calcipotriene and betamethasone dipropionate .5 mg/g; 50 ug/g Suspension — NDC 0713-0848-60 (Billing 00713-0848-60)
This is a package of calcipotriene and betamethasone dipropionate .5 mg/g; 50 ug/g Suspension from Cosette Pharmaceuticals, Inc., marketed since Aug 2024 and currently FDA-listed; retail pharmacies pay about $1.42 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.
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): 063988
- GCN: 99699
- GPI-14 (Medi-Span): 90559902321825
- HICL (First Databank): 022851
- AHFS class code: 84:24.12.00
- RxCUI (RxNorm): 833461
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
- 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...
Patient education
Supplement & herbal interactions
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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.421 | $85.25 / 60 g |
| Medicaid paysCMS SDUD · 12 mo | $2.82 | $169.19 / 60 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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 | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00713-0848-60 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE | $1.42 / g | $85.25 | 2024-08-02 | — | Active |
| 00713-0848-92 0713-0848-92 | 2 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE | $1.21 / g | $145.59 | 2024-08-02 | — | Active |
Per g, this pack runs about 17% above the cheapest pack (NDC 00713-0848-92, $1.21 vs $1.42 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 86% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of calcipotriene and betamethasone dipropionate .5 mg/g; 50 ug/g Suspension?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| calcipotriene and betamethasone dipropionate .5 mg/g; 50 ug/gthis 00713-0848-60 | Cosette | 1 bottle | $1.421 | AB | Availability likely | — |
| Calcipotriene and Betamethasone Dipropionate 50 ug/g; 50 mg/g 51672-1402-04 | Sun | 1 bottle | $1.421 | AB | Availability likely | — |
| Taclonex 50 ug/g; .5 mg/g 50222-0501-06 | LEO | 1 bottle | $20.697 | AB | Availability likely | +1357% |
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- 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 ▾
1 INDICATIONS AND USAGE Calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.
Calcipotriene and betamethasone dipropionate topical suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients age 18 years and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instruct patients to shake bottle prior to using calcipotriene and betamethasone dipropionate topical suspension. Apply calcipotriene and betamethasone dipropionate topical suspension to affected areas on the scalp and body once daily for up to 8 weeks. Calcipotriene and betamethasone dipropionate topical suspension should be discontinued when control is achieved.
Instruct patients to wash their hands after applying the product. Inform patients that they should not take a bath or shower or wash their hair right after application of calcipotriene and betamethasone dipropionate topical suspension. Patients 12 to 17 years should not use more than 60 grams per week and patients 18 years and older should not use more than 100 grams per week.
Calcipotriene and betamethasone dipropionate topical suspension should not be: Used with occlusive dressings unless directed by a healthcare provider. Used on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Applied to the scalp in the 12 hours before or after any chemical treatments to the hair.
Calcipotriene and betamethasone dipropionate topical suspension is not for oral, ophthalmic, or intravaginal use. Shake bottle before use. ( 2 ) Apply calcipotriene and betamethasone dipropionate topical suspension to affected areas on the scalp and body once daily for up to 8 weeks.
Discontinue therapy when control is achieved. ( 2 ) Patients age 12 to 17 years should not use more than 60 grams per week. ( 2 ) Adult patients should not use more than 100 grams per week.
( 2 ) Do not use with occlusive dressings unless directed by a healthcare provider. ( 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 ▾
3 DOSAGE FORMS AND STRENGTHS Topical Suspension: 0.005%/0.064% - each gram contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate in a viscous, nearly odorless, almost clear, colorless to slightly off-white suspension. Topical Suspension: 0.005%/0.064% - each gram of calcipotriene and betamethasone dipropionate topical suspension contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize. ( 5.1 ) Effects on Endocrine System: Can cause 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, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. ( 5.2 , 8.4 ) Ophthalmic Adverse Reactions: May increase the risk of cataracts and glaucoma.
If visual symptoms occur, consider referral to an ophthalmologist. ( 5.5 )
5.1Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of calcipotriene and betamethasone dipropionate topical suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following calcipotriene and betamethasone dipropionate topical suspension treatment of more than 8 weeks has not been evaluated [see Clinical Pharmacology ( 12.2 )] .
