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
Penetrex Indications, Dosage, Storage, Stability - Enoxacin
Penetrex Indications, Dosage, Storage, Stability - Enoxacin
INDICATIONS
AND USES
Penetrex® (enoxacin) is indicated for the treatment of adults ( ≥18 years
of age) with the following infections caused by susceptible strains of the designated
microorganisms:
Sexually Transmitted Diseases (See WARNINGS.)
Uncomplicated urethral or cervical gonorrhea due to Neisseria gonorrhoeae.
Urinary Tract
Uncomplicated urinary tract infections (cystitis) due to Escherichia coli,
Staphylococcus epidermidis*, or Staphylococcus saprophyticus*.
Complicated urinary tract infections due to Escherichia coli, Klebsiella
pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus epidermidis,
or Enterobacter cloacae*.
*Efficacy for this organism in this organ system at the recommended dose was
studied in fewer than ten infections. The dosage regimens for complicated and
uncomplicated urinary tract infections are different. (See DOSAGE AND ADMINISTRATION
.)
Penicillinase production should have no effect on enoxacin activity.
Appropriate culture and susceptibility tests should be performed before treatment
in order to isolate and identify organisms causing the infection and to determine
their susceptibility to enoxacin. Therapy with enoxacin may be initiated while
awaiting the results of these studies; therapy should be adjusted if necessary
once the results are known. Culture and susceptibility testing performed periodically
during therapy will provide information not only on the therapeutic effect of
the antimicrobial agent but also on the possible emergence of bacterial resistance.
DOSAGE AND ADMINISTRATION
Penetrex® (enoxacin) should be taken at least one hour before or at least two
hours after a meal. Magnesium-, aluminum-, or calcium-containing antacids, bismuth
subsalicylate, products containing iron, or multivitamins containing zinc, or
Videx, (Didanosine), chewable/buffered tablets or the pediatric powder for oral
solution should not be taken within 8 hours before or 2 hours after enoxacin
administration.
See INDICATIONS
AND USAGE for information on appropriate pathogens and
patient populations.
Sexually Transmitted Diseases
Uncomplicated urethral or cervical gonorrhea: 400 mg single dose
Urinary Tract Infections
Uncomplicated urinary tract infections: 200 mg q12h for 7 days
Complicated urinary tract infections: 400 mg q12h for 14 days
Dosage Adjustment for Renal Impairment: Dosage should be
adjusted in patients with a creatinine clearance value of 30 mL/min/1.73 m 2
or less. After a normal initial dose, the dosing interval should be adjusted
as follows:
|
Creatinine Clearance
|
Dosage Adjustment |
Dosage Interval |
|
>30 mL/min/1.73 m 2
|
None |
12 hours |
|
≤30 mL/min/1.73 m 2
|
1 / 2 recommended dose
|
12 hours |
When only the serum creatinine is known, the following formula may be used to
estimate creatinine clearance.
|
Men:
creatinine
clearance (mL/min)
|
=
|
Weight (kg) × (140-age)
72 × serum creatinine (mg/dL)
|
|
Women: 0.85 × the value calculated for men.
|
The serum creatinine should represent a steady state of renal function.
Dosage adjustment is not necessary in elderly patients with normal
renal function, but dose should be adjusted according to the previous guidelines
in elderly patients with compromised renal function.
HOW SUPPLIED
| Strength |
Size |
NDC 0075- |
Color |
|
200 mg
|
Bottles
of 50
|
5100-50
|
light blue
|
|
400 mg
|
Bottles
of 50
|
5140-50
|
dark blue
|
Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) [see USP].
This product should be dispensed in a container with a child-resistant cap.
Keep out of the reach of children.
REFERENCES
- National Committee for Clinical Laboratory Standards, Performance Standards
for Antimicrobial Disk Susceptibility Tests Fourth Edition. Approved Standard
NCCLS Document M2-A4, Vol. 10, No. 7, NCCLS, Villanova, PA, 1990.
- National Committee for Clinical Laboratory Standards, Methods for Dilution
Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically Second
Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8, NCCLS, Villanova,
PA, 1990.
Rx only
Aventis Pharmaceuticals Products Inc.
Parsippany, NJ 07054
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