SERNIVO- betamethasone dipropionate spray

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Հասանելի է:

Primus Pharmaceuticals, Inc.

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. None. There are no available data on SERNIVO Spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that SERNIVO Spray may increase the risk of having a low birthweight infant and to use SERNIVO Spray on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis (see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of SERNIVO Spray. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Administration of 0.05 mg/kg betamethasone dipropionate intramuscularly to pregnant rabbits during the period of organogenesis caused malformations. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. Risk Summary There are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of SERNIVO Spray to women who are breastfeeding. It is possible that topical administration of betamethasone dipropionate 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 SERNIVO Spray and any potential adverse effects on the breastfed infant from SERNIVO Spray or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use SERNIVO Spray on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply SERNIVO Spray directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4) ]. Safety and effectiveness of SERNIVO Spray in patients younger than 18 years of age have not been studied, therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions (5.1)] Rare systemic effects 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 skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. Clinical studies of SERNIVO Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects. Instructions for Use SERNIVO™ (ser-ne-vo) (betamethasone dipropionate) Spray, 0.05% Important: SERNIVO Spray is for use on the skin only. Do not get SERNIVO Spray near or in your eyes, mouth, or vagina. Read this “Instructions for Use” before you start using SERNIVO Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Parts of the SERNIVO Spray bottle. (See Figure A) Figure A How to apply SERNIVO Spray: Step 1: Shake the SERNIVO Spray bottle well. Remove the cap from the pump top. Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply SERNIVO Spray to the affected area as instructed by your doctor. (See Figure B) Figure B Step 3: Spray only enough SERNIVO Spray to cover the affected area, for example, the elbow (See Figure C) . Rub in SERNIVO Spray gently. Figure C Repeat Steps 2 and 3 to apply SERNIVO Spray to other affected areas as instructed by your doctor. Step 4: After applying SERNIVO Spray, place the cap back onto the pump top. (See Figure D) Figure D How should I store SERNIVO Spray? - Store SERNIVO Spray at room temperature between 68°F to 77°FF (20°FC to 25°C). - Throw away (discard) any unused SERNIVO Spray after 28 days. Keep SERNIVO Spray and all medicines out of the reach of children. This "Instructions for Use" has been approved by the U.S. Food and Drug Administration. Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Distributed by: Encore Dermatology, Inc., Scottsdale AZ 85254 SERNIVO is a registered trademark of Encore Dermatology, Inc Issued: 02/2016 Revised: 04/2019 SER1289 4/19

Ապրանքի ամփոփագիր:

SERNIVO Spray is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes: Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature ]. Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

SERNIVO- BETAMETHASONE DIPROPIONATE SPRAY
PRIMUS PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SERNIVO SPRAY SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SERNIVO SPRAY.
SERNIVO (BETAMETHASONE DIPROPIONATE) SPRAY, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
SERNIVO Spray is a corticosteroid indicated for the treatment of mild
to moderate plaque psoriasis in
patients 18 years of age or older. (1)
DOSAGE AND ADMINISTRATION
Apply to the affected skin areas twice daily. Rub in gently. (2)
Use SERNIVO Spray for up to 4 weeks and not beyond. (2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician.
(2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous
areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
SERNIVO Spray can produce reversible HPA axis suppression with the
potential for glucocorticosteroid
insufficiency during or after treatment. High potency corticosteroids,
large treatment surface areas,
prolonged use, use of occlusive dressings, altered skin barrier, liver
failure and use in pediatric patients
may predispose to HPA axis suppression. Use of topical corticosteroids
may require periodic evaluation
for HPA axis suppression. Modify use if HPA axis suppression develops.
(5.1) High potency
corticosteroids, large treatment surface areas, prolonged use, use of
occlusive dressings, altered skin
barrier, liver failure and young age may predispose to HPA axis
suppression. (5.1)
Topical corticosteroids may increase the risk of cataracts and
glaucoma. If visual symptoms occur,
consider referral to an ophthalmologist. (5.2)
ADVERSE REACTIONS
The most common adverse reactions (≥1%) are application site
react