Calcipotriene 0.005% Ointment 120gm
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 medicine similar to vitamin D that is used to treat psoriasis. It works by slowing down the growth of skin cells and helping them develop normally, which reduces the thick, scaly patches of psoriasis.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
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 thoroughly before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Apply a thin layer of the medication to the affected skin area and gently rub it in.
Be careful not to apply the medication to healthy skin.
Storage and Disposal
Store this medication at room temperature, away from refrigeration and freezing.
Keep the medication in a dry place, avoiding storage in a bathroom.
Ensure that all medications are kept in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
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 thoroughly before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Apply a thin layer of the medication to the affected skin area and gently rub it in.
Be careful not to apply the medication to healthy skin.
Storage and Disposal
Store this medication at room temperature, away from refrigeration and freezing.
Keep the medication in a dry place, avoiding storage in a bathroom.
Ensure that all medications are kept in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply a thin layer only to the affected skin areas as directed by your doctor.
- Wash your hands thoroughly after applying the ointment to avoid spreading it to unaffected areas, especially your face or eyes.
- Do not apply to the face, eyes, or mucous membranes, as it can cause irritation.
- Avoid excessive exposure to natural or artificial sunlight (tanning beds, sunlamps) while using this medication, as it may increase sensitivity to light.
- Do not exceed the recommended weekly dose (100 grams per week) to minimize the risk of too much calcium in your blood.
- Inform your doctor if you are taking calcium supplements or other vitamin D medications.
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:
Not established (Safety and efficacy not established in pediatric patients under 12 years of age)
Adolescent:
Apply a thin layer to affected areas twice daily (Safety and efficacy not established in pediatric patients under 12 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution
Moderate:
No specific adjustment recommended, use with caution
Severe:
Use with caution due to potential for hypercalcemia if significant systemic absorption occurs
Dialysis:
Use with caution; monitor serum calcium if used on large body surface areas
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution
Moderate:
No specific adjustment recommended, use with caution
Severe:
Use with caution due to potential for hypercalcemia if significant systemic absorption occurs
Confidence:
Medium
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 regulates cell proliferation and differentiation. In psoriatic skin, calcipotriene inhibits the proliferation of keratinocytes and promotes their normal differentiation, thereby reducing the characteristic epidermal hyperplasia of psoriasis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% of the applied dose is absorbed systemically when applied to psoriatic plaques. Systemic absorption is higher on damaged skin or when applied under occlusive dressings.
Tmax:
Not well-defined for topical application; systemic concentrations are generally low and transient.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not available
ProteinBinding:
Not available (expected to be high, similar to other vitamin D analogs)
CnssPenetration:
Limited
Elimination:
HalfLife:
Systemic half-life is short, estimated to be hours (e.g., 5-6 hours for calcipotriol, the active form after absorption).
Clearance:
Rapid
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2 weeks, with maximal effect by 8 weeks.
PeakEffect:
8 weeks
DurationOfAction:
Not applicable (requires continuous application for sustained effect)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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 have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Dry skin
Peeling
Burning or stinging
* Skin tingling
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 help right away:
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 have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Dry skin
Peeling
Burning or stinging
* Skin tingling
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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:
- Increased skin irritation (redness, itching, burning, stinging, peeling)
- Signs of too much calcium in the blood (hypercalcemia): nausea, vomiting, constipation, muscle weakness, fatigue, increased thirst, increased urination, confusion, or changes in mental status.
- Worsening of psoriasis or no improvement after several weeks of use.
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 allergic reaction you experienced, including any symptoms that occurred.
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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 allergic reaction you experienced, including any symptoms that occurred.
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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 to experience the full effects of this drug.
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. This will enable you to make an informed decision about the benefits and risks of taking this medication, both for yourself and your baby. Additionally, if you are breast-feeding, do not apply this drug 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. This will enable you to make an informed decision about the benefits and risks of taking this medication, both for yourself and your baby. Additionally, if you are breast-feeding, do not apply this drug to your chest area, and consult with your doctor for further guidance.
