Micozole (Miconazole Nitrate)

MICOZOLE

Taro

Miconazole Nitrate

Antifungal

Indications And Clinical Uses: For the local treatment of vulvovaginal candidiasis (moniliasis) and has been shown to be effective in both pregnant and nonpregnant women and in women taking oral contraceptives.

Miconazole, a synthetic imidazole derivative, exhibits a broad spectrum of antimicrobial activity for the use in the systemic treatment and local treatment of vaginal and topical fungal infections. It is particularly active against Candida species, Trichophyton species, Epidermophyton species and Microsporum species as well as possessing some activity against gram-positive bacteria.

The exact mechanism of miconazole’s antifungal activity has not been fully established. The primary site of action appears to be the cell membrane. Studies with C. albicans indicate that at low concentrations, miconazole acts primarily on the yeast cell membrane resulting in selective inhibition of the uptake of precursors of RNA and DNA (purines) and mucopolysaccharides (glutamine). Depending on dose and duration of exposure, yeast cells show progressive degradation of cytoplasmic organelles and the cell wall. Growth, cell permeability and respiration of C. albicans are inhibited at low miconazole concentrations. These observations indicate that miconazole may have multiple actions and/or pathways to inhibit and/or kill microbial cells.

Contra-Indications: Patients known to be hypersensitive to miconazole or to any of its components.

Manufacturers’ Warnings In Clinical States: The vaginal cream is used to treat the symptoms of a vaginal yeast infection, which include itching and burning of the vagina and, sometimes, a white discharge.

A physician should be consulted if there is no improvement in 3 days, if the symptoms have not disappeared within 7 days, or if abdominal pain, fever or foul-smelling vaginal discharge occur before or during treatment with this medication.

Pregnancy, Lactation and Children: This product should not be used except on the advice of a physician in pregnant or nursing women or in children under 12 years of age.

A physician should be consulted if symptoms recur within 2 months.

This product should be discontinued if a skin rash or new irritation occurs.

If you are at increased risk for sexually transmitted diseases, have multiple partners or change partners often, consult a doctor before starting each treatment.

Precautions: If sensitization or a new irritation occurs from intravaginal use, discontinue use. Avoid contact of miconazole vaginal cream with the eyes; if this happens, rinse thoroughly with water.

As unrecognized diabetes has intractable candidiasis as a presenting symptom the appropriate urine/blood studies may be indicated in patients unresponsive to treatment. It may be necessary to repeat microbiological studies to confirm the diagnosis of vulvovaginal candidiasis and to rule out the presence of other pathogens and concomitant disease, in any case not responsive to therapy.

During vaginal therapy, it is advisable to postpone sexual relations until treatment is finished.

Pregnancy: Miconazole cream, like other imidazoles, has low toxicity and is safe for use during pregnancy when administered intravaginally; however it should only be used in pregnant or nursing women on the advice of a physician.

Pregnant patients should be advised to exercise caution is the use of the vaginal applicator.

Follow-up reports on infants born to 167 of 263 pregnant patients (some follow-up reports are not yet available) who participated in North American clinical evaluations of miconazole cream 2% described no complications or adverse effects attributed to the therapeutic agent. Nevertheless, since miconazole is absorbed in small quantities from the human vagina, miconazole vaginal cream should be used in the first trimester only when the physician considers it essential to the welfare of the patient.

Children: No information is available on the relationship of age to the effects of vaginal miconazole application. However, it is advisable not to use the vaginal preparation on children under 12 years of age except on the advice of a physician. Do not use on children under 2 years of age.

Lactation: It is not known whether miconazole is excreted in breast milk. Although no appreciable systemic absorption has been noted, do not use either preparation while nursing except on the advice of a physician.

Adverse Reactions: Miconazole preparations are generally well tolerated. On rare occasions, it has been reported that patients treated with miconazole cream have experienced vulvovaginal burning, mild pruritus, irritation.

Few side effects are associated with miconazole. The most frequently reported side effects during treatment with systemic miconazole are listed in decreasing order of frequency. Phlebitis, pruritus, nausea, fever, chills, rash, vomiting, anemia, drowsiness, diarrhea, hyperlipidemia, anorexia, rushes, thrombocytosis, leukopenia, hyponatremia, hypotension and pain on injection.

Miconazole topical preparations are generally well-tolerated. The most common adverse effects encountered with vaginal miconazole therapy include vulvovaginal burning, itching, irritation, edema and hives.

The safety of miconazole cream has been characterized by its minimal systemic absorption and the fact that no teratogenic effects have been reported.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Overdose of miconazole in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the LD50 values were found to be 578.1, >640, 275.9 and >160 mg/kg, respectively.

Dosage And Administration: Administer one 5 g applicator of cream intravaginally once daily at bedtime for 7 consecutive days. The course of therapy may be repeated if the patient remains symptomatic and other possible pathogens have been ruled out.

Tampons should not be used during treatment since they may absorb some of the medication. Patients should be advised to dry the vaginal area well after bathing and avoid damp clothing (e.g., bathing suits), avoid feminine hygiene sprays and cleanse the vaginal area from front to back after using the toilet.

Availability And Storage: Each g of vaginal cream contains: miconazole nitrate 2%. Nonmedicinal ingredients: apricot kernel oil/PEG-6, benzoic acid, butylated hydroxytoluene, mineral oil, PEG-6-32 stearate/glycol stearate and purified water. Tubes of 45 g sufficient for one 7-day course of therapy. Packages include a consumer information leaflet and 1 reusable applicator. Each tube of vaginal cream has sufficient cream for the treatment period and sufficient cream for extravaginal use, if necessary. Each full applicator supplies miconazole nitrate 100 mg in 5 g cream. Store at 15 to 30°C. Protect from freezing.

MICOZOLE Taro Miconazole Nitrate Antifungal

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