taclonex
Taclonex is a combination medicine containing Betamethasone Dipropionate, Calcipotriene, and Calcipotriene Hydrate.
Betamethasone Dipropionate and Calcipotriene and Calcipotriene Hydrate · by Leo Pharma As
Key facts
- Active ingredient
- Betamethasone Dipropionate and Calcipotriene and Calcipotriene Hydrate
- Form
- Suspension
- Strength
- Betamethasone Dipropionate 0.064%; Calcipotriene 0.005% · Betamethasone Dipropionate 0.064%; Calcipotriene Hydrate 0.005%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Leo Pharma As
- FDA application
- NDA022185
What is Taclonex?
From the FDA label:Taclonex Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene hydrate is a synthetic vitamin D 3 analog. Calcipotriene Hydrate Calcipotriene hydrate is a vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol,24-cyclo-propyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C 27 H 40 O 3 ∙H 2 O, a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound): Betamethasone Dipropionate Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21- bis (1-oxypropoxy)-(11β,16β), with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder): Taclonex ® Topical Suspension Each gram of Taclonex Topical Suspension contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of hydrogenated castor oil, polyoxypropylene stearyl ether, all- rac -alpha-tocopherol, butylhydroxytoluene, and mineral oil. Taclonex Topical Suspension is an odorless, clear to slightly off-white…
How to use
Instruct patients to shake bottle prior to using Taclonex Topical Suspension. Apply Taclonex Topical Suspension to affected areas on the scalp and body once daily for up to 8 weeks. Taclonex Topical Suspension should be discontinued when control is achieved. Instruct patients to wash their hands after applying the product. Inform patients that they should not take a bath or shower or wash their hair right after application of Taclonex Topical Suspension. Patients 12 to 17 years should not use more than 60 grams per week and patients 18 years and older should not use more than 100 grams per week. Taclonex Topical Suspension should not be: Used with occlusive dressings unless directed by a healthcare provider. Used on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Applied to the scalp in the 12 hours before or after any chemical treatments to the hair. Taclonex Topical Suspension is not for oral, ophthalmic, or intravaginal use. Shake bottle before use. ( 2 ) Apply Taclonex Topical Suspension to affected areas on the scalp and body once daily for up to 8 weeks. Discontinue therapy when control is achieved. ( 2 ) Patients age 12 to 17 years should not use more than 60 grams per week.( 2 ) Adult patients should not use more than 100 grams per week. ( 2 ) Do not use with occlusive dressings unless directed by a healthcare provider. ( 2 ) Avoid use…
Side effects
The most common adverse reactions (≥ 1%) are folliculitis and burning sensation of skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Conducted in Subjects 18 years and older with Psoriasis of the Scalp The rates of adverse reactions described below were from randomized, multicenter, vehicle- and/or active controlled clinical trials in adult subjects with psoriasis of the scalp [see Clinical Studies (14) ]. Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 grams. Adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1. Table 1. Number and Percentage of Subjects with Adverse Reactions in Scalp Psoriasis Trials (Events Reported by ≥1% of Subjects and for Which a Relationship is Possible) Taclonex Topical Suspension Betamethasone Dipropionate in vehicle Calcipotriene in vehicle Vehicle N=1,953 N=1,214 N=979 N=173 Event # of…
Warnings
Important safety information
Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize. ( 5.1 ) Effects on Endocrine System: Can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. ( 5.2 , 8.4 ) Ophthalmic Adverse Reactions: May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.5 ) 5.1 Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of Taclonex Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following Taclonex Topical Suspension treatment of more than 8 weeks has not been evaluated [see Clinical Pharmacology (12.2) ]. 5.2 Effects on Endocrine System Hypothalamic-Pituitary-Adrenal Axis Suppression Taclonex Topical Suspension can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is documented, gradually withdraw Taclonex Topical Suspension, reduce the frequency of application, or substitute with a less potent corticosteroid. The following trials evaluated the effects of Taclonex Topical Suspension on HPA axis suppression: In a trial evaluating the effects of Taclonex Topical Suspension and Taclonex Ointment on the HPA axis, 32 adult subjects applied both Taclonex Topical Suspension on the scalp and Taclonex Ointment on the body. Adrenal suppression was identified in 5 of 32 subjects (16%) after 4 weeks of treatment and in 2 of 11 subjects (18%) who continued treatment for 8 weeks. In another trial, 36 adult subjects applied Taclonex Topical Suspension on the body and scalp and 7 subjects applied Taclonex Topical Suspension on the body. Adrenal suppression occurred in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects who continued treatment for 8 weeks [ see Clinical Pharmacology (12.2) ]. In two trials, the effects of Taclonex Topical Suspension on the HPA axis were evaluated in 31 and 30 pediatric subjects aged 12 to 17 years old who applied Taclonex Topical suspension on the scalp and the scalp/body, respectively. Adrenal suppression occurred in 1 of 30 evaluable subjects (3%) after 4 weeks of treatment (scalp) and 5 of 31 evaluable subjects (16%) after up to 8 weeks of treatment (scalp and body) [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2) ]. Cushing's Syndrome and Hyperglycemia Cushing's syndrome and hyperglycemia may occur due to the systemic effects of the topical corticosteroid. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. Additional Considerations for Endocrine Adverse Reactions Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2) ]. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. 5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to a topical corticosteroid is usually diagnosed by observing a failure to heal rather than a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. 5.4 Allergic Contact Dermatitis with Topical Calcipotriene Allergic contact dermatitis has been observed with use of topical calcipotriene. Such an observation should be corroborated with appropriate diagnostic patch testing. 5.5 Ophthalmic Adverse Reactions Use of topical corticosteroids, including Taclonex ® Topical Suspension, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported with the postmarketing use of topical corticosteroid products [see Adverse Reactions (6.2) ]. Avoid contact of Taclonex Topical Suspension with eyes. Taclonex Topical Suspension may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
Who should not take Taclonex
None. None. ( 4 )
Dosage forms
Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- Is there a coupon or discount for Taclonex?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Taclonex. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Taclonex?
- Taclonex is marketed by Leo Pharma As. You can see Leo Pharma As's full profile, rating, and other products on pharmaranks.
- Is Taclonex a brand-name or generic drug?
- Taclonex is a brand-name product with the active ingredient Betamethasone Dipropionate and Calcipotriene and Calcipotriene Hydrate.
- Is Taclonex available over the counter?
- No. Taclonex is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Taclonex come in?
- Taclonex is currently marketed as suspension, per the FDA's National Drug Code Directory.
- Is Taclonex FDA-registered?
- Taclonex is on record with the U.S. FDA under application number NDA022185. You can verify this on its official FDA label.
- Is Taclonex safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Taclonex. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Taclonex?
- Taclonex's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (≥ 1%) are folliculitis and burning sensation of skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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