calcitriol 3 ug/g Ointment
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Vitamin D3 Analog class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Calcitriol topical is used to treat mild to moderate plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults and children 2 years of age and older. Calcitriol is in a class of medications called vitamin D analogs. It works by helping to stop the production of extra skin cells that may build up and form scales on the skin and by decreasing the activity of immune cells in the skin.
Read the full MedlinePlus article ↗- Calcitriol is actually the active form that vitamin D becomes after your liver and kidneys process it. If your kidneys aren't working well, they can't make enough calcitriol on the...
- What exactly is calcitriol, and why did my doctor prescribe it instead of regular vitamin D?
- The biggest thing to watch for is high calcium — the early signs are things like unusual weakness, headache, nausea, dry mouth, a metallic taste, or constipation. If those get wors...
- What side effects should I actually watch out for while taking this?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 7QWA1RIO01
A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
-
UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
-
UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $4.550 | $455.00 / 100 g |
| Medicaid paysCMS SDUD · 12 mo | $4.52 | $452.09 / 100 g |
| Medicare drug plans payPart D · Q2 2026 | $5.27 | $527.11 / 100 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| calcitriol 3 ug/gthis 45802-0608-01 | Padagis | 1 tube | $4.550 | — | FDA listed | — |
| Vectical 3 ug/g 00299-2012-05 | Galderma | 5 g | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 45802-0608-01 You're viewing this | 1 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBE | 2012-03-08 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Calcitriol Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older ( 1.1 ) Limitations of Use The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. ( 1.2 )
1.1Indication Calcitriol Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older.
1.2Limitations of Use The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply Calcitriol Ointment to affected areas twice daily, morning and evening. Adults: the maximum weekly dose should not exceed 200 grams. Pediatrics: 2 to 6 years of age: the maximum weekly dose should not exceed 100 grams.
7 years of age and older: the maximum weekly dose should not exceed 200 grams Calcitriol Ointment should not be applied to the eyes, lips, or facial skin. Calcitriol Ointment is for topical use only. Calcitriol Ointment is not for oral, ophthalmic or intravaginal use.
Apply Calcitriol Ointment to affected areas of the body twice daily ( 2 ). Adults: The maximum weekly dose should not exceed 200 grams. ( 2 ) Pediatrics: 2 to 6 years of age: the maximum weekly dose should not exceed 100 grams.
( 2 ) 7 years of age and older: the maximum weekly dose should not exceed 200 grams. ( 2 ) For topical use only. ( 2 ) Not for oral, ophthalmic, or intravaginal use.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ointment, 3mcg/g. Each gram of Calcitriol Ointment contains 3 micrograms (mcg/g) of calcitriol. Ointment, 3 mcg/g ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Effects on Calcium metabolism: Risk of hypercalcemia. If aberrations in parameters of calcium metabolism are noted discontinue Calcitriol Ointment until these normalize. Increased absorption may occur with occlusive use.
( 5.1 ) Calcitriol Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics, and in patients receiving calcium supplements or high doses of vitamin D. ( 5.1 )
5.1Effects on Calcium Metabolism In controlled clinical trials hypercalcemia was observed in subjects exposed to Calcitriol Ointment. If aberrations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have normalized. The effects of Calcitriol Ointment on calcium metabolism following treatment durations greater than 52 weeks have not been evaluated.
Increased absorption may occur with occlusive use. Calcitriol Ointment should be used with caution in patients receiving medications know to increase the serum calcium level, such as thiazide diuretics, and in patients receiving calcium supplements or high doses of vitamin D.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (incidence > 3%) are hypercalcemia, hypercalciuria, and skin discomfort. ( 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 Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Calcitriol Ointment was studied in two vehicle-controlled trials and one open label trial, resulting in 743 subjects exposed to Calcitriol Ointment. Table 1 describes adverse events in subjects treated with Calcitriol Ointment twice daily for 8 weeks.
