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| Product NDC Code | 68308-665 | ||||
|---|---|---|---|---|---|
| Drug Name | Calcitrol |
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| Type | Brand | ||||
| Pharm Class | Cholecalciferol [CS], Vitamin D3 Analog [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 388517 | ||||
| Application Number | NDA022087 | ||||
| Labeler Name | Mayne Pharma Commercial LLC. | ||||
| Packages |
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Overdosage of Calcitrol
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Topically applied calcitriol can be absorbed in sufficient amounts to produce systemic effects [ see Warnings and Precautions ( 5.1 ) ].
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 3%) are hypercalcemia, hypercalciuria, and skin discomfort. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the 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 Averse Events Occurring in at least 1% of Subjects in the Two Pooled Vehicle-Controlled Trials Calcitriol (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, the elevations were less than 10% above the upper limit of normal ) [see Warnings and Precautions ( 5.1 ) ]. The open label trial enrolled 324 subjects with psoriasis who were 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. 6.2 Postmarketing Experience The following adverse reactions have been identified during 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.
| Calcitriol (n = 419) | Vehicle Ointment (n = 420) | |
| Discomfort skin | 3% | 2% |
| Pruritus | 1% | 1% |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY The contribution to efficacy of individual components of the vehicle has not been established. 12.1 Mechanism of Action The mechanism of action of calcitriol in the treatment of psoriasis has not been established. 12.3 Pharmacokinetics 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 – 12 hr) increased by 44%. 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. 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
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action The mechanism of action of calcitriol in the treatment of psoriasis has not been established.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics 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 – 12 hr) increased by 44%. 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. 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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None None ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Calcitriol (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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Ointment, 3 mcg/g. Each gram of Calcitriol Ointment contains 3 micrograms (mcg/g) of calcitriol. Ointment, 3 mcg/g ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Calcitrol Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult 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 ) 1.1 Indication Calcitriol Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older. 1.2 Limitations of Use The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.
Spl product data elements
Usually a list of ingredients in a drug product.Calcitrol calcitriol CALCITRIOL CALCITRIOL mineral oil .ALPHA.-TOCOPHEROL, DL- Petrolatum chemical-structure 100-g-carton-image
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility When calcitriol was applied topically to mice for up to 24 months, no significant changes in tumor incidence were observed. Concentrations of calcitriol in ointment base of 0 (vehicle control), 0.3, 0.6 and 1.0 ppm were evaluated. A two-year carcinogenicity study was conducted in which calcitriol was orally administered to rats at dosages of approximately 0.005, 0.03, and 0.1 mcg/kg/day (0.03, 0.18, and 0.6 mcg/m 2 /day, respectively). The incidence of benign pheochromocytomas was significantly increased in female rats. No other significant differences in tumor incidence were observed. Calcitriol did not elicit genotoxic effects in the mouse lymphoma TK locus assay. Studies in which male and female rats received oral doses of calcitriol of up to 0.6 mcg/kg/day (3.6 mcg/m 2 /day) indicated no impairment of fertility or general reproductive performance.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility When calcitriol was applied topically to mice for up to 24 months, no significant changes in tumor incidence were observed. Concentrations of calcitriol in ointment base of 0 (vehicle control), 0.3, 0.6 and 1.0 ppm were evaluated. A two-year carcinogenicity study was conducted in which calcitriol was orally administered to rats at dosages of approximately 0.005, 0.03, and 0.1 mcg/kg/day (0.03, 0.18, and 0.6 mcg/m 2 /day, respectively). The incidence of benign pheochromocytomas was significantly increased in female rats. No other significant differences in tumor incidence were observed. Calcitriol did not elicit genotoxic effects in the mouse lymphoma TK locus assay. Studies in which male and female rats received oral doses of calcitriol of up to 0.6 mcg/kg/day (3.6 mcg/m 2 /day) indicated no impairment of fertility or general reproductive performance.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL - 100 g CARTON NDC 68308- 665 -10 Calcitriol Ointment 3 mcg/g For Topical Use Only Rx Only NET WT. 100 g maynepharma For topical use only. Not for ophthalmic, oral or intravaginal use. Usual dosage: Apply to affected areas twice daily. See package insert for complete prescribing information. Each gram contains: calcitriol 3 mcg in an ointment base consisting of mineral oil, dl-α-tocopherol, and white petrolatum, Storage: Store at controlled room temperature 68° - 77° (20° -25°C) with excursions permitted between 59° - 86°F (15° - 30°C). Do not freeze or refrigerate. Distributed by: Mayne Pharma Raleigh, NC 27609 Product of Canada. All trademarks are the property of their respective owners. P57133-0
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indications and Usage ( 1 ) Date 07/2020 Dosage and Administration ( 2 ) Date 07/2020
Calcitrol: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients using Calcitriol Ointment should receive the following information: This medication is to be used as directed by the physician. It is for external use only. This medication is to be applied only to areas of the skin affected by psoriasis, as directed. It should be gently rubbed into the skin so that no medication remains visible. This medication may affect calcium metabolism. Hypercalcemia has been observed in subjects exposed to this medicine. Increased absorption may occur with use of occlusive dressings. Avoid use of more than 100 grams per week in patients ages 2-6 years and use of more than 200 grams per week in patients ages 7 years and older. Instruct patients to report any signs of adverse reactions to their physician. Avoid contact with eyes, lips, and facial skin. Advise breastfeeding women not to apply Calcitriol Ointment directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations ( 8.2 )]. To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Mayne Pharma Raleigh, NC 27609 Product of Canada. P57134-0
