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Calcipotriene and Betamethasone Dipropionate 50 ug/g; .643 mg/g Ointment — NDC 72162-1428-6 (Billing 72162-1428-06)

by Bryant Ranch Prepack · 1 TUBE in 1 CARTON / 60 g in 1 TUBE

This is a package of Calcipotriene and Betamethasone Dipropionate 50 ug/g; .643 mg/g Ointment from Bryant Ranch Prepack, marketed since Jan 2020 and currently FDA-listed.

NDC 72162-1428-06
🏷️ FDA NDC (as labeled) 72162-1428-6 billing pads the package segment with a zero
This package
Contains60 g in 1 tube Pack sizes2 compare ↓
Also priced by: Part D plans $4.33/unit — full pricing hub ↓
Product page 72162-1428-01 Also comes in: 100 g 72162-1428-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 72162-1428-6 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72162 labeler · 1428 product · 6 package
Package marketed since
Dec 5, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7216214286 8
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72162-1428-6
Product NDC 72162-1428
11-digit billing NDC 72162142806
NCPDP billing unit GM — per gram (weight)
RxCUI 388525
UNII 143NQ3779B, 826Y60901U
Application # ANDA200174
SPL Set ID d223e857-590e-48b9-b33e-1275537a508e
Established class (EPC) Vitamin D Analog
Chemical class Vitamin D
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-30
Route TOPICAL
Dosage form OINTMENT
Substance CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 048366
GCN 13785
HICL code 022851
Ingredient (HICL) Calcipotriene/Betamethasone
HIC1 code T
Therapeutic class — broad (HIC1) Ear,Eye,Nose,Rectum,Top,Vag.,Spec.senses(Q Cont.)
HIC2 code T0
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin (Q5 Cont'd)
HIC3 code T0A
Therapeutic class — specific (HIC3) Topical Vit D Analog/Anti-Inflammatory Steroid
AHFS code 84:24.12.00
AHFS class Basic Ointments And Protectants
FDB label name CALCIPOTRIENE-BETAMETH DP OINT
FDB brand name Calcipotriene-Betamethasone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048366
  • GCN: 13785
  • HICL (First Databank): 022851
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 388525
Why two NDCs? The FDA registers this code as 72162-1428-6 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 72162-1428-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CALCIPOTRIENE-BETAMETH DP OINT Ingredient Calcipotriene/Betamethasone
📗 Our plain-language guide HelloPharmacist
  • It treats plaque psoriasis. Depending on the product, it is approved for scalp psoriasis, body psoriasis, or both. Check which one you were given.
  • Usually once a day until the psoriasis is controlled, up to 4 or 8 weeks depending on the product. Stay within the weekly limit on your label and follow your prescriber.
  • Avoid the face, groin, and underarms, and skin that has become thin. Keep it out of your eyes and do not use it by mouth or vaginally. Don't cover it with tight dressings unless yo...
  • Itching, scaly rash, redness, or burning where you apply it are the common ones. Call your doctor if you notice vision changes, skin that isn't healing, or your psoriasis getting w...
📖 Read our full Betamethasone / Calcipotriene guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $4.33 $259.63 / 60 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72162-1428-06 You're viewing this 1 TUBE in 1 CARTON / 60 g in 1 TUBE 2023-12-05 — Active
72162-1428-01 72162-1428-1 Main listing 1 TUBE in 1 CARTON / 100 g in 1 TUBE 2023-12-05 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 60 g in 1 tube.
What NDC number is used to bill for this package of Calcipotriene and Betamethasone Dipropionate 50 ug/g; .643 mg/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calcipotriene and Betamethasone Dipropionate 50 ug/g; .643 mg/g 45802-0816-01 Padagis 1 tube $1.433 AB Availability likely —
Calcipotriene and Betamethasone Dipropionate 50 ug/g; .5 mg/g 66993-0938-61 Prasco 1 tube $2.183 AB Availability likely —
Calcipotriene and Betamethasone Dipropionate 50 ug/g; .643 mg/g 63629-2520-01 Bryant 1 tube — AB FDA listed —
Calcipotriene and Betamethasone Dipropionate 50 ug/g; .643 mg/g 63629-8617-01 Bryant 1 tube — AB FDA listed —
Calcipotriene and Betamethasone Dipropionate 50 ug/g; .643 mg/gthis 72162-1428-06 Bryant 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Betamethasone / Calcipotriene inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA200174 (ANDA)
Labeler code72162
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 72162

