Recommended Topic Related To:

Penetrex

"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.

TPN is an intravenous"...

Penetrex

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Indications
Dosage
How Supplied

INDICATIONS

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

  1. 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.
  2. 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

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.