Oxymetazoline Hydrochloride (Rhofade)

Trade Name : RHOFADE

Allergan, Inc.

CREAM

Strength 10 mg/g

OXYMETAZOLINE HYDROCHLORIDE Vasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [CS]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oxymetazoline Hydrochloride (Rhofade) which is also known as RHOFADE and Manufactured by Allergan, Inc.. It is available in strength of 10 mg/g per ml. Read more

Oxymetazoline Hydrochloride (Rhofade) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

RHOFADEu2122 cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
RHOFADEu00a0is an alpha adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. ()

For topical use only. u00a0RHOFADE is not for oral, ophthalmic, or intravaginal use.
PrimetheRHOFADE pump before using for the first time. u00a0To do so, with the pump in the upright position, repeatedly depress the actuator until cream is dispensed and then pump three times. Discard the cream from priming actuations. It is only necessary to prime the pump before the first dose.
RHOFADE tubes do not require priming.
Apply a pea-sized amount of RHOFADE cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips.u00a0u00a0Wash hands immediately after applying RHOFADE cream.u00a0

Not for oral, ophthalmic, or intravaginal use. ()n
Prime pump bottle before initial use and discard product from first three pumps. ()n
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. ()n
Wash hands after application.u00a0()

RHOFADEu00a0(oxymetazoline hydrochloride) cream, 1% is a white to off-white cream. Each gram of cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8u00a0mg (0.88%) of oxymetazoline free base.
Cream, 1%.u00a0u00a0Each gram of cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8u00a0mg (0.88%) of oxymetazoline free base.u00a0()

None.

None. ()

No data

Alpha-adrenergic agonists as a classu00a0may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.u00a0()n
Use with caution in patients with cerebral or coronary insufficiency, Raynaudu2019s phenomenon, thromboangiitis obliterans, scleroderma, or Sju00f6grenu2019s syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.u00a0()n
Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop. ()

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 489 subjects with persistent facial erythema associated with rosacea were treated with RHOFADE once daily for 4 weeks in 3 controlled clinical trials. An additional 440 subjectsu00a0with persistent facial erythema associated with rosacea were also treated with RHOFADE once daily for up to one year in a long-termu00a0(open-label)u00a0clinical trial. u00a0Adverse reactions that occurred in at least 1% of subjects treated with RHOFADEu00a0through 4 weeks of treatment are presented in Table 1 below.
In the long-term (open-label) clinical trial,u00a0the rates of adverse reactions over a one-year treatment period were as follows: worsening inflammatory lesions of rosacea (3%), application site dermatitis (3%), application site pruritus (2%), application site pain (2%), and application site erythema (2%).u00a0u00a0Subjects with persistent erythema along with inflammatory lesions were allowed to use additional therapy for the inflammatory lesions of rosacea.
Most common adverse reactions (incidence 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritus, application site erythema, and application site pain. ()

No data

No data

RHOFADE is not for oral use. If oral ingestion occurs, seek medical advice. u00a0Monitor patient closely and administer appropriate supportive measures as necessary. Accidental ingestion of topical solutionsu00a0(nasal sprays) containing imidazoline derivatives (e.g., oxymetazoline) in children has resulted in serious adverse events requiring hospitalization, including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma. Keep RHOFADE out of reach of children.

RHOFADE (oxymetazoline hydrochloride) cream 1% contains oxymetazoline hydrochloride,u00a0anu00a0alpha adrenoceptor agonist.u00a0u00a0RHOFADE is a white to off-white cream.u00a0u00a0It has a chemical name of 3-[(4,5-Dihydro-1H-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethyl-phenol hydrochloride and a molecular weight of 296.8.u00a0It is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water. The molecular formula of oxymetazoline HCl is CHClNO and its structural formula is:
u00a0n
Each gram of RHOFADE (oxymetazoline hydrochloride) cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8u00a0mg (0.88%) of oxymetazoline free base. The cream contains the following inactive ingredients: sodium citrate dihydrate, citric acid anhydrous, disodium edetate dihydrate, butylated hydroxytoluene, anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, oleyl alcohol, polyethylene glycol 300, PEG-6 stearate, glycol stearate, PEG-32 stearate, cetostearyl alcohol, ceteareth-6, stearyl alcohol, ceteareth-25, methylparaben, propylparaben, phenoxyethanol, and purified water.