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 56 words ▾

1 INDICATIONS AND USAGE Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Calcipotriene and Betamethasone Dipropionate Ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Apply an adequate layer of Calcipotriene and Betamethasone Dipropionate Ointment to the affected area(s) once daily for up to 4 weeks. Calcipotriene and Betamethasone Dipropionate Ointment should be rubbed in gently and completely. Patients should wash their hands after applying Calcipotriene and Betamethasone Dipropionate Ointment.

Therapy should be discontinued when control is achieved. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week. Treatment of more than 30% body surface area is not recommended.

Calcipotriene and Betamethasone Dipropionate Ointment should not be used with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Calcipotriene and Betamethasone Dipropionate Ointment is not for oral, ophthalmic, or intravaginal use. • Apply Calcipotriene and Betamethasone Dipropionate Ointment to affected area(s) once daily for up to 4 weeks.

Discontinue therapy when control is achieved. (2) • Adult patients should not use more than 100 g per week. (2) • Patients ages 12 to 17 years should not use more than 60 g per week.

(2) • Treatment of more than 30% body surface area is not recommended. (2) • Do not use with occlusive dressings unless directed by a physician. (2) • Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

(2) • Not for oral, ophthalmic, or intravaginal use. (2)

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS Ointment, 0.005%/0.064% Each gram of Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base. Ointment, 0.005%/0.064%

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypercalcemia and hypercalciuria have been observed. If either occurs, discontinue treatment until parameters of calcium metabolism normalize. (5.1) • Calcipotriene and Betamethasone Dipropionate Ointment can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment.

Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, concomitant use of more than one corticosteroid-containing product, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (5.2, 8.4) • Calcipotriene and Betamethasone Dipropionate Ointment may increase the risk of cataract and glaucoma.

If visual symptoms occur, consider referral to an ophthalmologist. (5.3)

5.1Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of calcipotriene and betamethasone dipropionate ointment. If hypercalcemia or hypercalciuria develops, treatment should be discontinued until parameters of calcium metabolism have normalized. In the trials that included assessment of the effects of calcipotriene and betamethasone dipropionate ointment on calcium metabolism, such testing was done after 4 weeks of treatment.

The effects of calcipotriene and betamethasone dipropionate ointment on calcium metabolism following treatment durations of longer than 4 weeks have not been evaluated [see Clinical Pharmacology (12.2)] .

5.2Effects on Endocrine System Calcipotriene and betamethasone dipropionate ointment can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, concomitant use of more than one corticosteroid-containing product, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the cosyntropin stimulation test [see Clinical Pharmacology (12.2)]. In a trial evaluating the effects of calcipotriene and betamethasone dipropionate topical suspension and calcipotriene and betamethasone dipropionate ointment on the HPA axis, 32 adult subjects were treated with calcipotriene and betamethasone dipropionate topical suspension on the scalp and calcipotriene and betamethasone dipropionate ointment on the body. Adrenal suppression was identified in 5 of 32 subjects (15.6%) after 4 weeks of treatment [see Clinical Pharmacology (12.2)] .

The effects of calcipotriene and betamethasone dipropionate ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Cushing's syndrome and hyperglycemia may also occur due to the systemic effects of topical corticosteroids.

These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. Pediatric patients may be more susceptible to systemic toxicity due to their higher skin surface to body mass ratios [see Use in Specific Populations (8.4), Clinical Pharmacology (12.2)]. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

5.3Ophthalmic Adverse Reactions Use of topical corticosteroids, including Calcipotriene and Betamethasone Dipropionate Ointment, may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥1%) are pruritus and scaly rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Clinical Trials Conducted in Subjects 18 years and older with Plaque Psoriasis The data described below reflect exposure to calcipotriene and betamethasone dipropionate ointment in 2448 subjects with plaque psoriasis, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. Calcipotriene and betamethasone dipropionate ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe.

