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

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              Serious - Use Alternative (46)

              • aluminum hydroxide

                aluminum hydroxide decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Separate by 2 hours.

              • aminolevulinic acid oral

                aminolevulinic acid oral, gemifloxacin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period.

              • aminolevulinic acid topical

                gemifloxacin increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.

              • artemether

                artemether and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

              • BCG vaccine live

                gemifloxacin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.

              • carbonyl iron

                carbonyl iron decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • ceritinib

                ceritinib and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

              • cholera vaccine

                gemifloxacin, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

              • clarithromycin

                clarithromycin and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

              • desflurane

                desflurane and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

              • didanosine

                didanosine decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Separate by 4-8 hours.

              • dofetilide

                dofetilide increases toxicity of gemifloxacin by QTc interval. Avoid or Use Alternate Drug.

              • entrectinib

                gemifloxacin and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

              • ferric maltol

                ferric maltol decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • ferrous fumarate

                ferrous fumarate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • ferrous gluconate

                ferrous gluconate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • ferrous sulfate

                ferrous sulfate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • fexinidazole

                fexinidazole and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval.

              • glasdegib

                gemifloxacin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

              • hydroxychloroquine sulfate

                hydroxychloroquine sulfate and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

              • inotuzumab

                inotuzumab and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

              • iron dextran complex

                iron dextran complex decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • iron sucrose

                iron sucrose decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • ivosidenib

                ivosidenib and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

              • lefamulin

                lefamulin and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

              • macimorelin

                macimorelin and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

              • methyl aminolevulinate

                gemifloxacin, methyl aminolevulinate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

              • mobocertinib

                mobocertinib and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

              • ondansetron

                gemifloxacin and ondansetron both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.

              • panobinostat

                gemifloxacin and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

              • pitolisant

                gemifloxacin and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

              • polysaccharide iron

                polysaccharide iron decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • ribociclib

                ribociclib increases toxicity of gemifloxacin by QTc interval. Avoid or Use Alternate Drug.

              • rose hips

                rose hips decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • saquinavir

                saquinavir increases levels of gemifloxacin by QTc interval. Avoid or Use Alternate Drug. Potential for increased toxicity. Increased risk of QT prolongation and cardiac arrhythmias.

                saquinavir increases levels of gemifloxacin by pharmacodynamic synergism. Avoid or Use Alternate Drug. Potential for increased toxicity. Increased risk of QT prolongation and cardiac arrhythmias.

              • selinexor

                selinexor, gemifloxacin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

              • sodium bicarbonate

                sodium bicarbonate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Separate by 2 hours.

              • sodium citrate/citric acid

                sodium citrate/citric acid decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Separate by 2 hours.

              • strontium ranelate

                strontium ranelate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Suspend strontium ranelate during antibiotic therapy.

              • tretinoin

                gemifloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

              • tretinoin topical

                gemifloxacin, tretinoin topical. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

              • typhoid vaccine live

                gemifloxacin decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.

              • umeclidinium bromide/vilanterol inhaled

                gemifloxacin increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

              • vandetanib

                gemifloxacin, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.

              • vemurafenib

                vemurafenib and gemifloxacin both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended.

              • vilanterol/fluticasone furoate inhaled

                gemifloxacin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

              Monitor Closely (132)

              • acarbose

                gemifloxacin increases effects of acarbose by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • albuterol

                albuterol and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • alfuzosin

                gemifloxacin and alfuzosin both increase QTc interval. Use Caution/Monitor.

                alfuzosin and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • amifampridine

                gemifloxacin increases toxicity of amifampridine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Amifampridine can cause seizures. Coadministration with drugs that lower seizure threshold may increase this risk.

              • apomorphine

                apomorphine and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • arformoterol

                arformoterol and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • aripiprazole

                aripiprazole and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • atomoxetine

                atomoxetine and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • azithromycin

                azithromycin increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor.

