Calcipotriene 0.005% Cream 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 cream is a medicine that looks like vitamin D. It's used on the skin to treat psoriasis, a skin condition that causes red, scaly patches. It works by slowing down the growth of skin cells and helping them mature normally, which reduces the scaling and thickness of the patches.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
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.
Before and after using the medication, wash your hands thoroughly. However, if your hand is the area being treated, do not wash it 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
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding refrigeration or freezing.
Keep it in a dry place, away from bathrooms.
Store all medications in a secure location, out of the reach of children and pets.
Missed Dose
If you miss a dose, follow these steps:
Apply the missed dose 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 use extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
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.
Before and after using the medication, wash your hands thoroughly. However, if your hand is the area being treated, do not wash it 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
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding refrigeration or freezing.
Keep it in a dry place, away from bathrooms.
Store all medications in a secure location, out of the reach of children and pets.
Missed Dose
If you miss a dose, follow these steps:
Apply the missed dose 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 use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply only to affected skin areas as directed by your doctor.
- Wash hands thoroughly after applying the cream to avoid accidental transfer to unaffected areas, especially the face or eyes.
- Avoid applying to the face, eyes, lips, or skin folds (e.g., armpits, groin) as it may cause irritation.
- Do not use more than the recommended amount or for longer than prescribed, as this can increase the risk of side effects like high calcium levels.
- Avoid excessive exposure to natural or artificial sunlight (tanning beds, sunlamps) while using this medication, as calcipotriene can be degraded by UV light and may increase photosensitivity.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected skin areas twice daily.
Condition-Specific Dosing:
Psoriasis Vulgaris:
Apply a thin layer to affected skin areas twice daily. Maximum weekly dose should not exceed 100g of cream.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 12 years of age). For patients 12-18 years, apply a thin layer to affected skin areas twice daily, not exceeding 60g per week.
Adolescent:
Apply a thin layer to affected skin areas twice daily, not exceeding 60g per week (for patients 12-18 years).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but use with caution due to potential for systemic absorption and hypercalcemia.
Moderate:
Use with caution; monitor for hypercalcemia.
Severe:
Use with caution; monitor for hypercalcemia. Systemic absorption may be increased.
Dialysis:
Use with caution; monitor for hypercalcemia. Systemic absorption may be increased.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
Use with caution; monitor for hypercalcemia.
Severe:
Use with caution; monitor for hypercalcemia.
Pharmacology
Mechanism of Action
Calcipotriene is a synthetic analog of vitamin D3. It binds to the vitamin D receptor (VDR) in keratinocytes, which are skin cells. This binding modulates the proliferation and differentiation of keratinocytes, inhibiting their excessive growth and promoting their normal maturation. In psoriasis, keratinocytes proliferate abnormally fast. Calcipotriene helps to normalize this process, reducing the characteristic scaling and thickening of psoriatic plaques.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (systemic absorption after topical application). Absorption can be increased with occlusive dressings, application to large surface areas, or to damaged skin.
Tmax:
Not precisely defined for topical application, but systemic levels peak within hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantified for topical application.
ProteinBinding:
Not precisely quantified for topical application, but vitamin D analogs are generally highly protein-bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely quantified for topical application; systemic half-life of calcipotriene is short (minutes to hours) once absorbed, but the effect on skin cells persists.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Biliary/fecal and renal (as inactive metabolites).
Unchanged:
Minimal systemic excretion of unchanged drug.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2 weeks, with maximal effect by 8 weeks.
PeakEffect:
8 weeks
DurationOfAction:
Variable; continued application is necessary to maintain 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 minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
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, 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 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 minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
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, 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 body (hypercalcemia): nausea, vomiting, constipation, muscle weakness, tiredness, confusion, increased urination, increased thirst.
- Severe skin irritation: burning, itching, redness, stinging, or peeling that worsens or does not go away.
- Allergic reaction: rash, hives, swelling of the face/lips/tongue, difficulty breathing.
