9. Pregnancy and breastfeeding
It's generally safe to use Monizole while you're pregnant or breastfeeding.
If you're breastfeeding, take care when applying Monizole cream or gel. Make sure you do not accidentally get it on your breasts. If this happens, wash off any cream or gel from your breasts before feeding your baby.
For more information about how Monizole can affect you and your baby during pregnancy, visit the Best Use of Medicines in Pregnancy (BUMPS) website.
The following reactions have been reported during treatment with Monizole:
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Monizole is used to treat a wide variety of infections caused by certain types of germ (anaerobic bacteria) and types of micro-organisms called protozoa. These types of organisms often cause infections in areas of the body such as the gums, pelvic cavity and tummy (stomach or intestines) because they do not need oxygen to grow and multiply.
Case 1. Elevations in serum aminotransferase levels during intravenous Monizole therapy.
A 58 year old man underwent prostate biopsy and cystoscopy and 32 hours later developed fever and was admitted for treatment of suspected urosepsis. After a combination of cephalosporin and tobramycin failed to affect his course, intravenous Monizole (500 mg every 6 hours) was added. He had rapid clinical improvement, but then complained of abdominal pain, nausea, headache, and a metallic taste. Monizole was stopped after 5 days, and he was switched on oral cefaclor. At the same time, serum ALT and alkaline phosphatase levels were found to be elevated. Physical exam showed slight hepatomegaly without jaundice. Hepatitis B serology was negative. Over the following week, the patient recovered symptomatically and was discharged home. All laboratory tests were normal 4 weeks after stopping Monizole.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Tumors affecting the liver, lungs, mammary, and lymphatic tissues have been detected in several studies of Monizole in rats and mice, but not hamsters.
Pulmonary tumors have been observed in all six reported studies in the mouse, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). Malignant liver tumors were increased in male mice treated at approximately 1500 mg/m² (similar to the maximum recommended daily dose, based on body surface area comparisons). Malignant lymphomas and pulmonary neoplasms were also increased with lifetime feeding of the drug to mice. Mammary and hepatic tumors were increased among female rats administered oral Monizole compared to concurrent controls. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.
Monizole has shown mutagenic activity in in vitro assay systems including the Ames test. Studies in mammals in vivo have failed to demonstrate a potential for genetic damage.
Monizole failed to produce any adverse effects on fertility or testicular function in male rats at doses up at 400 mg/kg/day (similar to the maximum recommended clinical dose, based on body surface area comparisons) for 28 days. However, rats treated at the same dose for 6 weeks or longer were infertile and showed severe degeneration of the seminiferous epithelium in the testes as well as marked decreases in testicular spermatid counts and epididymal sperm counts. Fertility was restored in most rats after an eight week, drug-free recovery period.