CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE ointment

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

CALCIPOTRIENE (UNII: 143NQ3779B) (CALCIPOTRIENE - UNII:143NQ3779B), BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

थमां उपलब्ध:

Sandoz Inc.

INN (इंटरनेशनल नाम):

CALCIPOTRIENE

रचना:

CALCIPOTRIENE 50 ug in 1 g

प्रशासन का मार्ग:

TOPICAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. None. Risk Summary Calcipotriene and betamethasone dipropionate ointment contains calcipotriene and betamethasone dipropionate. The limited data with calcipotriene and betamethasone dipropionate ointment and calcipotriene use in pregnant women are not sufficient to evaluate a calcipotriene and betamethasone dipropionate ointment -associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids (see Data ) . Advise pregnant women that calcipotriene and betamethasone dipropionate ointment may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs (see Data ) . Oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development. Subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) (see Data ) . The available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone diproprionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate ointment. The estimated background risk of major birth defects and miscarriage of the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. However, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. Animal Data Embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits. Pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) on days 6-15 of gestation (the period of organogenesis). There were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. Fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs. Pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m2 /day, respectively) on days 6-18 of gestation (the period of organogenesis). Mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. The incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group. The incidence of major malformations among fetuses was not affected. An increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. Embryo-fetal development studies with betamethasone dipropionate were performed via subcutaneous injection in mice and rabbits. Pregnant mice were administered doses of 0, 156, 625, or 2500 mcg/kg/day (0, 468, 1875, and 7500 mcg/m2 /day, respectively) on days 7 through 13 of gestation (the period of organogenesis). Betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, malformations (increased incidence of the cleft palate and crooked or short tail), and minor skeletal abnormalities (delayed ossification of vertebra and sternebrae). Fetal toxicity was observed at the lowest exposure that was evaluated (156 mcg/kg/day). Pregnant rabbits were injected subcutaneously at dosages of 0, 0.625, 2.5, and 10 mcg/kg/day (0, 7.5, 30, and 120 mcg/m2 /day, respectively) on days 6 through 18 of gestation (the period of organogenesis). Betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, external malformations (including malformed ears, cleft palate, umbilical hernia, kinked tail, club foot, and club hand), and skeletal malformations (including absence of phalanges of the first digit and cranial dysplasia) at dosages of 2.5 mcg/kg/day and above. Calcipotriene was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 6, 18 or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) from gestation day 15 through day 20 postpartum. No remarkable effects were observed on any parameter, including survival, behavior, body weight, litter parameters, or the ability to nurse or rear pups. Betamethasone dipropionate was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 100, 300, and 1000 mcg/kg/day (0, 600, 1800, and 6000 mcg/m2 /day, respectively) from gestation day 6 through day 20 postpartum. Mean maternal body weight was significantly reduced on gestation day 20 in animals dosed at 300 and 1000 mcg/kg/day. The mean duration of gestation was slightly, but statistically significantly, increased at 100, 300, and 1000 mcg/kg/day. The mean percentage of pups that survived to day 4 was reduced in relation to dosage. On lactation day 5, the percentage of pups with a reflex to right themselves when placed on their back was significantly reduced at 1000 mcg/ kg/day. No effects on the ability of pups to learn were observed, and the ability of the offspring of treated rats to reproduce was not affected. Risk Summary There is no information regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for calcipotriene and betamethasone dipropionate ointment and any potential adverse effects on the breastfed child from calcipotriene and betamethasone dipropionate ointment or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply calcipotriene and betamethasone dipropionate ointment directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations ( 8.4 )] . Safety and effectiveness of the use of calcipotriene and betamethasone dipropionate ointment in pediatric patients under the age of 12 years have not been established. The safety and effectiveness of calcipotriene and betamethasone dipropionate ointment for the treatment of plaque psoriasis have been established in the age group 12 to 17 years. In a prospective, uncontrolled trial, 33 pediatric subjects ages 12-17 years with plaque psoriasis on the body were treated with calcipotriene and betamethasone dipropionate ointment for 4 weeks up to a maximum of 55.8 g per week. Subjects were assessed for HPA axis suppression and effects on calcium metabolism. No adverse effects on adrenal suppression were observed. No hypercalcemia was observed but one subject had a possible treatment-related increase in urinary calcium [see Clinical Pharmacology ( 12.2)]. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids [see Warnings and Precautions (5.2) ]. Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients. Of the total number of subjects in the clinical studies of calcipotriene and betamethasone dipropionate ointment, approximately 14% were 65 years and older and approximately 3% were 75 years and over. No overall differences in safety or effectiveness of calcipotriene and betamethasone dipropionate ointment were observed between these subjects and younger subjects. All other reported clinical experience has not identified any differences in response between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