5.2Effects on Endocrine System Hypothalamic-Pituitary-Adrenal Axis Suppression Calcipotriene and betamethasone dipropionate topical suspension 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 steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is documented, gradually withdraw calcipotriene and betamethasone dipropionate topical suspension, reduce the frequency of application, or substitute with a less potent corticosteroid. The following trials evaluated the effects of calcipotriene and betamethasone dipropionate topical suspension on HPA axis suppression: 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 applied both calcipotriene and betamethasone dipropionate topical suspension on the scalp and calcipotriene and betamethasone dipropionate topical ointment on the body.
Adrenal suppression was identified in 5 of 32 subjects (16%) after 4 weeks of treatment and in 2 of 11 subjects (18%) who continued treatment for 8 weeks. In another trial, 36 adult subjects applied calcipotriene and betamethasone dipropionate topical suspension on the body and scalp and 7 subjects applied calcipotriene and betamethasone dipropionate topical suspension on the body. Adrenal suppression occurred in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects who continued treatment for 8 weeks [see Clinical Pharmacology ( 12.2 )] .
In two trials, the effects of calcipotriene and betamethasone dipropionate topical suspension on the HPA axis were evaluated in 31 and 30 pediatric subjects aged 12 to 17 years old who applied calcipotriene and betamethasone dipropionate topical suspension on the scalp and the scalp/body, respectively. Adrenal suppression occurred in 1 of 30 evaluable subjects (3%) after 4 weeks of treatment (scalp) and 5 of 31 evaluable subjects (16%) after up to 8 weeks of treatment (scalp and body) [see Use in Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.2 )] .
Cushing’s Syndrome and Hyperglycemia Cushing’s syndrome and hyperglycemia may occur due to the systemic effects of the t… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (≥ 1%) are folliculitis and burning sensation of skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information .
6.1Clinical Trials Experience 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. Clinical Trials Conducted in Subjects 18 years and older with Psoriasis of the Scalp The rates of adverse reactions described below were from randomized, multicenter, vehicle- and/or active controlled clinical trials in adult subjects with psoriasis of the scalp [see Clinical Studies ( 14 )] .
Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 grams. Adverse reactions that occurred in ≥1% of subjects treated with calcipotriene and betamethasone dipropionate topical suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1. Table 1.
Number and Percentage of Subjects with Adverse Reactions in Scalp Psoriasis Trials (Events Reported by ≥1% of Subjects and for Which a Relationship is Possible) Calcipotriene and betamethasone dipropionate topical suspension N=1,953 Betamethasone Dipropionate in vehicle N=1,214 Calcipotriene in vehicle N=979 Vehicle N=173 Event # of subjects (%) Folliculitis 16 (1%) 12 (1%) 5 (1%) 0 (0%) Burning sensation of skin 13 (1%) 10 (1%) 29 (3%) 0 (0%) Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.
In a 52-week trial, adverse reactions that were reported by >1% of subjects treated with calcipotriene and betamethasone dipropionate topical suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%). Clinical Trials Conducted in Subjects 18 years and older with Psoriasis of the Body In randomized, multicenter, vehicle- and/or active controlled clinical trials in adult subjects with plaque psoriasis on non-scalp areas, 824 subjects applied calcipotriene and betamethasone dipropionate topical suspension once daily for 8 weeks [see Clinical Studies ( 14 )] .
The median weekly dose was 22.6 grams. There were no adverse reactions that occurred in ≥1% of subjects treated with calcipotriene and betamethasone dipropionate topical suspension and at a rate higher than in subjects treated with vehicle. Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: rash and folliculitis.
Clinical Trials Conducted in Subjects 12 to 17 years with Psoriasis of the Scalp In two uncontrolled clinical trials, 109 subjects aged 12 to 17 years with plaque psoriasis of the scalp applied calcipotriene and betamethasone dipropionate topical suspension once daily for up to 8 weeks. The median weekly dose was 40 grams. Adverse reactions included acne, acneiform dermatitis and application site pruritus (0.9% each) [see Use in Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.2 )] .
Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.
6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relati… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see Clinical Pharmacology ( 12.3 )] .
Observational studies suggest an increased risk of having low birth weight infants with the maternal use of potent or super potent topical corticosteroids (see Data ). Advise pregnant women that calcipotriene and betamethasone dipropionate topical suspension may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate topical suspension 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 dipropionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate topical suspension.
The estimated background risk of major birth defects and miscarriage of the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated 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 super potent topical corticosteroids exceeded 300 grams 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 s… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see Clinical Pharmacology ( 12.3 )] .
