AMRIZOLE-N (METRONIDAZOLE 500 MG + NYSTATIN 100,000 IU) – 5 VAGINAL SUPPOSITORIES

Active Ingredients:

• Metronidazole 500 mg
• Nystatin 100,000 IU

Pharmaceutical Form: Vaginal suppositories
Pack Size: 5 vaginal suppositories + applicator
Therapeutic Class: Vaginal antimicrobial and antifungal combination.

Product Overview

Amrizole-N is a combination vaginal medication containing metronidazole, an antibacterial and antiprotozoal agent, and nystatin, an antifungal agent.

This combination is intended for the local treatment of vaginal infections involving susceptible anaerobic bacteria, protozoa, and Candida species.

• Metronidazole: Acts against susceptible anaerobic bacteria and protozoa by interfering with their DNA synthesis.
• Nystatin: An antifungal agent that binds to ergosterol in the fungal cell membrane, disrupting membrane integrity and causing leakage of essential cellular components.

The combination provides complementary antimicrobial and antifungal activity against susceptible vaginal pathogens.

Indications and Uses

Amrizole-N may be prescribed for the local treatment of vaginal infections involving susceptible microorganisms, including:

• Mixed vaginal infections: When bacterial or protozoal infections coexist with fungal infections.
• Bacterial vaginosis: Associated with an imbalance of vaginal bacteria and overgrowth of anaerobic microorganisms.
• Vaginal candidiasis: Caused by susceptible Candida species, including Candida albicans.
• Trichomoniasis: Vaginal infection caused by Trichomonas vaginalis, when local treatment is considered appropriate as part of a clinician-directed treatment plan.

Important: Vaginal metronidazole and nystatin should not be assumed to provide adequate treatment for every cause of vaginitis. In particular, vaginal metronidazole alone is not an established substitute for recommended oral treatment of trichomoniasis.

Administration

• For vaginal use only. Do not swallow.
• Insert the suppository gently and deeply into the vagina, preferably at bedtime.
• Use the supplied applicator if instructed in the product leaflet.
• Follow the prescribed frequency and treatment duration.
• Complete the full prescribed course, even if symptoms improve earlier.

Possible Side Effects

Possible side effects include:

• Vaginal burning, itching, or irritation.
• Local redness or discomfort.
• Increased vaginal discharge.
• Mild abdominal discomfort.
• Nausea or an unpleasant or metallic taste.
• Headache.

Rare but potentially serious reactions include:

• Allergic reactions, including rash and swelling.
• Severe skin reactions.
• Neurological symptoms such as numbness or tingling, particularly with significant systemic metronidazole exposure.

Discontinue use and seek medical advice if severe irritation or signs of an allergic reaction occur.

Contraindications and Precautions

Contraindications:

Known hypersensitivity to metronidazole, nystatin, other nitroimidazole derivatives, or any product component.

Precautions:

• Consult a healthcare professional before use during pregnancy or breastfeeding.
• Inform your doctor if you have liver disease, neurological disorders, or a history of blood disorders.
• Avoid using other vaginal preparations simultaneously unless recommended by your doctor.
• Persistent or recurrent vaginal symptoms require proper medical evaluation to identify the underlying cause.
• Patients with suspected sexually transmitted infections should undergo appropriate testing and treatment.

Important Drug and Lifestyle Considerations

• Inform your healthcare professional about all medications being used, especially if oral metronidazole or other antimicrobial treatments are prescribed simultaneously.
• Avoid vaginal douching during treatment, as it may disturb the normal vaginal microbiota.
• Follow medical advice regarding sexual activity during treatment.
• If trichomoniasis is diagnosed, oral treatment and evaluation and treatment of sexual partners are essential; vaginal suppositories alone are not adequate treatment.

Storage Conditions

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

Patient Counseling Points

• Amrizole-N is intended exclusively for vaginal administration.
• Maintain good intimate hygiene without excessive washing or vaginal douching.
• Complete the prescribed treatment course.
• Do not use the medication to treat vaginal symptoms without identifying their cause.
• Consult a gynecologist if symptoms persist, worsen, or recur after treatment.

Medical References

1. Singapore National Drug Formulary: Metronidazole 500 mg + Nystatin 100,000 IU vaginal ovule product information.
2. CDC: Bacterial Vaginosis – Sexually Transmitted Infections Treatment Guidelines.
3. CDC: Trichomoniasis – STI Treatment Guidelines.
4. WHO: Recommendations for the treatment of vulvovaginal candidiasis.
5. IDSA: Clinical Practice Guideline for the Management of Candidiasis.

Patient Disclaimer: This information is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before using this medication, particularly during pregnancy or breastfeeding. The appropriate dosage and duration depend on the type of infection and individual patient circumstances.