MICONAZ 400 mg

Miconazole Nitrate 400 mg

Vaginal Ovules – 3 Ovules

Medical Description

MICONAZ 400 mg Vaginal Ovules contain miconazole nitrate 400 mg, a topical imidazole antifungal formulated for intravaginal treatment of vulvovaginal candidiasis (vaginal yeast infection).

Miconazole acts locally against susceptible Candida species and helps control fungal overgrowth responsible for symptoms such as vaginal itching, vulvar irritation, redness, soreness and abnormal vaginal discharge.

The product provides a convenient 3-day intravaginal treatment course, with one 400 mg ovule administered once daily, preferably at bedtime.

Active Ingredient

Miconazole nitrate 400 mg per vaginal ovule

Pack size: 3 vaginal ovules

Pharmacological class: Imidazole antifungal

Indications

MICONAZ 400 mg Vaginal Ovules are indicated for the treatment of vulvovaginal candidiasis, commonly known as vaginal yeast infection, caused by susceptible Candida species.

Typical symptoms of vulvovaginal candidiasis may include:

• Vaginal itching
• Vulvar itching and irritation
• Vulvar redness and soreness
• Thick, white vaginal discharge
• Vaginal discomfort or burning
• Discomfort during sexual intercourse
• Burning or discomfort during urination when the vulvar tissues are affected

Vaginal candidiasis is commonly caused by Candida albicans, although other Candida species may also be responsible.

Mechanism of Action

Miconazole is an imidazole antifungal agent that inhibits fungal ergosterol synthesis.

Ergosterol is an essential component of the fungal cell membrane. By interfering with its formation, miconazole alters the structure and permeability of the fungal cell membrane, impairing fungal growth and viability.

When administered vaginally, miconazole provides antifungal activity directly at the site of infection.

Clinical Benefits

MICONAZ 400 mg Vaginal Ovules may:

• Treat susceptible vaginal Candida infections.
• Inhibit the growth of pathogenic yeast in the vagina.
• Help relieve vaginal and vulvar itching and irritation associated with candidiasis.
• Help reduce redness, soreness and burning associated with the infection.
• Provide a convenient 3-day intravaginal treatment course.
• Deliver the antifungal agent directly to the affected vaginal tissues.

Dosage & Administration

Adults and adolescents for whom this formulation is appropriate:

One 400 mg vaginal ovule intravaginally once daily for 3 consecutive days, preferably at bedtime, or as directed by a healthcare professional.

Directions for Use

1. Wash hands before and after administration.
2. Remove the ovule from its packaging immediately before use.
3. Gently insert one ovule deep into the vagina, preferably while lying down at bedtime.
4. Repeat once daily for 3 consecutive days.
5. A sanitary pad may be used during treatment because some leakage of the melted ovule may occur.
6. Complete the recommended course even if symptoms begin to improve.

WHO recommendations include miconazole 400 mg intravaginally once daily for 7 days as one regimen for vulvovaginal candidiasis, while established vaginal miconazole products also use shorter-dose regimens depending on the formulation and strength. Therefore, the exact duration should follow the specific MICONAZ 400 mg product labeling, which for a 3-ovule pack is typically one ovule daily for 3 days.

Important Warnings & Precautions

• For vaginal use only.
• Do not swallow the ovule.
• Do not use if you have never previously been diagnosed with a vaginal yeast infection unless advised by a healthcare professional.
• Seek medical advice before use if symptoms occur for the first time.
• Medical evaluation is particularly important in the presence of fever, chills, lower abdominal/pelvic pain, back or shoulder pain, nausea, vomiting, or foul-smelling vaginal discharge, as these symptoms may indicate a condition other than uncomplicated candidiasis.
• Consult a healthcare professional if infections recur frequently, such as approximately once a month or three or more episodes within six months.
• If symptoms do not improve within the expected period or worsen during treatment, seek medical advice.
• Avoid vaginal douching and other potentially irritating vaginal products during treatment.

Sexual Intercourse & Contraception

Avoid vaginal intercourse during treatment if it causes discomfort or irritation.

Some vaginal miconazole formulations contain excipients that may damage latex condoms or diaphragms and reduce their effectiveness. Patients should check the specific product leaflet and consider alternative contraception during treatment and for the period specified by the product manufacturer.

Possible Side Effects

Miconazole vaginal preparations are generally well tolerated. Possible adverse effects include:

• Vaginal burning or irritation
• Increased itching or discomfort
• Local redness
• Vaginal or vulvar irritation
• Abdominal or pelvic discomfort
• Hypersensitivity or allergic reaction, rarely

If severe irritation, swelling, rash or other signs of hypersensitivity occur, discontinue use and seek medical attention.

Drug Interactions

Systemic absorption from vaginal miconazole is generally limited; however, clinically relevant interactions can occur with certain medicines.

Patients taking warfarin or other anticoagulants should inform their healthcare professional before using vaginal miconazole, particularly if treatment is prolonged or repeated, because azole antifungals may increase anticoagulant effects in some circumstances.

Patients should also inform their healthcare professional about all prescription medicines, OTC medicines, vitamins and supplements they are taking.

Pregnancy & Breastfeeding

Pregnancy should be discussed with a healthcare professional before treatment.

For pregnant patients with vulvovaginal candidiasis, treatment recommendations may differ from those for non-pregnant patients. WHO specifically recommends selected topical vaginal antifungal regimens during pregnancy and does not recommend oral fluconazole for pregnant women in its current guidance.

Breastfeeding patients should consult a healthcare professional before use, particularly if symptoms are recurrent or diagnosis is uncertain.

When to Seek Medical Advice

Medical evaluation is recommended when:

• This is the first episode of suspected vaginal yeast infection.
• Symptoms are severe or unusual.
• There is fever, pelvic/lower abdominal pain or foul-smelling discharge.
• Symptoms worsen during treatment.
• Symptoms fail to improve after treatment.
• Infections occur repeatedly.
• The patient is pregnant or may be pregnant.
• There is concern about an STI or another vaginal infection.

Not every cause of vaginal discharge or itching is candidiasis; bacterial vaginosis, trichomoniasis and other conditions may require different treatment.

Storage

• Store according to the manufacturer's recommended temperature.
• Keep in the original packaging until use.
• Protect from excessive heat and moisture.
• Keep out of reach of children.
• Do not use after the expiry date.

Key Product Advantages

MICONAZ 400 mg Vaginal Ovules provide:

• 400 mg miconazole nitrate per ovule
• Targeted intravaginal antifungal therapy
• Treatment directed against susceptible Candida species
• Convenient 3-ovule treatment pack
• Once-daily administration
• Local delivery of the antifungal agent directly to the site of infection

Patient Disclaimer

This information is provided for educational purposes only and does not replace the advice of a qualified healthcare professional. MICONAZ 400 mg Vaginal Ovules should be used according to the approved product information and/or as directed by a physician. This product is intended for the treatment of susceptible vaginal fungal infections and is not intended to diagnose, treat, cure, or prevent other causes of vaginal symptoms. Consult a healthcare professional if symptoms are severe, recurrent, unusual, do not improve, or if pregnancy is suspected.

References