gemifloxacin (Rx)

Brand and Other Names:Factive
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablets

  • 320mg

Acute Exacerbations of Chronic Bronchitis

320 mg PO qDay x5 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis

Pneumonia (community-acquired)

(Multidrug resistant S. pneumoniae; K. pneumoniae; M. catarrhalis): 320 mg PO qDay x7 days

(S. pneumoniae; M. pneumoniae; H. influenzae; C. pneumoniae): 320 mg PO qDay x 5days

Dosage Modifications

Renal impairment

  • CrCl <40 mL/min: Decrease dose by 50%

Other Indications & Uses

Mild-to-moderate community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant), H. influenzae, H. parainfluenzae, K. pneumoniae, Chlamydia pneumoniae, Moraxella catarrhalis, Mycoplasma pneumoniae

Possibly effective against S. aureus (MSSA), S. pyogenes, Acinetobacter lwoffi, Klebsiella oxytoca, Legionella pneumophila, Proteus vulgaris

Safety and efficacy not established

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Interactions

Interaction Checker

and gemifloxacin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Diarrhea (5%)

            Headache (4%)

            Nausea (4%)

            Rash (4%)

            Transaminases increased (1-4%)

            Abdominal pain (2%)

            Dizziness (2%)

            Vomiting (2%)

            Neutropenia (1%)

            Platelets increased (1%)

            Thrombocythemia (1%)

            GGT increased (1%)

            <1%

            Peripheral neuropathy

            Photosensitivity

            Tendon rupture

            Postmarketing Reports

            Blood and lymphatic disorders: Agranulocytosis, pancytopenia

            Cardiovascular disorders: Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes)

            Vascular disorders: Aortic aneurysm and dissection

            Ear and labyrinth disorders: Hearing impairment, including deafness (reversible in most cases)

            Eye disorders: Vision loss (especially in the course of CNS reactions, transient in majority of cases)

            Hepatobiliary disorders: Hepatitis, hepatic failure, jaundice, acute hepatic necrosis

            Immune system disorders: Anaphylactic reactions including shock, angioedema (including laryngeal edema)

            Musculoskeletal/connective tissue disorders: Tendon rupture, arthralgia, myalgia

            Nervous system disorders: Exacerbation of myasthenia gravis symptoms, altered coordination, abnormal gait, muscle weakness, peripheral neuropathy, poly neuropathy

            Central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion)

            Psychiatric disorders: Psychotic reaction (very rarely culminating in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts)

            Renal and urinary disorders: Renal dysfunction, interstitial nephritis

            Respiratory disorders: Allergic pneumonitis

            Skin and tissue disorders: Photosensitivity/phototoxicity reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis

            Endocrine disorders: Blood glucose disturbances

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            Warnings

            Black Box Warnings

            Serious adverse effects and limitations-of-use

            • Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: tendinitis and tendon rupture, peripheral neuropathy, and CNS effects
            • Both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system
            • These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
            • Discontinue the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions
            • Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options
            • For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option

            Contraindications

            All drugs or conditions that prolong QT interval

            Documented hypersensitivity to gemifloxacin or other fluoroquinolones

            Cautions

            May prolong QT interval

            May cause maculopapular rash

            Although not reported in gemifloxacin clinical trials, convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis reported with other fluoroquinolones

            Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent

            In prolonged therapy, perform periodic evaluations of organ system functions (eg, renal, hepatic, hematopoietic); adjust dose in renal function impairment; superinfections may occur with prolonged or repeated antibiotic therapy

            Not drug of first choice in pediatrics due to increased incidence of adverse events compared to controls, including arthropathy; no data exist for dose for pediatric patients with renal impairment (ie, CrCl <50 mL/min)

            Fluoroquinolones are associated with increased risk of tendinitis and tendon rupture in all ages, this risk is further increased in older patients usually over 60 yr, in patients taking corticosteroids, and in patients with kidney, heart, or lung transplants (see Black Box Warnings)

            May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis

            Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190

            CNS effects

            • Fluoroquinolones have been associated with an increased risk of CNS effects, including: convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis
            • May also cause CNS events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide; reactions may occur following the first dose; advise patients to inform their healthcare provider immediately if these reactions occur, discontinue treatment, and institute appropriate care
            • Fluoroquinolone are also known to trigger seizures or lower the seizure threshold; use with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (eg, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction)

            FDA MedWatch Safety Alert

            • Issued 12-20-2018
            • Increase in rate of aortic aneurysm and dissection reported within two months following use of fluoroquinolones, particularly in elderly patients
            • May occur with fluoroquinolones for systemic use (IV or PO)
            • Patients who have an aortic aneurysm or are at risk for an aortic aneurysm (eg, patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions [eg, Marfan syndrome, Ehlers-Danlos syndrome], elderly patients)
            • Prescribe fluoroquinolones to these patients only when no other treatment options are available
            • Advise patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm
            • Stop treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection

            FDA MedWatch Safety Alert

            • Issued July 10, 2018
            • The FDA is strengthening the current warnings in the prescribing information for fluoroquinolone antibiotics to inform clinicians of significant decreases in blood glucose and certain mental health adverse effects
            • Hypoglycemia, sometimes resulting in coma, occurred more frequently in elderly patients or in diabetic patients taking oral hypoglycemic medicine or insulin
            • Alert patients regarding hypoglycemic symptoms and carefully monitor blood glucose levels; instruct patients how to treat themselves if symptoms of hypoglycemia occur
            • This safety alert affects only systemic formulations; early signs and symptoms of low blood glucose include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, and/or unusual anxiety
            • Mental health side effects are to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium
            • Inform patients of the potential risk of psychiatric adverse reactions that can occur after just 1 dose
            • Immediately discontinue treatment if CNS adverse effects occur, including psychiatric adverse reactions, or blood glucose disturbances occur and switch to a nonfluoroquinolone antibiotic if possible
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            Pregnancy & Lactation

            Pregnancy

            Limited available human data with use in pregnant women are insufficient to inform an associated risk of miscarriages, major birth defects, and/or adverse maternal or fetal outcomes; based on animal studies with gemifloxacin, therapy, may cause fetal harm; in animal reproduction studies, administration of drug to pregnant mice and rabbits during the period of organogenesis produced embryofetal toxicity at exposures up to 2 and 3 times, respectively, the maximum recommended human dose; advise pregnant women of potential risk to fetus

            Lactation

            There is no data on presence of gemifloxacin in human milk, effects on milk production, on breastfed infant; drug is excreted in breast milk of rats; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Acts by inhibiting both DNA gyrase and topoisomerase IV, which are essential for bacterial growth. Because of this dual mechanism, MIC values remain in the susceptible range for some double mutants (eg, S pneumoniae)

            Absorption

            Bioavailability: 71%

            Peak Plasma Time: 0.5-2 hr

            Peak Plasma Concentration: 1.61 mcg/mL

            AUC: 9.93 mcg•hr/mL

            Distribution

            Protein bound: 60-70%

            Metabolism

            Hepatic (limited)

            Elimination

            Half-Life: 5-9 hr

            Dialyzable: yes (20-30%)

            Excretion: feces (60%); urine (40%)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.