Most subjects received once daily application, and the median weekly dose was 24.5 g. The percentage of subjects reporting at least one adverse event was 27.1% in the calcipotriene and betamethasone dipropionate ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group. Table 1 Adverse Events Reported by ≥1% of Subjects by Preferred Term Calcipotriene and betamethasone dipropionate ointment N = 2448 Calcipotriene N = 3197 Betamethasone dipropionate N = 1164 Vehicle N = 470 Any Adverse Event 663 (27.1) 1055 (33.0) 329 (28.3) 157 (33.4) Preferred Term # of subjects (%) Pruritus 75 (3.1) 183 (5.7) 38 (3.3) 43 (9.1) Headache 69 (2.8) 75 (2.3) 44 (3.8) 12 (2.6) Nasopharyngitis 56 (2.3) 77 (2.4) 34 (2.9) 9 (1.9) Psoriasis 30 (1.2) 47 (1.5) 14 (1.2) 5 (1.1) Rash scaly 30 (1.2) 40 (1.3) 0 (0.0) 1 (0.2) Influenza 23 (0.9) 34 (1.1) 14 (1.2) 6 (1.3) Upper respiratory tract infection 20 (0.8) 19 (0.6) 12 (1.0) 3 (0.6) Erythema 15 (0.6) 54 (1.7) 3 (0.3) 5 (1.1) Application site pruritus 13 (0.5) 24 (0.8) 10 (0.9) 6 (1.3) Skin irritation 11 (0.4) 60 (1.9) 8 (0.7) 5 (1.1) Pain 7 (0.3) 12 (0.4) 3 (0.3) 5 (1.1) Burning sensation 6 (0.2) 30 (0.9) 3 (0.3) 6 (1.3) A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border.

Table 2 Lesional/Perilesional Adverse Events Reported by ≥ 1% of Subjects Calcipotriene and betamethasone dipropionate ointment N = 2448 Calcipotriene N = 3197 Betamethasone dipropionate N = 1164 Vehicle N = 470 Any Adverse Event 213 (8.7) 419 (13.1) 85 (7.3) 76 (16.2) Preferred Term # of subjects (%) Pruritus 69 (2.8) 170 (5.3) 31 (2.7) 41 (8.7) Rash scaly 29 (1.2) 38 (1.2) 0 (0.0) 0 (0.0) Application site pruritus 12 (0.5) 24 (0.8) 10 (0.9) 6 (1.3) Erythema 9 (0.4) 36 (1.1) 2 (0.2) 4 (0.9) Skin irritation 9 (0.4) 51 (1.6) 8 (0.7) 5 (1.1) Burning sensation 6 (0.2) 25 (0.8) 3 (0.3) 5 (1.1) For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for calcipotriene and betamethasone dipropionate ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle.

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%). In a separate trial, subjects (N = 207) with at least moderate disease severity were given calcipotriene and betamethasone dipropionate ointment intermittently on an “as needed” basis for up to 52 weeks.

The median use was 15.4 g per week. The effects of calcipotriene and betamethasone dipropionate ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Calcipotriene and Betamethasone Dipropionate Ointment contains calcipotriene and bethamethasone dipropionate. The limited data with Calcipotriene and Betamethasone Dipropionate Ointment and calcipotriene use in pregnant women are not sufficient to evaluate a Calcipotriene and Betamethasone Dipropionate Ointment-associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids ( see Data ).

Advise pregnant women that Calcipotriene and Betamethasone Dipropionate Ointment may increase the potential risk of having a low birth weight infant and to use Calcipotriene and Betamethasone Dipropionate Ointment on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs ( see Data ).

Oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development. Subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone diproprionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate ointment.

The estimated background risk of major birth defects and miscarriage of the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency.

However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits. Pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m 2 /day, respectively) on days 6-15 of gestation (the period of organogenesis).

There were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. Fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs. Pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m 2 /day, respectively) on days 6-18 of gestation (the period of organogenesis).

Mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. The incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group. The incidence of major malformations among fetuses was not affected.

An increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. Embryo-fetal development stu… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Calcipotriene and Betamethasone Dipropionate Ointment contains calcipotriene and bethamethasone dipropionate. The limited data with Calcipotriene and Betamethasone Dipropionate Ointment and calcipotriene use in pregnant women are not sufficient to evaluate a Calcipotriene and Betamethasone Dipropionate Ointment-associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids ( see Data ).

Advise pregnant women that Calcipotriene and Betamethasone Dipropionate Ointment may increase the potential risk of having a low birth weight infant and to use Calcipotriene and Betamethasone Dipropionate Ointment on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs ( see Data ).

Oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development. Subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone diproprionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate ointment.

The estimated background risk of major birth defects and miscarriage of the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency.

However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits. Pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m 2 /day, respectively) on days 6-15 of gestation (the period of organogenesis).

There were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. Fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs. Pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m 2 /day, respectively) on days 6-18 of gestation (the period of organogenesis).

Mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. The incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group. The incidence of major malformations among fetuses was not affected.

An increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. Embryo-fetal development studies with betamethasone diprop… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness of the use of Calcipotriene and Betamethasone Dipropionate Ointment in pediatric patients under the age of 12 years have not been established. The safety and effectiveness of Calcipotriene and Betamethasone Dipropionate Ointment for the treatment of plaque psoriasis have been established in the age group 12 to 17 years. In a prospective, uncontrolled trial, 33 pediatric subjects ages 12-17 years with plaque psoriasis on the body were treated with calcipotriene and betamethasone dipropionate ointment for 4 weeks up to a maximum of 55.8 g per week.

Subjects were assessed for HPA axis suppression and effects on calcium metabolism. No adverse effects on adrenal suppression were observed. No hypercalcemia was observed but one subject had a possible treatment-related increase in urinary calcium [see Clinical Pharmacology (12.2)] .

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 [see Warnings and Precautions (5.2)] . Rare systemic toxicities 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 striae have also been reported with use of topical corticosteroids in pediatric patients.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use Of the total number of subjects in the clinical studies of calcipotriene and betamethasone dipropionate ointment, approximately 14% were 65 years and older and approximately 3% were 75 years and over. No overall differences in safety or effectiveness of calcipotriene and betamethasone dipropionate ointment were observed between these subjects and younger subjects. All other reported clinical experience has not identified any differences in response between elderly and younger patients.

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

🆘 Overdosage 27 words ▾

10 OVERDOSAGE Topically applied Calcipotriene and Betamethasone Dipropionate Ointment can be absorbed in sufficient amounts to produce systemic effects [ see Warnings and Precautions (5.1, 5.2) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Calcipotriene and Betamethasone Dipropionate Ointment combines the pharmacological effects of calcipotriene as a synthetic vitamin D 3 analogue and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in plaque psoriasis are unknown.

12.2Pharmacodynamics Vasoconstriction: In a vasoconstrictor trial in healthy subjects, the skin blanching response of calcipotriene and betamethasone dipropionate ointment was consistent with that of a potent corticosteroid when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: HPA axis suppression was evaluated in four trials (Trial A, B, C and D) following the application of calcipotriene and betamethasone dipropionate ointment.

In Trial A, calcipotriene and betamethasone dipropionate ointment was applied once daily for 4 weeks to adult subjects (N = 12) with plaque psoriasis to study its effects on the hypothalamic-pituitary-adrenal (HPA) axis. Of eleven subjects tested, none demonstrated adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤ 18 mcg/dL. In Trial B, calcipotriene and betamethasone dipropionate ointment was evaluated in adult subjects with plaque psoriasis (N = 19).

One subject demonstrated adrenal suppression. In Trial C, HPA axis suppression was evaluated in adult subjects (N=32) with extensive plaque psoriasis involving at least 30% of the scalp and, in total, 15-30% of the body surface area. Treatment consisted of once daily application of calcipotriene and betamethasone dipropionate topical suspension on the scalp in combination with calcipotriene and betamethasone dipropionate ointment on the body.

