M-ZOLE 7 DUAL PACK

Clinical safety rating: caution

Comprehensive clinical and safety monograph for M-ZOLE 7 DUAL PACK (M-ZOLE 7 DUAL PACK).

How it works

M-ZOLE 7 DUAL PACK contains miconazole, an imidazole antifungal that inhibits fungal lanosterol 14α-demethylase (CYP51), blocking ergosterol synthesis, disrupting fungal cell membrane integrity, and increasing permeability, leading to cell death.

What the body does with it

Metabolism	Miconazole is extensively metabolized in the liver via oxidative pathways, primarily by cytochrome P450 enzymes, including CYP3A4. Less than 1% is excreted unchanged in urine; metabolites are excreted in urine and feces.
Excretion	Primarily renal (80% unchanged drug, 20% as metabolites); biliary/fecal excretion is minimal (<5%).
Half-life	Terminal half-life approximately 48–72 hours. Prolonged in renal impairment (up to 72–120 hours in ESRD), requiring dose adjustment.
Protein binding	>99% bound to plasma proteins (primarily albumin and alpha-1-acid glycoprotein).
Volume of Distribution	Extensive: 25 L/kg, indicating deep tissue penetration (skin, hair, nails, adipose).
Bioavailability	Oral: 40% (due to first-pass effect, improves with food); Topical: <5% systemic absorption.
Onset of Action	Oral: 3–5 days for clinical response; topical: 2–4 weeks for visible improvement in Tinea infections.
Duration of Action	Clinical effect persists 2–7 days after last dose due to prolonged half-life. For onychomycosis, effect lasts until nail regrowth (6–12 months).

Classification & Brands

Dosing & administration

Adults: One vaginal tablet (containing 500 mg metronidazole and 150 mg miconazole nitrate) inserted vaginally once daily at bedtime for 7 days.

Dosage form	CREAM, SUPPOSITORY
Renal impairment	No dose adjustment required for GFR ≥10 mL/min. For GFR <10 mL/min, reduce metronidazole dose by 50% or extend interval to every 12 hours; miconazole not significantly renally excreted.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce metronidazole dose by 50%. Child-Pugh Class C: Contraindicated due to metronidazole accumulation risk.
Pediatric use	Not indicated for pediatric use; safety and efficacy not established.
Geriatric use	No specific dose adjustment required; use with caution due to potential age-related renal and hepatic impairment.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for M-ZOLE 7 DUAL PACK (M-ZOLE 7 DUAL PACK).

Breastfeeding	Not recommended during breastfeeding. Enters breast milk with an M/P ratio of approximately 0.5; may cause sedation, feeding difficulties, and weight loss in infants.
Teratogenic Risk	Pregnancy Category C. First trimester: Associated with increased risk of miscarriage and congenital malformations (craniofacial, cardiac). Second and third trimesters: Risk of preterm birth, low birth weight, and neonatal withdrawal syndrome. Use only if benefit outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to miconazole, other azole antifungals, or any components of the formulation

Clinical Precautions

Precautions

For vaginal use only; not for oral or ophthalmic use. May cause local irritation, burning, or pruritus. Discontinue if hypersensitivity occurs. Use with caution in patients with known sensitivity to azole antifungals. Possible drug interactions with anticoagulants (e.g., warfarin) due to CYP inhibition. Not recommended during pregnancy unless clearly needed; use during breastfeeding only if essential. Do not use in children under 12 years unless directed.

Clinical Tips & Counseling

Drug interactions

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M-ZOLE 7 DUAL PACK

Clinical safety rating: caution

Comprehensive clinical and safety monograph for M-ZOLE 7 DUAL PACK (M-ZOLE 7 DUAL PACK).

How it works

What the body does with it

Metabolism	Miconazole is extensively metabolized in the liver via oxidative pathways, primarily by cytochrome P450 enzymes, including CYP3A4. Less than 1% is excreted unchanged in urine; metabolites are excreted in urine and feces.
Excretion	Primarily renal (80% unchanged drug, 20% as metabolites); biliary/fecal excretion is minimal (<5%).
Half-life	Terminal half-life approximately 48–72 hours. Prolonged in renal impairment (up to 72–120 hours in ESRD), requiring dose adjustment.
Protein binding	>99% bound to plasma proteins (primarily albumin and alpha-1-acid glycoprotein).
Volume of Distribution	Extensive: 25 L/kg, indicating deep tissue penetration (skin, hair, nails, adipose).
Bioavailability	Oral: 40% (due to first-pass effect, improves with food); Topical: <5% systemic absorption.
Onset of Action	Oral: 3–5 days for clinical response; topical: 2–4 weeks for visible improvement in Tinea infections.
Duration of Action	Clinical effect persists 2–7 days after last dose due to prolonged half-life. For onychomycosis, effect lasts until nail regrowth (6–12 months).

Classification & Brands

Dosing & administration

Adults: One vaginal tablet (containing 500 mg metronidazole and 150 mg miconazole nitrate) inserted vaginally once daily at bedtime for 7 days.

Dosage form	CREAM, SUPPOSITORY
Renal impairment	No dose adjustment required for GFR ≥10 mL/min. For GFR <10 mL/min, reduce metronidazole dose by 50% or extend interval to every 12 hours; miconazole not significantly renally excreted.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce metronidazole dose by 50%. Child-Pugh Class C: Contraindicated due to metronidazole accumulation risk.
Pediatric use	Not indicated for pediatric use; safety and efficacy not established.
Geriatric use	No specific dose adjustment required; use with caution due to potential age-related renal and hepatic impairment.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for M-ZOLE 7 DUAL PACK (M-ZOLE 7 DUAL PACK).

Breastfeeding	Not recommended during breastfeeding. Enters breast milk with an M/P ratio of approximately 0.5; may cause sedation, feeding difficulties, and weight loss in infants.
Teratogenic Risk	Pregnancy Category C. First trimester: Associated with increased risk of miscarriage and congenital malformations (craniofacial, cardiac). Second and third trimesters: Risk of preterm birth, low birth weight, and neonatal withdrawal syndrome. Use only if benefit outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to miconazole, other azole antifungals, or any components of the formulation