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 DOSAGE AND ADMINISTRATION ). 4. Patients should report any signs of local adverse reactions.
5. Other corticosteroid-containing products should not be used with Betamethasone Dipropionate Lotion USP, 0.05% without first talking to your physician. Laboratory Tests - The following tests may be helpful in evaluating HPA axis suppression: Urinary-free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
Betamethasone was negative in the bacterial mutagenicity assay ( Salmonella typhimurium and Escherichia coli ), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in-vitro human lymphocyte chromosome aberration assay, and equivocal in the in-vivo 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 0.5 and 4 fold the estimated maximum human dose based on a mg/m 2 comparison, respect… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers - It is not known whether topical administration of corticosteroids could 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, caution should be exercised when topical corticosteroids are prescribed for a nursing woman.
🧬 Pharmacokinetics ▾
Pharmacokinetics - 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 (see DOSAGE AND ADMINISTRATION ). Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Twenty-five pediatric patients ages 6 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study.
Betamethasone dipropionate lotion 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 45% (range 35% to 72%). In 11 of 15 (73%) evaluable patients, adrenal suppression was indicated by either a < 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol < 18 mcg/dL and an increase of < 7 mcg/dL from the baseline cortisol. Studies performed with betamethasone dipropionate lotion 0.05% indicate that it is in the medium range of potency as compared with other topical corticosteroids.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay ( Salmonella typhimurium and Escherichia coli ), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in-vitro human lymphocyte chromosome aberration assay, and equivocal in the in-vivo 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 0.5 and 4 fold the estimated maximum human dose based on a mg/m 2 comparison, respectively.
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Rx Only Betamethasone Dipropionate Lotion USP, 0.05% (Potency expressed as Betamethasone) For Dermatologic Use Only Not for Ophthalmic Use NET CONTENTS 60 mL (56.2 g) label