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Raxar

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Raxar

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

Side Effects
Interactions

SIDE EFFECTS

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 RAXAR (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 RAXAR (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 RAXAR (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.

Read the Raxar (grepafloxacin) Side Effects Center for a complete guide to possible side effects

DRUG 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 (see WARNINGS ).

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.

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

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