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
Macrobid Indications, Dosage, Storage, Stability - Nitrofurantoin
Macrobid Indications, Dosage, Storage, Stability - Nitrofurantoin
INDICATIONS AND USAGE
Macrobid is indicated only for the treatment of acute
uncomplicated urinary tract infections (acute cystitis) caused by susceptible
strains of Escherichia coli or Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis
or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain
the effectiveness of Macrobid and other antibacterial drugs, Macrobid
should be used only to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria. When culture and susceptibility
information are available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy.
Nitrofurantoins lack the broader tissue distribution of other
therapeutic agents approved for urinary tract infections. Consequently, many
patients who are treated with Macrobid are predisposed to persistence
or reappearance of bacteriuria. (See CLINICAL STUDIES.)
Urine specimens for culture and susceptibility testing should be obtained before
and after completion of therapy. If persistence or reappearance of bacteriuria
occurs after treatment with Macrobid, other therapeutic agents with broader
tissue distribution should be selected. In considering the use of Macrobid,
lower eradication rates should be balanced against the increased potential for
systemic toxicity and for the development of antimicrobial resistance when agents
with broader tissue distribution are utilized.
DOSAGE AND ADMINISTRATION
Macrobid capsules should be taken with food.
Adults and Pediatric Patients Over 12 Years
One 100 mg capsule every 12 hours for seven days.
HOW SUPPLIED
Macrobid is available as 100 mg opaque black and yellow
capsules imprinted "Macrobid" on one half and "Norwich Eaton"
on the other.
NDC 0149-0710-01 bottle of 100
Store at controlled room temperature (59° to 86°F or 15° to
30°C).
CLINICAL STUDIES
Controlled clinical trials comparing Macrobid 100 mg
p.o. q12h and Macrodantin 50 mg p.o. q6h in the treatment of acute uncomplicated
urinary tract infections demonstrated approximately 75% microbiologic eradication
of susceptible pathogens in each treatment group.
Mfg. By: OSG Norwich Pharmaceuticals, Inc.
North Norwich, NY 13814 Dist. by: Procter & Gamble Pharmaceuticals, TM
Owner, Cincinnati, OH 45202 REVISED March 2003
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