Taclonex Ointment 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 Analog, Corticosteroid (topical)
Pregnancy Category
Category C
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Taclonex Ointment is a medication 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 inflammation and redness.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Applying the Medication
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 the medication to your face, underarms, or groin area.
Do not use the medication on skin that is thinning.
Do not insert the medication into your vagina.
Wash your hands before and after applying the medication, unless your hand is the area being treated. If your hand is the treated area, do not wash it after applying the medication.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from freezing temperatures.
Keep the lid tightly closed when not in use.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular 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 safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Applying the Medication
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 the medication to your face, underarms, or groin area.
Do not use the medication on skin that is thinning.
Do not insert the medication into your vagina.
Wash your hands before and after applying the medication, unless your hand is the area being treated. If your hand is the treated area, do not wash it after applying the medication.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from freezing temperatures.
Keep the lid tightly closed when not in use.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer of ointment to the affected skin areas once daily, as directed by your doctor.
- Wash your hands thoroughly before and after applying the ointment.
- Do not apply the ointment to your face, groin, or armpits, or if your skin is broken or infected.
- Avoid using occlusive dressings (like bandages or wraps) over the treated areas unless specifically instructed by your doctor, as this can increase absorption.
- Limit your exposure to natural or artificial sunlight (tanning beds) while using this medication, as calcipotriene can make your skin more sensitive to UV light.
- Do not use more than 100 grams of ointment per week.
- Do not use for longer than 4 weeks at a time unless directed by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily for up to 4 weeks. Do not exceed 100 grams per week.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply once daily for up to 4 weeks. Re-treatment may be initiated after 4 weeks if needed, under medical supervision.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in patients under 12 years of age).
Adolescent:
Not established (Safety and efficacy not established in patients under 12 years of age). For patients 12-17 years, use with caution and limited to small areas due to increased risk of systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required due to minimal systemic absorption.
Moderate:
No specific adjustment typically required due to minimal systemic absorption.
Severe:
No specific adjustment typically required due to minimal systemic absorption. Use with caution if extensive application or impaired skin barrier.
Dialysis:
No specific adjustment typically required due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment typically required due to minimal systemic absorption.
Moderate:
No specific adjustment typically required due to minimal systemic absorption.
Severe:
No specific adjustment typically required due to minimal systemic absorption. Use with caution if extensive application or impaired skin barrier.
Pharmacology
Mechanism of Action
Calcipotriene is a synthetic analog of vitamin D3. It regulates cell proliferation and differentiation, inhibiting the proliferation of keratinocytes, which are overproduced 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, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-5% for calcipotriene, <1% for betamethasone) through intact skin. Absorption can increase with occlusive dressings, inflamed skin, or application to large surface areas.
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application.
ProteinBinding:
Betamethasone is highly protein bound (approximately 64%). Calcipotriene is also protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption. Systemic half-life of betamethasone is approximately 5 hours.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily renal and fecal excretion of metabolites.
Unchanged:
Minimal unchanged drug excreted systemically.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks.
PeakEffect:
Maximal effect often observed by 4 weeks.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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 fainting
+ 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
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
* Itching
This is not an exhaustive list of all possible side effects. If you have 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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 fainting
+ 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
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
* Itching
This is not an exhaustive list of all possible side effects. If you have 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, stretch marks, or shiny skin.
- Signs of skin infection (pus, worsening redness, fever).
- Symptoms of high calcium levels (rare): nausea, vomiting, constipation, muscle weakness, confusion, excessive thirst or urination.
- Symptoms of steroid absorption (rare, especially with extensive use): weight gain, swelling in the face, fatigue, muscle weakness.
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 prescribed dose, 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.
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 prescribed dose, 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.
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:
- Excessive use of calcipotriene can lead to hypercalcemia (high calcium levels in the blood), characterized by nausea, vomiting, constipation, muscle weakness, confusion, and increased thirst/urination.
- Excessive or prolonged use of betamethasone can lead to Cushing's syndrome (due to HPA axis suppression), characterized by weight gain, moon face, fatigue, and hyperglycemia.
What to Do:
If overdose is suspected, discontinue the medication and seek immediate medical attention. Call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Other topical corticosteroids (increased risk of HPA axis suppression)
- Other topical vitamin D analogs (increased risk of hypercalcemia)
Monitoring
Baseline Monitoring
Extent and severity of psoriasis
Rationale: To establish baseline for treatment efficacy assessment.
Timing: Prior to initiation of therapy
Skin integrity
Rationale: To identify areas of broken skin or infection that may increase systemic absorption.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, irritation)
Frequency: Regularly during treatment, especially with prolonged use
Target: Absence of significant adverse reactions
Action Threshold: If severe or persistent, consider discontinuation or dose reduction.
Signs of HPA axis suppression (e.g., Cushing's syndrome symptoms, growth retardation in children)
Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients
Target: Normal adrenal function
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or taper if confirmed.
Serum calcium levels (rarely needed)
Frequency: Only if signs of hypercalcemia develop or with extensive/prolonged use
Target: Normal serum calcium (8.5-10.2 mg/dL)
Action Threshold: If elevated, discontinue treatment and manage hypercalcemia.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Erythema
- Folliculitis
- Skin atrophy
- Striae
- Telangiectasias
- Signs of secondary infection
- Symptoms of Cushing's syndrome (e.g., weight gain, moon face, fatigue)
- Symptoms of hyperglycemia (e.g., increased thirst, urination)
- Symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, muscle weakness, confusion)
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Systemic absorption is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data; minimal systemic absorption reduces risk.
Second Trimester:
Potential for fetal harm based on animal data; minimal systemic absorption reduces risk.
Third Trimester:
Potential for fetal harm based on animal data; minimal systemic absorption reduces risk.
Lactation
Use with caution. It is not known whether calcipotriene or betamethasone are excreted in human milk following topical application. Due to minimal systemic absorption, excretion into breast milk is expected to be low. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk, but monitor for potential adverse effects if significant exposure occurs.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids and calcipotriene due to a larger skin surface area to body weight ratio. Use with extreme caution and for limited durations/areas if used off-label in older children/adolescents.
Geriatric Use
No specific dose adjustments are required. Elderly patients may have thinner skin and be more prone to skin atrophy or other local adverse effects from corticosteroids. Monitor for skin fragility and other adverse reactions.
Clinical Information
Clinical Pearls
- Taclonex Ointment is for external use only. Avoid contact with eyes, face, groin, and axillae due to increased risk of irritation and systemic absorption.
- Instruct patients to apply a thin layer and rub it in gently until it disappears.
- Advise patients to wash hands thoroughly after application to avoid accidental transfer to sensitive areas.
- Emphasize the importance of not exceeding the recommended dose (100g/week) or duration (4 weeks) to minimize risks of HPA axis suppression and hypercalcemia.
- Patients should be aware of increased photosensitivity with calcipotriene and take precautions against excessive sun exposure.
- If no improvement is seen after 4 weeks, re-evaluate the diagnosis and treatment plan.
Alternative Therapies
- Topical corticosteroids (e.g., clobetasol, fluocinonide)
- Topical vitamin D analogs (e.g., calcipotriene cream/solution, calcitriol ointment)
- Topical retinoids (e.g., tazarotene)
- Coal tar preparations
- Anthralin
- Phototherapy (UVB, PUVA)
- Systemic agents for psoriasis (e.g., methotrexate, cyclosporine, biologics, oral retinoids)
Cost & Coverage
Average Cost:
$800 - $1200+ per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 this medication, don't 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 information about the medication taken, the amount, and the time it happened.