Dazomon (brimonidine tartrate)

Treatments for Rosacea Erythema Topical Gel (Gram)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Brimonidine tartrate is a relatively selective alpha2-adrenergic agonist.

Brimonidine tartrate is a relatively selective alpha2-adrenergic agonist. Topical application of brimonidine gel appears to reduce erythema through direct vasoconstriction. Brimonidine is thought to act by targeting alpha-adrenergic receptors present in the smooth muscle sheath encasing the vessel wall of superficial cutaneous blood vessels.

In clinical trials of brimonidine gel therapy in patients with rosacea, maximal effects typically occurred 3 hours after application of the gel and continued until about 6 hours after application. A total duration of effect (e.g., 1-grade improvement in both Clinical Erythema Assessment (CEA) scale and Patient Self Assessment (PSA) scale) exceeding 12 hours has been reported in the majority of patients.

Following administration of brimonidine tartrate gel (1 g of gel containing 5 mg of brimonidine tartrate applied to the entire face) once daily for 29 days in patients with erythema associated with rosacea, peak plasma concentration and area under the concentration-time curve (AUC) were 40 and 20%, respectively, those observed following administration of brimonidine tartrate 0.2% ophthalmic solution (1 drop in each eye every 8 hours for 24 hours). Mean peak plasma concentration and AUC were highest on day 15 in patients receiving brimonidine gel. Systemic exposure was slightly lower on day 29, indicating no further drug accumulation with brimonidine gel application.

Brimonidine is extensively metabolized by the liver. Urinary excretion is the major route of elimination of brimonidine and its metabolites.

USES: This medication is used to treat a certain skin disorder called rosacea. It works by narrowing blood vessels to reduce redness. Brimonidine belongs to a class of drugs known as alpha agonists.

Generic name: brimonidine tartrate
Pronunciation: (bri-MON-i-deen)
Drug class: Treatments for Rosacea Erythema
Therapeutic class: Dermatological

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Dazomon:

  • Acne Rosacea

Also known as: Acne Erythematosa, Rosacea.

Dosing

For the topical treatment of erythema associated with rosacea in adults, a pea-sized amount of brimonidine gel should be applied once daily to each of the 5 areas of the face (central forehead, chin, nose, and each cheek, for a total of 5 pea-sized amounts). The gel 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 after application of the gel.

Drug interactions

There is no enhanced messaging for this drug.

Contraindications

The manufacturer states that there are no contraindications to the use of brimonidine tartrate topical gel.

Adverse reactions

Adverse effects occurring in at least 2% of patients and at a higher incidence with brimonidine gel than with vehicle placebo include erythema, flushing, and burning sensation of the skin.

Adverse effects occurring in at least 4% of patients receiving brimonidine gel (alone or in combination with other rosacea therapy) once daily for 12 months in an open-label trial include flushing, erythema, worsening of rosacea, nasopharyngitis, burning sensation of the skin, increased intraocular pressure, and headache.

Precautions

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ICD codes

CodeTypeDescription
Acne rosacea
L71.0ICD10CMPerioral dermatitis
L71.9ICD10CMRosacea, unspecified

ICD code information from First Databank (FDB).

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data