Calcipotriene 0.005% Ointment 60gm
It is used to treat plaque psoriasis.
Drug Class
Antipsoriatic
Pharmacologic Class
Vitamin D Analog
Pregnancy Category
Category C
FDA Approved
Dec 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Calcipotriene is a medication similar to vitamin D that is applied to the skin to treat psoriasis. It works by slowing down the rapid growth of skin cells and helping them mature normally, which reduces the thick, scaly patches of psoriasis.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Applying the Medication
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply this medication to your face.
Wash your hands before and after applying the medication, unless your hand is the area being treated. If your hand is the treated area, do not wash it after applying the medication.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to healthy skin.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from moisture and heat. Do not refrigerate or freeze.
Keep the medication in a dry place, such as a closet or drawer. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
Do not apply two doses at the same time or extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Applying the Medication
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply this medication to your face.
Wash your hands before and after applying the medication, unless your hand is the area being treated. If your hand is the treated area, do not wash it after applying the medication.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to healthy skin.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from moisture and heat. Do not refrigerate or freeze.
Keep the medication in a dry place, such as a closet or drawer. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
Do not apply two doses at the same time or extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer only to the affected skin areas. Do not apply to the face, eyes, or mucous membranes.
- Wash hands thoroughly after applying the ointment to avoid accidental transfer to other areas.
- Do not use more than the recommended amount (e.g., no more than 100 grams per week) to minimize the risk of side effects.
- Avoid excessive exposure to natural or artificial sunlight (tanning beds, sunlamps) while using this medication, as it may increase sensitivity to UV light.
- Do not use occlusive dressings (bandages, wraps) over the treated areas unless directed by your doctor, as this can increase absorption.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas twice daily.
Condition-Specific Dosing:
maximumWeeklyDose:
Do not exceed 100 grams per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established for pediatric patients under 12 years of age.
Adolescent:
Safety and efficacy not established for pediatric patients under 12 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
Use with caution; monitor for signs of hypercalcemia if significant absorption is suspected.
Severe:
Use with caution; monitor for signs of hypercalcemia if significant absorption is suspected.
Dialysis:
Considerations: Minimal systemic absorption, but caution advised if significant skin barrier compromise or extensive use could lead to increased systemic exposure.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
Use with caution; monitor for signs of hypercalcemia if significant absorption is suspected.
Severe:
Use with caution; monitor for signs of hypercalcemia if significant absorption is suspected.
Pharmacology
Mechanism of Action
Calcipotriene is a synthetic analog of vitamin D3. It binds to and activates the vitamin D receptor (VDR), a nuclear receptor that modulates the transcription of genes involved in keratinocyte proliferation and differentiation. In psoriatic skin, calcipotriene normalizes abnormal keratinocyte proliferation and promotes differentiation, thereby reducing the characteristic hyperproliferation and scaling. It also has immunomodulatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% of the applied dose is absorbed systemically when applied topically to psoriatic plaques. Absorption can be increased by occlusive dressings, application to large surface areas, or damaged skin.
Tmax:
Not precisely defined for topical application due to minimal systemic absorption; systemic concentrations are generally very low.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-characterized for topical application due to minimal systemic absorption.
ProteinBinding:
Not well-characterized for topical application due to minimal systemic absorption.
CnssPenetration:
Limited
Elimination:
HalfLife:
Systemic half-life of calcipotriene and its metabolites is short (on the order of hours), but not precisely defined for topical application.
Clearance:
Rapid systemic clearance of absorbed drug and metabolites.
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion of metabolites.
Unchanged:
Negligible systemic excretion of unchanged drug.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 2-4 weeks.
PeakEffect:
Maximal therapeutic effect may take 6-8 weeks.
DurationOfAction:
Effects persist as long as treatment is continued; relapse occurs upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry skin
Peeling
Burning or stinging
* Skin tingling
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry skin
Peeling
Burning or stinging
* Skin tingling
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of too much calcium in the blood (hypercalcemia): nausea, vomiting, constipation, muscle weakness, fatigue, increased urination, increased thirst, confusion, or changes in mental status. Contact your doctor immediately if these occur.
- Severe skin irritation, burning, stinging, redness, or peeling at the application site. Discontinue use and contact your doctor.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including high calcium levels in the blood or excessive vitamin D in the body.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including high calcium levels in the blood or excessive vitamin D in the body.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Please note that it may take several weeks for the full effects of the medication to become apparent.