Adrenal suppression as indicated by a 30-minutes post-stimulation cortisol level < 18 mcg/dL was observed in 5 of 32 subjects (15.6%) after 4 weeks of treatment as per the recommended duration of use [see Dosage and Administration (2)] . In Trial D, HPA axis suppression was evaluated in subjects 12 to 17 years (N=32) with plaque psoriasis of the body involving 5-30% of the body surface area. Treatment consisted of once daily application of calcipotriene and betamethasone dipropionate ointment to the affected areas for up to 4 weeks.

Mean weekly dose was 29.6 g with a range of 8.1-55.8 g/week. Adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤18 mcg/dL was observed in none of 32 evaluable subjects after 4 weeks of treatment [see Use in Specific Populations (8.4)] . Effects on Calcium Metabolism In Trial C described above, the effects of once daily application of calcipotriene and betamethasone dipropionate ointment on the body in combination with calcipotriene and betamethasone dipropionate topical suspension on the scalp on calcium metabolism were also examined.

Elevated urinary calcium levels outside the normal range were observed in 1 of 35 subjects (2.9%) after 4 weeks of treatment. In Trial D described above, calcium metabolism was evaluated in a total of 33 subjects aged 12 to 17 years with plaque psoriasis involving 5-30% of the body surface area who underwent once daily application of calcipotriene and betamethasone dipropionate ointment for up to 4 weeks. No cases of hypercalcemia and no clinically relevant changes in urinary calcium were reported.

However, one subject had a normal urinary calcium: creatinine ratio at baseline (3.75 mmol/g), which increased above the normal range at week 4 (16 mmol/g). There were no relevant changes in albumin-corrected serum calcium or other markers of calcium metabolism for this subject. The clinical significance of this finding is unknown.

12.3Pharmacokinetics Absorption In Trial C described above, the systemic effect of calcipotriene and betamethasone dipropionate ointment in extensive p… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action Calcipotriene and Betamethasone Dipropionate Ointment combines the pharmacological effects of calcipotriene as a synthetic vitamin D 3 analogue and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in plaque psoriasis are unknown.

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% is off-white to yellow in color, available in collapsible tubes of: NDC: 72162-1428-6: 60 g in a TUBE NDC: 72162-1428-1: 100 g in a TUBE

16.2Storage Store Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% between 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature].

16.3Handling Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 152 words ▾

11 DESCRIPTION Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D 3 analogue.

Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.3, and the following structural formula: Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-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 almost white odorless powder.

Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Inform patients of the following: • Instruct adult patients (18 years and older) not to use more than 100 g per week. • Instruct pediatric patients (12 to 17 years) not to use more than 60 g per week. • Discontinue therapy when control is achieved unless directed otherwise by the physician. • Avoid use of Calcipotriene and Betamethasone Dipropionate Ointment on the face, underarms, groin or eyes. If this medicine gets on face or in eyes, wash area right away. • Do not occlude the treatment area with a bandage or other covering unless directed by the physician. • Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. • Wash hands after application. • Advise patients to report any visual symptoms to their healthcare providers. • Advise a woman to use Calcipotriene and Betamethasone Dipropionate Ointment on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding.

Advise breastfeeding women not to apply Calcipotriene and Betamethasone Dipropionate Ointment directly to the nipple and areola to avoid direct infant exposure. • Instruct patients not to use other products containing calcipotriene or a corticosteroid should not be used with Calcipotriene and Betamethasone Dipropionate Ointment without first talking to the physician. • Instruct patients who use Calcipotriene and Betamethasone Dipropionate Ointment to avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).

Made in Israel Manufactured By Padagis Yeruham, Israel Distributed By Padagis Allegan, MI 49010 • www.padagis.com Rev 01-22 1V200 RC J2

PATIENT INFORMATION Calcipotriene (kal-si-POE-try-een) and Betamethasone (bay-ta-METH-a-sone) Dipropionate Ointment, 0.005%/0.064% Read the Patient Information that comes with Calcipotriene and Betamethasone Dipropionate Ointment before you start using it and each time you refill your prescription. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

Important information: Calcipotriene and Betamethasone Dipropionate Ointment is for use on the skin only (topical use only). Do not use Calcipotriene and Betamethasone Dipropionate Ointment on the face, under arms or on groin area. Do not swallow Calcipotriene and Betamethasone Dipropionate Ointment.

