Grepafloxacin Dosage

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. Grepafloxacin (Grepafloxacin) Tablets are contraindicated in patients with hepatic failure.

How supplied

Grepafloxacin (Grepafloxacin) was removed from the US market in 1999 and is, therefore, not available. Information below for reference only

Grepafloxacin 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

Grepafloxacin 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

Grepafloxacin 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) 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.

What other drugs will affect Grepafloxacin?

Do not take antacids that contain magnesium or aluminum (e.g., Tums or Rolaids), the ulcer medicine sucralfate (Carafate), or vitamin or mineral supplements that contain iron or zinc for a minimum of 4 hours before or 4 hours after a dose of Grepafloxacin. Taking antacids, sucralfate, or vitamin or mineral supplements too close to a dose of Grepafloxacin can greatly decrease the effects of the antibiotic.

Do not take Grepafloxacin without first talking to your doctor if you are taking any of the following drugs:

• the heart medicines amiodarone (Cordarone), disopyramide (Norpace), quinidine (Cardioquin, Quinidex, Quinaglute, others), procainamide (Procan SR, Pronestyl), sotalol (Betapace), and bepridil (Vascor);

• terfenadine (Seldane, Seldane-D) or astemizole (Hismanal);

• a tricyclic antidepressant including amitriptyline (Elavil, Endep), amoxapine (Asendin), imipramine (Tofranil), nortriptyline (Pamelor), doxepin (Sinequan), and others;

• a phenothiazine including chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), thioridazine (Mellaril), and others;

• erythromycin (E-Mycin, Ery-Tab, E.E.S., others); or

• cisapride (Propulsid).

Grepafloxacin and the drugs listed above may affect the rhythm of your heartbeats. You may not be able to take Grepafloxacin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Before taking Grepafloxacin, tell your doctor if you are taking:

• warfarin (Coumadin);

• theophylline (Theo-Dur, Theolair, Slo-Phyllin, Slo-Bid, Elixophyllin, others);

• insulin or an oral diabetes medication such as glipizide (Glucotrol), glyburide (Micronase, Diabeta, Glynase), and others; or

• a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), and others.

You may not be able to take Grepafloxacin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with Grepafloxacin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Grepafloxacin interactions

Antacids, Sucralfate, Metal Cations, Multivitamins

Quinolones form chelates with alkaline earth and transition metal cations. Administration of quinolones with antacids containing aluminum, magnesium, or calcium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as VIDEX (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, may substantially interfere with the absorption of quinolones, resulting in systemic concentrations considerably lower than desired. These agents should not be taken within 4 hours before or 4 hours after Grepafloxacin administration.

Caffeine Theobromine

Grepafloxacin, like other quinolones, may inhibit the metabolism of caffeine and theobromine. These stimulants are commonly found in coffee and tea, respectively. In some patients, this may lead to reduced clearance, prolongation of plasma half-life, and enhanced effects of caffeine and theobromine.

Theophylline

Grepafloxacin is a competitive inhibitor of the metabolism of theophylline. Serum theophylline concentrations increase when Grepafloxacin is initiated in a patient maintained on theophylline. When initiating a multi-day course of Grepafloxacin in a patient maintained on theophylline, the theophylline maintenance dose should be halved for the period of concurrent use of Grepafloxacin and monitoring of serum theophylline concentrations should be initiated as a guide to further dosage adjustments.

Warfarin

In subjects receiving warfarin, no significant change in clotting time was observed when Grepafloxacin was coadministered. However, because some quinolones have been reported to enhance the effects of warfarin or its derivatives, prothrombin time or other suitable anticoagulation test should be monitored closely if a quinolone antimicrobial is administered with warfarin or its derivatives.

Drugs Metabolized by Cytochrome P450 Enzymes

The drug interaction study evaluating the effect of Grepafloxacin on theophylline indicates that Grepafloxacin inhibits theophylline metabolism, which is mediated by CYP1A2. While no clinical studies have been conducted to evaluate the effect of Grepafloxacin on the metabolism of C.P.A. substrates, in vitro data suggest similar effects of Grepafloxacin in CYP3A4 mediated metabolism and theophylline metabolism. In addition, other quinolones have been reported to decrease the CYP3A4-mediated metabolism of cyclosporine. Other drugs metabolized by C.P.A. include terfenadine, astemizole, cisapride, midazolam, and triazolam. The clinical relevance of the potential effect of Grepafloxacin on the metabolism of C.P.A. substrates is not known. Patients receiving concurrent administration of substrates of C.P.A. were not excluded from clinical trials of Grepafloxacin.

Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

The concomitant administration of a nonsteroidal anti inflammatory drug with a quinolone may increase the risks of CNS stimulation and convulsions.

Antidiabetic Agents

Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are coadministered.

References

1. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "Grepafloxacin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. Wikipedia. "grepafloxacin: Link to the compound information in Wikipedia.". https://en.wikipedia.org/wiki/Grepaf... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology