Ametrol-VT

Approved Indications:

• Bacterial Vaginosis with Coexistent Vulvovaginal Candidiasis: Effective when simultaneous infections occur.
• Mixed Vaginal Infections (VVC + BV): Ideal for symptomatic relief where both anaerobic bacteria and Candida species are present.

Off‑Label / Clinically Accepted Uses:

• Complex or recurrent mixed vaginal infections where both organisms are resistant.
• Post-antibiotic vaginitis involving both bacteria and fungi.
• Symptomatic relief of vulvovaginal discharge, irritation, and odour due to mixed infections.

Form: Intravaginal cream or gel

Adults:

• Single-place applicator-full intravaginally at bedtime for 7 consecutive nights (approx. 5g each dose).

Pediatrics (postmenarcheal only):

• Same as adult regimen, under specialist guidance.

Elderly:

• Same dose; no adjustments required.

Renal/Hepatic Impairment:

• No systemic absorption; no dose adjustment indicated.

Administration Notes:

• Insert deep into the vagina using applicator.
• Wash hands thoroughly before and after application.
• Continue therapy even during menstruation unless advised otherwise.

• Metronidazole is reduced by anaerobic bacteria into reactive metabolites that cause DNA strand breakage and loss of helical structure, leading to bacterial death.
• Miconazole nitrate binds to ergosterol in fungal cell membranes, disrupting membrane integrity and increasing permeability, ultimately leading to fungal cell lysis.
• Combined effect ensures simultaneous eradication of anaerobic bacteria (BV) and Candida species (VVC), while preserving healthy vaginal flora.

• Absorption: Minimal systemic absorption (<10%) due to local intravaginal route.
• Distribution: Drug remains primarily localized in vaginal tissues.
• Metabolism:
• Metronidazole: metabolized in liver if absorbed.
• Miconazole: minor topical/systemic metabolism.
• Half‑life: Irrelevant for local therapy.
• Elimination: Metronidazole excreted via urine; miconazole via feces (if absorbed).
• Onset of action: Local antimicrobial activity starts within hours of first application.

• Pregnancy:
• Metronidazole: FDA Category B—used safely in pregnancy for BV at recommended dosages.
• Miconazole (vaginal): Category C—limited data but considered safe with short-term use.
• Combination: Avoid first trimester unless clinician-directed; second and third trimesters are acceptable when indicated.
• Breastfeeding:
• Minimal systemic absorption—both agents excreted in breast milk in negligible amounts.
• Generally considered safe; no infant monitoring required.

• Primary Class: Antimicrobial combination therapy
• Subclasses: Nitroimidazole + Azole antifungal
• Formulation Type: Topical intravaginal combination

• Hypersensitivity to metronidazole, miconazole, or any excipient
• First trimester of pregnancy (unless strongly justified by clinician)
• Known alcohol misuse (metronidazole can cause unpleasant reactions if alcohol is consumed concurrently or within 3 days after use)

• Avoid Alcohol Intake: During treatment and for 3 days post‑therapy to prevent disulfiram-like reactions (flushing, headache, tachycardia).
• Vaginal burning or irritation: Common; symptomatic relief with external soothing agents may be advised.
• Persistent symptoms: If no improvement within 7 days or symptoms recur within 2 months, reevaluate for alternative diagnoses or treatment-resistant organisms.
• Rare allergic reactions: Discontinue if signs of hypersensitivity (rash, swelling, difficulty breathing) develop.

Common:

• Mild to moderate vaginal irritation, burning, itching
• Vaginal discharge

Rare or Serious:

• Allergic reactions (urticaria, angioedema)
• Transient headache or GI upset (due to systemic absorption of metronidazole)

Onset & Severity: Local side effects often begin within days and resolve quickly after stopping treatment.

• Alcohol: Contraindicated during treatment and for 3 days post‑therapy (due to metronidazole’s disulfiram-like reaction).
• Warfarin & Anticoagulants: Systemic metronidazole may potentiate effects — monitor INR if concomitant oral metronidazole is used.
• No significant topical drug interactions with other vaginal agents, though spacing products 2 hours apart is advisable.

• CDC & ACOG (2023): Acknowledge combination therapy as appropriate for mixed BV/VVC infections with dual symptoms.
• FDA Label Update (2024): Added negative pregnancy test recommendation before prescribing during the first trimester.
• WHO Trichomoniasis/Vaginitis Guidelines (2025): Support combined therapy where dual diagnosis is confirmed or suspected.

• Temperature: Store at 20°C to 25°C (68°F to 77°F)
• Protect from Freezing: Do not freeze
• Humidity & Light: Keep in a dry, well‑closed container, away from sunlight
• Handling: Use one applicator per dose; discard applicator after each use
• Refrigeration: Not required; stable at room temperature