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jem-i-FLOX-a-sin
Fluoroquinolones, including gemifloxacin mesylate, 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 of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants .
Fluoroquinolones, including gemifloxacin mesylate, are associated with an increased risk of tendinitis and tendon rupture in all ages. Risk further increases with age over 60 years, concomitant steroid therapy, and kidney, heart, or lung transplants .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antibiotic
Chemical Class: Fluoroquinolone
Gemifloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It is used to treat bronchitis and pneumonia caused by bacterial infections.
Gemifloxacin works by killing bacteria or preventing their growth. However, gemifloxacin will not work for colds, flu, or other virus infections.
gemifloxacin is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For gemifloxacin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to gemifloxacin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of gemifloxacin in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemifloxacin in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems, or develop severe tendon problems (including tendon rupture), which may require caution in patients receiving gemifloxacin.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using gemifloxacin.
Using gemifloxacin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using gemifloxacin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using gemifloxacin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of gemifloxacin. Make sure you tell your doctor if you have any other medical problems, especially:
Take gemifloxacin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
gemifloxacin should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Gemifloxacin may be taken with or without food. The tablet must be swallowed whole. Do not chew the tablet.
Drink plenty of fluids while you are taking gemifloxacin. Drinking extra water will help prevent some unwanted effects of gemifloxacin.
gemifloxacin works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Try to take the medicine at the same time each day.
If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, sucralfate, or zinc, do not take them at the same time that you take gemifloxacin. It is best to take these medicines 3 hours before or 2 hours after taking gemifloxacin. These medicines may keep gemifloxacin from working properly.
Keep using gemifloxacin for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
The dose of gemifloxacin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of gemifloxacin. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of gemifloxacin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
For patients with low potassium levels, gemifloxacin may increase your risk of having a fast, slow or irregular heartbeat; loss of consciousness, or fainting spells. If these symptoms occur, tell your doctor right away.
gemifloxacin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash; itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you take gemifloxacin.
Gemifloxacin may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.
Gemifloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can occur while you are taking the medicine or after you finish taking it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (e.g., dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (e.g., rheumatoid arthritis), or if you have received an organ transplant (e.g., heart, kidney, or lung). Stop using gemifloxacin and check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (e.g., ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.
Some people who take gemifloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn; skin rash, redness, itching, or discoloration. When you begin taking gemifloxacin:
If you have a severe reaction from the sun, check with your doctor.
Gemifloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to gemifloxacin before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If these reactions are especially bothersome, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less commonSome side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
RareOther side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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