Dosing & Uses
Dosage Forms & Strengths
topical ointment
- 3mcg/g
Plaque Psoriasis
Indicated for mild-to-moderate plaque psoriasis in adults and pediatric patients aged 2 years and older
Apply to affected areas BID, AM and PM
Not to exceed 200 grams/week
Dosing Considerations
Limitation of use: Safety and effectiveness in patients with known or suspected disorders of calcium metabolism have not been evaluated
Dosage Forms & Strengths
topical ointment
- 3mcg/g
Plaque Psoriasis
Indicated for mild-to-moderate plaque psoriasis in adults and pediatric patients aged 2 years and older
<2 years: Safety and efficacy not established
≥2 years
- Apply to affected areas BID, AM and PM
- 2-6 years: Not to exceed 100 grams/week
- ≥7 years: Not to exceed 200 grams/week
Dosing Considerations
Limitation of use: Safety and effectiveness in patients with known or suspected disorders of calcium metabolism have not been evaluated
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (3)
- aminolevulinic acid oral
aminolevulinic acid oral, calcitriol topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period.
- aminolevulinic acid topical
calcitriol topical, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- methyl aminolevulinate
calcitriol topical, methyl aminolevulinate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
Monitor Closely (0)
Minor (13)
- bendroflumethiazide
calcitriol topical, bendroflumethiazide. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential additive hypercalcemia.
- calcium acetate
calcitriol topical increases levels of calcium acetate by pharmacodynamic synergism. Minor/Significance Unknown. Topical calcitriol may lead to hypercalcemia.
- calcium carbonate
calcitriol topical increases levels of calcium carbonate by pharmacodynamic synergism. Minor/Significance Unknown. Topical calcitriol may lead to hypercalcemia.
- calcium chloride
calcitriol topical increases levels of calcium chloride by pharmacodynamic synergism. Minor/Significance Unknown. Topical calcitriol may lead to hypercalcemia.
- calcium citrate
calcitriol topical increases levels of calcium citrate by pharmacodynamic synergism. Minor/Significance Unknown. Topical calcitriol may lead to hypercalcemia.
- calcium gluconate
calcitriol topical increases levels of calcium gluconate by pharmacodynamic synergism. Minor/Significance Unknown. Topical calcitriol may lead to hypercalcemia.
- chlorothiazide
calcitriol topical, chlorothiazide. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential additive hypercalcemia.
- chlorthalidone
calcitriol topical, chlorthalidone. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential additive hypercalcemia.
- cyclopenthiazide
calcitriol topical, cyclopenthiazide. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential additive hypercalcemia.
- hydrochlorothiazide
calcitriol topical, hydrochlorothiazide. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential additive hypercalcemia.
- indapamide
calcitriol topical, indapamide. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential additive hypercalcemia.
- methyclothiazide
calcitriol topical, methyclothiazide. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential additive hypercalcemia.
- metolazone
calcitriol topical, metolazone. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential additive hypercalcemia.
Adverse Effects
>10%
Hypercalcemia (24%)
1-10%
Urine abnormality (4%)
Psoriasis (4%)
Hypercalciuria (3%)
Skin discomfort (3%)
Pruritus (1%)
Postmarketing Reports
Acute blistering dermatitis
Erythema
Skin burning sensation
Warnings
Contraindications
None
Cautions
In controlled clinical trials hypercalcemia was observed; increased absorption may occur with occlusive dressings; caution if coadministered with medications known to increase serum calcium level (eg, thiazide diuretics, calcium supplements, high-dose vitamin D)
Pregnancy & Lactation
Pregnancy
Available data of oral and IV calcitriol use in pregnant females have not identified a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes
Animal data
- Topical administration of calcitriol to pregnant rabbits during organogenesis resulted in an increased incidence of fetal deaths, as well as an increased incidence of minor skeletal abnormalities
- 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
Lactation
No data available on presence in human milk, effects on breastfed infants, or on milk production
Advise breastfeeding women not to apply ointment directly to nipple and areola to avoid direct infant exposure
Unknown whether topical administration could result in sufficient systemic absorption to produce detectable quantities in human milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Vitamin D analog
Mechanism of action for psoriasis has not established
Administration
Topical Administration
Do not apply to the eyes, lips, or facial skin
Topical use only
Not for oral, ophthalmic, or intravaginal use
Storage H3
Store at room temperature 68-77ºF (20-25ºC); excursions permitted to 59-86ºF (15-30ºC)
Do not freeze or refrigerate
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Rocaltrol oral - | 1 mcg/mL solution |  | |
