FACTIVE (gemifloxacin mesylate)

There are 8 contraindications. Absolute contraindication.

Contraindication List
Aortic aneurysm
Congenital long QT syndrome
Dissection of aorta
Ehlers-danlos syndrome
Loeys-dietz syndrome
Marfan syndrome
Myasthenia gravis
Torsades de pointes

There are 12 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Cardiac transplantation
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Clostridioides difficile infection
Hypokalemia
Hypomagnesemia
Lung transplantation
Prolonged QT interval
Renal transplant
Tendon rupture
Tendonitis

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Bradycardia
Diabetes mellitus
Hypoglycemic disorder
Idiopathic intracranial hypertension
Intracranial hypertension
Peripheral neuropathy
Seizure disorder
Toxic psychosis

There are 59 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare

Abnormal hepatic function tests Agranulocytosis Anaphylaxis Anemia Angioedema Aortic aneurysm Aplastic anemia Arterial dissection Clostridioides difficile infection Dissection of aorta Drug-induced psychosis Dysesthesia Dyspnea Eosinophilia Erythema multiforme Facial edema Granulocytopenic disorder Hemolytic anemia Hemorrhage Hepatic necrosis Hepatitis Hyperbilirubinemia Hypersensitivity drug reaction Hypersensitivity pneumonitis Hypoesthesia Hypoglycemic disorder Increased alanine transaminase Increased aspartate transaminase Interstitial nephritis Intracranial hypertension Jaundice Leukopenia Muscle weakness Neuromuscular blockade Non-traumatic rupture of achilles tendon Pancytopenia Paresthesia Peripheral neuropathy Pharyngitis Prolonged QT interval Renal failure Retinal hemorrhage Rhabdomyolysis Rotator cuff tendon rupture Serum sickness Stevens-johnson syndrome Suicidal ideation Syncope Tendon rupture Tendon rupture extensor of hand and wrist Tendon rupture flexor of hand and wrist Tendonitis Thrombocytopenic disorder Thrombotic thrombocytopenic purpura Torsades de pointes Toxic epidermal necrolysis Transient cerebral ischemia Valvular regurgitation Vasculitis

There are 48 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Headache disorder Nausea Skin rash	None.

Rare/Very Rare

Abdominal pain with cramps Acute cognitive impairment Agitation Anorexia Arthralgia Arthritis Back pain Candidiasis Constipation Cramps in legs Delirium Depression Disturbance of attention Dizziness Drowsy Dysgeusia Dyspepsia Eczema Fatigue Fever Flushing Fungal infection Gastroenteritis General weakness Genital organ pruritus Hallucinations Hyperglycemia Insomnia Memory impairment Myalgia Nervousness Pain Peripheral edema Pruritus of skin Skin inflammation Skin photosensitivity Supraventricular tachycardia Tremor Urticaria Vaginitis Vertigo Visual changes Vomiting Xerostomia

Available data regarding use of gemifloxacin in pregnant women are insufficient to inform any drug-associated risk for miscarriages, major birth defects, and/or adverse maternal or fetal outcomes. Based on results of animal studies, gemifloxacin may cause fetal harm. Administration of gemifloxacin to pregnant mice or rabbits produced embryofetal toxicity (e.g., fetal growth retardation, reduced fetal body weight, delayed skeletal ossification) at exposures 2 or 3 times, respectively, the human exposure reported with the maximum recommended dosage of the drug. Pregnant women should be advised of the potential risk to the fetus.

It is not known whether gemifloxacin is distributed into human milk, affects milk production, or affects the breast-fed infant. Gemifloxacin is distributed into milk in rats. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for gemifloxacin and potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Approximately 29% of patients included in clinical studies of gemifloxacin were 65 years of age or older and 11% were 75 years of age or older. No overall differences in safety or efficacy were observed between geriatric individuals and younger adults. Although the incidence of rash appears to be lower in geriatric patients than in those younger than 40 years of age, the reason for this observation has not been clearly elucidated.

The risk of developing severe tendon disorders, including tendon rupture, is increased in older adults (usually those older than 60 years of age). This risk is further increased in those receiving concomitant corticosteroids. (See Tendinitis and Tendon Rupture under Warnings/Precautions: Warnings, in Cautions.) Caution is advised if gemifloxacin is used in geriatric adults, especially those receiving concomitant corticosteroids.

The risk of aortic aneurysm and dissection may be increased in geriatric patients. (See Risk of Aortic Aneurysm and Dissection under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) The risk of QT interval prolongation may be increased in geriatric patients. Concomitant use of gemifloxacin and class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents and use in patients with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia) should be avoided.

(See Prolongation of QT Interval under Warnings/Precautions: Warnings, in Cautions.) The pharmacokinetics of gemifloxacin in adults are not affected by age.