Calcipotrien/betamet Dip Oint 60gm
It is used to treat plaque psoriasis. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antipsoriatic, Corticosteroid (topical), Vitamin D Analog
Pharmacologic Class
Synthetic vitamin D3 analog, Potent corticosteroid
Pregnancy Category
Category C
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a topical ointment used to treat plaque psoriasis. It contains two active ingredients: calcipotriene, a form of vitamin D that helps slow down skin cell growth, and betamethasone, a strong steroid that reduces redness, swelling, and itching.
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 directly to the affected skin area, but avoid putting it in your mouth, nose, or eyes, as it may cause burning.
Do not apply this medication to sensitive areas, including the face, underarms, groin area, or skin that is thinning.
Additionally, do not insert this medication into the vagina.
Before and after applying the medication, wash your hands thoroughly, unless your hand is the area being treated, in which case you should not wash it after application.
Gently rub a thin layer of the medication onto the affected skin area.
Unless instructed to do so by your doctor, avoid covering the treated area with bandages, dressings, or makeup.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing.
Keep the lid tightly closed when not in use.
* Store all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
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 make up for the 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 only as directed.
Apply this medication directly to the affected skin area, but avoid putting it in your mouth, nose, or eyes, as it may cause burning.
Do not apply this medication to sensitive areas, including the face, underarms, groin area, or skin that is thinning.
Additionally, do not insert this medication into the vagina.
Before and after applying the medication, wash your hands thoroughly, unless your hand is the area being treated, in which case you should not wash it after application.
Gently rub a thin layer of the medication onto the affected skin area.
Unless instructed to do so by your doctor, avoid covering the treated area with bandages, dressings, or makeup.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing.
Keep the lid tightly closed when not in use.
* Store all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
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 make up for the missed one.
Lifestyle & Tips
- Apply a thin layer to the affected skin areas only, as directed by your doctor.
- Wash your hands thoroughly after applying the ointment.
- Do not apply to the face, groin, or armpits, or if skin atrophy is present.
- Avoid using on large areas of the body or for longer than recommended, as this can increase the risk of side effects.
- Do not use with occlusive dressings unless specifically instructed by your doctor.
- Avoid excessive exposure to natural or artificial sunlight (tanning beds, sunlamps) while using this medication, as calcipotriene can increase photosensitivity.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily.
Condition-Specific Dosing:
plaquePsoriasis:
Apply once daily for up to 4 weeks. Do not exceed 100 grams per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For patients 12 to 17 years of age, apply once daily for up to 4 weeks. Do not exceed 60 grams per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
Use with caution due to potential for increased systemic absorption with extensive use or impaired skin barrier.
Dialysis:
Considerations: Monitor for systemic effects if used extensively.
Hepatic Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
Use with caution due to potential for increased systemic absorption with extensive use or impaired skin barrier.
Confidence:
Medium
Pharmacology
Mechanism of Action
Calcipotriene is a synthetic vitamin D3 analog that regulates cell proliferation and differentiation, inhibiting keratinocyte proliferation and promoting normal keratinocyte differentiation. Betamethasone dipropionate is a potent corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It reduces inflammation and suppresses immune responses in the skin.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption; typically <1% for calcipotriene and <5% for betamethasone dipropionate, but can increase with occlusive dressings, large surface areas, or impaired skin barrier.
Tmax:
Not clinically relevant for topical application.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application; systemically absorbed components distribute throughout the body.
ProteinBinding:
Betamethasone is highly protein bound (~64%). Calcipotriene also binds to plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Calcipotriene: Approximately 5-6 hours (systemic). Betamethasone: Approximately 5.6 hours (systemic).
Clearance:
Primarily hepatic and renal.
ExcretionRoute:
Urine and feces.
Unchanged:
<1% (systemically absorbed)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 2 weeks.
PeakEffect:
Maximal effect often seen by 4 weeks.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Skin breakdown where the medication is used
Change in skin color
Change in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
* Itching
This is not an exhaustive list of all possible 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Skin breakdown where the medication is used
Change in skin color
Change in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
* Itching
This is not an exhaustive list of all possible 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:
- Worsening of psoriasis or new skin irritation (burning, itching, redness, dryness)
- Signs of skin infection (pus, spreading redness, fever)
- Signs of skin thinning (easy bruising, shiny skin, stretch marks)
- Symptoms of high calcium levels (increased thirst, frequent urination, nausea, vomiting, fatigue, muscle weakness)
- Symptoms of adrenal gland problems (unusual tiredness, weight loss, dizziness, nausea, vomiting)
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 elevated calcium levels in your blood.
If you currently have a skin infection.
If the skin area where you will be applying this medication is thinning.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions 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 issues. 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 allergic reaction you experienced, including any symptoms that occurred.
If you have elevated calcium levels in your blood.
If you currently have a skin infection.
If the skin area where you will be applying this medication is thinning.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions 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 issues. 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. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
Before using any other medications or skin products, including soaps, consult with your doctor. If you are undergoing light therapy, also inform your doctor to ensure safe treatment.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and consult your doctor if you have any concerns.
To minimize the risk of severe side effects, use this medication only as directed by your doctor. Do not exceed the recommended dosage, frequency, or duration of treatment.
You may be more susceptible to sunburn while using this medication. To protect yourself, avoid exposure to sunlight, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
If you are a parent or caregiver of a child using this medication, be aware that children may be more prone to certain side effects. Additionally, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. Consult your doctor to discuss the potential risks and benefits.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
Before using any other medications or skin products, including soaps, consult with your doctor. If you are undergoing light therapy, also inform your doctor to ensure safe treatment.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and consult your doctor if you have any concerns.
