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DESCRIPTION:
gemifloxacin mesylate is a synthetic broad-spectrum antibacterial agent for oral administration. Gemifloxacin, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form.
USES
Acute Exacerbations of Chronic Bronchitis
Pneumonia (community-acquired)
How to take
- Use gemifloxacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Gemifloxacin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get gemifloxacin refilled.
- Take gemifloxacin by mouth with or without food.
- Swallow gemifloxacin whole. Do not break, crush, or chew before swallowing.
- Take gemifloxacin with a full glass of water.
- Gemifloxacin works best if it is taken at the same time each day.
- Drinking extra fluids while you are taking gemifloxacin is recommended. Check with your doctor for instructions.
- Avoid taking gemifloxacin with dairy products (eg, milk, yogurt) or calcium-fortified juices by themselves. However, taking gemifloxacin as part of a full meal that contains these products is permitted.
- If you are also taking aluminum or magnesium (eg, certain antacids), calcium, iron, zinc, multivitamins, or certain forms of didanosine (chewable/buffered tablets, pediatric powder for oral solution), do not take it within 3 hours before or 2 hours after you take gemifloxacin.
- If you are also taking sucralfate, take gemifloxacin at least 2 hours before taking sucralfate.
- To clear up your infection completely, take gemifloxacin for the full course of treatment. Keep taking it even if you feel better in a few days.
- Do not miss any doses of gemifloxacin. If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose in the same day.
- Gemifloxacin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to gemifloxacin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Gemifloxacin may cause dizziness, drowsiness, or light-headedness. These effects may be worse if you take it with certain medicines. Use gemifloxacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Dosage and Administration
Dosage in adult patients with normal renal function
Acute Exacerbations of Chronic Bronchitis
320 mg orally every 24 hours for 5 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis
Use: For the treatment of ABECB due to susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, H parainfluenzae, or Moraxella catarrhalis
Pneumonia (community-acquired)
(Multidrug resistant S. pneumoniae; K. pneumoniae; M. catarrhalis):320 mg orally every 24 hours for 7 days
(S. pneumoniae; M. pneumoniae; H. influenzae; C. pneumoniae): 320 mg orally every 24 hours for 5 days
Dosage Modifications
Renal impairment
CrCl 40 mL/min or less: 160 mg orally every 24 hours
Pediatric: Safety and effectiveness in children and adolescents less than 18 years of age have not been established.
Warning and Precautions
- Tell your doctor right away if you experience pain or swelling of a tendon, or weakness or loss of use of a joint area. Rest the area and avoid exercise until your doctor gives you instructions.
- Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and dietary supplements. Gemifloxacin and other medicines may affect each other, causing serious side effects. Be sure to tell your healthcare provider if you take:
medicines for your heart rhythm called “antiarrhythmics” , erythromycin , medicines for your mental health called “antipsychotics” or “tricyclic
antidepressants” , medicines called “corticosteroids”, taken by mouth or by injection , medicines called “water pills” (diuretics) such as furosemide and
hydrochlorothiazide; medicines to thin your blood (called oral anticoagulants) such as warfarin.
Contact your doctor or health care provider right away if any of these apply to you.
- you are allergic to any ingredient in gemifloxacin or to any other fluoroquinolone antibiotic (eg, ciprofloxacin)
- you have uncorrected blood electrolyte levels (eg, low potassium or magnesium)
- you have a history of myasthenia gravis or of a certain type of irregular heartbeat (eg, QT interval prolongation)
- you are taking certain medicines for heart rhythm problems (eg, amiodarone, procainamide, quinidine, sotalol)
- have central nervous system problems (such as epilepsy)
Pregnancy and breastfeeding
Pregnancy: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus; safety has not been established during pregnancy. US FDA pregnancy category: C
Lactation: excretion in milk unknown; do not use unless benefit to mother outweighs risk
Side effects
All medicines may cause side effects, but many people have no, or minor, side effects.
- Those indicating need for medical attention:
Rash, anemia, dyspnea ( shortness of breath, difficult or labored breathing, tightness in chest, wheezing), fungal infection,
peripheral neuropathy, pharyngitis, pneumonia, pruritus, thrombocytopenia
-
Those indicating need for medical attention only if they continue or are bothersome:
Abdominal pain, abnormal urin, back pain , constipation, dermatitis, dizziness, dry mouth, fatigue, leg cramps, insomnia,
photosensitivity, vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.
Storage
- Store gemifloxacin below 30˚C.
- Store away from heat, moisture, and light.
- Keep gemifloxacin out of the reach of children and away from pets.