Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (oxymetazoline - UNII:8VLN5B44ZY)
Aclaris Therapeutics, Inc.
TOPICAL
PRESCRIPTION DRUG
RHOFADE® (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. None. Risk Summary There are no available data on RHOFADE cream use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. A literature article describing intranasal decongestant use in pregnant women identified a potential association between second-trimester exposure to oxymetazoline (with no decongestant exposure in the first trimester) and renal collecting system anomalies [see Data] . In animal reproduction studies, there were no adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 3 times and 73 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) [see Data] . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All p
RHOFADE® (oxymetazoline hydrochloride) cream, 1%, is a white to off-white cream. The product is available in a laminated tube and an airless pump polypropylene bottle in the following packaging configurations, each with a child-resistant closure: Storage : Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
New Drug Application
RHOFADE- OXYMETAZOLINE HYDROCHLORIDE CREAM ACLARIS THERAPEUTICS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RHOFADE TOPICAL CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RHOFADE TOPICAL CREAM. RHOFADE (OXYMETAZOLINE HYDROCHLORIDE) CREAM, 1%, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1964 INDICATIONS AND USAGE Rhofade cream is an alpha adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. (1) DOSAGE AND ADMINISTRATION Not for oral, ophthalmic, or intravaginal use. (2) Prime pump bottle before initial use and discard product from first three pumps. (2) Apply a pea-sized amount once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. (2) Wash hands after application. (2) DOSAGE FORMS AND STRENGTHS Cream, 1%. Each gram of cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8 mg (0.88%) of oxymetazoline free base. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Alpha-adrenergic agonists as a class may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens. (5.1) Use with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop. (5.2) Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop. (5.3) ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACLARIS THERAPEUTICS, Přečtěte si celý dokument