A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Flagyl Indications, Dosage, Storage, Stability - Metronidazole (oral)
Flagyl Indications, Dosage, Storage, Stability - Metronidazole (oral)
INDICATIONS
Symptomatic Trichomoniasis: Metronidazole is indicated for the
treatment of symptomatic trichomoniasis in females and males when the
presence of the trichomonad has been confirmed by appropriate laboratory
procedures (wet smears and/or cultures).
Asymptomatic Trichomoniasis: Metronidazole is indicated in the
treatment of asymptomatic females when the organism is associated with
endocervicitis, cervicitis or cervical erosion. Since there is evidence
that presence of the trichomonad can interfere with accurate assessment
of abnormal cytological smears, additional smears should be performed
after eradication of the parasite.
Treatment of Asymptomatic Consorts: T. vaginalis infection
is a venereal disease. Therefore, asymptomatic sexual partners of treated
patients should be treated simultaneously if the organism has been found
to be present, in order to prevent reinfection of the partner. The decision
as to whether to treat an asymptomatic male partner who has a negative
culture or one for whom no culture has been attempted is an individual
one. In making this decision, it should be noted that there is evidence
that a woman may become reinfected if her consort is not treated. Also,
since there can be considerable difficulty in isolating the organism from
the asymptomatic male carrier negative smears and cultures cannot be relied
upon in this regard. In any event, the consort should be treated with
metronidazole in cases of reinfection.
Amebiasis: Metronidazole is indicated in the treatment of acute
intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic
liver abscess, metronidazole therapy does not obviate the need for aspiration
or drainage of pus.
Anaerobic Bacterial Infections: Metronidazole is indicated in
the treatment of serious infections caused by susceptible anaerobic bacteria.
Indicated surgical procedures should be performed in conjunction with
metronidazole therapy. In a mixed aerobic and anaerobic infection, antimicrobials
appropriate for the treatment of the aerobic infection should be used
in addition to metronidazole.
In the treatment of most serious anaerobic infections, the intravenous
form of metronidazole is usually administered initially. This may be followed
by oral therapy with metronidazole at the discretion of the physician.
Intra-Abdominal Infections, including peritonitis, intra-abdominal
abscess, and liver abscess, caused by Bacteroides species, including the
B. fragilis group, (B. fragilis, B. distasonis, B. ovatus, B.
thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium
species, Peptococcus niger, and Peptostreptococcus species.
Skin and Skin Structure Infections caused by Bacteroides
species including the B. fragilis group, Clostridium species,
Peptococcus niger, Peptostreptococcus species, and Fusobacterium
species.
Gynecologic Infections, including endometritis, endomyometritis,
tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused
by Bacteroides species including the B. fragilis group,
Clostridium species, Peptococcus niger and Peptostreptococcus
species.
Bacterial Septicemia caused by Bacteroides species
including the B. fragilis group and Clostridium species.
Bone and Joint Infections, as adjunctive therapy, caused
by Bacteroides species, including the B. fragilis group
Central Nervous System (CNS) infection, including meningitis
and brain abscess, caused by Bacteroides species, including the
B. fragilis group.
Lower Respiratory Tract Infections, including pneumonia,
empyema, and lung abscess, caused by Bacteroides species including
the B. fragilis group.
Endocarditis caused by Bacteroides species including
the B. fragilis group.
DOSAGE AND ADMINISTRATION
In elderly patients, the pharmacokinetics of metronidazole may be altered,
and, therefore, monitoring of serum levels may be necessary to adjust
the metronidazole dosage accordingly.
Trichomoniasis
In the Female
One day treatment: Two grams of metronidazole given either
as a single dose or in two divided doses of one gram each given in the
same day.
Seven-day course of treatment: 250 mg three times daily
for seven consecutive days.
There is some indication from controlled comparative studies that cure
rates as determined by vaginal smears, signs and symptoms, may be higher
after a seven-day course of treatment than after a one day treatment regimen.
The dosage regimen should be individualized. Single-dose treatment can
assure compliance, especially if administered under supervision, in those
patients who cannot be relied on to continue the seven-day regimen. A
seven-day course of treatment may minimize reinfection by protecting the
patient long enough for the sexual contacts to obtain appropriate treatment.
Further, some patients may tolerate one treatment regimen better than
the other.
In pregnant patients in whom alternative treatment has been inadequate,
the one-day course of therapy should not be used, as it results in higher
serum levels which can reach the fetal circulation (see PRECAUTIONS:
Pregnancy).
When repeat courses of the drug are required, it is recommended that
an interval of four to six weeks elapse between courses and that the presence
of the trichomonad be reconfirmed by appropriate laboratory measures.
Total and differential leukocyte counts should be made before and after
re-treatment.
In the Male
Treatment should be individualized as for the female.
Amebiasis
Adults
For Acute Intestinal Amebiasis (Acute Amebic Dysentery):
750 mg orally three times daily for 5 to 10 days.
For Amebic Liver Abscess: 500 mg or 750 mg orally three
times daily for 5 to 10 days.
Children
35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.
Anaerobic Bacterial Infections
In the treatment of most serious anaerobic infections, the intravenous
form of metronidazole is usually administered initially.
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500
mg for a 70 kg adult). A maximum of 4 g should not be exceeded during
a 24 hour period.
The usual duration of therapy is 7 to 10 days; however, infections of
the bone and joint, lower respiratory tract, and endocardium may require
longer treatment.
Patients with severe hepatic disease metabolize metronidazole slowly,
with resultant accumulation of metronidazole and its metabolites in the
plasma. Accordingly, for such patients, doses below those usually recommended
should be administered cautiously. Close monitoring of plasma metronidazole
levels˛ and toxicity is recommended.
The dose of metronidazole should not be specifically reduced in anuric
patients since accumulated metabolites may be rapidly removed by dialysis.
HOW SUPPLIED
Metronidazole Tablets, USP:
250 mg - White, round, convex, unscored tablets in bottles of 100, 250,
500 and 1000.
Debossed: SL 333
500 mg - White, oblong, convex, unscored tablets in bottles of 100, 500
and 1000.
Debossed: SL 334
Dispense in a well-closed, light-resistant container as defined in the
USP. Store at controlled room temperature 15°-30°C (59°-86°F). Protect
from light.
REFERENCES
1. Proposed standard: PSM-11-Proposed Reference Dilution
Procedure for Antimicrobic Susceptibility Testing of Anaerobic Bacteria,
National Committee for Clinical Laboratory Standards, and Sutter, et al:
Collaborative Evaluation of a Proposed Reference Dilution Method of Susceptibility
Testing of Anaerobic Bacteria, Antimicrob. Agents Chemother. 16:495-502
(Oct.) 1979; and Tally et al: In Vitro Activity of Thienamycin,
Antimicrob Agents Chemother. 14:436-438 (Sept.) 1978.
2. Ralph, E.D., and Kirby, WM. M.: Bioassay of Metronidazole
With Either Anaerobic or Aerobic Incubation, J. Infect Dis 132:587-591
(Nov.) 1975; or Gulaid, et al.: Determination of Metronidazole and Its
Major Metabolites in Biological Fluids by High Pressure Liquid Chromatography,
Br. J. Clin. Pharmacol 6:430-432, 1978.
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