Another product, Calcipotriene and Betamethasone Topical Suspension contains the same medicine that is in Calcipotriene and Betamethasone Dipropionate Ointment and is used to treat plaque psoriasis on the scalp. If you use both medicines to treat your plaque psoriasis, be sure to follow your doctor’s directions carefully so that you do not use too much of one or both of these medications. What is Calcipotriene and Betamethasone Dipropionate Ointment?

Calcipotriene and Betamethasone Dipropionate Ointment is a prescription medicine that is for use on the skin only (a topical medicine). Calcipotriene and Betamethasone Dipropionate Ointment is used to treat plaque psoriasis in patients 12 years of age and older. Calcipotriene and Betamethasone Dipropionate Ointment has not been studied in patients under the age of 12 years.

Who should not use Calcipotriene and Betamethasone Dipropionate Ointment? Do not use Calcipotriene and Betamethasone Dipropionate Ointment if you: • have thin skin (atrophy) at the site to be treated • are allergic to anything in Calcipotriene and Betamethasone Dipropionate Ointment. See the end of this leaflet for a complete list of ingredients.

What should I tell my doctor before using Calcipotriene and Betamethasone Dipropionate Ointment? Tell your doctor about all of your health conditions, including if you: • have a skin infection. Your skin infection should be treated before starting Calcipotriene and Betamethasone Dipropionat… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption In Trial C described above, the systemic effect of calcipotriene and betamethasone dipropionate ointment in extensive plaque psoriasis was investigated. In this trial, the serum levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 weeks (maximum recommended duration of treatment) and also after 8 weeks of once daily application of calcipotriene and betamethasone dipropionate ointment on the body in combination with calcipotriene and betamethasone dipropionate topical suspension on the scalp.

Both calcipotriene and betamethasone dipropionate were below the lower limit of quantification in all serum samples of the 34 subjects evaluated. However, one major metabolite of calcipotriene (MC1080) was quantifiable in 10 of 34 (29.4%) subjects at week 4 and in five of 12 (41.7%) subjects at week 8. The major metabolite of betamethasone dipropionate, betamethasone 17-propionate (B17P) was also quantifiable in 19 of 34 (55.9%) subjects at week 4 and seven of 12 (58.3%) subjects at week 8.

The serum concentrations for MC1080 ranged from 20-75 pg/mL. The clinical significance of this finding is unknown. Metabolism Calcipotriene: Calcipotriene metabolism following systemic uptake is rapid and occurs in the liver.

The primary metabolites of calcipotriene are less potent than the parent compound. Calcipotriene is metabolized to MC1046 (the alpha, beta-unsaturated ketone analogue of calcipotriene), which is metabolized further to MC1080 (a saturated ketone analogue). MC1080 is the major metabolite in plasma.

MC1080 is slowly metabolized to calcitroic acid. Betamethasone dipropionate: Betamethasone dipropionate is metabolized to betamethasone 17-propionate and betamethasone, including the 6beta-hydroxy derivatives of those compounds by hydrolysis. Betamethasone 17-propionate (B17P) is the primary metabolite.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Vasoconstriction: In a vasoconstrictor trial in healthy subjects, the skin blanching response of calcipotriene and betamethasone dipropionate ointment was consistent with that of a potent corticosteroid when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: HPA axis suppression was evaluated in four trials (Trial A, B, C and D) following the application of calcipotriene and betamethasone dipropionate ointment.

In Trial A, calcipotriene and betamethasone dipropionate ointment was applied once daily for 4 weeks to adult subjects (N = 12) with plaque psoriasis to study its effects on the hypothalamic-pituitary-adrenal (HPA) axis. Of eleven subjects tested, none demonstrated adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤ 18 mcg/dL. In Trial B, calcipotriene and betamethasone dipropionate ointment was evaluated in adult subjects with plaque psoriasis (N = 19).

One subject demonstrated adrenal suppression. In Trial C, HPA axis suppression was evaluated in adult subjects (N=32) with extensive plaque psoriasis involving at least 30% of the scalp and, in total, 15-30% of the body surface area. Treatment consisted of once daily application of calcipotriene and betamethasone dipropionate topical suspension on the scalp in combination with calcipotriene and betamethasone dipropionate ointment on the body.

