1236-cs Antifungal Powder (talc Free)

Standard dosing for Miconazole depends entirely on the formulation and the location of the infection. According to clinical guidelines:

• Vulvovaginal Candidiasis:
• 7-day treatment: 100 mg vaginal suppository or one applicator of 2% cream inserted vaginally once daily at bedtime for 7 days.
• 3-day treatment: 200 mg vaginal suppository once daily at bedtime for 3 days.
• 1-day treatment: 1200 mg vaginal suppository (ovule) as a single dose at bedtime.
• Tinea Pedis (Athlete's Foot): Apply 2% cream, powder, or spray to the affected area and surrounding skin twice daily (morning and night) for 4 weeks.
• Tinea Cruris or Tinea Corporis: Apply 2% cream or powder twice daily for 2 weeks.
• Oropharyngeal Candidiasis (Buccal): One 50 mg buccal tablet applied to the upper gum (canine fossa) once daily for 14 days.

Miconazole is generally considered safe for pediatric use when used topically for skin infections.

• Children >2 years: The dosage is typically the same as the adult dosage for topical skin infections (twice daily for 2-4 weeks).
• Infants/Children <2 years: Safety and efficacy have not been established for all formulations. Consult a pediatrician before use.
• Vaginal Use: Not recommended for girls under 12 years of age unless directed by a physician.

Renal Impairment

Because systemic absorption of topical and vaginal Miconazole is extremely low, dosage adjustments are generally not required for patients with kidney disease. However, patients with end-stage renal disease should be monitored if using systemic (buccal) forms.

Hepatic Impairment

Miconazole is metabolized by the liver. While topical use is unlikely to cause issues, healthcare providers may exercise caution when prescribing the buccal tablet (Oravig) to patients with severe hepatic impairment (liver failure).

Elderly Patients

No specific dosage adjustments are required for geriatric patients. Clinical trials have shown that the efficacy and safety profile in the elderly is similar to that in younger adults, though skin fragility in the elderly should be considered when applying topical creams.

Proper administration is key to the success of antifungal therapy:

• Topical Use: Wash and dry the affected area thoroughly before application. Apply a thin layer and rub in gently. If treating athlete's foot, pay special attention to the spaces between the toes and wear well-fitting, ventilated shoes.
• Vaginal Use: Insert the suppository or cream high into the vagina using the provided applicator, preferably at bedtime. Use a panty liner to protect clothing from leakage. Continue the full course even if symptoms disappear or if your menstrual period begins.
• Buccal Use: Do not swallow, chew, or crush the buccal tablet. Apply it with dry fingers to the upper gum. It will slowly dissolve throughout the day.
• Storage: Store all forms at room temperature (59°F to 86°F or 15°C to 30°C). Do not freeze.

If you miss a dose, apply or insert it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not double the amount to 'catch up,' as this may increase the risk of local irritation.

Systemic overdose of Miconazole is highly unlikely due to its poor absorption. If accidental ingestion occurs (especially in children), symptoms may include nausea, vomiting, or abdominal pain. In the event of a suspected oral overdose, contact your local poison control center or seek emergency medical attention immediately.

> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or stop treatment early without medical guidance, as this can lead to a recurrence of the infection.

Most patients tolerate Miconazole well, particularly in topical forms. However, local reactions at the site of application are common. These may include:

• Burning or Stinging: A mild, transient sensation immediately after application.
• Pruritus (Itching): Temporary worsening of itching before the medication begins to work.
• Irritation: Redness or slight swelling of the treated skin or vaginal tissue.
• Vaginal Discharge: Increased discharge is common when using vaginal suppositories or creams as the medication melts and is expelled.

• Contact Dermatitis: A localized skin reaction characterized by a rash, blisters, or dry, flaky skin.
• Abdominal Cramping: Occasionally reported with vaginal use.
• Headache: Reported by some patients using the high-dose 1-day vaginal treatment or the buccal tablet.
• Dysgeusia (Taste Perversion): Specific to the buccal tablet (Oravig), patients may notice a metallic or bitter taste in the mouth.

