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
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 |
|---|---|---|---|
| calcitriol intravenous - | 1 mcg/mL solution |  | |
| calcitriol intravenous - | 1 mcg/mL solution |  | |
| Rocaltrol oral - | 0.5 mcg capsule |  | |
| Rocaltrol oral - | 0.25 mcg capsule |  | |
| Rocaltrol oral - | 1 mcg/mL solution |  | |
| calcitriol oral - | 0.25 mcg capsule |  | |
| 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 - | 0.5 mcg capsule |  | |
| calcitriol oral - | 0.25 mcg capsule |  | |
| calcitriol oral - | 0.25 mcg capsule |  | |
| calcitriol oral - | 1 mcg/mL solution |  | |
| calcitriol topical - | 3 mcg/gram ointment |  | |
| Vectical topical - | 3 mcg/gram ointment |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
calcitriol intravenous
CALCITRIOL - INJECTION
(KAL-si-TRYE-ol)
COMMON BRAND NAME(S): Calcijex
USES: Calcitriol is a man-made active form of vitamin D (vitamin D3). Vitamin D is a vitamin stored in the body that is needed for building and keeping strong bones. Calcitriol is used to treat or prevent certain problems that can happen with long-term kidney dialysis, such as low levels of calcium or high levels of parathyroid hormone. Calcitriol is usually used along with a certain diet, supplements, and sometimes other medications.Most people get enough vitamin D from exposure to the sun and from fortified food products (such as dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. People with kidney disease cannot make enough of the active form of vitamin D. This medication works by affecting parathyroid hormone (PTH) levels and increasing blood calcium levels.
HOW TO USE: This medication is given by injection into a vein as directed by your doctor, usually 3 times a week (every other day) or during dialysis. The dosage is based on your condition and response to treatment. Your doctor will do blood tests to find the best dose for you.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.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 (such as calcium, vitamin D) unless directed by your doctor.
SIDE EFFECTS: Nausea, headache, constipation, or pain/discomfort at the injection site may occur. If any of these effects last or get worse, tell your doctor promptly.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 you have any serious side effects, including: back/bone/joint/muscle pain, dry mouth, metallic taste, vomiting, sleepiness, weakness, loss of appetite, dizziness, eye pain/redness/sensitivity to light, fever, fast/slow/irregular heartbeat, decreased interest in sex, mental/mood changes (such as confusion), stomach/abdominal pain, swelling of the ankles/feet/hands (edema), increased thirst, signs of kidney problems (such as change in the amount of urine), weight loss.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 using 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high calcium levels (hypercalcemia), heart problems (such as irregular heartbeat, coronary artery disease), kidney disease (such as 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 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: 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 (such as digoxin, digitalis), magnesium-containing medications (such as antacids, milk of magnesia), phosphate binders, vitamins/nutritional supplements (especially calcium and vitamin D).Check the labels on all your prescription and nonprescription/herbal products (such as 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.
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: irregular heartbeat, severe stomach pain, unusually deep sleep.
NOTES: Lab and/or medical tests (such as calcium, magnesium, phosphorus, parathyroid levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.It is important to closely follow your doctor's diet orders while taking this medication. 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 short periods of exposure to the sun. Calcium supplements may be recommended in addition to this medication. The usual recommendation for calcium is 600-1200 milligrams per day. Discuss this with your doctor. Do not take supplements unless directed by your doctor.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature 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.
Information last revised December 2022. Copyright(c) 2022 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
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