Gemifloxacin mesylate

Gemifloxacin mesylate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Black Box Warning

WARNING: See full prescribing information for complete Boxed Warning. * Fluoroquinolones, including FACTIVE®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart and lung transplants. Fluoroquinolones, including FACTIVE, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid FACTIVE in patients with known history of myasthenia gravis.

Overview

Gemifloxacin mesylate is an antibiotic that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include rash, abdominal pain, diarrhea, nausea, vomiting,dizziness, headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

FACTIVE is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dosage

FACTIVE can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of FACTIVE is 320 mg daily, according to the following table (Table 4).

Recommended Dosage Regimen of FACTIVE

• The clinical decision regarding the use of a 5 or 7 day regimen should be guided by results of the initial sputum culture.

This image is provided by the National Library of Medicine.

The recommended dose and duration of FACTIVE should not be exceeded.

Use in Renally Impaired Patients: Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance ≤40 mL/min. Table 5 provides dosage guidelines for use in patients with renal impairment.

This image is provided by the National Library of Medicine.

• Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) should receive 160 mg every 24 hours.

• When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

This image is provided by the National Library of Medicine.

Creatinine Clearance Formula

Women: 0.85 x the value calculated for men

Use in Hepatically Impaired Patients: No dosage adjustment is recommended in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.

Use in Elderly: No dosage adjustment is recommended.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Gemifloxacin mesylate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Gemifloxacin mesylate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Gemifloxacin mesylate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Gemifloxacin mesylate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Gemifloxacin mesylate in pediatric patients.

Contraindications

There is limited information regarding Gemifloxacin mesylate Contraindications in the drug label.

Warnings

WARNING: See full prescribing information for complete Boxed Warning. * Fluoroquinolones, including FACTIVE®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart and lung transplants. Fluoroquinolones, including FACTIVE, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid FACTIVE in patients with known history of myasthenia gravis.

There is limited information regarding Gemifloxacin mesylate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Gemifloxacin mesylate in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Gemifloxacin mesylate in the drug label.

Drug Interactions

There is limited information regarding Gemifloxacin mesylate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Gemifloxacin mesylate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Gemifloxacin mesylate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Gemifloxacin mesylate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Gemifloxacin mesylate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Gemifloxacin mesylate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Gemifloxacin mesylate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Gemifloxacin mesylate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Gemifloxacin mesylate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Gemifloxacin mesylate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Gemifloxacin mesylate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Gemifloxacin mesylate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Gemifloxacin mesylate in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Gemifloxacin mesylate in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Gemifloxacin mesylate in the drug label.

Pharmacology

There is limited information regarding Gemifloxacin mesylate Pharmacology in the drug label.

Mechanism of Action

Structure

• FACTIVE (gemifloxacin mesylate) is a synthetic broad-spectrum antibacterial agent for oral administration. Gemifloxacin, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form. Chemically, gemifloxacin is (R,S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid.

• The mesylate salt is a white to light brown solid with a molecular weight of 485.49. Gemifloxacin is considered freely soluble at neutral pH (350 μg/mL at 37ºC, pH 7.0). Its empirical formula is C18H20FN5O4•CH4O3S and its chemical structure is:

This image is provided by the National Library of Medicine.

• Each white to off-white, oval, film-coated FACTIVE tablet has breaklines and GE 320 debossed on both faces and contains gemifloxacin mesylate equivalent to 320 mg gemifloxacin. The inactive ingredients are crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Gemifloxacin mesylate in the drug label.

Pharmacokinetics

There is limited information regarding Gemifloxacin mesylate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Gemifloxacin mesylate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Gemifloxacin mesylate in the drug label.

How Supplied

Storage

There is limited information regarding Gemifloxacin mesylate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Gemifloxacin mesylate in the drug label.

Precautions with Alcohol

• Alcohol-Gemifloxacin mesylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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