RESTIMO (ivermectin/metronidazole)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Blood dyscrasias

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

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.

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.

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.