Grepafloxacin Uses

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What is Grepafloxacin?

Grepafloxacin nasal was withdrawn from the U.S. market in 1999.

Grepafloxacin is an antibiotic in a class of drugs called fluoroquinolones. Grepafloxacin fights bacteria in your body.

Grepafloxacin is used to treat various types of bacterial infections.

Grepafloxacin may also be used for purposes other than those listed in this medication guide.

Grepafloxacin indications

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Grepafloxacin (Grepafloxacin) 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 .

Community-acquired Pneumonia caused by Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, or Mycoplasma pneumoniae .

Uncomplicated Gonorrhea urethral in males and endocervical and rectal in females caused by Neisseria gonorrhoeae.

Nongonococcal Urethritis and Cervicitis caused by Chlamydia trachomatis .

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.

Grepafloxacin dosage

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Grepafloxacin (Grepafloxacin) 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 Grepafloxacin (Grepafloxacin) is 400 mg or 600 mg orally every 24 hours as described in Table 5.

Table 5
Recommended Daily Dosages

Infection*
Dose
Frequency
Duration (days)
Acute bacterial exacerbations of chronic bronchitis.

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.

Grepafloxacin interactions

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What other drugs will affect Grepafloxacin?

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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.

Grepafloxacin side effects

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What are the possible side effects of Grepafloxacin?

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Adverse reactions were assessed in clinical trials involving approximately 2500 patients receiving single-dose or multiple-dose regimens of Grepafloxacin.

Multiple dose Regimens

Most of the adverse reactions reported in clinical trials were transient in nature, mild to moderate in severity, and required no treatment. Twenty of 1069 patients (1.9%) receiving Grepafloxacin 400 mg daily and 50 of 925 patients (5.4%) receiving Grepafloxacin 600 mg daily discontinued Grepafloxacin (Grepafloxacin) Tablets due to an adverse reaction thought by the investigator to be drug-related.

Table 3 lists adverse events that occurred with frequencies of 1% or greater. These events were thought by the investigators to be drug-related in patients treated with Grepafloxacin in multiple dose clinical trials.

Table 3
Drug-related Adverse Reactions in Grepafloxacin Treated Patients on Multiple dose Dosing Regimens in Clinical Trials

Adverse Reaction
400 mg daily (n=1069)
600 mg daily (n=925)
Nausea
11.1 %
15.8 %
Taste perversion
9.0 %
17.8 %
Headache
4.6 %
4.9 %
Dizziness
4.3 %
5.4 %
Diarrhea
3.5 %
4.2 %
Vaginitis
3.3 %
1.4 %
Abdominal pain
2.2 %
2.1 %
Vomiting
1.7 %
5.7 %
Pruritus
1.6 %
1.2 %
Dyspepsia
1.5 %
3.1 %
Leukorrhea
1.4 %
0.0 %
Asthenia
1.4 %
2.3 %
Infection
1.3 %
0.4 %
Insomnia
1.3 %
2.1 %
Rash
1.1 %
1.9 %
Anorexia
0.8 %
1.8 %
Somnolence
1.0 %
1.5 %
Dry mouth
0.8 %
1.1 %
Photosensitivity reaction
0.7 %
1.8 %
Constipation
0.7 %
2.2 %
Pain
0.6 %
1.0 %
Nervousness
0.6 %
1.7 %

Additional drug-related events, occurring in multiple-dose clinical trials at a rate of less than 1% were:

Body as a Whole: Back pain, body odor, chest pain, chills, facial edema, fever, malaise, neck rigidity, pelvic pain.

Cardiovascular System: Arrhythmia, hypotension, palpitations, peripheral vascular disorder, postural hypotension, syncope, tachycardia, vasodilatation.

Digestive System: Abnormal liver function tests, abnormal stools, cheilitis, dysphagia, eructation, flatulence, gastritis, gastrointestinal disorder, gingivitis, glossitis, increased appetite, melena, mouth ulceration, oral moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue discoloration, tongue disorder, tongue edema.

Hemic and Lymphatic System: Anemia, eosinophilia, hypochromic, anemia, leukocytosis, leukopenia, lymphadenopathy, lymphocytosis, lymphoma like reaction, prothrombin decreased, prothrombin increased, reticuloendothelial hyperplasia, thrombocytopenia, thromboplastin increased.

