Calcipotriene 0.005% Scalp Solution
It is used to treat plaque psoriasis.
Drug Class
Antipsoriatic, Vitamin D analogue
Pharmacologic Class
Vitamin D analogue
Pregnancy Category
Category C
FDA Approved
Mar 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Calcipotriene scalp solution is a medicine similar to vitamin D that is applied to the scalp to treat psoriasis. It works by slowing down the rapid growth of skin cells that causes 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 as directed.
Apply this medication only to your scalp and hair. Do not ingest it.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause irritation or burning.
Do not apply this medication to your face.
Before and after using the medication, wash your hands thoroughly.
Prior to application, comb your hair to remove any dead skin cells.
Be cautious not to spread or drip the medication onto your forehead.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store the medication at room temperature.
Do not refrigerate or freeze the medication.
Protect the medication from heat sources or open flames.
Keep the medication in a dry location, avoiding storage in a bathroom.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if the missed dose 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 dose.
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 scalp and hair. Do not ingest it.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause irritation or burning.
Do not apply this medication to your face.
Before and after using the medication, wash your hands thoroughly.
Prior to application, comb your hair to remove any dead skin cells.
Be cautious not to spread or drip the medication onto your forehead.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store the medication at room temperature.
Do not refrigerate or freeze the medication.
Protect the medication from heat sources or open flames.
Keep the medication in a dry location, avoiding storage in a bathroom.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if the missed dose 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 dose.
Lifestyle & Tips
- Apply the solution directly to the affected areas of the scalp, not to the face or eyes.
- Wash your hands thoroughly immediately after applying the medication to avoid accidental transfer to other areas, especially the face or eyes.
- Do not exceed the recommended dose or apply to more than 20% of your body surface area, as this can increase the risk of side effects.
- Avoid using occlusive dressings (e.g., shower caps) over the treated area unless specifically instructed by your doctor, as this can increase absorption.
- Avoid excessive exposure to natural or artificial sunlight (tanning beds, sunlamps) while using this medication, as calcipotriene can be inactivated by UV light and may increase photosensitivity.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected scalp areas twice daily, morning and evening.
Condition-Specific Dosing:
maximumWeeklyDose:
Do not exceed 50 g (50 mL) per week of Calcipotriene Scalp Solution.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established for patients under 12 years of age.
Adolescent:
Safety and efficacy not established for patients under 12 years of age. For adolescents 12 years and older, dosing is generally similar to adults, but caution is advised regarding total body surface area treated and duration of use due to potential for systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption with topical use. Use with caution in patients with severe renal impairment.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption with topical use. Use with caution in patients with severe renal impairment.
Severe:
Use with caution. Although systemic absorption is minimal, patients with severe renal impairment may be at increased risk of hypercalcemia if significant absorption occurs.
Dialysis:
Use with caution. Monitor serum calcium levels if used on large body surface areas or for prolonged periods.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption with topical use. Use with caution in patients with severe hepatic impairment.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption with topical use. Use with caution in patients with severe hepatic impairment.
Severe:
Use with caution. Although systemic absorption is minimal, patients with severe hepatic impairment may be at increased risk of altered metabolism if significant absorption occurs.
Pharmacology
Mechanism of Action
Calcipotriene is a synthetic analogue of vitamin D3. It binds to the vitamin D receptor (VDR), which is present in various cells, including keratinocytes. Binding of calcipotriene to the VDR modulates the transcription of genes involved in keratinocyte proliferation and differentiation. In psoriasis, calcipotriene helps to normalize abnormal keratinocyte proliferation and promotes their differentiation, thereby reducing the characteristic plaques.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% of the applied dose is absorbed systemically when applied topically to psoriatic lesions. Absorption can increase with occlusive dressings or application to damaged skin.
Tmax:
Not precisely determined for topical application, as systemic levels are very low. Peak systemic concentrations are generally negligible.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well characterized due to minimal systemic absorption.
ProteinBinding:
Not well characterized due to minimal systemic absorption.
CnssPenetration:
Limited/Not applicable for topical use.
Elimination:
HalfLife:
Systemic half-life is short, estimated to be a few hours, but not clinically relevant for topical application.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily via bile (feces) and urine.
Unchanged:
Minimal unchanged drug excreted systemically.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 2-4 weeks.
PeakEffect:
Maximal effect usually seen 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
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 immediate medical attention:
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
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 immediate medical attention:
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
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 your blood (hypercalcemia): feeling very tired, nausea, vomiting, constipation, increased thirst or urination, muscle weakness, confusion.
- Severe skin irritation, redness, burning, or itching at the application site.
- Worsening of your 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.