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.PATIENT INFORMATION Calcitriol Ointment Important: Calcitriol Ointment is for use on the skin only (topical use). Do not use Calcitriol Ointment in your mouth, eyes, or vagina. What is Calcitriol Ointment? Calcitriol Ointment is a prescription medicine used on the skin (topical) to treat mild to moderate plaque psoriasis in adults and children 2 years and older. It is not known if Calcitriol Ointment is safe and effective in children under 2 years of age. It is not known if Calcitriol Ointment is safe and effective in people with known or suspected problems with calcium metabolism. Before using Calcitriol Ointment, tell your healthcare provider about all your medical conditions, including if you: are pregnant or planning to become pregnant. It is not known if Calcitriol Ointment will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Calcitriol Ointment passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Calcitriol Ointment. If you use Calcitriol Ointment and breastfeed, do not apply Calcitriol Ointment to your nipple and areola to avoid getting Calcitriol Ointment into your baby’s mouth. Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: medicines that can increase your calcium levels, such as water pills (thiazide diuretics) calcium or vitamin D supplements Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use Calcitriol Ointment? Use Calcitriol Ointment exactly as your healthcare provider tells you to use it. Apply Calcitriol Ointment to the affected areas 2 times each day in the morning and evening. Adults and children 7 years of age and older should not use more than 200 grams in 1 week. Children 2 to 6 years of age should not use more than 100 grams in 1 week. Avoid applying Calcitriol Ointment to your eyes, lips, or facial skin. Apply only enough Calcitriol Ointment to cover your affected skin area. You should not cover the treated area(s) with a waterproof (occlusive) bandage or overdosage may occur. Gently rub Calcitriol Ointment into the affected area until it disappears into your skin. Wash your hands after using Calcitriol Ointment, unless you are using the medicine to treat your hands. What are the possible side effects of Calcitriol Ointment? Calcitriol Ointment may cause serious side effects, including: Too much calcium in your blood (hypercalcemia) may occur with Calcitriol Ointment. Your healthcare provider may tell you to stop using Calcitriol Ointment until your calcium levels become normal. The most common side effects of Calcitriol Ointment include increased urine calcium level, itching, and skin discomfort. These are not all of the possible side effects of Calcitriol Ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Mayne Pharma at 1-844-825-8500. How should I store Calcitriol Ointment? Store Calcitriol Ointment at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze or refrigerate Calcitriol Ointment. Keep Calcitriol Ointment and all medicines out of the reach of children. General information about the safe and effective use of Calcitriol Ointment. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Calcitriol Ointment for a condition for which it was not prescribed. Do not give Calcitriol Ointment to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Calcitriol Ointment that is written for health professionals. What are the ingredients in Calcitriol Ointment? Active ingredient: calcitriol Inactive ingredients: mineral oil, dl-α-tocopherol, and white petrolatum. Distributed by: Mayne Pharma Raleigh, NC 27609 This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 09/2022
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES In two, multicenter, double-blind, vehicle-controlled studies, a total of 839 subjects with psoriasis rated "mild" or "moderate" using an investigator global assessment scale were treated twice daily for 8 weeks. Subjects were randomized in a 1:1 ratio to receive either Calcitriol Ointment or vehicle ointment. The mean age of the subjects was 48 years and 66% were male; most subjects were rated "moderate" at baseline. Success was defined as "Clear or Minimal" (up to light red or pink in coloration, surface dryness with some white coloration, and slight elevation above normal skin) with at least a 2-grade change from baseline. The success rates are displayed in the Table 2. Table 2. Percentage of Subjects with Clear or Minimal Disease AND Two Grade Improvement at End of Treatment (8 weeks) Study 1 Study 2 Calcitriol Ointment (N = 209) Vehicle Ointment (N = 209) Calcitriol Ointment (N = 210) Vehicle Ointment (N = 211) 23.4% 14.4% 20.5% 6.6%
| Study 1 | Study 2 | ||
| Calcitriol Ointment (N = 209) | Vehicle Ointment (N = 209) | Calcitriol Ointment (N = 210) | Vehicle Ointment (N = 211) |
| 23.4% | 14.4% | 20.5% | 6.6% |
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric 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.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.8.2 Lactation 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.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric 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 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 12 years of age; and 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 have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary Available data from pregnancies that occurred during the clinical development of Calcitriol Ointment and published case series 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 of 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 (3 ppm) 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.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data from pregnancies that occurred during the clinical development of Calcitriol Ointment and published case series 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 of 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 (3 ppm) 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. 8.2 Lactation 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. 8.4 Pediatric 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 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 12 years of age; and 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 have not been established. 8.5 Geriatric 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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Calcitriol Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes: 100 g tube (NDC 68308-665-10) 16.2 Storage 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.
16.1 How Supplied Calcitriol Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes: 100 g tube (NDC 68308-665-10)
Storage and handling
Information about safe storage and handling of the drug product.16.2 Storage 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API