Metabolic and Nutritional System: Dehydration, edema, electrolyte abnormality, gout, hyperglycemia, hyperlipidemia, hypernatremia, hyperuricemia, increased alkaline phosphatase, increased BUN, increased creatinine, increased gamma glutamyl transpeptidase, increased SGOT, increased SGPT, peripheral edema, weight loss.

Musculoskeletal System: Arthralgia, myalgia.

Nervous System: Abnormal dreams, abnormal gait, agitation, anxiety, confusion, depression, emotional lability, hallucinations, hyperkinesia, hypesthesia, hypokinesia, paresthesia, speech disorder, stupor, thinking abnormal, tremor, vertigo.

Respiratory System: Asthma, atelectasis, bronchitis, dyspnea, epistaxis, hemoptysis, increased cough, laryngismus, pharyngitis, pleural effusion, rhinitis, sputum increased.

Skin and Appendages: Acne, alopecia, dry skin, epidermal necrolysis, exfoliative dermatitis, fungal dermatitis, herpes simplex, maculopapular rash, skin disorder, sweating, urticaria, vesiculobullous rash.

Special Senses: Amblyopia, conjunctivitis, deafness, dry eyes, ear disorder, eye pain, lacrimation disorder, parosmia, photophobia, taste loss, tinnitus.

Urogenital System: Albuminuria, balanitis, dysuria, hematuria, impotence, polyuria, urethral pain, uricaciduria, urinary frequency, urinary tract disorder, urination impaired, urine abnormality, vulvovaginal disorder.

Single dose Regimens

In clinical trials, patients were treated for uncomplicated gonorrhea using a single dose of Grepafloxacin (Grepafloxacin) 400 mg. There were no deaths or permanent disabilities in these studies.

Table 4 lists the adverse events which occurred with frequencies of 1% or greater. These events were thought by the investigators to be drug related in patients treated with Grepafloxacin (Grepafloxacin) Tablets in single-dose clinical trials.

Table 4
Drug-related Adverse Reactions in Grepafloxacin Treated Patients on a Single dose Dosing Regimen in Clinical Trials

Adverse Reaction
400 mg daily (n=487)
Vaginitis
5.0%
Nausea
3.3%
Dizziness
2.1%
Vomiting
2.1%
Headache
1.8%
Leukorrhea
1.2%
Abdominal pain
1.2%
Diarrhea
1.2%
Pruritus
1.2%
Taste perversion
1.2%

Additional drug-related events occurring in single dose clinical trials at a rate of less than 1 were:

    Body as a Whole: Asthenia, chest pain, chills, flu-like syndrome, infection, malaise.
    Cardiovascular System: Syncope, vasodilatation.
    Digestive System: Anorexia, constipation, increased appetite, tenesmus.
    Hemic and Lymphatic System: Lymphadenopathy.
    Nervous System: Hyperkinesia, insomnia, nervousness, somnolence.
    Respiratory System: Rhinitis.
    Skin and Appendages: Acne, rash, sweating.
    Urogenital System: Balanitis.

Observed During Clinical Practice

In addition to adverse reactions reported from clinical trials the following events have been identified during post-approval use of Grepafloxacin formulations. Because they are reported voluntarily from a population of unknown size estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Grepafloxacin.

    Eye: Disturbances in vision.
    Non Site specific: Allergic reactions, including anaphylactoid reaction/anaphylactic shock, angioedema, laryngeal edema.

Grepafloxacin contraindications

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What is the most important information I should know about Grepafloxacin?

Grepafloxacin (Grepafloxacin) Tablets are contraindicated in persons with a history of hypersensitivity to Grepafloxacin or other members of the quinolone class of antimicrobial agents. Grepafloxacin (Grepafloxacin) Tablets are contraindicated in patients with hepatic failure. Because prolongation of the QT interval and/or torsade de pointes (e.g., terfenadine) unless appropriate cardiac monitoring can be assured (e.g., in hospitalized patients).

Active ingredient matches for Grepafloxacin:

Grepafloxacin


List of Grepafloxacin substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Grepafloxacin Hydrochloride 200 mg (Glaxo wellcome)
Tablet; Oral; Grepafloxacin Hydrochloride 400 mg (Glaxo wellcome)
Tablet; Oral; Grepafloxacin Hydrochloride 600 mg (Glaxo wellcome)

References

  1. PubChem. "Grepafloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "Grepafloxacin". http://www.drugbank.ca/drugs/DB00365 (accessed September 17, 2018).
  3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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