Miconazole Nitrate

Generic Details

Generic Name

Miconazole Nitrate

Other Names

  • Monistat
  • Lotrimin

Drug Class

  • Antifungal

Chemical Formula

C18H14Cl4N2O.HNO3

Molecular Weight

479.14 g/mol

Mechanism of Action

  • Miconazole nitrate inhibits the ergosterol synthesis in fungal cell membranes, leading to increased cellular permeability, and ultimately cell death.

Indications

  • Vaginal yeast infections (vulvovaginal candidiasis)
  • Tinea corporis (ringworm)
  • Tinea pedis (athlete's foot)
  • Tinea cruris (jock itch)
  • Tinea versicolor (superficial fungal infection of skin)

Common Dosage Forms

  • Vaginal cream
  • Topical cream
  • Topical powder
  • Topical spray

Typical Dosage

  • Vaginal cream: 1 applicatorful (approximately 5g) intravaginally once daily at bedtime for 7 days

Pediatric Dosage

  • Dosage and administration should be determined by a healthcare provider for pediatric patients.

Geriatric Dosage

  • Dosage and administration should be determined by a healthcare provider for geriatric patients.

Side Effects

  • Local skin irritation
  • Burning sensation
  • Itching
  • Redness
  • Hypersensitivity reactions

Contraindications

  • Hypersensitivity to miconazole or any components of the formulation

Pregnancy Category

  • Category C - Animal reproduction studies have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation Safety

  • Caution advised as it is unknown whether miconazole is excreted in human milk.

Drug Interactions

  • Avoid concomitant use with warfarin or other coumarin anticoagulants due to the potential for increased bleeding risk

Overdose Symptoms

  • Oral ingestion of miconazole may result in symptoms such as nausea, vomiting, confusion, and hallucinations.

Antidote for Overdose

  • There is no specific antidote for miconazole overdose. Treatment is symptomatic and supportive.

Storage Conditions

  • Store at controlled room temperature between 20°C to 25°C (68°F to 77°F)

Pharmacokinetics

  • Absorption: Absorbed following topical application
  • Distribution: Distributed widely in body tissues
  • Metabolism: Metabolized in the liver
  • Excretion: Excreted in the urine

Precautions

  • Avoid contact with eyes and mucous membranes
  • Not for ophthalmic use
  • For external use only

Warnings

  • For vaginal use only. Do not use tampons while using the vaginal cream.

Others

  • It is important to complete the full course of treatment even if symptoms improve before the end of the treatment period.