• Urticaria (Hives): A systemic allergic reaction manifesting as raised, itchy welts on various parts of the body.
• Pelvic Pain: Sharp or dull pain in the lower pelvic region following vaginal administration.
• Nausea: Very rare with topical use, but possible with buccal administration.

> Warning: Stop taking Miconazole and call your doctor immediately if you experience any of the following serious symptoms:

• Anaphylaxis: Signs include difficulty breathing, swelling of the face, lips, tongue, or throat, and severe dizziness. This is a medical emergency.
• Severe Skin Reactions: Extensive blistering, peeling, or a rash that spreads rapidly (e.g., Stevens-Johnson Syndrome, though extremely rare for this class).
• Severe Vaginal Burning: If the burning sensation is intense and does not subside within minutes, it may indicate a hypersensitivity reaction.
• Unusual Bleeding: Any unexpected vaginal bleeding not related to your menstrual cycle while using Miconazole.

Miconazole is intended for short-term use (usually 1 to 4 weeks). Prolonged or chronic use without medical supervision can lead to:

• Skin Atrophy: Thinning of the skin, especially if the Miconazole is used in a combination product containing a corticosteroid.
• Fungal Resistance: While less common than with bacterial antibiotics, overuse of antifungals can potentially lead to the selection of resistant fungal strains.
• Secondary Infections: Disruption of the natural flora (especially in the vagina) may occasionally lead to secondary bacterial infections.

No FDA black box warnings for Miconazole. Miconazole has a long-established safety profile when used as directed. It does not carry the severe cardiovascular or hepatic warnings associated with some systemic azole antifungals like ketoconazole.

Report any unusual symptoms to your healthcare provider. If you experience side effects, you may also report them to the FDA at 1-800-FDA-1088.

Before using Miconazole, it is essential to ensure that the condition being treated is actually a fungal infection. Miconazole will not treat viral infections (like herpes) or bacterial infections (like bacterial vaginosis). Using Miconazole for the wrong type of infection can delay proper treatment and may worsen the condition. If this is your first time experiencing vaginal symptoms, or if your skin rash does not improve within the first few days of treatment, consult your healthcare provider.

No FDA black box warnings for Miconazole.

• Allergic Reactions / Anaphylaxis Risk: Patients with a known hypersensitivity to other 'azole' antifungals (such as clotrimazole, econazole, or ketoconazole) may experience cross-sensitivity to Miconazole. If you have ever had an allergic reaction to an antifungal, discuss this with your doctor before use.
• Latex and Oil-Based Products: Many vaginal Miconazole creams and suppositories contain mineral oil or petrolatum. These substances can weaken the latex in condoms and diaphragms, significantly increasing the risk of pregnancy or the transmission of sexually transmitted infections (STIs). Do not rely on these forms of birth control for at least 3 days after finishing treatment.
• Vulvovaginal Precautions: Do not use tampons, douches, spermicides, or other vaginal products while using Miconazole. These can interfere with the medication's effectiveness or irritate the vaginal lining.
• Eye Contact: Miconazole is for external or vaginal use only. Avoid contact with the eyes. If the medication gets into your eyes, rinse thoroughly with cool water.

For standard topical or vaginal use, routine laboratory monitoring is generally not required. However, for patients using the buccal tablet (Oravig) or those with underlying conditions:

• Liver Function Tests (LFTs): May be monitored in patients with pre-existing liver disease, although systemic absorption is low.
• Prothrombin Time (INR): Crucial for patients taking Warfarin (Coumadin), as Miconazole can significantly increase the risk of bleeding even when used topically or vaginally.

Miconazole does not typically affect the central nervous system. It is considered safe to drive or operate heavy machinery while using this medication, as it does not cause drowsiness or impaired coordination.

While there is no direct contraindication between alcohol and topical Miconazole, it is generally advised to avoid excessive alcohol consumption if you are experiencing a systemic infection or oral thrush, as alcohol can irritate the oral mucosa and potentially weaken the immune response.

It is vital to complete the full course of treatment as prescribed by your doctor or as indicated on the product packaging. Stopping the medication too early, even if symptoms improve, may allow the fungus to continue growing, leading to a relapse of the infection.

