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Drug overview for RHOFADE (oxymetazoline hcl):
Generic name: oxymetazoline HCl (OX-i-me-TAZ-oh-leen)
Drug class: Treatments for Rosacea Erythema
Therapeutic class: Dermatological
Oxymetazoline hydrochloride, an imidazoline-derivative sympathomimetic amine, is a vasoconstrictor.
No enhanced Uses information available for this drug.
Generic name: oxymetazoline HCl (OX-i-me-TAZ-oh-leen)
Drug class: Treatments for Rosacea Erythema
Therapeutic class: Dermatological
Oxymetazoline hydrochloride, an imidazoline-derivative sympathomimetic amine, is a vasoconstrictor.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for RHOFADE (oxymetazoline hcl) have been approved by the FDA:
Indications:
Acne rosacea
Professional Synonyms:
Acne erythematosa
Rosacea
Indications:
Acne rosacea
Professional Synonyms:
Acne erythematosa
Rosacea
The following dosing information is available for RHOFADE (oxymetazoline hcl):
For the topical treatment of facial erythema associated with rosacea in adults, a pea-sized amount of oxymetazoline 1% cream should be applied once daily to the 5 areas of the face (forehead, chin, nose, and each cheek). The cream should be applied smoothly and evenly as a thin layer across the entire face, but avoiding the eyes and lips. The hands should be washed immediately after application of the cream.
Oxymetazoline hydrochloride is applied topically to the skin as a 1% cream, which is available in a tube or pump bottle. Oxymetazoline cream is for external use only and should not be used orally, ophthalmically, or vaginally. The pump bottle should be primed prior to initial use by actuating the pump until cream appears, then the pump should be actuated 3 additional times.
The cream resulting from the priming actuations should be discarded. It is only necessary to prime the pump prior to the first dose.
The cream resulting from the priming actuations should be discarded. It is only necessary to prime the pump prior to the first dose.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| RHOFADE 1% CREAM | Maintenance | Adults apply a pea-sized amount by topical route once daily to cover areas of face with thin layer avoiding the eyes and lips |
No generic dosing information available.
The following drug interaction information is available for RHOFADE (oxymetazoline hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for RHOFADE (oxymetazoline hcl):
Drug contraindication overview.
The manufacturer states that there are no known contraindications to the use of oxymetazoline hydrochloride topical cream.
The manufacturer states that there are no known contraindications to the use of oxymetazoline hydrochloride topical cream.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Angle-closure glaucoma |
There are 0 severe contraindications.
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Coronary artery disease |
| Hypertension |
| Orthostatic hypotension |
| Raynaud's phenomenon |
| Sjogren's syndrome |
The following adverse reaction information is available for RHOFADE (oxymetazoline hcl):
Adverse reaction overview.
Adverse effects occurring in at least 1% of patients with persistent facial edema of rosacea receiving topical oxymetazoline cream in clinical studies and at a higher incidence than with vehicle placebo include application site dermatitis, pruritus, erythema, and pain and worsening inflammatory lesions of rosacea.
Adverse effects occurring in at least 1% of patients with persistent facial edema of rosacea receiving topical oxymetazoline cream in clinical studies and at a higher incidence than with vehicle placebo include application site dermatitis, pruritus, erythema, and pain and worsening inflammatory lesions of rosacea.
There are 0 severe adverse reactions.
There are 4 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Erythema Pain Pruritus of skin Skin inflammation |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for RHOFADE (oxymetazoline hcl):
Safety and efficacy of oxymetazoline topical cream have not been established in pediatric patients younger than 18 years of age. Accidental ingestion of oxymetazoline nasal solutions has caused serious adverse reactions in children. (See Serious Adverse Reactions Following Ingestion under Cautions: Warnings/Precautions.)
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and well-controlled studies of topical oxymetazoline in pregnant women. Data regarding topical use of oxymetazoline cream in pregnant women are inadequate. Two pregnancies were reported across all clinical studies with oxymetazoline cream resulting in the delivery of a healthy child in one case and a spontaneous abortion in the second case.
However, the spontaneous abortion was not considered to be drug related. Animal reproduction studies using oral oxymetazoline have not revealed evidence of developmental abnormalities in pregnant rats or rabbits at oxymetazoline systemic exposures of 3 or 73 times, respectively, the human exposures at the maximum recommended human dose.
However, the spontaneous abortion was not considered to be drug related. Animal reproduction studies using oral oxymetazoline have not revealed evidence of developmental abnormalities in pregnant rats or rabbits at oxymetazoline systemic exposures of 3 or 73 times, respectively, the human exposures at the maximum recommended human dose.
Oxymetazoline is distributed into milk in rats. It is not known whether oxymetazoline is distributed into human milk or affects human milk production. The benefits of breast-feeding and the importance of oxymetazoline to the woman should be considered along with the potential adverse effects on the breast-fed child from the drug or underlying maternal condition.
In clinical trials, no overall differences in safety and efficacy were observed in patients 65 years of age or older compared with younger patients. However, the manufacturer states that clinical studies of oxymetazoline cream did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger adults.
The following prioritized warning is available for RHOFADE (oxymetazoline hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for RHOFADE (oxymetazoline hcl)'s list of indications:
| Acne rosacea | |
| L71.0 | Perioral dermatitis |
| L71.9 | Rosacea, unspecified |
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