Flagyl Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Mechanism of Action
Flagyl Indications
Indications
Flagyl Dosage and Administration
Adult
Children
Renal Impairment
End-stage renal disease (ESRD)
-
Decreased renal function does not change the single-dose pharmacokinetics for metronidazole.
-
Subjects with ESRD had no significant change in pharmacokinetics, but had higher Cmax of metabolites compared with healthy subjects.
-
Monitor for metronidazole associated adverse events in ESRD patients.
Effect of Dialysis
-
A hemodialysis session lasting for 4–8 hours removed 40–65% of the administered metronidazole dose. Consider supplementing metronidazole dose after hemodialysis if metronidazole cannot be separated from the dialysis session.
-
A peritoneal dialysis session lasting for 7.5 hours removed ~10% of the administered metronidazole dose.
-
No dose adjustment is needed in ESRD patients undergoing continuous ambulatory peritoneal dialysis (CAPD).
Hepatic Impairment
-
Severe hepatic impairment (Child-Pugh C): reduce metronidazole dose by 50%.
-
No dose adjustment needed for mild to moderate hepatic impairment, but monitor for metronidazole associated adverse events.
Flagyl Contraindications
Contraindications
Flagyl Boxed Warnings
Not Applicable
Flagyl Warnings/Precautions
Warnings/Precautions
Flagyl Pharmacokinetics
Absorption
-
Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms.
-
Following oral administration, the peak plasma concentration is reached between 1 to 2 hours.
-
Plasma concentrations of oral metronidazole are proportional to the administered dose. Oral 250mg, 500mg, or 2000mg achieved peak plasma concentrations of 6 mcg/mL, 12 mcg/mL, and 40 mcg/mL, respectively.
Distribution
-
<20% is bound to plasma proteins.
-
Distributed in CSF, saliva, and breast milk at concentrations similar to those found in plasma.
Elimination
-
Renal (60% to 80% of the dose), fecal (6% to 15%).
-
Half-life: 8 hours.
Flagyl Interactions
Interactions
Flagyl Adverse Reactions
Adverse Reactions
Flagyl Clinical Trials
See Literature
Flagyl Note
Not Applicable
Flagyl Patient Counseling
Flagyl Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Mechanism of Action
Flagyl Indications
Indications
Flagyl Dosage and Administration
Adult
Children
Renal Impairment
End-stage renal disease (ESRD)
-
Decreased renal function does not change the single-dose pharmacokinetics for metronidazole.
-
Subjects with ESRD had no significant change in pharmacokinetics, but had higher Cmax of metabolites compared with healthy subjects.
-
Monitor for metronidazole associated adverse events in ESRD patients.
Effect of Dialysis
-
A hemodialysis session lasting for 4–8 hours removed 40–65% of the administered metronidazole dose. Consider supplementing metronidazole dose after hemodialysis if metronidazole cannot be separated from the dialysis session.
-
A peritoneal dialysis session lasting for 7.5 hours removed ~10% of the administered metronidazole dose.
-
No dose adjustment is needed in ESRD patients undergoing continuous ambulatory peritoneal dialysis (CAPD).
Hepatic Impairment
-
Severe hepatic impairment (Child-Pugh C): reduce metronidazole dose by 50%.
-
No dose adjustment needed for mild to moderate hepatic impairment, but monitor for metronidazole associated adverse events.
Flagyl Contraindications
Contraindications
Flagyl Boxed Warnings
Not Applicable
Flagyl Warnings/Precautions
Warnings/Precautions
Flagyl Pharmacokinetics
Absorption
-
Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms.
-
Following oral administration, the peak plasma concentration is reached between 1 to 2 hours.
-
Plasma concentrations of oral metronidazole are proportional to the administered dose. Oral 250mg, 500mg, or 2000mg achieved peak plasma concentrations of 6 mcg/mL, 12 mcg/mL, and 40 mcg/mL, respectively.
Distribution
-
<20% is bound to plasma proteins.
-
Distributed in CSF, saliva, and breast milk at concentrations similar to those found in plasma.
Elimination
-
Renal (60% to 80% of the dose), fecal (6% to 15%).
-
Half-life: 8 hours.
Flagyl Interactions
Interactions
Flagyl Adverse Reactions
Adverse Reactions
Flagyl Clinical Trials
See Literature
Flagyl Note
Not Applicable
Flagyl Patient Counseling
Flagyl Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Mechanism of Action
Flagyl Indications
Indications
Flagyl Dosage and Administration
Adult
Children
Renal Impairment
End-stage renal disease (ESRD)
-
Decreased renal function does not change the single-dose pharmacokinetics for metronidazole.
-
Subjects with ESRD had no significant change in pharmacokinetics, but had higher Cmax of metabolites compared with healthy subjects.
-
Monitor for metronidazole associated adverse events in ESRD patients.
Effect of Dialysis
-
A hemodialysis session lasting for 4–8 hours removed 40–65% of the administered metronidazole dose. Consider supplementing metronidazole dose after hemodialysis if metronidazole cannot be separated from the dialysis session.
-
A peritoneal dialysis session lasting for 7.5 hours removed ~10% of the administered metronidazole dose.
-
No dose adjustment is needed in ESRD patients undergoing continuous ambulatory peritoneal dialysis (CAPD).
Hepatic Impairment
-
Severe hepatic impairment (Child-Pugh C): reduce metronidazole dose by 50%.
-
No dose adjustment needed for mild to moderate hepatic impairment, but monitor for metronidazole associated adverse events.
Flagyl Contraindications
Contraindications
Flagyl Boxed Warnings
Not Applicable
Flagyl Warnings/Precautions
Warnings/Precautions
Flagyl Pharmacokinetics
Absorption
-
Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms.
-
Following oral administration, the peak plasma concentration is reached between 1 to 2 hours.
-
Plasma concentrations of oral metronidazole are proportional to the administered dose. Oral 250mg, 500mg, or 2000mg achieved peak plasma concentrations of 6 mcg/mL, 12 mcg/mL, and 40 mcg/mL, respectively.
Distribution
-
<20% is bound to plasma proteins.
-
Distributed in CSF, saliva, and breast milk at concentrations similar to those found in plasma.
Elimination
-
Renal (60% to 80% of the dose), fecal (6% to 15%).
-
Half-life: 8 hours.
Flagyl Interactions
Interactions
Flagyl Adverse Reactions
Adverse Reactions
Flagyl Clinical Trials
See Literature
Flagyl Note
Not Applicable