RHOFADE- oxymetazoline hydrochloride cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (oxymetazoline - UNII:8VLN5B44ZY)

Available from:

EPI Health, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pregn

Product summary:

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-30ºC (59°F-86ºF) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

RHOFADE- OXYMETAZOLINE HYDROCHLORIDE CREAM
EPI HEALTH, LLC
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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 EPI HEALTH, LLC AT
1-800-499-446