As this medication may increase your sensitivity to the sun, it is crucial to take precautions to avoid sunburn. To minimize your risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use a broad-spectrum sunscreen with a high sun protection factor (SPF) and wear protective clothing and eyewear that shields you from the sun.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is vital to discuss your situation with your doctor. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby. Additionally, if you are breast-feeding, do not apply this medication to your chest area, and consult with your doctor for further guidance.
As this medication may increase your sensitivity to the sun, it is crucial to take precautions to avoid sunburn. To minimize your risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use a broad-spectrum sunscreen with a high sun protection factor (SPF) and wear protective clothing and eyewear that shields you from the sun.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is vital to discuss your situation with your doctor. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby. Additionally, if you are breast-feeding, do not apply this medication to your chest area, and consult with your doctor for further guidance.
Overdose Information
Overdose Symptoms:
- Hypercalcemia (nausea, vomiting, constipation, muscle weakness, fatigue, polyuria, polydipsia, mental status changes).
- Severe local skin irritation.
What to Do:
Discontinue use immediately. Contact a poison control center (1-800-222-1222) or seek emergency medical attention. Management involves supportive care and correction of hypercalcemia if present.
Drug Interactions
Moderate Interactions
- Other topical vitamin D analogs (e.g., calcitriol, tacalcitol) - potential for additive hypercalcemic effects.
- Systemic calcium or vitamin D supplements - increased risk of hypercalcemia, especially with extensive use or impaired renal function.
Monitoring
Routine Monitoring
Serum Calcium
Frequency: Generally not required for typical topical use. Consider if patient uses large amounts, has impaired renal function, or develops symptoms of hypercalcemia.
Target: 8.5-10.2 mg/dL
Action Threshold: >10.5 mg/dL or symptomatic hypercalcemia
Psoriasis Lesion Assessment
Frequency: Periodically, as clinically indicated (e.g., every 4-8 weeks during initial treatment).
Target: Reduction in erythema, scaling, and plaque thickness.
Action Threshold: Lack of improvement after 8 weeks, or worsening of condition.
Symptom Monitoring
- Signs and symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, muscle weakness, fatigue, polyuria, polydipsia, mental status changes).
- Local skin reactions (e.g., burning, stinging, itching, erythema, peeling, dryness, irritation).
Special Patient Groups
Pregnancy
Calcipotriene is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but animal studies have shown some developmental toxicity at high doses.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; minimal human data. Use only if clearly needed.
Second Trimester:
Potential risk based on animal data; minimal human data. Use only if clearly needed.
Third Trimester:
Potential risk based on animal data; minimal human data. Use only if clearly needed.
Lactation
It is not known whether calcipotriene is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from calcipotriene, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Minimal systemic absorption suggests low risk, but caution is advised.
Infant Risk:
Low risk, but unknown. Monitor infant for signs of hypercalcemia if significant maternal absorption is suspected.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. Use in children should be approached with caution due to higher body surface area to weight ratio, potentially leading to increased systemic absorption and risk of hypercalcemia.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to potential for age-related thinning of skin and increased absorption, caution is advised, and monitoring for hypercalcemia may be prudent in elderly patients with extensive use or compromised skin barrier.
Clinical Information
Clinical Pearls
- Calcipotriene ointment is generally well-tolerated, but local irritation (burning, stinging, itching) is common, especially at the beginning of treatment.
- Advise patients to avoid applying calcipotriene to the face, groin, or axillae, as these areas are more sensitive and prone to irritation.
- Emphasize the importance of not exceeding the maximum weekly dose (100 grams) to minimize the risk of hypercalcemia, although this is rare with appropriate topical use.
- Calcipotriene can be used in combination with topical corticosteroids (e.g., in a morning/evening regimen or alternating days) to enhance efficacy and reduce irritation.
- Patients should be educated on the signs and symptoms of hypercalcemia, although it is a rare systemic side effect with topical application.
Alternative Therapies
- Topical corticosteroids (e.g., clobetasol, fluocinonide)
- Topical retinoids (e.g., tazarotene)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - off-label for psoriasis)
- Coal tar preparations
- Anthralin
- Phototherapy (UVB, PUVA)
- Systemic agents (e.g., methotrexate, cyclosporine, biologics, oral retinoids) for moderate-to-severe psoriasis.
Cost & Coverage
Average Cost:
$150 - $400 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with a separate patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.