"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
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.)
*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:
|Dosage Adjustment||Dosage Interval|
>30 mL/min/1.73 m 2
≤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.
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.
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.
- 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.
Aventis Pharmaceuticals Products Inc.
Parsippany, NJ 07054This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Penetrex Information
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