Calcipotriene And Betamethasone Dipropionate

Prescription

Nama merek: Calcipotriene and Betamethasone Dipropionate

Bentuk Sediaan

Topical

Rute Pemberian

TOPICAL

Produsen

Sun Pharmaceutical Industries, Inc.

About This Medication

11 DESCRIPTION Calcipotriene and betamethasone dipropionate 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-cyclopropyl-,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): Chemical Structure Betamethasone Dipropionate Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11hydroxy-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): Chemical Structure Calcipotriene and Betamethasone Dipropionate Topical Suspension Each gram of calcipotriene and betamethasone dipropionate topical suspension contains 50 mcg of calcipotriene (equivalent to 52.18 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of all- rac -alpha-tocopherol, butylhydroxytoluene, hydrogenated castor oil, mineral oil, and polyoxypropylene stearyl ether. Calcipotriene and betamethasone dipropionate topical suspension is an odorless, clear to slightly off-white suspension.

Bahan Aktif

Bahan	Kekuatan
Betamethasone Dipropionate	-
Calcipotriene	-

Indikasi & Penggunaan

1 INDICATIONS AND USAGE Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information. Calcipotriene and Betamethasone Dipropionate Topical Suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. ( 1 )

Cara kerja

12.1 Mechanism of Action Calcipotriene and betamethasone dipropionate topical suspension combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D 3 analog and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in the treatment of plaque psoriasis of the scalp and body are unknown.

Dosis & Cara Pemberian

2 DOSAGE AND ADMINISTRATION Instruct patients to shake bottle prior to using calcipotriene and betamethasone dipropionate topical suspension. Apply calcipotriene and betamethasone dipropionate topical suspension to affected areas on the scalp and body once daily for up to 8 weeks. Calcipotriene and betamethasone dipropionate 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 calcipotriene and betamethasone dipropionate 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. Calcipotriene and Betamethasone Dipropionate 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. Calcipotriene and Betamethasone Dipropionate Topical Suspension is not for oral, ophthalmic, or intravaginal use. Shake bottle before use. ( 2 ) Apply Calcipotriene and Betamethasone Dipropionate 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 on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

Side Effects Overview

6 ADVERSE REACTIONS The most common adverse reactions (≥1%) are folliculitis and burning sensation of skin ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information. 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 calcipotriene and betamethasone dipropionate 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) Calcipotriene and Betamethasone Dipropionate Topical Suspension Betamethasone dipropionate in vehicle Calcipotriene in vehicle Vehicle N=1,953 N=1,214 N=979 N=173 Event # of subjects (%) Folliculitis 16 (1%) 12 (1%) 5 (1%) 0 (0%) Burning sensation of skin 13 (1%) 10 (1%) 29 (3%) 0 (0%) Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash. In a 52-week trial, adverse reactions that were reported by >1% of subjects treated with calcipotriene and betamethasone dipropionate topical suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%). Clinical Trials Conducted in Subjects18 years and older with Psoriasis of the Body In randomized, multicenter, vehicle- and/or active controlled clinical trials in adult subjects with plaque psoriasis on non-scalp areas, 824 subjects applied calcipotriene and betamethasone dipropionate topical suspension once daily for 8 weeks [see Clinical Studies (14) ]. The median weekly dose was 22.6grams. There were no adverse reactions that occurred in ≥1%of subjects treated with calcipotriene and betamethasone dipropionate topical suspension and at a rate higher than in subjects treated with vehicle. Other less common adverse reactions (<1%but >0.1%) were, in decreasing order of incidence: rash and folliculitis. Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information. Clinical Trials Conducted in Subjects 12 to 17 years with Psoriasis of the Scalp In two uncontrolled clinical trials, 109 subjects aged 12 to 17 years with plaque psoriasis of the scalp applied calcipotriene and betamethasone dipropionate topical suspension once daily for up to 8 weeks. The median weekly dose was 40 grams. Adverse reactions included acne, acneiform dermatitis and application site pruritus (0.9% each) [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2) ] . 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids included atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria. Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported during use of topical corticosteroids, including topical betamethasone products.