To minimize the risk of severe side effects, use this medication only as directed by your doctor. Do not exceed the recommended dosage, frequency, or duration of treatment.
You may be more susceptible to sunburn while using this medication. To protect yourself, avoid exposure to sunlight, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
If you are a parent or caregiver of a child using this medication, be aware that children may be more prone to certain side effects. Additionally, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. Consult your doctor to discuss the potential risks and benefits.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
Overdose Information
Overdose Symptoms:
- Hypercalcemia (due to calcipotriene): increased thirst, frequent urination, nausea, vomiting, fatigue, muscle weakness, confusion, constipation.
- HPA axis suppression (due to betamethasone): fatigue, weakness, weight loss, hypotension, dizziness, nausea, vomiting, Cushingoid features (moon face, buffalo hump).
What to Do:
Discontinue use immediately. Seek emergency medical attention or call Poison Control at 1-800-222-1222. Management is supportive and symptomatic, including hydration for hypercalcemia and gradual withdrawal of corticosteroids for HPA axis suppression.
Drug Interactions
Moderate Interactions
- Other topical or systemic vitamin D analogs (increased risk of hypercalcemia with calcipotriene)
- Other topical or systemic corticosteroids (increased risk of HPA axis suppression with betamethasone)
Monitoring
Baseline Monitoring
Psoriasis severity (PASI score, BSA)
Rationale: To establish baseline disease activity and guide treatment.
Timing: Prior to initiation of therapy.
Skin integrity of affected areas
Rationale: To assess for pre-existing skin damage that may increase absorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical efficacy (reduction in plaques, erythema, scaling, thickness)
Frequency: Weekly or bi-weekly during initial treatment, then as clinically indicated.
Target: Improvement in psoriasis symptoms.
Action Threshold: Lack of improvement or worsening of symptoms may require re-evaluation of treatment.
Local adverse reactions (skin irritation, atrophy, striae, folliculitis)
Frequency: At each follow-up visit.
Target: Absence or minimal local side effects.
Action Threshold: Significant irritation, signs of atrophy, or infection warrant discontinuation or modification of therapy.
Signs/symptoms of hypercalcemia (e.g., polyuria, polydipsia, nausea, vomiting, fatigue)
Frequency: Periodically, especially with extensive use or exceeding recommended dose.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms warrants immediate serum calcium measurement and discontinuation.
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Periodically, especially with extensive use, occlusive dressings, or long-term therapy.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms warrants evaluation of HPA axis function (e.g., ACTH stimulation test) and discontinuation.
Symptom Monitoring
- Skin irritation
- Burning
- Itching
- Redness
- Dryness
- Folliculitis
- Acneiform eruptions
- Perioral dermatitis
- Allergic contact dermatitis
- Skin atrophy
- Striae
- Telangiectasias
- Signs of secondary infection
- Increased thirst
- Increased urination
- Nausea
- Vomiting
- Fatigue
- Muscle weakness
- Weight loss
- Dizziness
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with both calcipotriene and betamethasone at high systemic doses. Topical absorption is generally low, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects observed in animal studies; avoid if possible.
Second Trimester:
Use with caution; systemic absorption is generally low but monitor for adverse effects.
Third Trimester:
Use with caution; systemic absorption is generally low but monitor for adverse effects.
Lactation
It is not known whether calcipotriene or betamethasone are excreted in human milk. Use with caution in nursing mothers. Avoid applying to areas that may come into direct contact with the infant's mouth or skin.
Infant Risk:
Low risk with appropriate topical use due to minimal systemic absorption, but potential for exposure exists if applied to breast or if infant comes into contact with treated skin.
Pediatric Use
Not recommended for children under 12 years of age due to increased risk of systemic absorption and HPA axis suppression. For adolescents 12-17 years, use with caution and limit duration/total amount due to higher body surface area to weight ratio and immature skin barrier.
Geriatric Use
No specific dose adjustments are required. However, elderly patients may have thinner skin and be more susceptible to local adverse effects (e.g., skin atrophy, purpura). Monitor closely for skin integrity and systemic effects.
Clinical Information
Clinical Pearls
- This ointment is for external use only. Do not ingest.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use on the face, groin, or axillae due to the high potency of betamethasone, which can cause significant skin thinning in these sensitive areas.
- Limit treatment duration to 4 weeks for adults and adolescents to minimize the risk of HPA axis suppression and other corticosteroid-related side effects.
- Do not exceed the maximum recommended weekly dose (100g for adults, 60g for adolescents) to reduce the risk of hypercalcemia and HPA axis suppression.
- Patients should be advised to wash their hands thoroughly after applying the ointment to avoid accidental transfer to other body areas or other individuals.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, fluocinonide)
- Other topical vitamin D analogs (e.g., calcipotriene cream/solution, calcitriol ointment)
- Topical retinoids (e.g., tazarotene)
- Coal tar preparations
- Salicylic acid preparations
- Phototherapy (UVB, PUVA)
- Systemic therapies for severe psoriasis (e.g., methotrexate, cyclosporine, apremilast, biologics like adalimumab, ustekinumab, secukinumab)
Cost & Coverage
Average Cost:
Varies widely, typically $500 - $1500+ per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 3 or higher, may require prior authorization.
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 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.