Precautions and Warnings With Gemifloxacin

Before using gemifloxacin, there are many precautions to be aware of, including warnings on who should not use the drug and possible side effects that may occur. For example, this prescription antibiotic could cause tendon problems or a dangerous irregular heart rhythm, and may not be safe for people with certain allergies.

What Should I Tell My Healthcare Provider Before Taking Gemifloxacin?

You should talk with your healthcare provider prior to using gemifloxacin mesylate (Factive®) if you have:
  • Kidney disease, such as kidney failure (renal failure)
  • Tendon problems
  • Any nerve disorders, such as neuropathy
  • A history of a seizure or have epilepsy
  • An irregular heartbeat or a heart rhythm problem known as QT prolongation, or have family members with these problems
  • Rheumatoid arthritis or other problems with your joints
  • Low potassium or magnesium levels in the blood
  • Myasthenia gravis
  • Any allergies, including to medications, foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Gemifloxacin Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this antibiotic include:
  • Like all quinolones, gemifloxacin may cause tendon problems, including tendon rupture. People who are over the age of 60, who have had liver, lung, or heart transplants, or who take corticosteroid drugs are at an increased risk for tendon problems.

Contact your healthcare provider right away if you have any tendon pain, soreness, or swelling, or if you experience weakness or difficulty moving any of your joints. Do not exercise until your healthcare provider makes sure you do not have a ruptured tendon (see Factive and Tendon Rupture for more information).

  • Quinolone antibiotics, including gemifloxacin, have been linked to worsening of myasthenia gravis. In some cases, this has led to hospitalization and even death. As a general rule, people who have myasthenia gravis should not take gemifloxacin.
  • Gemifloxacin can cause severe allergic reactions. Contact your healthcare provider immediately if you develop any signs of an allergic reaction, such as:
    • A rash
    • Hives
    • Itching
    • Swelling of the lips or throat
    • Wheezing
    • Difficulty breathing.
  • Central nervous system problems and neurological side effects have been reported with gemifloxacin use, sometimes even after just one dose. Such problems may include:
    • Seizures
    • Tremors
    • Confusion
    • Dizziness
    • Hallucinations
    • Paranoia
    • Anxiety
    • Depression
    • Nervousness
    • Agitation
    • Nightmares
    • Suicidal thoughts or acts.
Certain conditions, including epilepsy, cerebral arteriosclerosis, and kidney disease, can increase the risk for developing these problems. Let your healthcare provider know if you have any of these conditions.
  • Gemifloxacin may cause a rare and potentially dangerous heart rhythm problem known as QT prolongation. This problem may be more common in older adults, people with low blood potassium, or those taking certain other medications (see Drug Interactions With Gemifloxacin).
  • People taking gemifloxacin may be more sensitive to the sun. Try to avoid sun exposure, including natural sun and tanning beds, while taking gemifloxacin. If you do go out in the sun, wear protective clothing and sunscreen. Contact your healthcare provider if you develop a severe sunburn while taking this medication.
  • Gemifloxacin has been reported to cause a nerve problem called peripheral neuropathy. If you develop any unusual sensations while taking this medication, such as pain, burning, tingling, prickling, or weakness, contact your healthcare provider right away to reduce the chance of permanent nerve damage.
  • You may become dizzy or lightheaded while taking gemifloxacin. Therefore, you should avoid driving or doing anything that requires mental alertness until you know how you will react to this medication.
  • Gemifloxacin has been associated with muscle, joint, or tendon problems in children. This medication is not approved for use in children. However, if your child is taking it, contact his or her healthcare provider immediately if any muscle, joint, or tendon problems (such as weakness, soreness, or swelling) occur during or after gemifloxacin use.
  • Antibiotics like gemifloxacin can disrupt the normal bacteria in the digestive tract, allowing undesirable bacteria to overgrow. This can potentially lead to a serious problem known as pseudomembranous colitis.

Therefore, make sure to let your healthcare provider know if you experience bloody or watery diarrhea. While mild, short-term diarrhea is a common side effect of antibiotic use, bloody or watery diarrhea may be signs of a potentially life-threatening problem. This severe reaction can occur during gemifloxacin treatment, or months after you stop taking it.

  • Gemifloxacin is a pregnancy Category C medication, which means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Factive and Pregnancy for more information).
  • It is unknown if gemifloxacin passes through breast milk. Therefore, if you are breastfeeding a child, check with your healthcare provider before taking this drug (see Factive and Breastfeeding).
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