LEVOFLOXACIN- levofloxacin solution 
Department of State Health Services, Pharmacy Branch


17.6 FDA-Approved Medication Guide


LevofloxacinOral Solution

25 mg/mL

Read this Medication Guide Levofloxacin before you start taking Levofloxacin and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Levofloxacin?

Levofloxacin, a fluoroquinolone, can cause serious side effects. Some of these serious side effects could result in death.

If you have any of the following serious side effects while you take Levofloxacin, get medical help right away. Talk with your healthcare provider about whether you should continue to take Levofloxacin.

1. Tendon rupture or swelling of the tendon (tendinitis).

2. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like Levofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

What is Levofloxacin?

Levofloxacin is a fluoroquinolone antibiotic medicine used in adults age 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:

Studies of Levofloxacin for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.

Levofloxacin is also used to treat children who are 6 months of age or older and may have breathed in anthrax germs, have plague, or been exposed to plague germs.

It is not known if Levofloxacin is safe and effective in children under 6 months of age.

The safety and effectiveness in children treated with Levofloxacin for more than 14 days is not known.

Who should not take Levofloxacin?

Do not take Levofloxacin if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to Levofloxacin or any of the ingredients in Levofloxacin. See the end of this leaflet for a complete list of ingredients in Levofloxacin.

What should I tell my healthcare provider before taking Levofloxacin?

Before you take Levofloxacin, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements

Levofloxacin and other medicines can affect each other causing side effects.

Especially tell your healthcare provider if you take:

Ask your healthcare provider if you are not sure if any of your medicines are listed above.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Levofloxacin?

Taking all of your Levofloxacin doses will help make sure that all of the bacteria are killed. Taking all of your Levofloxacin doses will help you lower the chance that the bacteria will become resistant to Levofloxacin. If your infection does not get better while you take Levofloxacin, it may mean that the bacteria causing your infection may be resistant to Levofloxacin. If your infection does not get better, call your healthcare provider. If your infection does not get better, Levofloxacin and other similar antibiotic medicines may not work for you in the future.

What should I avoid while taking Levofloxacin?

What are the possible side effects of Levofloxacin?

Levofloxacin can cause serious side effects, including:

Levofloxacin may need to be stopped to prevent permanent nerve damage.

The most common side effects of Levofloxacin include:

In children 6 months and older who take Levofloxacin to treat anthrax disease or plague, vomiting is also common.

Levofloxacin may cause false-positive urine screening results for opiates when testing is done with some commercially available kits. A positive result should be confirmed using a more specific test.

These are not all the possible side effects of Levofloxacin. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1 800-FDA-1088.


How should I store Levofloxacin?

Store Levofloxacin Oral Solution at 59°F to 86°F (15°C to 30°C). Keep the container closed tightly.

Keep Levofloxacin and all medications out of the reach of children.

General information about the safe and effective use of Levofloxacin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Levofloxacin for a condition for which it is not prescribed. Do not give Levofloxacin to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Levofloxacin. If you would like more information about Levofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Levofloxacin that is written for healthcare professionals.

What are the ingredients in Levofloxacin?

Levofloxacin Oral Solution:

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

MG #27439

Revised August 2012

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 3/2016
Department of State Health Services, Pharmacy Branch