              • bazedoxifene/conjugated estrogens

                gemifloxacin will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • bedaquiline

                gemifloxacin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

              • betamethasone

                betamethasone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • calcium acetate

                calcium acetate, gemifloxacin. Either decreases levels of the other by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • calcium carbonate

                calcium carbonate, gemifloxacin. Either decreases levels of the other by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • calcium chloride

                calcium chloride, gemifloxacin. Either decreases levels of the other by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • calcium citrate

                calcium citrate, gemifloxacin. Either decreases levels of the other by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • calcium gluconate

                calcium gluconate, gemifloxacin. Either decreases levels of the other by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • celecoxib

                gemifloxacin, celecoxib. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • chloroquine

                chloroquine increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor.

              • chlorpropamide

                gemifloxacin increases effects of chlorpropamide by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • citalopram

                gemifloxacin and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

              • clozapine

                clozapine and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • conjugated estrogens

                gemifloxacin will decrease the level or effect of conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • corticotropin

                corticotropin and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • cortisone

                cortisone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • crizotinib

                crizotinib and gemifloxacin both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

              • dasatinib

                dasatinib and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • degarelix

                degarelix and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • deutetrabenazine

                deutetrabenazine and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • dexamethasone

                dexamethasone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • dichlorphenamide

                dichlorphenamide and gemifloxacin both decrease serum potassium. Use Caution/Monitor.

              • diclofenac

                gemifloxacin, diclofenac. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • dienogest/estradiol valerate

                gemifloxacin will decrease the level or effect of dienogest/estradiol valerate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. An alternate or additional form of birth control may be advisable during concomitant use.

              • diflunisal

                gemifloxacin, diflunisal. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • digoxin

                gemifloxacin will increase the level or effect of digoxin by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • dolasetron

                dolasetron and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • donepezil

                donepezil and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • escitalopram

                escitalopram increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor.

              • estradiol

                gemifloxacin will decrease the level or effect of estradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • estrogens conjugated synthetic

                gemifloxacin will decrease the level or effect of estrogens conjugated synthetic by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • estropipate

                gemifloxacin will decrease the level or effect of estropipate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • ethinylestradiol

                gemifloxacin will decrease the level or effect of ethinylestradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • ethotoin

                gemifloxacin decreases effects of ethotoin by unknown mechanism. Use Caution/Monitor. There are also case reports of quinolones increasing phenytoin levels.

              • etodolac

                gemifloxacin, etodolac. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • ezogabine

                ezogabine, gemifloxacin. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.

              • fennel

                fennel decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              • fenoprofen

                gemifloxacin, fenoprofen. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • ferric citrate

                ferric citrate will decrease the level or effect of gemifloxacin by drug binding in GI tract. Use Caution/Monitor. Administer at least 2 hours before or after ferric citrate

              • fludrocortisone

                fludrocortisone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • fluoxetine

                gemifloxacin and fluoxetine both increase QTc interval. Modify Therapy/Monitor Closely.

              • flurbiprofen

                gemifloxacin, flurbiprofen. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • fosphenytoin

                gemifloxacin decreases effects of fosphenytoin by unknown mechanism. Use Caution/Monitor. There are also case reports of quinolones increasing phenytoin levels.

              • fostemsavir

                gemifloxacin and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

              • glimepiride

                gemifloxacin increases effects of glimepiride by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • glipizide

                gemifloxacin increases effects of glipizide by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • glyburide

                gemifloxacin increases effects of glyburide by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • goserelin

                goserelin increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

              • haloperidol

                haloperidol and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • histrelin

                histrelin increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

              • hydrocortisone

                hydrocortisone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • hydrocortisone rectal

                hydrocortisone rectal and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • ibuprofen

                gemifloxacin, ibuprofen. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • ibuprofen IV

                gemifloxacin, ibuprofen IV. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • indacaterol, inhaled

                indacaterol, inhaled, gemifloxacin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