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, any of 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 health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or change the dose 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, any of 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 health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or change the dose 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 to experience the full effects of this drug.
As this medication can increase your sensitivity to the sun, you are at a higher risk of getting sunburned. To minimize this 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 crucial to discuss the potential benefits and risks of this medication with your doctor. This conversation will help you understand the effects of the drug on you and your baby.
If you are breast-feeding, do not apply this medication to your chest area. Instead, consult with your doctor to determine the best course of action and ensure your safety and the safety of your baby.
As this medication can increase your sensitivity to the sun, you are at a higher risk of getting sunburned. To minimize this 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 crucial to discuss the potential benefits and risks of this medication with your doctor. This conversation will help you understand the effects of the drug on you and your baby.
If you are breast-feeding, do not apply this medication to your chest area. Instead, consult with your doctor to determine the best course of action and ensure your safety and the safety of your baby.
Overdose Information
Overdose Symptoms:
- Hypercalcemia (nausea, vomiting, constipation, muscle weakness, fatigue, confusion, polyuria, polydipsia)
- Severe local skin irritation
What to Do:
Discontinue use immediately. Contact your doctor or poison control center (Call 1-800-222-1222). Treatment is supportive and may involve hydration and monitoring of serum calcium levels.
Drug Interactions
Moderate Interactions
- Other topical or systemic vitamin D analogs (e.g., calcitriol, doxercalciferol, paricalcitol) - increased risk of hypercalcemia.
Monitoring
Routine Monitoring
Serum Calcium
Frequency: Periodically, especially if using large amounts, on extensive body surface areas, or with occlusive dressings. Monitor if symptoms of hypercalcemia occur.
Target: 8.5-10.2 mg/dL
Action Threshold: >10.5 mg/dL or symptomatic hypercalcemia; discontinue treatment.
Local skin reactions (erythema, irritation, burning, itching)
Frequency: Regularly during treatment
Target: Minimal to none
Action Threshold: Severe or persistent reactions; consider discontinuation or dose reduction.
Symptom Monitoring
- Symptoms of hypercalcemia: nausea, vomiting, constipation, muscle weakness, fatigue, confusion, polyuria, polydipsia.
- Symptoms of local irritation: burning, itching, stinging, erythema, dryness, peeling, rash.
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:
Limited human data; animal studies show potential for skeletal abnormalities at high systemic doses.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
Lactation
It is not known whether calcipotriene is excreted in human milk. Use with caution in nursing mothers. Avoid applying to areas that may come into direct contact with the infant's skin or mouth.
Infant Risk:
Low risk with proper application, but potential for infant exposure is unknown. Monitor infant for signs of hypercalcemia if significant maternal absorption is suspected.
Pediatric Use
Safety and efficacy not established in pediatric patients under 12 years of age. For patients 12-18 years, the maximum weekly dose should not exceed 60g. Increased risk of hypercalcemia in children due to higher surface area to body weight ratio.
Geriatric Use
No specific dose adjustments are necessary. However, elderly patients may have thinner skin, potentially leading to increased absorption. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Calcipotriene is a first-line topical treatment for mild to moderate plaque psoriasis.
- It is often used in rotation or combination with topical corticosteroids to enhance efficacy and reduce side effects.
- Patients should be advised that it may take several weeks to see significant improvement.
- Emphasize the importance of not exceeding the maximum weekly dose to minimize the risk of hypercalcemia.
- Avoid application to the face, skin folds, or sensitive areas due to potential for irritation.
- Patients should be educated on the signs and symptoms of hypercalcemia.
Alternative Therapies
- Topical corticosteroids (e.g., clobetasol, fluocinonide)
- Topical retinoids (e.g., tazarotene)
- Coal tar
- Anthralin
- Salicylic acid
- Phototherapy (UVB, PUVA)
- Systemic agents (e.g., methotrexate, cyclosporine, biologics) for severe psoriasis
Cost & Coverage
Average Cost:
Varies widely, typically $300-$800 per 120gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization or step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.