Observational studies suggest an increased risk of having low birth weight infants with the maternal use of potent or super potent topical corticosteroids (see Data ). Advise pregnant women that calcipotriene and betamethasone dipropionate topical suspension may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate topical suspension 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 dipropionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate topical suspension.
The estimated background risk of major birth defects and miscarriage of the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated 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 super potent topical corticosteroids exceeded 300 grams 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, includi… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of calcipotriene and betamethasone dipropionate topical suspension for the treatment of plaque psoriasis of the scalp has been established in pediatric patients age 12 to 17 years. The use of calcipotriene and betamethasone dipropionate topical suspension for this indication is supported by evidence from adequate and well-controlled trials in adults and from uncontrolled trials in pediatric subjects that enrolled 109 adolescents with moderate psoriasis of the scalp. After 4 weeks of once daily treatment with calcipotriene and betamethasone dipropionate topical suspension, HPA axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.1 ), and 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 corticosteroids. Pediatric patients are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency with the use of topical corticosteroids including calcipotriene and betamethasone dipropionate topical suspension [see Clinical Pharmacology ( 12.2 )] . 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. The safety and effectiveness of calcipotriene and betamethasone dipropionate topical suspension in pediatric patients less than 12 years of age have not been established. Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of calcipotriene and betamethasone dipropionate topical suspension in plaque psoriasis on non-scalp areas included 124 subjects who were 65 years of age or older, and 36 were 75 years of age or older. Clinical studies of calcipotriene and betamethasone dipropionate topical suspension in subjects with psoriasis of the scalp included 334 subjects who were 65 years or older and 84 subjects who were 75 years or older. No overall differences in safety or effectiveness of calcipotriene and betamethasone dipropionate topical suspension were observed between these subjects and younger subjects, and other reported clinical experience has not identified any differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Calcipotriene and betamethasone dipropionate topical suspension combines the pharmacological effects of calcipotriene as a synthetic vitamin D 3 analog and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in the treatment of plaque psoriasis of the scalp and body are unknown.
12.2Pharmacodynamics 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 topical suspension. In all these trials, adrenal suppression was defined by a 30-minute post-stimulation cortisol level ≤18 mcg/dL. In Trial A, HPA axis suppression was evaluated in adult subjects (N=32) with extensive 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 for 4 to 8 weeks. Adrenal suppression was observed in 5 of 32 subjects (16%) after 4 weeks of treatment and in 2 of 11 subjects (18%) who continued treatment for 8 weeks. In Trial B, HPA axis suppression was evaluated in adult subjects (N=43) with extensive psoriasis involving 15-30% of the body surface area (including the scalp).
Treatment consisted of once daily application of calcipotriene and betamethasone dipropionate topical suspension to the body (including the scalp in 36 out of 43 subjects) for 4 to 8 weeks. Adrenal suppression was observed in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects (0%) who continued treatment for 8 weeks. In Trial C, HPA axis suppression was evaluated in pediatric subjects 12 to 17 years (N=30) with plaque psoriasis of the scalp involving at least 20% of the scalp area.
Treatment consisted of once daily application of calcipotriene and betamethasone dipropionate topical suspension to the affected area on the scalp for up to 8 weeks. Adrenal suppression was observed in 1 of 30 evaluable subjects (3%) after 4 weeks of treatment and in no subjects (0%) who continued treatment for 8 weeks [see Use in Specific Populations ( 8.4 )] . In Trial D, HPA axis suppression was evaluated in a subset of pediatric subjects aged 12 to 17 years (N=31) with plaque psoriasis of the scalp and body involving 10% to 29% of the body surface area.
Adrenal suppression was observed in 5 of 31 subjects (16%): 3 subjects after 4 weeks of treatment, 1 subject after 8 weeks of treatment, and 1 subject after both 4 and 8 weeks of treatment [see Use in Specific Populations ( 8.4 )] . Effects on Calcium Metabolism The effect on calcium metabolism was evaluated following the application of calcipotriene and betamethasone dipropionate topical suspension (these trials are described above). In Trial A, elevated urinary calcium levels outside the normal range were observed in two subjects (one at 4 weeks and one at 8 weeks).
In Trial B, there was no change in mean serum or urinary calcium levels. Elevated urinary calcium levels outside the normal range were observed in two subjects (one at 4 weeks and one at 8 weeks). In Trial C (N=109), including 31 subjects with at least 20% scalp involvement and 78 subjects with at least 10% scalp involvement, no cases of hypercalcemia and no clinically relevant changes in urinary calcium were reported.
12.3Pharmacokinetics Absorption The systemic effect of calcipotriene and betamethasone dipropionate topical suspension in psoriasis was investigated in Trials A and B [see Clinical Pharmacology ( 12.2 )] . In Trial A, the serum levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 and 8 weeks of once daily application of calcipotriene and be… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Calcipotriene and betamethasone dipropionate topical suspension combines the pharmacological effects of calcipotriene as a synthetic vitamin D 3 analog and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in the treatment of plaque psoriasis of the scalp and body are unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Calcipotriene and betamethasone dipropionate topical suspension is a viscous, nearly odorless, almost clear, colorless to slightly off-white suspension. It is available as: 60 gram bottle (NDC 0713-0848-60) 120 gram (2 bottles of 60 grams) (NDC 0713-0848-92) Store 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.] Do not refrigerate. Keep the bottle in the carton when not in use.
Unused product should be discarded six months after the bottle has been opened. Shake before use. Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION Calcipotriene and betamethasone dipropionate topical suspension contains calcipotriene and betamethasone dipropionate. It is for topical use only. Calcipotriene is a synthetic vitamin D 3 analog.
Calcipotriene Calcipotriene is a vitamin D analog and has the chemical name (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 Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21- bis (1-oxypropoxy)-(11ß,16ß), 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, crystalline powder): Calcipotriene and Betamethasone Dipropionate Topical Suspension Each gram of calcipotriene and betamethasone dipropionate topical suspension contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, mineral oil and polyoxypropylene stearyl ether.
Calcipotriene and betamethasone dipropionate topical suspension is an odorless clear to slightly off-white suspension. Calcipotriene Chemical Structure Betamethasone Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information and Instructions for Use ). Administration Instructions Instruct pediatric patients (12 to 17 years) not to use more than 60 grams per week. Instruct adult patients (18 years and older) not to use more than 100 grams per week.
Instruct patients to discontinue therapy when control is achieved unless directed otherwise by the healthcare provider. Advise patients not to apply calcipotriene and betamethasone dipropionate topical suspension to the scalp in the 12 hours before or after any chemical treatments to the hair since hair treatments may involve strong chemicals. Talk with the healthcare provider first.
Inform patients that they should not take a bath or shower or wash their hair right after application of calcipotriene and betamethasone dipropionate topical suspension. Advise patients to avoid use of calcipotriene and betamethasone dipropionate topical suspension on the face, underarms, groin or eyes. If this medicine gets on face or in eyes, wash area right away.
Advise patients not to occlude the treatment area with a bandage or other covering unless directed by the healthcare provider. Instruct patients to shake bottle prior to using calcipotriene and betamethasone dipropionate topical suspension and to wash hands after application. Local Reactions and Skin Atrophy Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.
Hypercalcemia and Hypercalciuria Advise patients that hypercalcemia and hypercalciuria have been observed with the use of calcipotriene and betamethasone dipropionate topical suspension [see Warnings and Precautions ( 5.1 )] . HPA Axis Suppression, Cushing’s Syndrome, and Hyperglycemia Advise patients that calcipotriene and betamethasone dipropionate topical suspension can cause HPA access suppression, Cushing’s syndrome, and/or hyperglycemia [see Warnings and Precautions ( 5.2 )] . Ophthalmic Adverse Reactions Advise patients to avoid contact of calcipotriene and betamethasone dipropionate topical suspension with eyes and to report any visual symptoms [see Warnings and Precautions ( 5.5 )] .
Possible Avoidance of Other Products Containing Calcipotriene or a Corticosteroid Instruct patients not to use other products containing calcipotriene or a corticosteroid with calcipotriene and betamethasone dipropionate topical suspension without first talking to the healthcare provider. Pregnancy and Lactation Advise pregnant women that calcipotriene and betamethasone dipropionate topical suspension may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate topical suspension on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations ( 8.1 )] .
Advise breastfeeding women not to apply calcipotriene and betamethasone dipropionate topical suspension directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations ( 8.2 )] . Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0848CPLNC2 Rev.