              • indomethacin

                gemifloxacin, indomethacin. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • insulin aspart

                gemifloxacin increases effects of insulin aspart by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • insulin detemir

                gemifloxacin increases effects of insulin detemir by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • insulin glargine

                gemifloxacin increases effects of insulin glargine by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • insulin glulisine

                gemifloxacin increases effects of insulin glulisine by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • insulin lispro

                gemifloxacin increases effects of insulin lispro by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • insulin NPH

                gemifloxacin increases effects of insulin NPH by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • insulin regular human

                gemifloxacin increases effects of insulin regular human by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • ketoprofen

                gemifloxacin, ketoprofen. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • ketorolac

                gemifloxacin, ketorolac. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • ketorolac intranasal

                gemifloxacin, ketorolac intranasal. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • lenvatinib

                gemifloxacin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

              • leuprolide

                leuprolide increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

              • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate

                gemifloxacin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.

              • magnesium chloride

                magnesium chloride decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • magnesium citrate

                magnesium citrate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • magnesium hydroxide

                magnesium hydroxide decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • magnesium oxide

                magnesium oxide decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • magnesium sulfate

                magnesium sulfate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • magnesium supplement

                magnesium supplement will decrease the level or effect of gemifloxacin by Other (see comment). Modify Therapy/Monitor Closely. Formation of an insoluble complex reduces absorption of the drug through intestinal tract; administer magnesium 2hr before the quinolone or 3hr after the quinolone

              • meclofenamate

                gemifloxacin, meclofenamate. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • mefenamic acid

                gemifloxacin, mefenamic acid. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • meloxicam

                gemifloxacin, meloxicam. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • mestranol

                gemifloxacin will decrease the level or effect of mestranol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • metformin

                gemifloxacin increases effects of metformin by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • methylprednisolone

                methylprednisolone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • mifepristone

                mifepristone, gemifloxacin. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.

              • miglitol

                gemifloxacin increases effects of miglitol by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • mometasone inhaled

                mometasone inhaled and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • nabumetone

                gemifloxacin, nabumetone. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • naproxen

                gemifloxacin, naproxen. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • nateglinide

                gemifloxacin increases effects of nateglinide by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • olodaterol inhaled

                gemifloxacin and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias

              • osilodrostat

                osilodrostat and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • osimertinib

                osimertinib and gemifloxacin both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

              • oxaliplatin

                oxaliplatin will increase the level or effect of gemifloxacin by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

              • oxaprozin

                gemifloxacin, oxaprozin. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • ozanimod

                ozanimod and gemifloxacin both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

              • pasireotide

                gemifloxacin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

              • phenytoin

                gemifloxacin decreases effects of phenytoin by unknown mechanism. Use Caution/Monitor. There are also case reports of quinolones increasing phenytoin levels.

              • pioglitazone

                gemifloxacin increases effects of pioglitazone by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • piroxicam

                gemifloxacin, piroxicam. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • prednisolone

                prednisolone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • prednisone

                prednisone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • quetiapine

                quetiapine, gemifloxacin. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.

              • quinine

                gemifloxacin and quinine both increase QTc interval. Use Caution/Monitor.

              • repaglinide

                gemifloxacin increases effects of repaglinide by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • rilpivirine

                rilpivirine increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsades de Pointes.

              • rosiglitazone

                gemifloxacin increases effects of rosiglitazone by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • saxagliptin

                gemifloxacin increases effects of saxagliptin by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • selpercatinib

                selpercatinib increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor.

              • sitagliptin

                gemifloxacin increases effects of sitagliptin by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • sodium picosulfate/magnesium oxide/anhydrous citric acid

                gemifloxacin decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.

                sodium picosulfate/magnesium oxide/anhydrous citric acid decreases levels of gemifloxacin by cation binding in GI tract. Use Caution/Monitor. Take at least 2 hours before and not less than 6 hours after administration of sodium picosulfate, magnesium oxide and anhydrous citric acid to avoid magnesium chelation.

              • sodium sulfate/?magnesium sulfate/potassium chloride

                sodium sulfate/?magnesium sulfate/potassium chloride decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer fluoroquinolones at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .

              • sodium sulfate/potassium sulfate/magnesium sulfate

                sodium sulfate/potassium sulfate/magnesium sulfate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer fluoroquinolones at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .

