Factive Warnings and Precautions
If you are taking Factive for your bacterial infection, it is important to know that this medication can cause problems, such as tendon problems and neurological side effects. Other safety precautions with Factive involve warnings about taking this drug while pregnant or breastfeeding. It should also be noted that this drug can cause severe allergic reactions in some people.
What Should I Tell My Healthcare Provider?You should talk with your healthcare provider prior to using Factive® (gemifloxacin mesylate) 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.
- Pregnant or thinking of becoming pregnant
Specific Precautions and Warnings With FactiveSome warnings and precautions to be aware of prior to taking this antibiotic include:
- Like all quinolones, Factive 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 Factive, 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 Factive.
- Factive can cause severe allergic reactions. Contact your healthcare provider immediately if you develop any signs of an allergic reaction, such as:
- A rash
- Swelling of the lips or throat
- Difficulty breathing.
- Central nervous system problems and neurological side effects have been reported with Factive use, sometimes even after just one dose. Such problems may include:
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.
- Factive 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 Factive Drug Interactions).
- People taking Factive may be more sensitive to the sun. Try to avoid sun exposure, including natural sun and tanning beds, while taking Factive. 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.
- Factive 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 Factive. Therefore, you should avoid driving or doing anything that requires mental alertness until you know how you will react to this medication.
- Factive 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 Factive use.
- Antibiotics like Factive 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 Factive treatment, or months after you stop taking it.
- Factive may react with several other medications (see Factive Drug Interactions).
- Factive 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 Factive passes through breast milk. Therefore, if you are breastfeeding a child, check with your healthcare provider before taking this drug (see Factive and Breastfeeding).