06/2024 VC7776
💬 Patient Medication Information ▾
PATIENT INFORMATION Calcipotriene and Betamethasone Dipropionate Topical Suspension (kal si poe trye een and bay ta meth a sone dye proe pee oh nate) Important: Calcipotriene and betamethasone dipropionate topical suspension is for use on skin only (topical). Do not get calcipotriene and betamethasone dipropionate topical suspension near or in your mouth, eyes, or vagina. There are other medicines that contain the same medicine that is in calcipotriene and betamethasone dipropionate topical suspension and are used to treat plaque psoriasis.
Do not use other products containing calcipotriene or a corticosteroid medicine with calcipotriene and betamethasone dipropionate topical suspension without talking to your healthcare provider first. What is calcipotriene and betamethasone dipropionate topical suspension? Calcipotriene and betamethasone dipropionate topical suspension is a prescription medicine used on the skin (topical) to treat plaque psoriasis of the scalp in people 12 years and older and plaque psoriasis of the scalp and body in people 18 years and older.
It is not known if calcipotriene and betamethasone dipropionate topical suspension is safe and effective in children under 12 years of age. Before you use calcipotriene and betamethasone dipropionate topical suspension, tell your healthcare provider about all of your medical conditions, including if you: have a calcium metabolism disorder. have thinning-skin (atrophy) at the treatment site. are pregnant or plan to become pregnant. It is not known if calcipotriene and betamethasone dipropionate topical suspension will harm your unborn baby.
Calcipotriene and betamethasone dipropionate topical suspension may increase your chance of having a low birth weight baby. If you use calcipotriene and betamethasone dipropionate topical suspension during pregnancy, use calcipotriene and betamethasone dipropionate topical suspension on the smallest area of the skin and for the shortest time needed. are breastfeeding or plan to breastfeed. It is not known if calcipotriene and betamethasone dipropionate topical suspension passes into your breast milk.
Breastfeeding women should use calcipotriene and betamethasone dipropionate topical suspension on the smallest area of the skin and for the shortest time needed. Do not apply calcipotriene and betamethasone dipropionate topical suspension directly to the nipple and areola to avoid contact with your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use calcipotriene and betamethasone dipropionate topical suspension? See the Instructions for Use for detailed information about the right way to use calcipotriene and betamethasone dipropionate topical suspension. Use calcipotriene and betamethasone dipropionate topical suspension exactly as your healthcare provider tells you to use it.
Your healthcare provider should tell you how much calcipotriene and betamethasone dipropionate topical suspension to use and where to use it. Apply calcipotriene and betamethasone dipropionate topical suspension to affected areas on the scalp and body 1 time a day for up to 8 weeks. You should stop treatment when your plaque psoriasis is under control, unless your healthcare provider gives you other instructions.
If you are 12 to 17 years of age, you should not use more than 60 grams of calcipotriene and betamethasone dipropionate topical suspension in 1 week . If you are 18 years of age or older, you should not use more than 100 grams of calcipotriene and betamethasone dipropionate topical suspension in 1 week . Do not use calcipotriene and betamethasone dipropionate topical suspension longer than prescribed.
Using too much calcipotriene and betamethasone dipropionate topical suspension, or using it too often, or for too long can increase your risk for having serious side effects. Do not apply calcipotriene and betamethasone dipropionate to… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption The systemic effect of calcipotriene and betamethasone dipropionate topical suspension in psoriasis was investigated in Trials A and B [see Clinical Pharmacology ( 12.2 )] . In Trial A, the serum levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 and 8 weeks 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.
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%) subjects at week 4 and in 5 of 12 (42%) subjects at week 8. The major metabolite of betamethasone dipropionate, betamethasone 17-propionate (B17P) was also quantifiable in 19 of 34 (56%) subjects at week 4 and 7 of 12 (58%) subjects at week 8.
The serum concentrations for MC1080 ranged from 20-75 pg/mL. The clinical significance of this finding is unknown. In Trial B, the plasma levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 weeks of once daily application of calcipotriene and betamethasone dipropionate topical suspension.
Calcipotriene and its metabolite MC1080 were below the lower limit of quantification in all plasma samples. Betamethasone dipropionate was quantifiable in 4 of 43 (9) subjects. The metabolite of betamethasone dipropionate (B17P) was quantifiable in 16 of 43 (37%) subjects.
