Calcipotriene 0.005% Cream 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 overgrowth of skin cells and helping them develop normally, which reduces the redness, scaling, and thickness of psoriasis plaques.
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 only as directed.
Apply this medication topically, directly to the affected skin area. 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 applying the medication, wash your hands thoroughly. However, if your hand is the treated area, do not wash it after application.
Gently rub a thin layer of the medication onto the affected skin, avoiding 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.
Ensure all medications are stored in a secure location, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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 use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication topically, directly to the affected skin area. 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 applying the medication, wash your hands thoroughly. However, if your hand is the treated area, do not wash it after application.
Gently rub a thin layer of the medication onto the affected skin, avoiding 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.
Ensure all medications are stored in a secure location, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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.
Lifestyle & Tips
- Apply only to affected areas as directed by your doctor. Do not apply to the face, eyes, or mucous membranes.
- Wash hands thoroughly after applying the cream to avoid accidental transfer to unaffected areas or eyes.
- Do not exceed the recommended amount or duration of use, as this can increase the risk of side effects like high calcium levels.
- Avoid excessive exposure to natural or artificial sunlight (tanning beds, UV lamps) while using calcipotriene, as it may increase sensitivity to light and potentially degrade the medication.
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. Max 100g/week (cream) or 50g/week (ointment) to avoid hypercalcemia risk.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years. For children 12 years and older, apply a thin layer to affected skin areas twice daily, not exceeding 60g/week.
Adolescent:
For adolescents 12 years and older, apply a thin layer to affected skin areas twice daily, not exceeding 60g/week.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution due to potential for systemic absorption and hypercalcemia.
Moderate:
Use with caution; monitor serum calcium levels. Consider reduced frequency or amount.
Severe:
Contraindicated due to increased risk of hypercalcemia.
Dialysis:
Contraindicated due to increased risk of hypercalcemia.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution due to potential for systemic absorption and hypercalcemia.
Moderate:
Use with caution; monitor serum calcium levels. Consider reduced frequency or amount.
Severe:
Contraindicated due to increased risk of hypercalcemia.
Confidence:
Medium
Pharmacology
Mechanism of Action
Calcipotriene is a synthetic analog of vitamin D3. It binds to the vitamin D receptor (VDR) in keratinocytes, inhibiting their proliferation and promoting their differentiation. This action helps to normalize the abnormal cell growth and differentiation seen in psoriasis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (systemic absorption after topical application), varies with skin integrity and application area.
Tmax:
Not precisely defined for topical application, but systemic levels peak within hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely defined for topical, but systemic half-life of calcipotriene is short (minutes to hours).
Clearance:
Not available
ExcretionRoute:
Primarily biliary/fecal, with some renal excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2 weeks.
PeakEffect:
Maximal effect usually observed after 6-8 weeks of continuous treatment.
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
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
Allergic reaction symptoms, 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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you're bothered by any of these or if they persist, contact your doctor for advice:
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, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
Allergic reaction symptoms, 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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you're bothered by any of these or if they persist, contact your doctor for advice:
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, don't hesitate to reach out to 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 high calcium (hypercalcemia): nausea, vomiting, constipation, muscle weakness, tiredness, confusion, increased urination, increased thirst.
- Severe skin irritation, burning, stinging, or worsening of psoriasis.
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.
If you have high calcium levels or an excess of vitamin D in your body, as these conditions may be relevant to your treatment.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor. Please 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
* Your health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions.
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.
If you have high calcium levels or an excess of vitamin D in your body, as these conditions may be relevant to your treatment.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor. Please 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
* Your health problems, including any medical conditions or concerns
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions.
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 the potential benefits and risks of this medication with your doctor. This conversation will help you understand the implications for both you and your baby.
For breast-feeding mothers, it is important to avoid applying this medication to the chest area to prevent any potential harm to your baby. Instead, consult with your doctor to determine the best course of action and ensure your safety and the safety of your child.
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 the potential benefits and risks of this medication with your doctor. This conversation will help you understand the implications for both you and your baby.
For breast-feeding mothers, it is important to avoid applying this medication to the chest area to prevent any potential harm to your baby. Instead, consult with your doctor to determine the best course of action and ensure your safety and the safety of your child.
Overdose Information
Overdose Symptoms:
- Hypercalcemia (nausea, vomiting, constipation, muscle weakness, fatigue, confusion, polyuria, polydipsia)
- Severe local skin irritation
What to Do:
Discontinue calcipotriene. Seek immediate medical attention. Symptomatic and supportive care for hypercalcemia. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Other topical or systemic vitamin D analogs (e.g., calcitriol, doxercalciferol, paricalcitol) - increased risk of hypercalcemia.
- Calcium supplements or vitamin D supplements - increased risk of hypercalcemia.
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To establish baseline and identify pre-existing hypercalcemia risk.
Timing: Before initiating treatment, especially if risk factors for hypercalcemia are present.
Routine Monitoring
Serum Calcium
Frequency: Periodically, especially if using large amounts, on extensive body surface areas, or if signs of hypercalcemia develop.
Target: 8.5-10.2 mg/dL
Action Threshold: >10.5 mg/dL or symptoms of hypercalcemia; discontinue treatment.
Psoriasis Lesion Assessment
Frequency: Regularly (e.g., every 2-4 weeks initially, then as needed)
Target: Reduction in erythema, scaling, and plaque thickness.
Action Threshold: Lack of improvement after 8 weeks, or worsening of condition.
Symptom Monitoring
- Signs of hypercalcemia: nausea, vomiting, constipation, muscle weakness, fatigue, confusion, polyuria, polydipsia.
- Local skin reactions: burning, stinging, itching, erythema, dryness, peeling, rash, folliculitis.
Special Patient Groups
Pregnancy
Calcipotriene is Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data; avoid if possible.
Second Trimester:
Potential for fetal harm based on animal data; use with caution.
Third Trimester:
Potential for fetal harm based on animal data; use with caution.
Lactation
It is not known whether calcipotriene is excreted in human milk. Systemic absorption is limited, but caution should be exercised. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for calcipotriene and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
Low risk, but monitor for potential adverse effects (e.g., hypercalcemia symptoms in infant). Avoid applying to areas where infant may ingest the medication.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in adolescents (12 years and older) should be limited to 60g/week due to potential for increased systemic absorption and hypercalcemia risk compared to adults.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Use with caution, especially if co-morbidities affecting calcium metabolism or renal function are present.
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 not to exceed the maximum weekly dose to minimize the risk of hypercalcemia.
- Avoid application to the face, skin folds, or sensitive areas due to increased risk of irritation.
- Systemic absorption is higher when applied to large body surface areas, occluded areas, or broken skin.
Alternative Therapies
- Topical Corticosteroids (e.g., Clobetasol, Triamcinolone)
- Topical Retinoids (e.g., Tazarotene)
- Topical Calcineurin Inhibitors (e.g., Tacrolimus, Pimecrolimus - off-label for psoriasis)
- Coal Tar
- Anthralin
- Phototherapy (UVB, PUVA)
- Systemic agents (e.g., Methotrexate, Cyclosporine, Biologics) for severe psoriasis.
Cost & Coverage
Average Cost:
$150 - $400 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 this 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.