DEKTAGEL

Miconazole is a broad-spectrum azole antifungal with some activity against Gram-positive bacteria as well.

It is widely used to treat mucosal yeast infections, including both oral and vaginal infections; although intravenous miconazole is no longer available, a wide variety of suppositories, creams, gels, and tablet-based products are available. 13, 14, 15, 16, 17 Miconazole is thought to act primarily through the inhibition of fungal CYP450 14α-lanosterol demethylase activity. 3, 4 Miconazole was first synthesized in and first granted FDA approval on January 8, 1974, for sale by INSIGHT Pharmaceuticals as a topical cream. 12, 13 It is currently available as a variety of prescription and over the counter products.

Despite having been in clinical use for an extended period, resistance to miconazole among susceptible organisms is relatively low.

Miconazole is indicated for the local treatment of oropharyngeal candidiasis in adult patients and for the adjunctive treatment of diaper dermatitis complicated by candidiasis in immunocompetent patients aged four weeks and older. 13, 14 Miconazole is available as both a suppository and cream for the treatment of vaginal yeast infections and the relief of associated vulvar itching and irritation.

Lastly, miconazole cream is effective in treating athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm infections (tinea corporis), 16 pityriasis (formerly tinea) versicolor, 2 and cutaneous candidiasis.

Miconazole is an azole antifungal that functions primarily through inhibition of a specific demethylase within the CYP450 complex.

As miconazole is typically applied topically and is minimally absorbed into the systemic circulation following application, the majority of patient reactions are limited to hypersensitivity and cases of anaphylaxis.

Patients using intravaginal miconazole products are advised not to rely on contraceptives to prevent pregnancy and sexually transmitted infections, as well as not to use tampons concurrently.

Miconazole given to healthy volunteers as a single 50 mg oral tablet produced a mean C max of 15.1 ± 16.2 mcg/mL, a mean AUC 0-24 of 55.2 ± 35.1 mcg*h/mL, and a median T max of 7 hours (range 2.0-24.1).

In these patients measurable plasma concentrations ranged from 0.5-0.83 mcg/mL.

Topical miconazole is absorbed poorly into the systemic circulation.

In pediatric patients aged 1-21 months given multiple topical applications of miconazole ointment for seven days, the plasma miconazole concentration was less than 0.5 ng/mL in 88% of the patients, with the remaining patients having a concentration of 0.57 and 0.58 ng/mL, respectively.

Similarly, patients. administered with a vaginal 1200 mg ovule had a mean C max of 10.71 ng/mL, mean T max of 18.4 hours, and mean AUC 0-96 of 477.3 ng*h/mL.

A 1200 mg miconazole vaginal suppository resulted in a calculated apparent volume of distribution of 95 546 L while a 100 mg vaginal cream yielded an apparent volume of distribution of 10 911 L.

Miconazole is metabolized in the liver and does not give rise to any active metabolites.

Miconazole is excreted through both urine and feces; less than 1% of unchanged miconazole is recovered in urine.

Miconazole has a terminal half-life of 24 hours.

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Miconazole overdose has not been reported.

Patients experiencing an overdose are at an increased risk of severe adverse effects such as headache, skin irritation, diarrhea, nausea, vomiting, abdominal pain, and dysgeusia.

Symptomatic and supportive measures are recommended.

Miconazole has an oral

LD of 500 mg/kg in rats.

For external use only

Do not use on children under 2 years of age unless directed by a doctor on scalp or nails When using this product avoid contact with the eyes Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks when used for the treatment of athlete's foot or ringworm there is no improvement within 2 weeks when used for the treatment of jock itch Keep out of reach of children If swallowed, get medical help or contact a Poison Control center right away.

Directions Clean the affected area and dry thoroughly Apply a thin layer of powder over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot, pay special attention between spaces in toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for 2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails.

Information protect from freezing.

Avoid excessive heat. do not use if package is damaged keep dry.