Taclonex Topical Suspension 120gm
It is used to treat plaque psoriasis. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antipsoriatic, Corticosteroid
Pharmacologic Class
Vitamin D Analog, Corticosteroid (Topical)
Pregnancy Category
Category C
FDA Approved
May 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Taclonex Topical Suspension is a medicine applied to the skin to treat plaque psoriasis. It contains two active ingredients: calcipotriene, which is a form of vitamin D that helps slow down skin cell growth, and betamethasone, which is a strong steroid that reduces redness, itching, and inflammation.
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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid applying the medication to sensitive areas, including the face, underarms, groin area, or skin that is thinning.
Do not apply the medication to the vagina or get it in your mouth, nose, or eyes, as it may cause burning.
Before and after applying the medication, wash your hands thoroughly. However, if your hand is the treated area, do not wash it after application.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Before use, shake the medication well.
Special Instructions for Scalp Application
To apply the medication to your scalp, part your hair and put the medication on the affected skin.
Gently rub in the medication and allow it to dry.
You can wash your hair as usual after application.
If you have chemically treated hair, wait 12 hours before applying the medication.
Avoid washing your hair immediately after using the medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the lid tightly closed and store all medications in a safe place, out of the reach of children and pets.
Missed 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 resume your regular schedule.
* Do not apply two doses at the same time or take 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 as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid applying the medication to sensitive areas, including the face, underarms, groin area, or skin that is thinning.
Do not apply the medication to the vagina or get it in your mouth, nose, or eyes, as it may cause burning.
Before and after applying the medication, wash your hands thoroughly. However, if your hand is the treated area, do not wash it after application.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Before use, shake the medication well.
Special Instructions for Scalp Application
To apply the medication to your scalp, part your hair and put the medication on the affected skin.
Gently rub in the medication and allow it to dry.
You can wash your hair as usual after application.
If you have chemically treated hair, wait 12 hours before applying the medication.
Avoid washing your hair immediately after using the medication.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the lid tightly closed and store all medications in a safe place, out of the reach of children and pets.
Missed 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 resume your regular schedule.
* Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply a thin layer to affected areas once daily. Do not use more than directed by your doctor.
- Wash your hands thoroughly after applying the medication, unless your hands are the treated area.
- Avoid applying to the face, groin, or armpits, or if skin atrophy is present, unless specifically directed by your doctor.
- Do not use with occlusive dressings (e.g., bandages, plastic wrap) unless directed by your doctor, as this can increase absorption and side effects.
- Avoid excessive 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 advised by your doctor.
- Inform your doctor if your condition worsens or does not improve after 4 weeks.
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 100g per week.
Condition-Specific Dosing:
Psoriasis Vulgaris:
Apply once daily for up to 4 weeks. Treatment beyond 4 weeks should be re-evaluated by a physician. Max 100g/week.
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)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption; use with caution with extensive application.
Moderate:
No specific adjustment recommended due to minimal systemic absorption; use with caution with extensive application.
Severe:
No specific adjustment recommended due to minimal systemic absorption; use with caution with extensive application.
Dialysis:
Considerations: Minimal systemic absorption, but monitor for signs of systemic effects if applied to large surface areas or for prolonged periods.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption; use with caution with extensive application.
Moderate:
No specific adjustment recommended due0 to minimal systemic absorption; use with caution with extensive application.
Severe:
No specific adjustment recommended due to minimal systemic absorption; use with caution with extensive application.
Pharmacology
Mechanism of Action
Calcipotriene is a synthetic vitamin D3 analog. In skin, it inhibits keratinocyte proliferation and promotes keratinocyte differentiation, thereby normalizing abnormal cell growth in psoriasis. Betamethasone dipropionate is a potent synthetic 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:
Low systemic absorption (typically <1% for calcipotriene, <5% for betamethasone dipropionate) after topical application.
Tmax:
Not typically reported for topical application due to low systemic absorption; peak systemic levels, if detectable, occur within hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Betamethasone: approximately 64% bound to plasma proteins. Calcipotriene: approximately 60% bound to plasma proteins.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely determined for topical application due to low systemic absorption; systemic half-life of absorbed calcipotriene is short (minutes to hours), betamethasone is longer (hours).
Clearance:
Not precisely determined for topical application.
ExcretionRoute:
Calcipotriene and its metabolites are primarily excreted in feces (major) and urine (minor). Betamethasone and its metabolites are primarily excreted in urine.
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 after 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 used
Change in skin color
Change in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild 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 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 used
Change in skin color
Change in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild 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:
- Increased skin irritation (burning, itching, redness, dryness) at the application site.
- Signs of skin thinning (atrophy), such as shiny skin, easy bruising, or stretch marks.
- Signs of infection (pus, spreading redness).
- Signs of too much steroid absorption (e.g., weight gain, swelling in face, fatigue, muscle weakness, high blood sugar).
