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Drug overview for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide):
Generic name: BRIMONIDINE TARTRATE/IVERMECTIN/METRONIDAZOLE/NIACINAMIDE
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
Brimonidine tartrate is a relatively selective alpha2-adrenergic agonist. Ivermectin, a semisynthetic, avermectin-derivative, is used topically as a Metronidazole is a synthetic, nitroimidazole-derivative antibacterial and antiprotozoal agent and also has direct anti-inflammatory effects and pediculicide. effects on neutrophil motility, lymphocyte transformation, and some aspects of cell-mediated immunity.
No enhanced Uses information available for this drug.
Generic name: BRIMONIDINE TARTRATE/IVERMECTIN/METRONIDAZOLE/NIACINAMIDE
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
Brimonidine tartrate is a relatively selective alpha2-adrenergic agonist. Ivermectin, a semisynthetic, avermectin-derivative, is used topically as a Metronidazole is a synthetic, nitroimidazole-derivative antibacterial and antiprotozoal agent and also has direct anti-inflammatory effects and pediculicide. effects on neutrophil motility, lymphocyte transformation, and some aspects of cell-mediated immunity.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide):
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.
Patients with severe hepatic disease metabolize metronidazole slowly, which can result in the accumulation of the drug and its metabolites in plasma. Therefore, the manufacturers recommend that metronidazole vaginal gel be used with caution in patients with severe hepatic disease.
Patients with severe hepatic disease metabolize metronidazole slowly, which can result in the accumulation of the drug and its metabolites in plasma. Therefore, the manufacturers recommend that metronidazole vaginal gel be used with caution in patients with severe hepatic disease.
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. Metronidazole is applied topically to the skin or intravaginally in appropriate formulations.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide):
Drug contraindication overview.
The manufacturer states that there are no contraindications to the use of brimonidine tartrate topical gel. The manufacturer states there are no contraindications to use of ivermectin 0.5% lotion.
The manufacturer states that there are no contraindications to the use of brimonidine tartrate topical gel. The manufacturer states there are no contraindications to use of ivermectin 0.5% lotion.
There are 0 contraindications.
There are 0 severe contraindications.
There are 8 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Blood dyscrasias |
| Chronic myocardial ischemia |
| Depression |
| No disease contraindications |
| Orthostatic hypotension |
| Raynaud's phenomenon |
| Scleroderma |
| Sjogren's syndrome |
The following adverse reaction information is available for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide):
Adverse reaction overview.
Adverse effects occurring in at least 2% of patients and at a higher Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and burning skin sensation were reported in less than 1% of patients 6 months incidence with brimonidine gel than with vehicle placebo include erythema, flushing, and burning sensation of the skin. of age or older after a single 10-minute topical application of ivermectin 0.5% lotion. 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.
Adverse effects occurring in at least 2% of patients and at a higher Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and burning skin sensation were reported in less than 1% of patients 6 months incidence with brimonidine gel than with vehicle placebo include erythema, flushing, and burning sensation of the skin. of age or older after a single 10-minute topical application of ivermectin 0.5% lotion. 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.
There are 11 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Angioedema Bradycardia Dyspnea Hypertension Hypotension Ocular irritation Peripheral neuropathy Skin rash Throat constriction Tongue swelling |
There are 29 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Erythema Flushing Headache disorder Pharyngitis Upper respiratory infection |
Acne vulgaris Blurred vision Contact dermatitis Dry skin Headache disorder Nasal congestion Ocular hypertension Skin irritation Stinging of skin |
| Rare/Very Rare |
|---|
|
Conjunctival hyperemia Contact dermatitis Dandruff Dry skin Dyschromia Eye tearing Lip swelling Ocular redness Orthostatic hypotension Pallor Pruritus of skin Skin irritation Stinging of skin Treatment site sequelae Urticaria |
The following precautions are available for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide):
Safety and efficacy of brimonidine topical gel have not been established in Safety and efficacy of ivermectin 0.5% lotion have not been established in children younger than 6 months of age. Because these young children have a pediatric patients.
greater skin surface area to body mass ratio and potentially immature skin Accidental ingestion of brimonidine topical gel has caused serious adverse barrier, systemic absorption may be increased and children younger than 6 months of age may be at increased risk of ivermectin toxicity. Ivermectin reactions in children; the drug should be kept out of reach of children. (See Serious Adverse Reactions Following Ingestion under Cautions: 0.5% lotion should not be used in children younger than 6 months of age. Warnings/Precautions.) The lotion should be kept out of the reach of children and should be used only under the direct supervision of an adult.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
greater skin surface area to body mass ratio and potentially immature skin Accidental ingestion of brimonidine topical gel has caused serious adverse barrier, systemic absorption may be increased and children younger than 6 months of age may be at increased risk of ivermectin toxicity. Ivermectin reactions in children; the drug should be kept out of reach of children. (See Serious Adverse Reactions Following Ingestion under Cautions: 0.5% lotion should not be used in children younger than 6 months of age. Warnings/Precautions.) The lotion should be kept out of the reach of children and should be used only under the direct supervision of an adult.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category B. (See Users Guide.) Category C. (See Users Guide) No fetotoxicity was observed in rats or mice receiving oral administration of metronidazole at dosages 200 or 20 times the usual dosage, respectively.