Certain health conditions, including:
+ High calcium levels in the blood
+ Excessive levels of 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 safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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
+ Excessive levels of 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 safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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, be cautious to avoid sun exposure, sunlamps, and tanning beds. To protect yourself, use sunscreen and wear protective clothing and eyewear when going outside.
Due to its flammable nature, exercise extreme caution when using this drug. Avoid exposure to open flames, sparks, or smoking during and immediately after application.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. When breastfeeding, avoid applying this drug to your chest area. Instead, consult with your doctor for guidance on safe usage.
As this medication can increase your sensitivity to the sun, be cautious to avoid sun exposure, sunlamps, and tanning beds. To protect yourself, use sunscreen and wear protective clothing and eyewear when going outside.
Due to its flammable nature, exercise extreme caution when using this drug. Avoid exposure to open flames, sparks, or smoking during and immediately after application.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. When breastfeeding, avoid applying this drug to your chest area. Instead, consult with your doctor for guidance on safe usage.
Overdose Information
Overdose Symptoms:
- Hypercalcemia (elevated blood calcium levels) symptoms: nausea, vomiting, constipation, polyuria (frequent urination), polydipsia (increased thirst), muscle weakness, fatigue, confusion, headache, anorexia, abdominal pain.
- In severe cases, hypercalcemia can lead to cardiac arrhythmias, renal impairment, and coma.
What to Do:
Discontinue the medication immediately. Contact your doctor or poison control center (Call 1-800-222-1222) for advice. Treatment for hypercalcemia typically involves hydration, discontinuation of calcium-containing products, and potentially loop diuretics or other medications to lower calcium levels.
Drug Interactions
Moderate Interactions
- Other topical vitamin D analogues (e.g., calcitriol, tacalcitol) - concurrent use may increase risk of hypercalcemia.
- Systemic vitamin D supplements - concurrent use may increase risk of hypercalcemia, especially with extensive topical application.
Monitoring
Baseline Monitoring
Extent and severity of psoriasis
Rationale: To establish baseline for treatment efficacy assessment.
Timing: Prior to initiation of therapy.
Serum calcium levels
Rationale: Although systemic absorption is minimal, monitoring may be considered in patients with pre-existing hypercalcemia, renal impairment, or if used on large body surface areas or for prolonged periods.
Timing: Prior to initiation of therapy, if indicated.
Routine Monitoring
Clinical response of psoriatic lesions
Frequency: Periodically (e.g., every 4-8 weeks) to assess efficacy.
Target: Reduction in plaque thickness, erythema, and scaling.
Action Threshold: If no improvement after 8 weeks, reassess diagnosis or treatment plan. If worsening, discontinue.
Signs/symptoms of hypercalcemia
Frequency: Routinely during treatment, especially if using maximum dose or on large areas.
Target: Absence of symptoms.
Action Threshold: If symptoms occur (e.g., nausea, vomiting, polyuria, weakness), discontinue treatment and check serum calcium.
Skin irritation/adverse reactions
Frequency: Routinely during treatment.
Target: Minimal to no irritation.
Action Threshold: If severe irritation, burning, or itching occurs, reduce frequency or discontinue.
Symptom Monitoring
- Signs of hypercalcemia (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion)
- Local skin reactions (burning, stinging, itching, erythema, dryness, peeling, folliculitis, rash, worsening of psoriasis)
Special Patient Groups
Pregnancy
Calcipotriene is classified as 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 during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than topical human exposure. Use with caution.
Second Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than topical human exposure. Use with caution.
Third Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than topical human exposure. Use with caution.
Lactation
It is not known whether calcipotriene is excreted in human milk. Systemic absorption is minimal following topical application. Caution should be exercised when calcipotriene is administered to a nursing woman. Avoid applying to areas that may come into direct contact with the infant.
Infant Risk:
Low risk due to minimal systemic absorption, but potential for exposure if applied to areas accessible to the infant. Monitor infant for signs of hypercalcemia (e.g., poor feeding, vomiting, constipation).
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 higher 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, increased absorption may occur. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Calcipotriene is a first-line topical treatment for mild to moderate psoriasis, particularly on the scalp.
- Patients should be instructed on proper application technique, including washing hands after use and avoiding contact with eyes and face.
- The maximum weekly dose (50 g or 50 mL) should not be exceeded to minimize the risk of hypercalcemia.
- Combination therapy with topical corticosteroids is common and can enhance efficacy and reduce irritation.
- Inform patients that improvement is gradual and may take several weeks.
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
- Salicylic acid
- Phototherapy (UVB, PUVA)
- Systemic agents (e.g., methotrexate, cyclosporine, biologics) for severe cases.
Cost & Coverage
Average Cost:
Varies widely, typically $100 - $500+ per 60 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.