• Treatment of the following bacterial respiratory infections: :
  • Acute bacterial exacerbations of chronic bronchitis (should be used only when there are no other alternative treatment options),
  • Community-acquired pneumonia.

Contraindicated in:

• Hypersensitivity (cross-sensitivity within class may exist)
• History of myasthenia gravis (may worsen symptoms including muscle weakness and breathing problems)
• QTc interval prolongation
• Uncorrected hypokalemia or hypomagnesemia
• Concurrent use of Class IA antiarrhythmics (disopyramide, quinidine, procainamide) or Class III antiarrhythmics (amiodarone, sotalol) (↑risk of QTc interval prolongation and torsades de pointes)
• OB: Pregnancy (may cause fetal harm).

Use Cautiously in:

• Known or suspected CNS disorder
• Renal impairment (↓ dose if CCr 40 mL/min)
• Concurrent use of erythromycin, antipsychotics, and tricyclic antidepressants (↑risk of QTc interval prolongation and torsade de pointes)
• Concurrent use of corticosteroids (↑ risk of tendinitis/tendon rupture)
• Kidney, heart, or lung transplant patients (↑ risk of tendinitis/tendon rupture)
• Patients with or at risk for aortic aneurysms
• Lactation: Use while breastfeeding only if potential maternal benefit outweighs potential risk to infant
• Pedi: Safety and effectiveness not established in children
• Geri: ↑risk of tendon disorders/rupture, aortic aneurysm/dissection (within 2 mo following discontinuation), and QT interval prolongation in older adults.

CV: AORTIC ANEURYSM/DISSECTION, TORSADE DE POINTES, QT interval prolongation.

Derm: STEVENS-JOHNSON SYNDROME, photosensitivity, rash.

Endo: hyperglycemia, hypoglycemia.

GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, abdominal pain, nausea, vomiting.

MS: arthralgia, myalgia, tendinitis, tendon rupture.

Neuro: peripheral neuropathy , ELEVATED INTRACRANIAL PRESSURE (INCLUDING PSEUDOTUMOR CEREBRI), SEIZURES, SUICIDAL THOUGHTS, agitation, anxiety, confusion, depression, dizziness, drowsiness, hallucinations, headache, insomnia, nightmares, paranoia, toxic psychosis, tremor.

Drug-Drug:

• Concurrent use ofamiodarone, disopyramide, erythromycin, procainamide, dofetilide, quinidine, some antipsychotics, sotalol, or tricyclic antidepressants↑ risk of torsade de pointes in susceptible individuals (avoid concurrent use).
• Administration with magnesium and aluminum-containing antacids, iron salts, bismuth subsalicylate, sucralfate, didanosine (chewable/buffered tablets or pediatric powder for oral solution), zinc salts, and other metals↓ absorption.
• Concurrent use of corticosteroids may ↑ the risk of tendon rupture.
• May ↑ the risk of nephrotoxicity from cyclosporine.
• Levels are ↑ by probenecid.
• May ↑ risk of hypoglycemia when used with antidiabetic agents.

(Generic available)

• Tablets: 320 mg;

Acute Bacterial Exacerbation of Chronic Bronchitis

• PO (Adults): 320 mg once daily for 5 days.

Community-Acquired-Pneumonia

• PO (Adults): 320 mg once daily for 7 days.

Factive

• Inhibits bacterial DNS synthesis by inhibiting DNA gyrase enzyme.

• Death of susceptible bacteria resulting in resolution of infection.

Spectrum:

• Active against gram-positive pathogens including:
  • Streptococcus pneumoniae.
• Gram-negative spectrum notable for:
  • Klebsiella pneumoniae,
  • Haemophilus influenzae,
  • Haemophilus parainfluenzae,
  • Moraxella catarrhalis.
• Additional spectrum includes:
  • Chlamydia pneumoniae,
  • Mycoplasma pneumoniae.

Therapeutic Classification: anti-infectives

Pharmacologic Classification: Fluoroquinolones

Absorption: 71% absorbed following oral administration.

Distribution: Widely distributed; penetrates lung tissue and fluids well.

Metabolism/Excretion: Minimal metabolism; 61% excreted unchanged in feces, 36% excreted unchanged in urine.

Half-life: 7 hr.

(blood levels)

• Instruct patient to take medication as directed and to finish drug completely, even if feeling better. Take missed doses as soon as remembered, unless almost time for next dose. Do not double doses or take more than 1 dose/day. Advise patient that sharing of this medication may be dangerous. Caution patients that gemifloxacin should only be used to treat bacterial infections; it is not effective against viral infections, such as the common cold.
• Encourage patient to maintain a fluid intake of at least 1500–2000 mL/day to prevent crystalluria.
• Advise patient that antacids or medications containing calcium, magnesium, aluminum, iron, or zinc will decrease absorption and should not be taken within 3 hr before or 2 hr after gemifloxacin.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to notify health care professional of any personal or family history of QTc prolongation or proarrhythmic conditions such as recent hypokalemia, significant bradycardia, or recent myocardial ischemia or if fainting spells or palpitations occur. Patients with this history should not receive gemifloxacin.
• Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions during and for 5 days after therapy. Notify health care professional if a sunburn-like reaction or skin eruption occurs.
• Advise patient to notify health care professional if signs and symptoms of peripheral neuropathy (pain, burning, tingling, numbness, weakness, other alterations in sensations of light touch, pain, temperature, position sense, and vibratory sensation). May require discontinuation of therapy; may be irreversible.
• Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools).
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
• Instruct patient to notify health care professional immediately if rash, jaundice, signs of hypersensitivity, seizures, or tendon (shoulder, hand, Achilles, and other) pain, swelling, or inflammation occur. If tendon rupture symptoms (patient hears or feels a snap or pop in a tendon area, bruising right after an injury in a tendon area, or is unable to move affected area or bear weight) occur, avoid exercise and use of the affected area. Increased risk in >65 yrs old, kidney, heart and lung transplant recipients, and patients taking corticosteroids concurrently. Therapy should be discontinued.
• Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior.
• Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

gem-i-FLOX-a-sin