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Product Name
:
STATIZOL (Gel)
Chemical Name
:
Metronidazole
Therapeutic Category
:
Antiprotozoal & Anthelmintic drugs
Pharmacologic Category
:
Antibiotic, Topical
Pharmaceutical Form
:
Gel
Composition
:
Metronidazole 0.75 g/100 g
Monitoring Parameters
Dosing
 
Dosing: Adult
Bacterial vaginosis or vaginitis due to Gardnerella, Mobiluncus: Vaginal: One applicatorful (~37.5 mg metronidazole) intravaginally once or twice daily for 5 days; apply once in morning and evening if using twice daily, if daily, use at bedtime

Dosing: Geriatric

Use the lower end of the dosing recommendations for adults
Use
 
Vaginal gel: Bacterial vaginosis
Adverse Reactions
 
Vaginal:
>10%: Genitourinary: Vaginal discharge (12%)
1% to 10%:
Central nervous system: Headache (5%), dizziness (2%)
Gastrointestinal: Gastrointestinal discomfort (7%), nausea and/or vomiting (4%), unusual/metallic taste (2%), appetite decreased (1%), cramping (1%), diarrhea (1%)
Genitourinary: Candida cervicitis/vaginitis (10%), vulva/vaginal irritation (9%), pelvic discomfort (3%)
<1%: Abdominal bloating, abdominal gas, darkened urine, depression, fatigue, itching, rash, thirst, xerostomia
Contraindications
 
Hypersensitivity to metronidazole, nitroimidazole derivatives, or any component of the formulation
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• Carcinogenic: Possibly carcinogenic based on animal data.
• CNS effects: Aseptic meningitis, encephalopathy, seizures, and neuropathies (peripheral and optic) have been reported with systemic metronidazole, especially with increased doses and chronic treatment; peripheral neuropathy has also been reported with topical products; monitor and consider discontinuation of therapy if signs/symptoms occur. Use with caution in patients with CNS disease.
• Eye irritation: May cause tearing of the eye; avoid contact with the eyes. In the event of accidental contact, wash out immediately.
• Hepatic impairment: Use with caution in patients with severe liver impairment due to potential accumulation.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection. Approximately 10% of women treated with the vaginal gel developed Candida vaginitis during or immediately after treatment.
Disease-related concerns:
• Blood dyscrasias: Use with caution in patients with or history of blood dyscrasias.
Dosage form related concerns:
• Vaginal gel: Disulfiram-like reaction to ethanol has been reported with systemic metronidazole and may occur with the vaginal gel; consider avoidance of alcoholic beverages during therapy with vaginal gel. Do not administer the vaginal gel to patients who have taken disulfiram within the past 2 weeks.
Metabolism/Transport Effects
Inhibits CYP2C9 (weak), 3A4 (moderate)
Interactions
 
Alcohol (Ethyl): MetroNIDAZOLE (Topical) may enhance the adverse/toxic effect of Alcohol (Ethyl). A disulfiram-like reaction may occur. Risk C: Monitor therapy
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Disulfiram: MetroNIDAZOLE (Topical) may enhance the adverse/toxic effect of Disulfiram. Risk C: Monitor therapy
Mebendazole: May enhance the adverse/toxic effect of MetroNIDAZOLE (Topical). Particularly the risk for Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis may be increased. Risk D: Consider therapy modification
Ritonavir: MetroNIDAZOLE (Topical) may enhance the adverse/toxic effect of Ritonavir. A disulfiram-like reaction could occur due to the alcohol contained in Kaletra (lopinavir/ritonavir) oral solution. Risk C: Monitor therapy
Tipranavir: MetroNIDAZOLE (Topical) may enhance the adverse/toxic effect of Tipranavir. Risk C: Monitor therapy
Pregnancy
 
B
Pregnancy Implications
Adverse events were not observed in animal reproduction studies; therefore, topical metronidazole is classified as pregnancy category B. Metronidazole crosses the placenta and rapidly distributes into the fetal circulation following oral administration. Although there have been a few reports of facial anomalies after in utero exposure, most studies with systemic metronidazole have not found an increased risk adverse fetal or neonatal outcomes. Refer to the Metronidazole (Systemic) monograph for details. The amount of metronidazole available systemically following topical application is less in comparison to oral doses. Oral metronidazole is preferred for the treatment of symptomatic bacterial vaginosis in pregnant patients (consult current CDC guidelines).
Lactation
 
Enters breast milk/not recommended (AAP rates “of concern”; AAP 2001 update pending)
Breast-Feeding Considerations
Following oral administration, metronidazole and its active metabolite are measurable in the maternal plasma, breast milk, and infant plasma. The amount of metronidazole available systemically following topical application is less in comparison to oral doses. Because of tumorigenicity observed in animal studies, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother (per manufacturer).
Mechanism of Action
 
After diffusing into the organism, interacts with DNA to cause a loss of helical DNA structure and strand breakage resulting in inhibition of protein synthesis and cell death in susceptible organisms
Pharmacodynamics / Kinetics
 
Absorption:
Vaginal gel: ~50% of oral dose
Time to peak, serum:
Vaginal gel: 6-12 hours
 
   
 
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