Overdose Information
Overdose Symptoms:
- Hypercalcemia (elevated blood calcium levels) characterized by nausea, vomiting, constipation, muscle weakness, fatigue, polyuria (frequent urination), polydipsia (increased thirst), anorexia, and mental status changes (confusion, lethargy).
- Topical overdose is unlikely to cause acute severe toxicity due to limited systemic absorption, but chronic excessive use can lead to hypercalcemia.
What to Do:
Discontinue the medication. If symptoms of hypercalcemia are present, seek immediate medical attention. Management involves hydration, dietary calcium restriction, and potentially loop diuretics or other agents to lower calcium. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Other vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol) - increased risk of hypercalcemia.
- Calcium supplements (high doses) - theoretical increased risk of hypercalcemia, especially with extensive use.
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To establish baseline and identify pre-existing hypercalcemia, especially if large body surface areas are treated or in patients with renal impairment.
Timing: Prior to initiation of therapy if clinically indicated.
Routine Monitoring
Serum Calcium
Frequency: Periodically, especially if using more than 100g/week or on large body surface areas, or if symptoms of hypercalcemia occur.
Target: Normal physiological range (e.g., 8.5-10.2 mg/dL)
Action Threshold: If elevated, reduce dose or discontinue therapy and investigate cause.
Clinical assessment of psoriasis
Frequency: Regularly (e.g., every 2-4 weeks initially, then as needed)
Target: Reduction in plaque thickness, erythema, and scaling
Action Threshold: Lack of improvement or worsening may indicate need for alternative therapy.
Signs and symptoms of hypercalcemia
Frequency: At each visit and patient education for self-monitoring
Target: Absence of symptoms
Action Threshold: Nausea, vomiting, constipation, muscle weakness, fatigue, polyuria, polydipsia, mental status changes - prompt evaluation and intervention.
Symptom Monitoring
- Skin irritation (burning, stinging, itching, erythema, dryness, peeling)
- Photosensitivity (sunburn-like reaction)
- Symptoms of hypercalcemia (nausea, vomiting, constipation, muscle weakness, fatigue, polyuria, polydipsia, mental status changes)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at doses higher than human topical exposure.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; systemic exposure is low with topical use.
Second Trimester:
Potential risk based on animal data; systemic exposure is low with topical use.
Third Trimester:
Potential risk based on animal data; systemic exposure is low with topical use.
Lactation
It is not known whether calcipotriene is excreted in human milk. Caution should be exercised when calcipotriene is administered to a nursing woman. Advise breastfeeding women to avoid applying calcipotriene to the breast or nipple area to prevent direct infant exposure.
Infant Risk:
Low risk due to minimal systemic absorption, but unknown if excreted in milk. Potential for infant exposure if applied to breast area.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children should be approached with caution due to potential for increased systemic absorption and risk of hypercalcemia, especially in infants and young children with a higher surface area to weight ratio.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. However, due to potential for age-related decreases in renal function, caution should be exercised, and monitoring for hypercalcemia may be prudent if used extensively.
Clinical Information
Clinical Pearls
- Calcipotriene is a first-line topical treatment for mild to moderate plaque psoriasis.
- Patients should be advised to wash their hands thoroughly after application to prevent accidental transfer to the face or eyes, which can cause irritation.
- Warn patients about potential photosensitivity and advise limiting sun exposure and using sunscreen.
- The maximum weekly dose of 100 grams should not be exceeded to minimize the risk of hypercalcemia.
- Skin irritation (burning, stinging, erythema) is a common side effect, especially at the beginning of treatment.
- Combination therapy with topical corticosteroids is common and can improve efficacy and reduce irritation (e.g., calcipotriene/betamethasone dipropionate combination products).
Alternative Therapies
- Topical corticosteroids (e.g., clobetasol, triamcinolone)
- Tazarotene (topical retinoid)
- Coal tar preparations
- Salicylic acid
- Calcitriol ointment (another vitamin D analog)
- Systemic therapies for severe psoriasis (e.g., methotrexate, cyclosporine, biologics)
- Phototherapy (UVB, PUVA)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and formulation (e.g., $100 - $500+ for 120gm) per 120gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic; Tier 3 or higher for 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 an additional 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 this medication, don't hesitate to discuss them with 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.