Please wait while the formulary information is being retrieved.
Drug overview for ROSITARA (ivermectin/metronidazole/niacinamide):
Generic name: IVERMECTIN/METRONIDAZOLE/NIACINAMIDE
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
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: IVERMECTIN/METRONIDAZOLE/NIACINAMIDE
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
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
No Image Available
The following indications for ROSITARA (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 ROSITARA (ivermectin/metronidazole/niacinamide):
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.
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 ROSITARA (ivermectin/metronidazole/niacinamide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ROSITARA (ivermectin/metronidazole/niacinamide):
Drug contraindication overview.
The manufacturer states there are no contraindications to use of ivermectin 0.5% lotion.
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 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Blood dyscrasias |
| No disease contraindications |
The following adverse reaction information is available for ROSITARA (ivermectin/metronidazole/niacinamide):
Adverse reaction overview.
Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and burning skin sensation were reported in less than 1% of patients 6 months of age or older after a single 10-minute topical application of ivermectin 0.5% lotion.
Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and burning skin sensation were reported in less than 1% of patients 6 months of age or older after a single 10-minute topical application of ivermectin 0.5% lotion.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Dyspnea Hypertension Ocular irritation Peripheral neuropathy Skin rash |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Headache disorder Pharyngitis Upper respiratory infection |
Dry skin Skin irritation Stinging of skin |
| Rare/Very Rare |
|---|
|
Conjunctival hyperemia Contact dermatitis Dandruff Dry skin Eye tearing Ocular redness Pruritus of skin Skin irritation Stinging of skin Treatment site sequelae |
The following precautions are available for ROSITARA (ivermectin/metronidazole/niacinamide):
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 greater skin surface area to body mass ratio and potentially immature skin barrier, systemic absorption may be increased and children younger than 6 months of age may be at increased risk of ivermectin toxicity.
Ivermectin 0.5% lotion should not be used in children younger than 6 months of age. 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
Ivermectin 0.5% lotion should not be used in children younger than 6 months of age. 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 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.
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.
Orally administered ivermectin is distributed into milk in low concentrations. Since it is not known if ivermectin is distributed into milk following topical administration, the 0.5% lotion should be used with caution in nursing women.
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.
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 numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger adults; other clinical experience has not identified differences in response between geriatric and younger patients.
The following prioritized warning is available for ROSITARA (ivermectin/metronidazole/niacinamide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ROSITARA (ivermectin/metronidazole/niacinamide)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
Formulary Reference Tool