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
Raxar Indications, Dosage, Storage, Stability - Grepafloxacin
Raxar Indications, Dosage, Storage, Stability - Grepafloxacin
INDICATIONS
RAXAR Tablets are indicated for treatment
of adults with mild to moderate infections caused by susceptible
strains of the designated microorganisms in the infections listed
below:
Acute Bacterial Exacerbations of Chronic Bronchitis caused
by Haemophilus influenzae, Streptococcus
pneumoniae, or Moraxella catarrhalis (see CLINICAL
PHARMACOLOGY: CLINICAL STUDIES subsection).
Community-acquired Pneumonia caused by Haemophilus
influenzae, Streptococcus
pneumoniae, Moraxella catarrhalis, or Mycoplasma pneumoniae
(see CLINICAL PHARMACOLOGY: CLINICAL
STUDIES subsection).
Uncomplicated Gonorrhea urethral
in males and endocervical
and rectal in females caused by Neisseria gonorrhoeae
(see WARNINGS ).
Nongonococcal Urethritis and Cervicitis caused by
Chlamydia trachomatis (see WARNINGS
).
Appropriate culture
and susceptibility
testing should be performed to determine susceptibility
of the causative microorganism(s) to grepafloxacin. Therapy may
be started while awaiting the results of this testing. Antimicrobial
therapy should be appropriately adjusted according to the results
of such testing.
DOSAGE AND ADMINISTRATION
RAXAR Tablets may be taken with or without meals. Sucralfate; antacids
containing magnesium,
calcium, or aluminum;
multivitamins containing iron or zinc; or VIDEX (didanosine) chewable/buffered
tablets or the pediatric powder for oral
solution should not
be taken within 4 hours before or 4 hours after taking grepafloxacin.
The usual dose for RAXAR
is 400 mg or 600 mg
orally every 24 hours as described in Table 5.
Table 5
Recommended Daily Dosages
|
Infection*
|
Dose
|
Frequency
|
Duration (days)
|
|
Acute bacterial exacerbations of chronic
bronchitis†
|
400 or 600 mg
|
once daily
|
10
|
|
Community-acquired pneumonia
|
600 mg
|
once daily
|
10
|
|
Nongonococcal urethritis
or cervicitis
|
400 mg
|
once daily
|
7
|
|
Uncomplicated gonorrhea
|
400 mg
|
single dose
|
1
|
- *DUE TO
THE DESIGNATED PATHOGENS (see
INDICATIONS
AND USAGE ).
- †(See CLINICAL PHARMACOLOGY: CLINICAL
STUDIES subsection).
As with other broad-spectrum antimicrobial
agents prolonged use of grepafloxacin may result in overgrowth
of nonsusceptible organisms. Repeated evaluation of the patient's
condition and microbial
susceptibility
testing is essential. If superinfection
occurs during therapy,
appropriate measures
should be taken.
Patients with Renal Failure
Dosage adjustment
is not required in patients with impaired renal
function.
Patients with Hepatic Disease
Metabolism and excretion
of grepafloxacin are reduced in patients with hepatic failure. RAXAR
Tablets are contraindicated in patients with hepatic failure (see
CLINICAL PHARMACOLOGY).
HOW SUPPLIED
Raxar was removed from the US market in 1999 and is, therefore,
not available. Information below for reference only
RAXAR Tablets 200 mg (grepafloxacin
hydrochloride
tablets) are supplied as white
to pale yellow, film-coated round, biconvex, bevel-edged tablets
containing 200 mg grepafloxacin
base. The tablets are imprinted with "GX CK3" on one side
and no printing on the other
side.
- 60 Tablets Bottle NDC 0173-0566-03
- Unit Dose Pack of 60 NDC 0173-0566-00
RAXAR Tablets 400 mg (grepafloxacin
hydrochloride
tablets) are supplied as white
to pale yellow, film-coated, oval, biconvex, bevel-edged tablets
containing 400 mg grepafloxacin
base. The tablets are imprinted with "GX CK5" on one side
and no printing on the other
side.
RAXAR Tablets 600 mg (grepafloxacin
hydrochloride
tablets) are supplied as white
to pale yellow, film-coated, oval, biconvex, bevel-edged tablets
containing 600 mg grepafloxacin
base. The tablets are imprinted with "GX CK7" on one side
and no printing on the other
side.
Store at controlled room
temperature of 25°
C (77° F) (see United States Pharmacopoeia.) Replace
cap securely after each
opening.
REFERENCES
- National Committee for Clinical Laboratory Standards.
Methods for Dilution Antimicrobial Susceptibility Tests for
Bacteria that Grow Aerobically - Fourth Edition. Approved
Standard NCCLS Document M7-A4, Volume 17, No. 2, NCCLS, Wayne,
PA, January, 1997.
- National Committee for Clinical Laboratory Standards.
Performance Standards for Antimicrobial Disk Susceptibility
Tests - Sixth Edition. Approved Standard NCCLS Document M2-A6,
Volume 17, No.1, NCCLS, Wayne, PA, January, 1997.
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