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.

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.

*DUE TO THE DESIGNATED PATHOGENS (see 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).

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.

Unit Dose Pack of 10 (Rax Pack 400) NDC 0173-0657-03

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.

Unit Dose Pack of 10 (Rax Pack 600) NDC 0173-0658-03.

Store at controlled room temperature of 25° C (77° F) (see United States Pharmacopoeia.) Replace cap securely after each opening.

REFERENCES

1. 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.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition. Approved Standard NCtaCLS Document M2-A6, Volume 17, No.1, NCCLS, Wayne, PA, January, 1997.

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