Adrenal suppression as indicated by a 30-minutes post-stimulation cortisol level < 18 mcg/dL was observed in 5 of 32 subjects (15.6%) after 4 weeks of treatment as per the recommended duration of use [see Dosage and Administration (2)] . In Trial D, HPA axis suppression was evaluated in subjects 12 to 17 years (N=32) with plaque psoriasis of the body involving 5-30% of the body surface area. Treatment consisted of once daily application of calcipotriene and betamethasone dipropionate ointment to the affected areas for up to 4 weeks.

Mean weekly dose was 29.6 g with a range of 8.1-55.8 g/week. Adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤18 mcg/dL was observed in none of 32 evaluable subjects after 4 weeks of treatment [see Use in Specific Populations (8.4)] . Effects on Calcium Metabolism In Trial C described above, the effects of once daily application of calcipotriene and betamethasone dipropionate ointment on the body in combination with calcipotriene and betamethasone dipropionate topical suspension on the scalp on calcium metabolism were also examined.

Elevated urinary calcium levels outside the normal range were observed in 1 of 35 subjects (2.9%) after 4 weeks of treatment. In Trial D described above, calcium metabolism was evaluated in a total of 33 subjects aged 12 to 17 years with plaque psoriasis involving 5-30% of the body surface area who underwent once daily application of calcipotriene and betamethasone dipropionate ointment for up to 4 weeks. No cases of hypercalcemia and no clinically relevant changes in urinary calcium were reported.

However, one subject had a normal urinary calcium: creatinine ratio at baseline (3.75 mmol/g), which increased above the normal range at week 4 (16 mmol/g). There were no relevant changes in albumin-corrected serum calcium or other markers of calcium metabolism for this subject. The clinical significance of this finding is unknown.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Clinical Trials Conducted in Subjects 18 years and older with Plaque Psoriasis In an international, multi-center, double-blind, vehicle- and active-controlled, parallel-group trial, 1603 subjects with mild to very severe plaque psoriasis on trunk and limbs were treated once daily for 4 weeks. Subjects were randomized to one of four treatment arms: calcipotriene and betamethasone dipropionate ointment, calcipotriene hydrate 50 mcg/g in the same vehicle, betamethasone dipropionate 0.64 mg/g in the same vehicle, and vehicle alone.

The mean age of the subjects was 48.4 years and 60.5% were male. Most subjects had disease of moderate severity at baseline. Efficacy was assessed as the proportion of subjects with absent or very mild disease according to the Investigator’s Global Assessment of Disease Severity at end of treatment (4 weeks). “Absent” disease was defined as no evidence of redness, thickness, or scaling. “Very mild disease” was defined as controlled disease, but not entirely cleared: lesions with some discoloration with absolutely minimal thickness, i.e. the edges to the lesion(s) could just be felt.

Table 3 contains the response rates for this trial. Table 3 Percentage of Subjects with Absent or Very Mild Disease According to the Investigator’s Global Assessment of Disease Severity at End of Treatment (4 weeks).* Calcipotriene and betamethasone dipropionate ointment N = 490 Calcipotriene N = 480 Betamethasone dipropionate N = 476 Vehicle N = 157 Absent or very mild disease 48.0% 16.5% 26.3% 7.6% * Subjects with mild disease at baseline were required to have “Absent” disease to be considered a success. In addition to the pivotal trial (N = 490), four randomized, double-blind, vehicle- or active-controlled, parallel-group trials were conducted and provided supportive evidence of efficacy.

These trials included a total of 1058 subjects treated with calcipotriene and betamethasone dipropionate ointment once daily for up to 4 weeks. Clinical Trial Conducted in Subjects 12 to 17 years with Plaque Psoriasis A prospective, uncontrolled trial (N=33) was conducted in pediatric subjects ages 12 to 17 years with plaque psoriasis involving 5-30% of the body surface area. Approximately 91% of subjects had moderate disease at baseline.