              • sodium zirconium cyclosilicate

                sodium zirconium cyclosilicate will decrease the level or effect of gemifloxacin by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

              • sorafenib

                sorafenib and gemifloxacin both increase QTc interval. Use Caution/Monitor.

              • sucralfate

                sucralfate decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              • sulindac

                gemifloxacin, sulindac. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • tolazamide

                gemifloxacin increases effects of tolazamide by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • tolbutamide

                gemifloxacin increases effects of tolbutamide by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • tolmetin

                gemifloxacin, tolmetin. Other (see comment). Modify Therapy/Monitor Closely. Comment: Increased risk of CNS stimulation and seizures with high doses of fluoroquinolones.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • trimagnesium citrate anhydrous

                trimagnesium citrate anhydrous decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Multivalent cation-containing products may reduce bioavailability of quinolones; administer quinolone at least 2 hr before or 6 hr after magnesium; use alternatives if available.

              • triptorelin

                triptorelin increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

              • vildagliptin

                gemifloxacin increases effects of vildagliptin by pharmacodynamic synergism. Use Caution/Monitor. Quinolone antibiotic administration may result in hyper- or hypoglycemia. Gatifloxacin is most likely to produce dysglycemia; moxifloxacin is least likely.

              • warfarin

                gemifloxacin increases effects of warfarin by Other (see comment). Use Caution/Monitor. Comment: Decr vitamin K-producing intestinal flora may increase INR after a few days.

                gemifloxacin increases effects of warfarin by unknown mechanism. Use Caution/Monitor. Ciprofloxacin, norfloxacin, & ofloxacin are most likely to interact w/warfarin; data for other quinolones is conflicting. Monitor INR closely.

              • zinc

                zinc will decrease the level or effect of gemifloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Administer gemifloxacin 3 hr before or 2 hr after administration of polyvalent cation containing products.

              Minor (24)

              • alprazolam

                gemifloxacin increases levels of alprazolam by decreasing metabolism. Minor/Significance Unknown.

              • balsalazide

                gemifloxacin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • biotin

                gemifloxacin will decrease the level or effect of biotin by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • chlordiazepoxide

                gemifloxacin increases levels of chlordiazepoxide by decreasing metabolism. Minor/Significance Unknown.

              • clonazepam

                gemifloxacin increases levels of clonazepam by decreasing metabolism. Minor/Significance Unknown.

              • clorazepate

                gemifloxacin increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

              • estazolam

                gemifloxacin increases levels of estazolam by decreasing metabolism. Minor/Significance Unknown.

              • flurazepam

                gemifloxacin increases levels of flurazepam by decreasing metabolism. Minor/Significance Unknown.

              • foscarnet

                gemifloxacin, foscarnet. Mechanism: unknown. Minor/Significance Unknown. Risk of tonic clonic seizure.

              • isotretinoin

                gemifloxacin, isotretinoin. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Increased phototoxicity.

              • loprazolam

                gemifloxacin increases levels of loprazolam by decreasing metabolism. Minor/Significance Unknown.

              • lorazepam

                gemifloxacin increases levels of lorazepam by decreasing metabolism. Minor/Significance Unknown.

              • lormetazepam

                gemifloxacin increases levels of lormetazepam by decreasing metabolism. Minor/Significance Unknown.

              • midazolam

                gemifloxacin increases levels of midazolam by decreasing metabolism. Minor/Significance Unknown.

              • oxazepam

                gemifloxacin increases levels of oxazepam by decreasing metabolism. Minor/Significance Unknown.

              • pantothenic acid

                gemifloxacin will decrease the level or effect of pantothenic acid by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • probenecid

                probenecid increases levels of gemifloxacin by decreasing renal clearance. Minor/Significance Unknown.

              • pyridoxine

                gemifloxacin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • pyridoxine (Antidote)

                gemifloxacin will decrease the level or effect of pyridoxine (Antidote) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • quazepam

                gemifloxacin increases levels of quazepam by decreasing metabolism. Minor/Significance Unknown.

