País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
CALCIPOTRIENE (UNII: 143NQ3779B) (CALCIPOTRIENE - UNII:143NQ3779B)
Trifluent Pharma LLC
TOPICAL
PRESCRIPTION DRUG
Calcipotriene foam should not be used by patients with known hypercalcemia. Calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. Risk Summary Although there are no available data on the drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes in pregnant women exposed to calcipotriene foam, systemic exposure to calcipotriene is likely to be low [see Clinical Pharmacology ( 12.2, 12.3)] . In animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits (see Data) . The available data do not allow the calculation of rel
Calcipotriene foam, 0.005%, is supplied as follows:
New Drug Application
CALCIPOTRIENE 0.005% 60 GRAM FOAM- CALCIPOTRIENE 0.005% 60 GRAM FOAM AEROSOL, FOAM TRIFLUENT PHARMA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CALCIPOTRIENE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCIPOTRIENE. CALCIPOTRIENE FOAM, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1993 RECENT MAJOR CHANGES Indications and Usage ( 1) 11/2019 DOSAGE AND ADMINISTRATION For topical use only; not for oral, ophthalmic, or intravaginal use. ( 2) Apply twice daily. ( 2) DOSAGE FORMS AND STRENGTHS 0.005%, foam. ( 3) CONTRAINDICATIONS Do not use in patients with known hypercalcemia.( 4) WARNINGS AND PRECAUTIONS Flammability: Contents are flammable. Instruct the patient the avoid fire, flame, and smoking during and immediately following application. ( 5.1) Effects on Calcium Metabolism: If elevation of serum calcium occurs, instruct patients to discontinue treatment until normal calcium levels are restored. ( 5.2) INDICATIONS AND USAGE Calcipotriene foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. ( 1) ADVERSE REACTIONS Adverse reactions reported in ≥ 1% of subjects treated with calcipotriene foam and at a higher incidence than subjects treated with vehicle were application site erythema and application site pain. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT 1-844-825-8500 OR FDA AT 1-800-FDA- 1088 OR _WWW.FDA.GOV/MEDWATCH_. (6) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 8/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Flammability 5.2 Effects on Calcium Metabolism 1 INDICATIONS AND USAGE 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMA Leia o documento completo