The plasma concentrations of betamethasone dipropionate ranged from 30.9-63.5 pg/mL and that of its metabolite betamethasone 17-propionate ranged from 30.5-257 pg/mL. The clinical significance of this finding is unknown. Elimination 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 α,ß-unsaturated ketone analog of calcipotriene), which is metabolized further to MC1080 (a saturated ketone analog). 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 6ß-hydroxy derivatives of those compounds by hydrolysis. Betamethasone 17-propionate (B17P) is the primary metabolite.
Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics 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 topical suspension. In all these trials, adrenal suppression was defined by a 30-minute post-stimulation cortisol level ≤18 mcg/dL. In Trial A, HPA axis suppression was evaluated in adult subjects (N=32) with extensive 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 for 4 to 8 weeks. Adrenal suppression was observed in 5 of 32 subjects (16%) after 4 weeks of treatment and in 2 of 11 subjects (18%) who continued treatment for 8 weeks. In Trial B, HPA axis suppression was evaluated in adult subjects (N=43) with extensive psoriasis involving 15-30% of the body surface area (including the scalp).
Treatment consisted of once daily application of calcipotriene and betamethasone dipropionate topical suspension to the body (including the scalp in 36 out of 43 subjects) for 4 to 8 weeks. Adrenal suppression was observed in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects (0%) who continued treatment for 8 weeks. In Trial C, HPA axis suppression was evaluated in pediatric subjects 12 to 17 years (N=30) with plaque psoriasis of the scalp involving at least 20% of the scalp area.
Treatment consisted of once daily application of calcipotriene and betamethasone dipropionate topical suspension to the affected area on the scalp for up to 8 weeks. Adrenal suppression was observed in 1 of 30 evaluable subjects (3%) after 4 weeks of treatment and in no subjects (0%) who continued treatment for 8 weeks [see Use in Specific Populations ( 8.4 )] . In Trial D, HPA axis suppression was evaluated in a subset of pediatric subjects aged 12 to 17 years (N=31) with plaque psoriasis of the scalp and body involving 10% to 29% of the body surface area.
Adrenal suppression was observed in 5 of 31 subjects (16%): 3 subjects after 4 weeks of treatment, 1 subject after 8 weeks of treatment, and 1 subject after both 4 and 8 weeks of treatment [see Use in Specific Populations ( 8.4 )] . Effects on Calcium Metabolism The effect on calcium metabolism was evaluated following the application of calcipotriene and betamethasone dipropionate topical suspension (these trials are described above). In Trial A, elevated urinary calcium levels outside the normal range were observed in two subjects (one at 4 weeks and one at 8 weeks).
In Trial B, there was no change in mean serum or urinary calcium levels. Elevated urinary calcium levels outside the normal range were observed in two subjects (one at 4 weeks and one at 8 weeks). In Trial C (N=109), including 31 subjects with at least 20% scalp involvement and 78 subjects with at least 10% scalp involvement, no cases of hypercalcemia and no clinically relevant changes in urinary calcium were reported.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Clinical Trials Conducted in Subjects 18 Years and Older with Psoriasis of the Scalp Two multicenter, randomized, double-blind trials were conducted in adult subjects with moderate to very severe psoriasis of the scalp. In Trial One, 1,407 subjects were randomized to 1 of 4 treatment groups: calcipotriene and betamethasone dipropionate topical suspension, betamethasone dipropionate in the same vehicle, calcipotriene in the same vehicle, or the vehicle alone. In Trial Two, 1,280 subjects were randomized to 1 of 3 treatment groups: calcipotriene and betamethasone dipropionate topical suspension, betamethasone dipropionate in the same vehicle, or calcipotriene in the same vehicle.
Both trials enrolled subjects with moderate to very severe psoriasis of the scalp. The majority of subjects had disease of moderate severity at baseline. Subjects were treated once daily for 8 weeks.
Efficacy was assessed as the proportion of subjects at Week 8 with absent or very mild disease according to the Investigator’s Global Assessment of Disease Severity. “Clear” was defined as no evidence of redness, thickness or scaling. “Almost clear” was defined as an overall clinical picture of lesions with the presence of minimal erythema. Table 2 contains the response rates in each of these 2 trials. Table 2.
