Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups. This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients. (See Tendinopathy and Tendon Rupture under Cautions.)
REMS:
FDA approved a REMS for levofloxacin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of levofloxacin and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. This medicine can be taken with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not skip doses or stop your medicine early even if you feel better. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or health care professional if your symptoms do not improve or if they get worse. Drink several glasses of water a day and cut down on drinks that contain caffeine. You must not get dehydrated while taking this medicine.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not sit or stand up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use a sunscreen. Do not use sun lamps or tanning beds/booths. Contact your doctor if you get a sunburn.
If you are a diabetic monitor your blood glucose carefully. If you get an unusual reading stop taking this medicine and call your doctor right away.
Do not treat diarrhea with over-the-counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if the diarrhea is severe and watery.
Avoid antacids, calcium, iron, and zinc products for 4 hours before and 2 hours after taking a dose of this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep in a tightly closed container. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
