Gemifloxacin

Gemifloxacin is a prescription medication used for the treatment of chronic bronchitis and community-acquired pneumonia.

• Gemifloxacin is available under the following different brand names: Factive

Adult dosage

Tablets

• 320mg

Acute Exacerbations of Chronic Bronchitis

Adult dosage

• 320 mg orally every day for 5 days

Pneumonia (community-acquired)

Adult dosage

• (Multidrug-resistant S. pneumoniae; K. pneumoniae; M. catarrhalis): 320 mg orally every day for 7 days
• (S. pneumoniae; M. pneumoniae; H. influenzae; C. pneumoniae): 320 mg orally every day for 5days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Gemifloxacin include:

• nausea,
• stomach pain,
• coughing up blood,
• headache,
• skin rash, and
• joint pain.

Serious side effects of the Gemifloxacin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• sore throat,
• burning in your eyes,
• skin pain,
• red or purple skin rash that spreads and causes blistering and peeling,
• mood or behavior changes,
• headache,
• hunger,
• sweating,
• irritability,
• dizziness,
• nausea,
• fast heart rate,
• anxiousness,
• shakiness,
• numbness,
• weakness,
• tingling,
• burning pain,
• nervousness,
• confusion,
• agitation,
• paranoia,
• hallucinations,
• memory problems,
• trouble concentrating,
• thoughts of self-harm,
• sudden pain,
• swelling,
• bruising,
• tenderness,
• stiffness,
• difficulty moving,
• snapping or popping sound in any of the joints,
• severe and continuous pain in your chest, stomach, or back,
• severe stomach pain,
• watery or bloody diarrhea,
• fast or pounding heartbeats,
• fluttering in your chest,
• shortness of breath,
• sudden dizziness,
• skin rash (no matter how mild),
• muscle weakness,
• yellowing of the skin or eyes (jaundice),
• seizure,
• severe headaches,
• ringing in the ears,
• vision problems, and
• pain behind the eyes

Rare side effects of the Gemifloxacin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Gemifloxacin has severe interactions with the following drugs:
  • dronedarone
  • quinidine
  • thioridazine
• Gemifloxacin has serious interactions with at least 86 other drugs.
• Gemifloxacin has moderate interactions with at least 185 other drugs.
• Gemifloxacin has minor interactions with at least 24 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• All drugs or conditions that prolong QT interval
• Documented hypersensitivity to gemifloxacin or other fluoroquinolones

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gemifloxacin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gemifloxacin?”

Cautions

• May prolong QT interval
• May cause a 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 (e.g., renal, hepatic, hematopoietic); adjust the dose in renal function impairment; superinfections may occur with prolonged or repeated antibiotic therapy
• Not drug of the 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 (i.e., CrCl less than 50 mL/min)
• Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all ages, this risk is further increased in older patients usually over 60 years, 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 a 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 that 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 is 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 the rate of aortic aneurysm and dissection reported within two months following the 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 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

Pregnancy and Lactation

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