Calcipotrien/betamet Dip Oint 100gm
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)
Pharmacologic Class
Vitamin D analogue, Corticosteroid (topical)
Pregnancy Category
Category C
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
This ointment contains two medicines: calcipotriene, a form of vitamin D, and betamethasone, a strong steroid. It is used to treat plaque psoriasis by helping to slow down the overgrowth of skin cells and reduce redness, itching, and scaling.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected skin area. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Application Instructions
- Apply the medication only to the skin, avoiding the face, underarms, groin area, and any areas with thinning skin.
- Do not apply the medication to the vagina.
- Before and after applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application.
- Gently rub a thin layer of the medication onto the affected skin area.
- Unless instructed otherwise by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
- Store the medication at room temperature, away from freezing temperatures.
- Keep the container tightly closed.
- Ensure all medications are kept in a safe location, out of the reach of children and pets.
Missing a Dose
- If you miss a dose, apply it as soon as you remember.
- If the missed dose is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule.
- Do not apply two doses at once or use extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected skin area. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Application Instructions
- Apply the medication only to the skin, avoiding the face, underarms, groin area, and any areas with thinning skin.
- Do not apply the medication to the vagina.
- Before and after applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application.
- Gently rub a thin layer of the medication onto the affected skin area.
- Unless instructed otherwise by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
- Store the medication at room temperature, away from freezing temperatures.
- Keep the container tightly closed.
- Ensure all medications are kept in a safe location, out of the reach of children and pets.
Missing a Dose
- If you miss a dose, apply it as soon as you remember.
- If the missed dose is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule.
- Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer only to the affected skin areas once a day. Do not use more than directed.
- Wash your hands thoroughly after applying the ointment, unless your hands are the treated area.
- Do not use on your face, groin, or armpits, or if your skin is broken or infected.
- Avoid using on large areas of the body or under bandages/occlusive dressings, as this can increase absorption and side effects.
- Limit exposure to natural or artificial sunlight (tanning beds, sunlamps) while using this medication, as calcipotriene can increase sensitivity to UV light.
- Do not use for longer than 4 weeks unless directed by your doctor.
- Inform your doctor if your condition worsens or does not improve after 4 weeks.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily for up to 4 weeks. Maximum weekly dose should not exceed 100 grams.
Condition-Specific Dosing:
psoriasis_vulgaris:
Apply once daily for up to 4 weeks. Treatment beyond 4 weeks should be re-evaluated by a physician. Not for use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children 12-18 years should be limited to 4 weeks and closely monitored due to increased risk of systemic absorption and HPA axis suppression.)
Adolescent:
Apply a thin layer to affected areas once daily for up to 4 weeks. Maximum weekly dose should not exceed 60 grams for patients 12-18 years of age. Closely monitor for signs of HPA axis suppression.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Severe:
Use with caution, especially with extensive application or prolonged use, as systemic absorption may occur. Monitor for hypercalcemia.
Dialysis:
Considerations: Use with caution. Monitor for hypercalcemia and HPA axis suppression if significant systemic absorption is suspected.
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Severe:
Use with caution, especially with extensive application or prolonged use, as systemic absorption may occur. Monitor for adverse effects.
Pharmacology
Mechanism of Action
Calcipotriene is a synthetic vitamin D3 analogue. It regulates cell proliferation and differentiation, inhibiting keratinocyte proliferation and promoting normal keratinocyte differentiation, which helps to normalize abnormal cell growth in psoriasis. Betamethasone dipropionate is a high-potency corticosteroid. It exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% for calcipotriene, <5% for betamethasone through intact skin). Increased with damaged skin, occlusive dressings, or large surface areas.
Tmax:
Not well-defined for topical application due to low systemic absorption. Systemic levels are generally below quantifiable limits.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application.
ProteinBinding:
Calcipotriene: Approximately 60% bound to plasma proteins. Betamethasone: Approximately 64% bound to plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application due to low systemic absorption. Systemic half-life of betamethasone is approximately 5 hours.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Calcipotriene metabolites primarily excreted in feces, with some in urine. Betamethasone metabolites primarily excreted in urine.
Unchanged:
Minimal unchanged drug excreted systemically.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks.
PeakEffect:
Maximal effect usually observed by 4 weeks.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 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
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 applied
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 mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
* Itching
This is not an exhaustive list of possible 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, 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 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
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 applied
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 mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
* Itching
This is not an exhaustive list of possible 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:
- Increased skin irritation, burning, itching, or redness at the application site.
- Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks.
- Signs of skin infection (e.g., pus, increased pain, warmth, swelling).
- Symptoms of high calcium levels (rare): nausea, vomiting, constipation, muscle weakness, confusion, increased thirst or urination.
- Symptoms of adrenal gland problems (rare): unusual tiredness or weakness, dizziness, nausea, vomiting, loss of appetite, weight loss.
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 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 with your other medications and health conditions.
Remember, do not 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 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 with your other medications and health conditions.
Remember, do not 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 to ensure safe use. If you are undergoing light therapy, inform your doctor to avoid any potential interactions.
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 with 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, as this may increase the risk of adverse effects.