| Rocaltrol oral - | 0.25 mcg capsule |  | |
| Rocaltrol oral - | 0.5 mcg capsule |  | |
| calcitriol oral - | 0.25 mcg capsule |  | |
| calcitriol oral - | 1 mcg/mL solution |  | |
| calcitriol oral - | 0.5 mcg capsule |  | |
| calcitriol oral - | 0.25 mcg capsule |  | |
| calcitriol oral - | 1 mcg/mL solution |  | |
| calcitriol oral - | 0.5 mcg capsule |  | |
| calcitriol oral - | 0.25 mcg capsule |  | |
| calcitriol oral - | 0.5 mcg capsule |  | |
| calcitriol oral - | 0.25 mcg capsule |  | |
| calcitriol oral - | 0.5 mcg capsule |  | |
| calcitriol oral - | 0.25 mcg capsule |  | |
| Vectical topical - | 3 mcg/gram ointment |  | |
| calcitriol topical - | 3 mcg/gram ointment |  | |
| calcitriol intravenous - | 1 mcg/mL solution |  | |
| calcitriol intravenous - | 1 mcg/mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
calcitriol oral
CALCITRIOL - ORAL
(KAL-si-TRYE-ol)
COMMON BRAND NAME(S): Rocaltrol
USES: Calcitriol is a man-made active form of vitamin D. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones.Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Calcitriol is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol is usually used along with specific diet recommendations and sometimes other medications.
HOW TO USE: Take this medication by mouth with or without food, usually once daily or as directed by your doctor. If you are using the liquid form, measure your dose with a special measuring spoon or device. Do not use a normal household spoon since you may not get the correct dose.Dosage is based on your medical condition and response to therapy. Your doctor may start you on a low dose and adjust the dose slowly to find the best dose for you. Follow your doctor's directions carefully. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day.It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins (e.g., calcium, vitamin D) unless ordered by your doctor.Certain medications (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat) can decrease the absorption of vitamin D. Separate your doses of these medications as far as possible from your doses of calcitriol (at least 2 hours apart, longer if possible). It may be easiest to take calcitriol at bedtime if you are also taking these other medications. Ask your doctor or pharmacist about finding a good dosing schedule that will work with all your medications.
SIDE EFFECTS: Calcitriol does not usually have side effects. Your doctor may check your calcium and phosphate blood levels and adjust your dose if you have side effects.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: loss of appetite, back/bone/joint/muscle pain, constipation, dry mouth, eye pain/redness/sensitivity to light, headache, fast/slow/irregular heartbeat, nausea/vomiting/diarrhea, sleepiness, stomach/abdominal pain, increased thirst, signs of kidney problems (such as change in the amount of urine), weakness.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking calcitriol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high calcium levels.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat, coronary artery disease), kidney disease, kidney stones.Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed (immobile) for a long time. Being immobile for long periods of time increases your risk of side effects.Be sure to drink plenty of fluids unless otherwise directed by your doctor.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: burosumab, cardiac glycosides (e.g., digoxin, digitalis), magnesium-containing medications (e.g., antacids, milk of magnesia), phosphate binders, vitamins/nutritional supplements (especially calcium and vitamin D), drugs that can speed up the removal of calcitriol from your body (e.g., ketoconazole, phenobarbital, phenytoin).Check the labels on all your prescription and nonprescription/herbal products (e.g., antacids, laxatives, vitamins) because they may contain calcium, magnesium, phosphate, and vitamin D. Ask your pharmacist about using those products safely.Calcitriol is very similar to other forms of vitamin D. Do not use medications containing other forms of vitamin D while using calcitriol.This medication may interfere with certain laboratory tests (e.g., cholesterol test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: weakness, headache, loss of appetite, metallic taste, nausea, vomiting, stomach cramps, dizziness.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., calcium, magnesium, phosphorus, parathyroid levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Foods rich in vitamin D include: fortified dairy products, eggs, sardines, cod liver oil, chicken livers and freshwater fish. Vitamin D is also obtained from periodic exposure to the sun.It is important to maintain a well-balanced diet while taking this medication. Calcium supplements may be recommended in addition to this medication. The usual recommendation for calcium is 600 to 1200 milligrams per day. Discuss this with your doctor. Do not take supplements unless directed by your doctor.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
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