In addition, reproduction studies in pregnant mice using oral metronidazole doses about 6 times the maximum recommended human dose (on a mg/m2 basis) have not revealed evidence of fetotoxicity or teratogenicity; however, intrauterine deaths have occurred following intraperitoneal administration of the drug. The fetal risk, if any, with the use of topical or vaginal metronidazole gel in pregnant women currently is not known. Metronidazole crosses the placenta and is rapidly distributed into fetal circulation.
There have been no adequate and controlled studies to date using oral, IV, topical, or intravaginal metronidazole in pregnant women. Because animal reproduction studies are not always predictive of human response and because oral metronidazole has been shown to be carcinogenic in some rodents, topical metronidazole preparations or the vaginal gel should be used in pregnant women only when clearly needed. Screening and/or treatment for bacterial vaginosis in pregnant women as clinically indicated should be conducted during the first prenatal visit.
Although some experts state that intravaginal therapy may be used solely for symptomatic relief (and not for prevention of adverse pregnancy outcomes) in women at low risk for preterm delivery, other experts prefer use of systemic therapy for all pregnant women, regardless of degree of risk for complications of pregnancy, because systemic treatment may be required to eradicate upper genital tract infection that may be associated with bacterial vaginosis. For the treatment of bacterial vaginosis and reduction in the incidence of adverse pregnancy outcomes associated with bacterial vaginosis (e.g., preterm birth), particularly in pregnant women at high risk for complications of pregnancy, a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin is recommended.
In addition, reproduction studies in pregnant mice using oral metronidazole doses about 6 times the maximum recommended human dose (on a mg/m2 basis) have not revealed evidence of fetotoxicity or teratogenicity; however, intrauterine deaths have occurred following intraperitoneal administration of the drug. The fetal risk, if any, with the use of topical or vaginal metronidazole gel in pregnant women currently is not known. Metronidazole crosses the placenta and is rapidly distributed into fetal circulation.
There have been no adequate and controlled studies to date using oral, IV, topical, or intravaginal metronidazole in pregnant women. Because animal reproduction studies are not always predictive of human response and because oral metronidazole has been shown to be carcinogenic in some rodents, topical metronidazole preparations or the vaginal gel should be used in pregnant women only when clearly needed. Screening and/or treatment for bacterial vaginosis in pregnant women as clinically indicated should be conducted during the first prenatal visit.
Although some experts state that intravaginal therapy may be used solely for symptomatic relief (and not for prevention of adverse pregnancy outcomes) in women at low risk for preterm delivery, other experts prefer use of systemic therapy for all pregnant women, regardless of degree of risk for complications of pregnancy, because systemic treatment may be required to eradicate upper genital tract infection that may be associated with bacterial vaginosis. For the treatment of bacterial vaginosis and reduction in the incidence of adverse pregnancy outcomes associated with bacterial vaginosis (e.g., preterm birth), particularly in pregnant women at high risk for complications of pregnancy, a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin is recommended.
Brimonidine is distributed into milk in animals. It is not known whether Orally administered ivermectin is distributed into milk in low brimonidine is distributed into human milk. A decision should be made concentrations.
Since it is not known if ivermectin is distributed into milk following topical administration, the 0.5% lotion should be used with whether to discontinue nursing or the drug, taking into account the caution in nursing women. importance of the drug to the woman.
Following oral administration, metronidazole is distributed into milk in concentrations similar to those attained in plasma. Although plasma concentrations of metronidazole following topical or intravaginal administration are lower than those achieved after oral administration of the drug, it is not known whether metronidazole distributes into milk following topical or intravaginal application. Therefore, because oral metronidazole has been shown to be carcinogenic in some rodents, a decision should be made whether to discontinue nursing or topical or intravaginal metronidazole, taking into account the importance of the drug to the woman.
Since it is not known if ivermectin is distributed into milk following topical administration, the 0.5% lotion should be used with whether to discontinue nursing or the drug, taking into account the caution in nursing women. importance of the drug to the woman.
Following oral administration, metronidazole is distributed into milk in concentrations similar to those attained in plasma. Although plasma concentrations of metronidazole following topical or intravaginal administration are lower than those achieved after oral administration of the drug, it is not known whether metronidazole distributes into milk following topical or intravaginal application. Therefore, because oral metronidazole has been shown to be carcinogenic in some rodents, a decision should be made whether to discontinue nursing or topical or intravaginal metronidazole, taking into account the importance of the drug to the woman.
Clinical studies of ivermectin 0.5% lotion did not include sufficient In clinical trials, no overall differences in safety and efficacy were numbers of patients 65 years of age or older to determine whether geriatric observed in patients 65 years of age or older compared with younger patients respond differently than younger adults; other clinical experience patients. However, the manufacturer states that clinical studies of brimonidine gel did not include sufficient numbers of patients 65 years of has not identified differences in response between geriatric and younger age and older to determine whether geriatric patients respond differently patients. than younger patients.
The following prioritized warning is available for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ROVIS (brimonidine tartrate/ivermectin/metronidazole/niacinamide)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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