Dazomon (brimonidine tartrate)
Treatments for Rosacea Erythema Topical Gel (Gram)
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.
Today’s intelligence on Dazomon
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.
Brimonidine tartrate is applied topically to the skin as a gel containing 0.33% brimonidine. Brimonidine gel is for external use only and should not be used orally or vaginally; contact with the eyes should be avoided.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
The manufacturer states that there are no contraindications to the use of brimonidine tartrate topical gel.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Chronic myocardial ischemia
- Depression
- Orthostatic hypotension
- Raynaud's phenomenon
- Scleroderma
- Sjogren's syndrome
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.
Rare or Very Rare
- Angioedema
- Bradycardia
- Hypotension
- Throat constriction
- Tongue swelling
More Frequent
- Erythema
- Flushing
Less Frequent
- Acne vulgaris
- Blurred vision
- Contact dermatitis
- Headache disorder
- Nasal congestion
- Ocular hypertension
- Stinging of skin
Rare or Very Rare
- Dyschromia
- Lip swelling
- Orthostatic hypotension
- Pallor
- Urticaria
Precautions
No enhanced messaging available.
Safety and efficacy of brimonidine topical gel have not been established in pediatric patients.
Accidental ingestion of brimonidine topical gel has caused serious adverse reactions in children; the drug should be kept out of reach of children. (See Serious Adverse Reactions Following Ingestion under Cautions: Warnings/Precautions.)
Category B. (See Users Guide.)
Brimonidine is distributed into milk in animals. It is not known whether brimonidine is distributed into human milk. A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
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 brimonidine gel did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients.
ICD codes
| Code | Type | Description |
|---|---|---|
| Acne rosacea | ||
| L71.0 | ICD10CM | Perioral dermatitis |
| L71.9 | ICD10CM | Rosacea, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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