- Signs of too much calcium (e.g., nausea, vomiting, constipation, muscle weakness, confusion, increased thirst or urination).
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 medications 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 medications 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 products on your skin, 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, adhere to the dosage and usage instructions provided by your doctor. Do not exceed the recommended amount, frequency, or duration of treatment.
As this medication may increase your susceptibility to sunburn, take necessary precautions to protect yourself from the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to prevent sun damage.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
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 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 products on your skin, 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, adhere to the dosage and usage instructions provided by your doctor. Do not exceed the recommended amount, frequency, or duration of treatment.
As this medication may increase your susceptibility to sunburn, take necessary precautions to protect yourself from the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to prevent sun damage.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
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 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 systemic absorption of calcipotriene can lead to hypercalcemia (high blood calcium levels), characterized by nausea, vomiting, constipation, muscle weakness, confusion, polyuria (frequent urination), and polydipsia (increased thirst).
- Excessive systemic absorption of betamethasone can lead to Cushing's syndrome (e.g., moon face, central obesity, striae, muscle weakness, hyperglycemia, glucosuria), and HPA axis suppression.
What to Do:
If overdose is suspected, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is symptomatic and supportive. Discontinue the medication. Monitor serum calcium and HPA axis function. Correct electrolyte imbalances as needed.
Drug Interactions
Moderate Interactions
- Other topical corticosteroids (increased risk of systemic corticosteroid effects)
- Other topical vitamin D analogs (increased risk of hypercalcemia)
Monitoring
Baseline Monitoring
Extent and severity of psoriasis
Rationale: To establish baseline for efficacy assessment and guide treatment duration.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical signs of HPA axis suppression (e.g., Cushing's syndrome, hyperglycemia, glucosuria)
Frequency: Periodically, especially with extensive or prolonged use
Target: Not applicable
Action Threshold: If suspected, perform ACTH stimulation test, plasma cortisol, and urinary free cortisol tests.
Serum calcium levels
Frequency: Periodically, especially with extensive or prolonged use or in patients with pre-existing hypercalcemia risk
Target: Normal range (e.g., 8.5-10.2 mg/dL)
Action Threshold: If elevated, discontinue treatment and manage hypercalcemia.
Skin integrity (e.g., atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)
Frequency: At each follow-up visit
Target: Absence of adverse skin reactions
Action Threshold: If severe or persistent, discontinue or reduce frequency of application.
Symptom Monitoring
- Skin irritation (burning, itching, redness, dryness)
- Folliculitis
- Acneiform eruptions
- Perioral dermatitis
- Skin atrophy
- Striae
- Telangiectasias
- Signs of systemic corticosteroid absorption (e.g., weight gain, moon face, fatigue, muscle weakness)
- Signs of hypercalcemia (e.g., nausea, vomiting, constipation, muscle weakness, confusion, polyuria, polydipsia)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Calcipotriene and betamethasone are Category C. Animal studies have shown teratogenic effects with both components at doses higher than those achieved with topical application. Systemic absorption is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though systemic absorption is low. Avoid extensive use.
Second Trimester:
Potential for fetal harm, though systemic absorption is low. Avoid extensive use.
Third Trimester:
Potential for fetal harm, though systemic absorption is low. Avoid extensive use. Risk of HPA axis suppression in the neonate if used extensively near term.
Lactation
Caution should be exercised when Taclonex Topical Suspension is administered to a nursing woman. It is not known whether calcipotriene or betamethasone are excreted in human milk. Due to minimal systemic absorption, risk to infant is likely low, but avoid applying to areas that may come into direct contact with the infant's mouth or skin.
Infant Risk:
Low risk, but monitor for potential adverse effects if significant exposure occurs. Avoid application to the breast area.
Pediatric Use
Safety and effectiveness 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 and immature skin barrier function, leading to increased systemic absorption. HPA axis suppression and hypercalcemia have been reported in pediatric patients.
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 be more susceptible to skin atrophy or other local adverse effects from corticosteroids. Use with caution and monitor for adverse reactions.
Clinical Information
Clinical Pearls
- Taclonex Topical Suspension is specifically formulated for the scalp but can be used on other body areas as directed by a physician.
- Instruct patients to shake the bottle well before each use.
- Advise patients to apply a thin layer to affected areas and rub in gently. Do not apply to the face, groin, or axillae due to increased risk of local adverse effects.
- Limit treatment duration to 4 weeks to minimize risk of HPA axis suppression and other corticosteroid-related side effects.
- Patients should be advised to avoid contact with eyes, mouth, and other mucous membranes.
- Warn patients about increased photosensitivity due to calcipotriene; advise sun protection.
- 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)
- 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, acitretin)
- Biologic agents (e.g., adalimumab, ustekinumab, secukinumab)
Cost & Coverage
Average Cost:
$1000 - $1500+ per 120gm bottle
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'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 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 occurred.