उत्पाद समीक्षा:

Calcipotriene and betamethasone dipropionate ointment is off-white to yellow in color, available in collapsible tubes of: 60 gram (NDC 0781-7165-35) 100 gram (NDC 0781-7165-95) Store calcipotriene and betamethasone dipropionate ointment at 20º to 25°C (68º to 77°F); excursions permitted between 15º to 30°C (59º to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE- CALCIPOTRIENE AND
BETAMETHASONE
DIPROPIONATE OINTMENT
Sandoz Inc.
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PATIENT INFORMATION
Calcipotriene and Betamethasone Dipropionate Ointment
(kal si poe trye' een and bay'' ta meth' a sone dye proe' pee oh nate)
Read the Patient Information that comes with calcipotriene and
betamethasone dipropionate ointment before
you start using it and each time you refill your prescription. There
may be new information. This leaflet does
not take the place of talking with your doctor about your condition or
treatment.
Important information: Calcipotriene and betamethasone dipropionate
ointment is for use on the skin only
(topical use only). Do not use calcipotriene and betamethasone
dipropionate ointment on the face, under arms
or on groin area. Do not swallow calcipotriene and betamethasone
dipropionate ointment. Another product,
Taclonex® Topical Suspension contains the same medicine that is in
calcipotriene and betamethasone
dipropionate ointment and is used to treat plaque psoriasis on the
scalp. If you use both medicines to treat
your plaque psoriasis, be sure to follow your doctor’s directions
carefully so that you do not use too much of
one or both of these medications.
What is calcipotriene and betamethasone dipropionate ointment?
Calcipotriene and betamethasone dipropionate ointment is a
prescription medicine that is for use on the skin
only (a topical medicine). Calcipotriene and betamethasone
dipropionate ointment is used to treat plaque
psoriasis in patients 12 years of age and older.
Calcipotriene and betamethasone dipropionate ointment has not been
studied in patients under the age of 12
years.
Who should not use calcipotriene and betamethasone dipropionate
ointment?
Do not use calcipotriene and betamethasone dipropionate ointment if
you:
•
have thin skin (atrophy) at the site to be treated
•
are allergic to anything in calcipotriene and betamethasone
dipropionate ointment. See the end of this
leaflet for a complete list of ingredients.
What should I

उत्पाद विशेषताएं

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE- CALCIPOTRIENE AND
BETAMETHASONE DIPROPIONATE OINTMENT
SANDOZ INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIPOTRIENE AND
BETAMETHASONE DIPROPIONATE OINTMENT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE OINTMENT.
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE OINTMENT FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Calcipotriene and betamethasone dipropionate ointment is a vitamin D
analogue and corticosteroid
combination product indicated for the topical treatment of plaque
psoriasis in patients 12 years of age and
older. (1)
DOSAGE AND ADMINISTRATION
Apply calcipotriene and betamethasone dipropionate ointment to
affected area(s) once daily for up to 4
weeks. Discontinue therapy when control is achieved. (2)
Adult patients should not use more than 100 g per week. (2)
Patients ages 12 to 17 years should not use more than 60 g per week.
(2)
Treatment of more than 30% body surface area is not recommended. (2)
Do not use with occlusive dressings unless directed by a physician.
(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)
DOSAGE FORMS AND STRENGTHS
Ointment, 0.005%/0.064% (3)
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Hypercalcemia and hypercalciuria have been observed. If either occurs,
discontinue treatment until
parameters of calcium metabolism normalize (5.1)
Calcipotriene and betamethasone dipropionate ointment can produce
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, concomitant use of more
than one corticosteroid-containing product, altered