The population included subjects ages 13 to 87 years, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis. Table 1. Selected Adverse Events Occurring in at least 1% of Subjects in the Two Pooled Vehicle-Controlled Trials Calcitriol Ointment (n=419) Vehicle Ointment (n=420) Discomfort Skin 3% 2% Pruritus 1% 1% Among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle, however the elevation were less than 10% above the upper limit of normal [ see WARNINGS AND PRECAUTIONS ( 5.1 ) ] The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks and included 239 subjects exposed for 6 months and 116 subjects exposed for one year.
Adverse events reported at a rate of greater than or equal to 3% of subjects treated with Calcitriol Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hypercalciuria (3%), and discomfort of skin (3%). Kidney stones were reported in 3 subjects and confirmed in two.
6.2Postmarketing Experience The following adverse reactions have been identified during the world-wide post-approval use of Calcitriol Ointment: acute blistering dermatitis, erythema,and skin burning sensation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from pregnancies that occurred during the clinical development of Calcitriol Ointment and published cases of oral and intravenous calcitriol use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. In animal reproduction studies, topical administration of calcitriol to pregnant rabbits during the period organogenesis resulted in an increased incidence of fetal deaths, as well as an increased incidence of minor skeletal abnormalities ( see Data ).
The available data do not allow the calculation of relevant comparisons between the systemic exposures of calcitriol observed in animal studies to the systemic exposures that would be expected in humans after topical use of Calcitriol Ointment. The background risk of major birth defects and miscarriage for 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Embryo-fetal development studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m 2 /day) and in which rabbits received topical application of calcitriol ointment (3ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats.
In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to delayed ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13th rib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity.
8.2Lactation Risk Summary There are no data on the presence of calcitriol in human milk, the effects on the breastfed infant or on milk production after treatment with Calcitriol Ointment. It is not known whether topical administration of calcitriol could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Calcitriol Ointment and any potential adverse effects on the breastfed infant from Calcitriol Ointment or from the underlying maternal conditions.
Clinical Considerations Advise breastfeeding women not to apply Calcitriol Ointment directly to the nipple and areola to avoid direct infant exposure.
8.4Pediatric Use The safety and effectiveness of Calcitriol Ointment have been established in pediatric patients age 2 years and older for topical treatment of mild to moderate plaque psoriasis. Use of Calcitriol Ointment in this age group is supported by two adequate and well-controlled 8-week trials and an open label trial in adult subjects, and additional data from trials conducted in pediatric subjects 2 to 17 years of age including: a vehicle controlled 8-week trial in 19 subjects 2 to 12 years of age with mild to moderate plaque psoriasis an open-label 8-week safety and pharmacokinetics (PK) trial in 25 subjects 12 to 17 years of age an open-label 14-day safety and PK trial in 18 subjects 2 to 17 years of age. an open-label 26-week safety and PK trial in 54 subjects 2 to 17 years of age.
Data from 63 subjects ages 2 to 12 years, and 42 subjects ages 13 to 17 years showed no significant effects on indices of calcium metabolism. The systemic exposure of calcitriol in the pediatric subjects was generally comparable to the endogenous levels observed at baseline. No new safety signals were identified in subjects 2 to 17 years [see Clinical Studies ( 14 ), Clinical Pharmacology ( 12.3 ) and Adverse Reactions ( 6.1 )].
The safety and effectiveness of Calcitriol Oin…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from pregnancies that occurred during the clinical development of Calcitriol Ointment and published cases of oral and intravenous calcitriol use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. In animal reproduction studies, topical administration of calcitriol to pregnant rabbits during the period organogenesis resulted in an increased incidence of fetal deaths, as well as an increased incidence of minor skeletal abnormalities ( see Data ).
The available data do not allow the calculation of relevant comparisons between the systemic exposures of calcitriol observed in animal studies to the systemic exposures that would be expected in humans after topical use of Calcitriol Ointment. The background risk of major birth defects and miscarriage for 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Embryo-fetal development studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m 2 /day) and in which rabbits received topical application of calcitriol ointment (3ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats.
