CALCIPOTRIENE 0.005% 60 GRAM FOAM aerosol, foam

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

CALCIPOTRIENE (UNII: 143NQ3779B) (CALCIPOTRIENE - UNII:143NQ3779B)

Dostupno od:

Trifluent Pharma LLC

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Calcipotriene foam, 0.005%, is supplied as follows:

Status autorizacije:

New Drug Application

Svojstava lijeka

CALCIPOTRIENE 0.005% 60 GRAM FOAM- CALCIPOTRIENE 0.005% 60 GRAM
FOAM AEROSOL, FOAM
TRIFLUENT PHARMA LLC
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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