GEMIFLOXACIN

Tendon damage can be rarely caused by this drug. Risks are greater if you are over 60 years of age, taking corticosteroids (such as prednisone), or have had a kidney, heart or lung transplant. Stop exercising, rest, and seek immediate medical attention if you develop joint/muscle/tendon pain or swelling.

Gemifloxacin should not be used in patients with myasthenia gravis because it worsens the condition. Seek immediate medical attention if you develop muscle weakness or trouble breathing.

Tell your doctor or pharmacist promptly if any of these effects persist or worsen:

• Nausea
• Diarrhea
• Dizziness
• Lightheadedness
• Headache
• trouble sleeping

Tell your doctor immediately if skin that sunburns more easily (sun sensitivity) occur.

Tell your doctor immediately if any of these rare but very serious side effects occur:

• unusual bruising/bleeding
• signs of a new infection (e.g., new/persistent fever, persistent sore throat)
• unusual change in the amount of urine
• signs of liver problems (e.g., unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine)

Seek immediate medical attention if any of these rare but very serious side effects occur:

• chest pain
• severe/persistent headache
• vision changes
• shaking (tremors)
• seizures
• severe dizziness
• fainting
• fast/irregular heartbeat
• mental/mood changes (e.g., anxiety, confusion, hallucinations, depression, rare thoughts of suicide)

Rarely, this medication may cause serious, possibly permanent, nerve problems (peripheral neuropathy). Stop taking gemifloxacin and tell your doctor right away if you have any pain/numbness/burning/tingling/weakness in your arms, hands, legs, or feet, and changes in how you sense touch/pain/temperature/vibration/body position.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is unlikely. The risk of developing a rash during gemifloxacin treatment is greater in people under age 40, in women, and also in women taking female hormone replacement medication (e.g., estrogens). This risk also increases when gemifloxacin is taken for more than 7 days. Seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction:

• new fever
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before using gemifloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (e.g., ciprofloxacin, levofloxacin); or if you have any other allergies. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• heart problems (e.g., slow/fast/irregular heartbeat, chest pain, recent heart attack)
• joint/tendon problems (e.g., tendonitis, bursitis)
• kidney disease
• myasthenia gravis
• nerve problems (such as peripheral neuropathy)
• seizure disorder
• conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors, cerebral atherosclerosis)

Gemifloxacin may cause fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using gemifloxacin safely.

Watch for symptoms of high blood sugar including increased thirst and urination. Also watch for symptoms of low blood sugar such as nervousness, shakiness, fast heartbeat, sweating, or hunger. Check your blood sugar regularly as directed by your doctor and report any changes. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Your doctor may need to switch you to another antibiotic or adjust your diabetes medications if any reaction occurs.

This drug may make you dizzy. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in children because they may be more sensitive to its possible side effects (e.g., joint/tendon problems). Discuss the risks and benefits with the doctor.

Older adults may be more sensitive to the side effects of this drug, such as tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone) and QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Laboratory and/or medical tests (e.g., blood pressure, complete blood counts before each dose, kidney function tests, liver function tests, serum albumin) should be performed from time to time to monitor for side effects and response to treatment. Consult your doctor for more details. Keep all scheduled medical appointments.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic and will not be stored at home.

Brands

Available Brands

Also marketed as