Peringatan & Tindakan Pencegahan

5 WARNINGS AND PRECAUTIONS 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 calcipotriene and betamethasone dipropionate topical suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following calcipotriene and betamethasone dipropionate 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 Calcipotriene and betamethasone dipropionate 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 calcipotriene and betamethasone dipropionate topical suspension, reduce the frequency of application, or substitute with a less potent corticosteroid. The following trials evaluated the effects of calcipotriene and betamethasone dipropionate topical suspension on HPA axis suppression: In a trial evaluating the effects of calcipotriene and betamethasone dipropionate topical suspension and calcipotriene and betamethasone dipropionate ointment on the HPA axis, 32 adult subjects applied both calcipotriene and betamethasone dipropionate topical suspension on the scalp and calcipotriene and betamethasone dipropionate 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 calcipotriene and betamethasone dipropionate topical suspension on the body and scalp and 7 subjects applied calcipotriene and betamethasone dipropionate 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 calcipotriene and betamethasone dipropionate topical suspension on the HPA axis were evaluated in 31 and 30 pediatric subjects aged 12 to 17 years old who applied calcipotriene and betamethasone dipropionate 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 calcipotriene and betamethasone dipropionate 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 calcipotriene and betamethasone dipropionate topical suspension with eyes. Calcipotriene and betamethasone dipropionate topical suspension may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

Kontraindikasi

4 CONTRAINDICATIONS None. None ( 4 )

Farmakokinetik

12.3 Pharmacokinetics Absorption The systemic effect of calcipotriene and betamethasone dipropionate topical suspension in psoriasis was investigated in Trials A and B [see Clinical Pharmacology (12.2) ]. In Trial A, the serum levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 and 8 weeks of once daily application of calcipotriene and betamethasone dipropionate topical suspension on the scalp in combination with calcipotriene and betamethasone dipropionate ointment on the body. Calcipotriene and betamethasone dipropionate were below the lower limit of quantification in all serum samples of the 34 subjects evaluated. However, one major metabolite of calcipotriene (MC1080) was quantifiable in 10 of 34 (29%) subjects at week 4 and in 5 of 12 (42%) subjects at week 8. The major metabolite of betamethasone dipropionate, betamethasone 17propionate (B17P) was also quantifiable in 19 of 34 (56%) subjects at week 4 and 7 of 12 (58%) subjects at week 8. The serum concentrations for MC1080 ranged from 20-75 pg/mL. The clinical significance of this finding is unknown. In Trial B, the plasma levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 weeks of once daily application of calcipotriene and betamethasone dipropionate topical suspension. Calcipotriene and its metabolite MC1080 were below the lower limit of quantification in all plasma samples. Betamethasone dipropionate was quantifiable in 4 of 43 (9) subjects. The metabolite of betamethasone dipropionate (B17P) was quantifiable in 16 of 43 (37%) subjects. The plasma concentrations of betamethasone dipropionate ranged from 30.9-63.5 pg/mL and that of its metabolite betamethasone 17-propionate ranged from 30.5 to 257 pg/mL. The clinical significance of this finding is unknown. Elimination Metabolism Calcipotriene: Calcipotriene metabolism following systemic uptake is rapid and occurs in the liver. The primary metabolites of calcipotriene are less potent than the parent compound. Calcipotriene is metabolized to MC1046 (the α,β-unsaturated ketone analog of calcipotriene), which is metabolized further to MC1080 (a saturated ketone analog). MC1080 is the major metabolite in plasma. MC1080 is slowly metabolized to calcitroic acid. Betamethasone dipropionate : Betamethasone dipropionate is metabolized to betamethasone 17-propionate and betamethasone, including the 6β-hydroxy derivatives of those compounds by hydrolysis. Betamethasone 17-propionate (B17P) is the primary metabolite. Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information.

Frequently Asked Questions

1 INDICATIONS AND USAGE Calcipotriene and Betamethasone Dipropionate Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information. Calcipotriene and …

2 DOSAGE AND ADMINISTRATION Instruct patients to shake bottle prior to using calcipotriene and betamethasone dipropionate topical suspension. Apply calcipotriene and betamethasone dipropionate topical suspension to affected areas on the scalp and body once daily for up to 8 weeks. Calcipotriene and betamethasone dipropionate 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 …

5 WARNINGS AND PRECAUTIONS 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 …

4 CONTRAINDICATIONS None. None ( 4 )

Calcipotriene And Betamethasone Dipropionate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

References & Data Sources

• DailyMed — Calcipotriene And Betamethasone Dipropionate drug label (National Library of Medicine)
• openFDA — Calcipotriene And Betamethasone Dipropionate label data (U.S. Food & Drug Administration)
• NDC Directory — Calcipotriene And Betamethasone Dipropionate (FDA National Drug Code)

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Sumber data: DailyMed (NLM), openFDA, MFDS