Percentage of Subjects with Clear or Almost Clear Disease According to the Investigator’s Global Assessment of Disease Severity in Trials on the Scalp Calcipotriene and betamethasone dipropionate topical suspension Betamethasone Dipropionate in vehicle Calcipotriene in vehicle Vehicle Trial One (N=494) (N=531) (N=256) (N=126) Week 2 55.5% 46.1% 18.4% 9.5% Week 8 70.0% 63.1% 36.7% 19.8% Trial Two (N=512) (N=517) (N=251) - Week 2 47.1% 36.4% 12.7% - Week 8 67.2% 59.6% 41.0% - Clinical Trials Conducted in Subjects 18 Years and Older with Psoriasis of the Body One multicenter, randomized, double-blind trial was conducted in subjects with mild to moderate plaque psoriasis on non-scalp areas, excluding face, axillae, and groin.
In this trial, 1152 subjects were randomized to 1 of 4 treatment groups: calcipotriene and betamethasone dipropionate topical suspension, betamethasone dipropionate in the same vehicle, calcipotriene in the same vehicle, or the vehicle alone. Seventy-eight percent (78%) of subjects had disease of moderate severity at baseline. Subjects were treated once daily for 8 weeks.
Efficacy was assessed at Week 4 and Week 8 as the proportion of subjects who were "Clear" or "Almost clear" according to the Investigator's Global Assessment of Disease Severity. Subjects with mild disease at baseline were required to be "Clear" to be considered a success. Table 3 contains the response rates in this trial.
Table 3. Percentage of Subjects with Clear or Almost Clear Disease According to the Investigator’s Global Assessment of Disease Severity* in Trial on the Body Calcipotriene and betamethasone dipropionate topical suspension (N=482) Betamethasone Dipropionate in vehicle (N=479) Calcipotriene in vehicle (N=96) Vehicle (N=95) Week 4 13.3% 12.5% 5.2% 2.1% Week 8 29.0% 21.5% 14.6% 6.3% * Subjects with mild disease at baseline were required to be "Clear" to be considered a success.
🧪 Nonclinical Toxicology ▾
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 ▾
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.
📄 Patient Package Insert ▾
Instructions for Use Calcipotriene and Betamethasone Dipropionate Topical Suspension (kal si poe trye’ een and bay’’ ta meth’ a sone dye proe’ pee oh nate) Important: Calcipotriene and betamethasone dipropionate topical suspension is for use on skin only (topical). Do not get calcipotriene and betamethasone dipropionate topical suspension near or in your mouth, eyes, or vagina. Read this Instructions for Use before you start using calcipotriene and betamethasone dipropionate topical suspension and each time you get a refill.
There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. How to apply calcipotriene and betamethasone dipropionate topical suspension to your body: Follow your healthcare provider’s instructions of how much calcipotriene and betamethasone dipropionate topical suspension to use and where to use it.
Apply calcipotriene and betamethasone dipropionate topical suspension directly to areas affected by plaque psoriasis and gently rub in. Wash your hands after applying calcipotriene and betamethasone dipropionate topical suspension, unless you are treating areas on your hands. How to apply calcipotriene and betamethasone dipropionate topical suspension to your scalp: You do not need to wash your hair before you apply calcipotriene and betamethasone dipropionate topical suspension.
How should I store calcipotriene and betamethasone dipropionate topical suspension? Store the calcipotriene and betamethasone dipropionate topical suspension at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate calcipotriene and betamethasone dipropionate topical suspension.
Keep bottle in the carton when not in use. Discard unused calcipotriene and betamethasone dipropionate topical suspension 6 months after it has been opened. Keep calcipotriene and betamethasone dipropionate topical suspension and all medicines out of reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Cosette Pharmaceuticals, Inc.
South Plainfield, NJ 07080 8-0848CPLNC2 Rev. 06/2024 VC7776 Diagram of Instructions for Use
📄 Recent Major Changes ▾
Indications and Usage ( 1 ) 7/2019 Warnings and Precautions, Ophthalmic Advserse Reactions ( 5.5 ) 7/2019 Warnings and Precautions, Ophthalmic Adverse Reactions ( 5.5 ) 7/2019
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
120 g carton NDC 0713- 0848 -92 Rx only Calcipotriene and Betamethasone Dipropionate Topical Suspension 0.005%/0.064% Shake before use For Topical Use Only Net Wt. 120 gram(2 bottles of 60 gram) Individual bottles (60 gram) not for individual retail sale 120 carton
60 g carton NDC 0713- 0848 -60 Rx only Calcipotriene and Betamethasone Dipropionate Topical Suspension 0.005%/0.064% Shake before use For Topical Use Only Net Wt. 60 gram 60 carton