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 and monitor your eye health accordingly.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with 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 to prevent infant exposure.
Before using any other medications or skin products, including soaps, consult with your doctor to ensure safe use. If you are undergoing light therapy, inform your doctor to avoid any potential interactions.
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 with 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, as this may increase the risk of adverse effects.
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 and monitor your eye health accordingly.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with 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 to prevent infant exposure.
Overdose Information
Overdose Symptoms:
- Hypercalcemia (due to calcipotriene): nausea, vomiting, constipation, muscle weakness, confusion, fatigue, increased thirst, increased urination.
- HPA axis suppression (due to betamethasone): fatigue, weakness, dizziness, nausea, vomiting, hypotension, weight loss, hyperglycemia.
What to Do:
Discontinue the medication. Seek immediate medical attention. For hypercalcemia, hydration and calcium-lowering measures may be needed. For HPA axis suppression, systemic corticosteroids may be tapered slowly under medical supervision. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Other topical or systemic corticosteroids (increased risk of HPA axis suppression)
- Other topical or systemic vitamin D analogues (increased risk of hypercalcemia)
Monitoring
Baseline Monitoring
Skin assessment (area, severity of psoriasis)
Rationale: To establish baseline for efficacy monitoring and identify areas unsuitable for treatment (e.g., face, intertriginous areas).
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical efficacy (reduction in plaque thickness, erythema, scaling)
Frequency: Weekly or bi-weekly during treatment period.
Target: Improvement in PASI score or visual assessment.
Action Threshold: Lack of improvement or worsening of condition may require re-evaluation of diagnosis or treatment.
Adverse skin reactions (atrophy, striae, telangiectasias, folliculitis, irritation)
Frequency: At each follow-up visit.
Target: Absence of significant adverse reactions.
Action Threshold: Development of significant skin adverse effects may require discontinuation or modification of therapy.
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, hypotension)
Frequency: Periodically, especially with extensive use, occlusive dressings, or in pediatric patients.
Target: Normal adrenal function.
Action Threshold: If suspected, perform ACTH stimulation test. Discontinue drug if HPA axis suppression is confirmed.
Serum calcium levels (rarely needed, only if excessive use or symptoms of hypercalcemia)
Frequency: Only if symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, muscle weakness, confusion) occur or with very extensive/prolonged use.
Target: Normal serum calcium (8.5-10.2 mg/dL).
Action Threshold: Elevated calcium levels require immediate discontinuation and management.
Symptom Monitoring
- Skin irritation, burning, itching, redness, dryness
- Signs of skin infection (pus, increased pain, warmth)
- Signs of skin thinning or damage (bruising easily, shiny skin, stretch marks)
- Symptoms of hypercalcemia (nausea, vomiting, constipation, muscle weakness, confusion, increased thirst/urination)
- Symptoms of HPA axis suppression (fatigue, weakness, dizziness, nausea, weight loss)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development with both calcipotriene and betamethasone at doses higher than those achieved with topical application.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is low. Avoid if possible.
Second Trimester:
Potential for fetal adrenal suppression with high-potency corticosteroids, especially with extensive use. Monitor for signs of systemic absorption.
Third Trimester:
Potential for fetal adrenal suppression and growth retardation with high-potency corticosteroids, especially with extensive use. Monitor for signs of systemic absorption.
Lactation
Use with caution. It is not known whether calcipotriene or betamethasone are excreted in human milk following topical application. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
L3 (Moderate concern). Potential for infant exposure through breast milk or direct contact. Monitor infant for signs of adverse effects (e.g., growth suppression, adrenal suppression).
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Children are more susceptible to systemic adverse effects (HPA axis suppression, hypercalcemia) due to a larger skin surface area to body weight ratio. Use in adolescents (12-18 years) should be limited to 4 weeks and closely monitored.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. However, elderly patients may have thinner skin and may be more susceptible to skin atrophy or other local side effects. Use with caution and monitor for adverse reactions.
Clinical Information
Clinical Pearls
- This combination ointment is highly effective for plaque psoriasis but should be used judiciously due to the potent corticosteroid component.
- Emphasize the 'thin layer, once daily' application and the maximum weekly dose to patients to minimize systemic absorption and local side effects.
- Educate patients on the importance of not using this product on the face, groin, or axillae, as these areas are more prone to corticosteroid-induced skin atrophy and other side effects.
- Advise patients to wash hands thoroughly after application to avoid accidental transfer to sensitive areas or ingestion.
- Monitor for signs of HPA axis suppression, especially in children or patients using the ointment on large body surface areas or under occlusion.
- Hypercalcemia is a rare but serious side effect of calcipotriene, usually associated with excessive use. Counsel patients on symptoms to watch for.
Alternative Therapies
- Topical corticosteroids (e.g., clobetasol, fluocinonide)
- Topical vitamin D analogues (e.g., calcipotriene, calcitriol)
- 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, apremilast)
- Biologics (e.g., adalimumab, ustekinumab, secukinumab)
Cost & Coverage
Average Cost:
$500 - $1500+ per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand, or Preferred 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's a good idea to check with your pharmacist. 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 information about the medication taken, the amount, and the time it happened.