              • quercetin

                quercetin decreases effects of gemifloxacin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • temazepam

                gemifloxacin increases levels of temazepam by decreasing metabolism. Minor/Significance Unknown.

              • thiamine

                gemifloxacin will decrease the level or effect of thiamine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • triazolam

                gemifloxacin increases levels of triazolam by decreasing metabolism. Minor/Significance Unknown.

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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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Factive oral
              -
              320 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              gemifloxacin oral

              GEMIFLOXACIN - ORAL

              (JEM-i-FLOX-a-sin)

              COMMON BRAND NAME(S): Factive

              WARNING: Quinolone antibiotics (including gemifloxacin) may cause serious and possibly permanent tendon damage (such as tendonitis, tendon rupture), nerve problems in the arms and legs (peripheral neuropathy), and nervous system problems. Get medical help right away if you have any of the following symptoms: pain/numbness/burning/tingling/weakness in your arms/hands/legs/feet, changes in how you sense touch/pain/temperature/vibration/body position, severe/lasting headache, vision changes, shaking (tremors), seizures, mental/mood changes (such as agitation, anxiety, confusion, hallucinations, depression, rare thoughts of suicide).Tendon damage may occur during or after treatment with this medication. Stop exercising, rest, and get medical help right away if you develop joint/muscle/tendon pain or swelling. Your risk for tendon problems is greater if you are over 60 years of age, if you are taking corticosteroids (such as prednisone), or if you have a kidney, heart, or lung transplant.This medication may make a certain muscle condition (myasthenia gravis) worse. Tell your doctor right away if you have new or worsening muscle weakness (such as drooping eyelids, unsteady walk) or trouble breathing.Discuss the risks and benefits with your doctor before using this medication.

              USES: Gemifloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking gemifloxacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage and length of treatment are based on your medical condition and response to treatment. Drink plenty of fluids while taking this drug unless your doctor tells you otherwise.Take this medication at least 2 hours before or 3 hours after taking other products that may make it work less well. Examples include quinapril, sucralfate, vitamins/minerals (including iron, zinc), and products that contain magnesium or aluminum (such as antacids, didanosine solution), among others. Ask your pharmacist about all the products you take.For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time every day.Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.

              SIDE EFFECTS: See also Warning section.Nausea, diarrhea, dizziness, headache, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: unusual bruising/bleeding, signs of kidney problems (such as change in the amount of urine), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).Get medical help right away if you have any very serious side effects, including: chest pain, severe dizziness, fainting, fast/irregular heartbeat, signs of a tear/break in the main blood vessel called the aorta (sudden/severe pain in the stomach/chest/back, cough, shortness of breath).This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Gemifloxacin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. The risk of developing a rash is higher in people younger than 40 years, in women (especially if on hormone replacement treatment), or when gemifloxacin is taken for longer than 7 days. Stop taking gemifloxacin and get medical help right away if you develop any rash.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using gemifloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, levofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, joint/tendon problems (such as tendonitis, bursitis), kidney problems, mental/mood disorders (such as depression), a certain muscle condition (myasthenia gravis), nerve problems (such as peripheral neuropathy), seizure disorder, blood vessel problems (such as aneurysm or blockage of the aorta or other blood vessels, hardening of the arteries), high blood pressure, certain genetic conditions (Marfan syndrome, Ehlers-Danlos syndrome).Gemifloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using gemifloxacin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using gemifloxacin safely.This medication may rarely cause serious changes in blood sugar, especially if you have diabetes. Check your blood sugar regularly as directed and share the results with your doctor. Watch for symptoms of high blood sugar, such as increased thirst/urination. Also watch for symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or by drinking fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Your doctor may need to switch you to another antibiotic or adjust your diabetes medications if any reaction occurs.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Gemifloxacin may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children may be at greater risk for joint/tendon problems while using this drug. Discuss the risks and benefits with the doctor.Older adults may be at greater risk for tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone), QT prolongation, and a sudden tear/break in the main blood vessel (aorta).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug passes into breast milk in small amounts. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: strontium.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Lab tests (such as kidney function, complete blood count, blood sugar, cultures) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              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.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each 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.