> Important: Discuss all your medical conditions, including any history of liver disease or immune system disorders, with your healthcare provider before starting Miconazole.

While Miconazole is primarily used topically, it is a potent inhibitor of certain liver enzymes (CYP2C9 and CYP3A4) if any significant amount enters the bloodstream.

• Warfarin (Coumadin): This is the most critical interaction. Even vaginal or topical Miconazole can inhibit the metabolism of Warfarin, leading to dangerously high levels of the blood thinner in the body. This significantly increases the risk of severe, potentially fatal bleeding. Patients on Warfarin should only use Miconazole under strict medical supervision with frequent INR monitoring.

• Oral Hypoglycemics (Sulfonylureas): Miconazole may inhibit the metabolism of drugs like glipizide or glyburide, potentially leading to severe hypoglycemia (low blood sugar).
• Phenytoin (Dilantin): Miconazole can increase the serum concentration of phenytoin, leading to toxicity (symptoms include ataxia, nystagmus, and confusion).
• Statins (Simvastatin, Lovastatin): Because these are metabolized by CYP3A4, Miconazole may increase the risk of muscle toxicity (rhabdomyolysis) if systemic absorption is significant.

• Calcium Channel Blockers: Drugs like amlodipine or nifedipine may have increased effects if Miconazole is present systemically.
• Immunosuppressants (Cyclosporine, Sirolimus): Miconazole can increase the levels of these drugs, requiring closer monitoring of drug concentrations to avoid kidney toxicity.

• Grapefruit Juice: While primarily relevant for oral medications, grapefruit juice also inhibits CYP3A4. Combining it with systemic (buccal) Miconazole could theoretically increase the drug's levels, though the clinical significance is low.
• Dairy: There are no known significant interactions between Miconazole and dairy products.

• St. John’s Wort: This herbal supplement is a potent inducer of CYP3A4 and may reduce the efficacy of systemically absorbed Miconazole.
• Garlic/Ginkgo: These supplements have mild anti-platelet effects and should be used cautiously if Miconazole is being used alongside Warfarin.

Miconazole use is not known to significantly interfere with common laboratory tests, such as blood glucose, electrolytes, or complete blood counts (CBC), unless a systemic hypersensitivity reaction occurs.

Mechanism of Interaction: Most Miconazole interactions occur via the inhibition of the Cytochrome P450 enzyme system. By 'clogging' these enzymes, Miconazole prevents the breakdown of other drugs, leading to their accumulation and subsequent toxicity.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those applied to the skin or used vaginally.

Conditions where Miconazole must NEVER be used include:

• Known Hypersensitivity: If you have had a documented severe allergic reaction (anaphylaxis, angioedema, or severe rash) to Miconazole Nitrate or any of the inactive ingredients in the formulation (such as benzoic acid or mineral oil).
• Hypersensitivity to Imidazoles: Due to the risk of cross-reactivity, Miconazole is contraindicated in patients with a history of severe allergy to other imidazole-class antifungals (e.g., ketoconazole, clotrimazole).

Conditions requiring a careful risk-benefit analysis by a healthcare provider:

• Porphyria: Some azole antifungals are considered 'porphyrinogenic' and should be used with caution in patients with this rare genetic blood disorder.
• Active Liver Disease: While topical absorption is low, patients with acute hepatitis or cirrhosis should be monitored if using the buccal formulation (Oravig).
• First Trimester of Pregnancy: While generally considered safe, some clinicians prefer to avoid all non-essential medications during the first 12 weeks of gestation unless the benefits clearly outweigh the risks.

Patients should be aware that Miconazole belongs to a chemical family called the imidazoles. If you have experienced contact dermatitis or hives when using products like Lotrimin (clotrimazole) or Nizoral (ketoconazole), there is a high probability of a similar reaction to Miconazole. Always perform a small patch test if you have a history of sensitive skin or multiple drug allergies.

> Important: Your healthcare provider will evaluate your complete medical history, including any previous reactions to antifungal creams or suppositories, before prescribing Miconazole.