In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to delayed ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13th rib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Calcitriol Ointment have been established in pediatric patients age 2 years and older for topical treatment of mild to moderate plaque psoriasis. Use of Calcitriol Ointment in this age group is supported by two adequate and well-controlled 8-week trials and an open label trial in adult subjects, and additional data from trials conducted in pediatric subjects 2 to 17 years of age including: a vehicle controlled 8-week trial in 19 subjects 2 to 12 years of age with mild to moderate plaque psoriasis an open-label 8-week safety and pharmacokinetics (PK) trial in 25 subjects 12 to 17 years of age an open-label 14-day safety and PK trial in 18 subjects 2 to 17 years of age. an open-label 26-week safety and PK trial in 54 subjects 2 to 17 years of age.
Data from 63 subjects ages 2 to 12 years, and 42 subjects ages 13 to 17 years showed no significant effects on indices of calcium metabolism. The systemic exposure of calcitriol in the pediatric subjects was generally comparable to the endogenous levels observed at baseline. No new safety signals were identified in subjects 2 to 17 years [see Clinical Studies ( 14 ), Clinical Pharmacology ( 12.3 ) and Adverse Reactions ( 6.1 )].
The safety and effectiveness of Calcitriol Ointment in pediatric subjects below the age of 2 years has not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Calcitriol Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported experience has not identified differences in responses between the elderly and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE Topically applied calcitriol can be absorbed in sufficient amounts to produce systemic effects [ see WARNINGS AND PRECAUTIONS ( 5.1 )]
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY The contribution to efficacy of individual components of the vehicle has not been established.
12.1Mechanism of Action The mechanism of action of calcitriol in the treatment of psoriasis has not been established.
12.3Pharmacokinetics The systemic exposure of calcitriol was assessed in subjects with chronic, plaque psoriasis. In the pivotal pharmacokinetic/pharmacodynamic study, calcitriol ointment 3 mcg/g, was applied twice daily for 21 days (for a total dose of 30 g/day) to 35% of the body surface area (psoriatic + surrounding healthy skin) of subjects with at least 25% of body surface area involvement. At Day 21, the geometric mean plasma concentration values of C max increased by approximately 36% over baseline and the geometric mean value of AUC (0-12hr) increased by 44%.
There was no correlation between the elevated calcitriol levels and the pharmacodynamic parameters or serum albumin adjusted calcium, serum phosphorus, urinary calcium and urinary phosphorus. Specific Populations Pediatric Patients The systemic exposure of calcitriol was assessed in pediatric subjects ages 2 to 17 years with plaque psoriasis in two trials. In one trial, 25 subjects ages 12 to 17 applied calcitriol ointment 3 mcg/g twice a day for 8 weeks to a body surface area of 10% to 35%.
The mean daily dose was 10.43 g/day. In the second trial, 17 subjects ages 2 to 12 applied calcitriol ointment 3 mcg/g twice a day for 14 days to a body surface area of 3% to 18%. The mean daily dose was 17.09 g/day.
In both trials, the systemic concentrations of calcitriol post treatment were relatively flat and were generally comparable to the endogenous levels observed at baseline. The PK parameters could not be reliably estimated. There was no correlation between the elevated calcitriol levels and the pharmacodynamic parameters of serum albumin adjusted calcium, serum phosphorus, urinary calcium and urinary phosphorus.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of calcitriol in the treatment of psoriasis has not been established.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Calcitriol Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes: 100 g tube (NDC 45802-608-01)
16.2Storage Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C). [See USP Controlled Room Temperature.] Do not freeze or refrigerate.
16.1How Supplied Calcitriol Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes: 100 g tube (NDC 45802-608-01)
📦 Storage and Handling ▾
16.2Storage Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C). [See USP Controlled Room Temperature.] Do not freeze or refrigerate.
📋 Description ▾
11 DESCRIPTION Calcitriol Ointment, 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9, 10-secocholesta-5,7,10(19)-triene-1α, 3β,25-triol. The structural formula is: Calcitriol is a white or almost white crystalline solid.
It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C 27 H 44 O 3 , and the molecular weight is 416.64. Calcitriol Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps.
Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum. chem-stuct