Subjects were treated once daily for up to 4 weeks with calcipotriene and betamethasone dipropionate ointment. All subjects were evaluated for safety including calcium metabolism (N=33) and 32 subjects were evaluated for HPA axis suppression [see Clinical Pharmacology (12.2)] .

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 mcg/kg/day (9, 30 and 90 mcg/m 2 /day, respectively), no significant changes in tumor incidence were observed when compared to control. A 104-week oral carcinogenicity study was conducted with calcipotriene in male and female rats at doses of 1, 5 and 15 mcg/kg/day (6, 30, and 90 mcg/m 2 /day, respectively). Beginning week 71, the dosage for high-dose animals of both genders was reduced to 10 mcg/kg/day (60 mcg/m 2 /day).

A treatment-related increase in benign C-cell adenomas was observed in the thyroid of females that received 15 mcg/kg/day. A treatment-related increase in benign pheochromocytomas was observed in the adrenal glands of males that received 15 mcg/kg/day. No other statistically significant differences in tumor incidence were observed when compared to control.

The relevance of these findings to patients is unknown. When betamethasone dipropionate was applied topically to CD-1 mice for up to 24 months at dosages approximating 1.3, 4.2 and 8.5 mcg/kg/day in females, and 1.3, 4.2, and 12.9 mcg/kg/day in males (up to 26 mcg/m 2 /day and 39 mcg/m 2 /day, in females and males, respectively), no significant changes in tumor incidence were observed when compared to control. When betamethasone dipropionate was administered via oral gavage to male and female Sprague Dawley rats for up to 24 months at dosages of 20, 60, and 200 mcg/kg/day (120, 360, and 1200 mcg/m 2 /day, respectively), no significant changes in tumor incidence were observed when compared to control.

Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test. Betamethasone dipropionate did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test. Studies in rats with oral doses of up to 54 mcg/kg/day (324 mcg/m 2 /day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Studies in male rats at oral doses of up to 200 mcg/kg/day (1200 mcg/m 2 /day), and in female rats at oral doses of up to 1000 mcg/kg/ day (6000 mcg/m 2 /day), of betamethasone dipropionate indicated no impairment of fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 mcg/kg/day (9, 30 and 90 mcg/m 2 /day, respectively), no significant changes in tumor incidence were observed when compared to control. A 104-week oral carcinogenicity study was conducted with calcipotriene in male and female rats at doses of 1, 5 and 15 mcg/kg/day (6, 30, and 90 mcg/m 2 /day, respectively). Beginning week 71, the dosage for high-dose animals of both genders was reduced to 10 mcg/kg/day (60 mcg/m 2 /day).

A treatment-related increase in benign C-cell adenomas was observed in the thyroid of females that received 15 mcg/kg/day. A treatment-related increase in benign pheochromocytomas was observed in the adrenal glands of males that received 15 mcg/kg/day. No other statistically significant differences in tumor incidence were observed when compared to control.

The relevance of these findings to patients is unknown. When betamethasone dipropionate was applied topically to CD-1 mice for up to 24 months at dosages approximating 1.3, 4.2 and 8.5 mcg/kg/day in females, and 1.3, 4.2, and 12.9 mcg/kg/day in males (up to 26 mcg/m 2 /day and 39 mcg/m 2 /day, in females and males, respectively), no significant changes in tumor incidence were observed when compared to control. When betamethasone dipropionate was administered via oral gavage to male and female Sprague Dawley rats for up to 24 months at dosages of 20, 60, and 200 mcg/kg/day (120, 360, and 1200 mcg/m 2 /day, respectively), no significant changes in tumor incidence were observed when compared to control.

Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test. Betamethasone dipropionate did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test. Studies in rats with oral doses of up to 54 mcg/kg/day (324 mcg/m 2 /day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Studies in male rats at oral doses of up to 200 mcg/kg/day (1200 mcg/m 2 /day), and in female rats at oral doses of up to 1000 mcg/kg/ day (6000 mcg/m 2 /day), of betamethasone dipropionate indicated no impairment of fertility.

📄 Package Label / Principal Display Panel 5 words ▾

Calcipotriene/Betamethasone Dipro Oint 60g Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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