FDA Pregnancy Category C (Legacy system): Animal studies have shown some embryotoxic effects when Miconazole was administered orally at high doses. However, clinical studies in pregnant women using vaginal or topical Miconazole have not demonstrated an increased risk of birth defects or adverse pregnancy outcomes.

• Vaginal Use: It is generally considered the treatment of choice for yeast infections during pregnancy, as these are common due to hormonal changes. However, healthcare providers often recommend the 7-day regimen over the 1-day high-dose regimen for pregnant patients to minimize any potential systemic exposure.
• Trimester-specific: Use with caution in the first trimester. Always consult your OB/GYN before use.

It is unknown whether Miconazole is excreted in human milk. However, because systemic absorption from topical or vaginal application is so low, it is considered likely compatible with breastfeeding.

• Precaution: If applying Miconazole cream to the chest or breast area for a fungal infection, ensure the medication is thoroughly washed off before nursing to prevent the infant from ingesting the drug.

• Approved Use: Miconazole is approved for the treatment of tinea infections in children as young as 2 years old.
• Diaper Rash: Miconazole is frequently used off-label or in specific prescription combinations for 'diaper dermatitis' complicated by Candida (yeast). This should only be done under the direction of a pediatrician.
• Safety: Children may be more susceptible to systemic absorption through thin or broken skin; therefore, use the minimum amount necessary.

Clinical data indicates no significant difference in safety or efficacy between elderly patients and younger adults. However, geriatric patients are more likely to be taking Warfarin, making the drug-drug interaction warning particularly critical for this population. Additionally, elderly patients with thinning skin (atrophy) should be monitored for increased local irritation.

No dosage adjustments are necessary for patients with impaired renal function when using topical or vaginal Miconazole. The drug is not significantly cleared by the kidneys in its topical form.

For topical and vaginal use, no adjustments are required. For the buccal tablet (Oravig), use with caution in patients with Child-Pugh Class C (severe) hepatic impairment, as the liver is the primary site of metabolism for the small amount of drug that is absorbed systemically.

> Important: Special populations require individualized medical assessment to ensure the safest and most effective treatment plan.

Miconazole is an imidazole antifungal that disrupts the biosynthesis of ergosterol, a vital component of the fungal cell membrane. It specifically inhibits the enzyme lanosterol 14-alpha-demethylase. By blocking this enzyme, Miconazole prevents the conversion of lanosterol to ergosterol. This leads to the accumulation of 14-alpha-methylsterols, which are toxic to the fungus and disrupt the packing of phospholipids in the membrane. This disruption increases membrane permeability, leading to the leakage of cellular contents and ultimately fungal cell death.

• Spectrum of Activity: Miconazole is active against Candida species, Cryptococcus neoformans, Aspergillus species, and dermatophytes. It also possesses some antibacterial activity against certain Gram-positive bacteria (e.g., Staphylococcus aureus).
• Onset of Action: Relief of itching and burning often begins within 1-2 days of starting treatment, though the infection itself may take longer to clear.
• Duration of Effect: Because it binds to the keratin in the skin and vaginal mucosa, Miconazole can provide antifungal activity for several days after the final dose.

| Parameter | Value |

|---|---|

| Bioavailability | <1% (Topical), ~1-2% (Vaginal) |

| Protein Binding | 91% - 93% |

| Half-life | 24 hours (Systemic) |

| Tmax | 2 hours (Buccal) |

| Metabolism | Hepatic (CYP3A4) |

| Excretion | Fecal (~50%), Renal (~10-20%) |

• Molecular Formula: C18H14Cl4N2O·HNO3 (as Miconazole Nitrate)
• Molecular Weight: 479.14 g/mol
• Solubility: Very slightly soluble in water; soluble in organic solvents like ethanol and methanol.
• Structure: It consists of an imidazole ring linked to a chlorinated benzene ring system, which is characteristic of the azole class of antifungals.

Miconazole is classified as an Imidazole Antifungal. It is related to other medications such as clotrimazole, ketoconazole, and oxiconazole. It is distinct from the 'triazole' class (like fluconazole), which generally has better systemic absorption and a slightly different metabolic profile.