No data

Oxymetazoline hydrochloride was not associated with an increased incidence of neoplastic or proliferative changes in transgenic mice given oral doses of 0.5, 1.0, or 2.5 mg/kg/day oxymetazoline hydrochlorideu00a0for 6 months.
Oxymetazoline hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and human lymphocyte chromosomal aberration assay) and one in vivo gentoxicity test (mouse micronucleus assay).
Effects on fertility and early embryonic development were evaluated in rats following oral administration of 0.05, 0.1, or 0.2 mg/kg/day oxymetazoline hydrochloride prior to and during mating and through early pregnancy. u00a0Decreased number of corpora lutea and increased post-implantation losses were noted at 0.2 mg/kg/day oxymetazoline hydrochloride (3 times the MRHD on an AUC comparison basis). However, no treatment related effects on fertility or mating parameters were noted at 0.2 mg/kg/day oxymetazoline hydrochloride (3 times the MRHD on an AUC comparison basis).

RHOFADEu00a0was evaluated for the treatment of persistent erythema associated with rosacea in two identical, randomized, double-blind, vehicle-controlled, parallel-group clinical trials. u00a0The trials enrolled 885 subjects aged 18 years and older. Overall, 90% of subjects were Caucasian and 79% were female. u00a0Subjects applied either RHOFADE or vehicle once daily for 29 days.
Disease severity was graded by the clinician using a 5-point clinician erythema assessment (CEA) scale and by the subject on a similar 5-point subject self-assessment (SSA) scale, on which subjects scored either u201cmoderateu201d or u201csevereu201d on both scales.
CEA and SSA were measured over a 12-hour period at equally-spaced timepoints (hours 3, 6, 9, and 12) post-dose on Days 1, 15, and 29. The primary efficacy endpoint was defined as the proportion of subjects with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on Day 1) on both the CEA and SSA measured at hours 3, 6, 9, and 12 on Day 29.u00a0u00a0The results from both trials on the composite endpoint for Day 29 are presented in Table 2.u00a0

RHOFADE
NDC 0023-5300-30nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt30 gram tube
NDC 0023-5300-60nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt60 gram tube
NDC 0023-5300-35nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt30 gram pump
NDC 0023-5300-65nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt60 gram pump
Storage

Advise the patient and/or caregiver to read the FDA-approved patient labeling n n andn n .
Important Administration Instructions
Advise patients of the following:
Distributed by: Allergan USA, Inc.
Madison, NJ 07940
u00a0
u00a9 2018u00a0Allergan.u00a0 All rights reserved.
All trademarks are the property of their respective owners.
Patented. See www.allergan.com/patents
v1.0USPI5300
This Patient Information has been approved by the U.S. Food and Drug Administrationnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntApproved: 01/2017
v1.0PPI5300

INSTRUCTIONS FOR USE
RHOFADEu2122 (roe' fayd)
(oxymetazoline hydrochloride)
cream
Tube
Read and follow the steps below so that you use your tube of RHOFADE cream correctly:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by: Allergan USA, Inc.Madison, NJ 07940
u00a0
u00a9 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners.Patented. See www.allergan.com/patents
Approved: 01/2017
v1.0IFUTube5300

INSTRUCTIONS FOR USE
RHOFADEu2122 (roeu2019 fayd)
(oxymetazoline hydrochloride) cream
Pump
Read and follow the steps below so that you use your RHOFADE cream pump correctly:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by: Allergan USA, Inc.Madison, NJ 07940
u00a0
u00a9 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners.Patented. See www.allergan.com/patents
Approved: 01/2017
v1.0IFUPump5300

NDC 0023-5300-30Rhofade(oxymetazoline hydrochloride) cream, 1%30 gRx Only

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Oxymetazoline Hydrochloride (Rhofade)

Trade Name : RHOFADE

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Oxymetazoline Hydrochloride (Rhofade)

Trade Name : RHOFADE

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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