Baxonil (metronidazole/mupirocin)

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 is available for this tab.

No dosing information is available for this tab.

Because metronidazole can be absorbed systemically following intravaginal application, the possibility that drug interactions could occur with this route of administration should be considered. Small amounts of metronidazole may be absorbed systemically following topical application to the skin, but the likelihood of systemic interactions following topical administration of the drug is less than with oral or parenteral administration.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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• Cockayne syndrome

There are no severe contraindications for this drug.

• Blood dyscrasias
• No disease contraindications

There is no enhanced messaging for this drug.

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Clostridioides difficile infection
• Hypertension
• Peripheral neuropathy

More Frequent

• Headache disorder
• Headache disorder
• Nausea
• Pharyngitis
• Skin rash
• Upper respiratory infection

Less Frequent

• Dry skin
• Dry skin
• Erythema
• Pruritus of skin
• Skin inflammation
• Skin irritation
• Skin swelling
• Stinging of skin
• Stinging of skin
• Treatment site sequelae

Rare or Very Rare

• Acute abdominal pain
• Aphthous stomatitis
• Contact dermatitis
• Dizziness
• Eye tearing
• Pain
• Pruritus of skin
• Urticaria

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No enhanced messaging available.

Data are insufficient to determine whether there is a drug-associated risk with use of mupirocin ointment for dermatologic use, mupirocin calcium cream for dermatologic use, or mupirocin calcium ointment for intranasal use in pregnant women. One manufacturer states that mupirocin ointment for dermatologic use should be used during pregnancy only if clearly needed.

Systemic absorption of mupirocin following topical application to intact skin is minimal. Although systemic absorption of mupirocin was reported to be negligible following intranasal application of mupirocin calcium ointment for intranasal use in adults, the dosage regimen used in this study did not mimic the recommended intranasal dosage.

Reproduction studies in rats or rabbits using subcutaneous mupirocin in dosages up to 22 or 43 times, respectively, the usual human topical dosage or up to 65 or 130 times, respectively, the usual human intranasal dosage have not revealed evidence of developmental toxicity.

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.

It is not known whether systemically absorbed mupirocin is distributed into human milk, affects milk production, or affects the breast-fed infant. Because systemic absorption of mupirocin is minimal following topical application to skin and negligible following intranasal administration, the manufacturers state that mupirocin exposure in breast-feeding infants is unlikely.

The benefits of breast-feeding and the importance of mupirocin to the woman should be considered along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

One manufacturer states that mupirocin ointment for dermatologic use should be used with caution in nursing women.

If a breast and/or nipple is being treated with mupirocin ointment for dermatologic use or mupirocin calcium cream for dermatologic use, the treated area should be thoroughly washed prior to breast-feeding to minimize oral exposure to the drug in the breast-feeding infant.

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.

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