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Oxymetazoline (topical): Drug information

Oxymetazoline (topical): Drug information
(For additional information see "Oxymetazoline (topical): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Rhofade
Pharmacologic Category
  • Adrenergic Agonist Agent;
  • Imidazoline Derivative
Dosing: Adult
Rosacea

Rosacea: Topical: Apply a pea-sized amount to entire face once daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External, as hydrochloride:

Rhofade: 1% (30 g) [contains cetostearyl alcohol, edetate (edta) disodium dihydrate, methylparaben, propylparaben]

Generic Equivalent Available: US

No

Administration: Adult

For topical use only; not for oral, ophthalmic, or intravaginal use. Prior to use, prime pump several times until cream is dispensed; pump 3 more times onto a tissue and discard tissue (tube does not require priming). Apply smoothly and evenly as a thin layer across entire face (forehead, each cheek, nose, and chin); avoid eyes and lips. Do not apply to irritated skin or open wounds. Wash hands immediately after applying.

Use: Labeled Indications

Rosacea: Treatment of persistent facial erythema associated with rosacea in adults

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Exacerbation of acne rosacea (1%)

Local: Application site dermatitis (2%), application site erythema (1%), application site pain (1%)

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Disease-related concerns:

• Cardiovascular disease: May affect blood pressure; use with caution in patients with uncontrolled hypertension or hypotension, orthostatic hypotension or with severe, unstable, or uncontrolled cardiovascular disease. May potentiate vascular insufficiency; use with caution in patients with cerebral or coronary insufficiency, scleroderma, thromboangiitis obliterans, and Raynaud phenomenon.

• Glaucoma: Use may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma; use with caution.

• Sjögren syndrome: Use with caution in patients with Sjögren syndrome.

Other warnings/precautions:

• Appropriate use: For topical use only; not for oral, ophthalmic, or intravaginal use; avoid contact with eyes and lips. Do not apply to open wounds or irritated skin.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Information related to topical use of oxymetazoline in pregnancy is limited. During clinical trials, two pregnancies were reported, resulting in one healthy baby and one spontaneous abortion (not considered related to treatment). Most available information is related to maternal use following nasal inhalation (see the oxymetazoline nasal monograph for additional information).

Breastfeeding Considerations

It is not known if oxymetazoline is present in breast milk following topical application. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Mechanism of Action

Relatively selective alpha1A-receptor agonist that when applied topically may decrease erythema through direct vasoconstriction.

Pharmacokinetics

Protein binding: 56.7% to 57.5%

Metabolism: Hepatic (minimal)

Pricing: US

Cream (Rhofade External)

1% (per gram): $22.72

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

  1. Rhofade (oxymetazoline hydrochloride) [prescribing information]. San Antonio, TX: DPT Laboratories, Ltd; November 2019.
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