SPL MEDGUIDE SECTION
What is the most important information I should know about levofloxacin tablets?
Levofloxacin tablets, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.
If you have any of the following serious side effects while you take levofloxacin tablets, you should stop taking levofloxacin tablets immediately and get medical help right away.
1. Tendon rupture or swelling of the tendon (tendinitis).
• Tendon problems can happen in people of all ages who take levofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Some tendon problems include:
o tears and swelling of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
• The risk of getting tendon problems while you take levofloxacin tablets is higher if you:
o are over 60 years of age
o are taking steroids (corticosteroids)
o have had a kidney, heart or lung transplant.
• Tendon problems can happen in people who do not have the above risk factors when they take levofloxacin tablets.
• Other reasons that can increase your risk of tendon problems can include:
o physical activity or exercise
o kidney failure
o tendon problems in the past, such as in people with rheumatoid arthritis (RA)
• Stop taking levofloxacin tablets immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. Avoid exercise and using the affected area.
• The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
• Tendon rupture can happen while you are taking or after you have finished taking levofloxacin tablets. Tendon ruptures can happen within hours or days of taking levofloxacin tablets and have happened up to several months after people have finished taking their fluoroquinolone.
• Stop taking levofloxacin tablets immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
o hear or feel a snap or pop in a tendon area
o bruising right after an injury in a tendon area
o unable to move the affected area or bear weight
2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including levofloxacin tablets. Stop taking levofloxacin tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
• pain • numbness
• burning • weakness
The nerve damage may be permanent.
3. Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including levofloxacin tablets. Tell your healthcare provider if you have a history of seizures before you start taking levofloxacin tablets. CNS side effects may happen as soon as after taking the first dose of levofloxacin tablets. Stop taking levofloxacin tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
• seizures • trouble sleeping
• hear voices, see things, or sense things that are not there (hallucinations) • nightmares
• feel restless • feel lightheaded or dizzy
• tremors • feel more suspicious (paranoia)
• feel anxious or nervous • suicidal thoughts or acts
• confusion • headaches that will not go away, with or without blurred vision
4. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like levofloxacin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking levofloxacin tablets. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
What are levofloxacin tablets?
Levofloxacin tablets are 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:
• nosocomial pneumonia • plague
• community acquired pneumonia • urinary tract infections, complicated and uncomplicated
• skin infections, complicated and uncomplicated • acute kidney infection (pyelonephritis)
• chronic prostate infection • acute sinus infection
• inhalation anthrax germs • acute worsening or chronic bronchitis
Studies of levofloxacin tablets 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 tablets should not be used in patients with uncomplicated urinary tract infections, acute bacterial exacerbation of chronic bronchitis, or acute bacterial sinusitis if there are other treatment options available.
Levofloxacin tablets are also used to treat children who weigh at least 66 pounds (or at least 30 kilograms) and may have breathed in anthrax germs, have plague, or been exposed to plague germs.
It is not known if levofloxacin tablets are safe and effective in children under 6 months of age.
The safety and effectiveness in children treated with levofloxacin tablets for more than 14 days is not known.
Who should not take levofloxacin tablets?
Do not take levofloxacin tablets: 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 tablets. See the end of this leaflet for a complete list of ingredients in levofloxacin tablets.
Before you take levofloxacin tablets, tell your healthcare provider about all of your medical conditions, including if you:
• have tendon problems; levofloxacin tablets should not be used in people who have a history of tendon problems.
• have a problem that causes muscle weakness (myasthenia gravis); levofloxacin tablets should not be used in people who have a known history of myasthenia gravis.
• have central nervous system problems such as seizures (epilepsy).
• have nerve problems; levofloxacin tablets should not be used in patients how have a history of a nerve problem called peripheral neuropathy.
• have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation.”
• have low blood potassium (hypokalemia).
• have bone problems.
• have joint problems including rheumatoid arthritis (RA).
• have kidney problems. You may need a lower dose of levofloxacin tablets if your kidneys do not work well.
• have liver problems.
• have diabetes or problems with low blood sugar (hypoglycemia).
• are pregnant or plan to become pregnant. It is not known if levofloxacin tablets will harm your unborn child.
• are breastfeeding or plan to breastfeed. It is not known if levofloxacin passes into your breast milk. You and your healthcare provider should decide if you will take levofloxacin tablets or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Levofloxacin tablets and other medicines can affect each other causing side effects.
Especially tell your healthcare provider if you take:
• a steroid medicine.
• an anti-psychotic medicine.
• a tricyclic antidepressant.
• a water pill (diuretic).
• certain medicines may keep levofloxacin tablets from working correctly. Take levofloxacin tablets either 2 hours before or 2 hours after taking these medicines or supplements:
o an antacid, multivitamin, or other medicines or supplements that have magnesium, aluminum, iron, or zinc
o sucralfate (Carafate®)
o didanosine (Videx®, Videx® EC)
• a blood thinner (warfarin, Coumadin, Jantoven).
• an oral anti-diabetes medicine or insulin.
• an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take levofloxacin tablets or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
• theophylline (Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®).
• a medicine to control your heart rate or rhythm (antiarrhythmics).
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 tablets?
• Take levofloxacin tablets exactly as your healthcare provider tells you to take them.
• Take levofloxacin tablets at about the same time each day.
• Drink plenty of fluids while you take levofloxacin tablets.
• Levofloxacin tablets can be taken with or without food.
• If you miss a dose of levofloxacin tablets, take it as soon as you remember. Do not take more than 1 dose in 1 day.
• Do not skip any doses of levofloxacin tablets or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:
o you have tendon problems. See “What is the most important information I should know about levofloxacin tablets?”.
o you have a nerve problem. See “What are the possible side effects of levofloxacin tablets?”.
o you have a central nervous system problem. See “What are the possible side effects of levofloxacin tablets?”.
o you have a serious allergic reaction. See “What are the possible side effects of levofloxacin tablets?”.
o your healthcare provider tells you to stop taking levofloxacin tablets.
Taking all of your levofloxacin tablets doses will help make sure that all of the bacteria are killed. Taking all of your levofloxacin tablets 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 tablets, it may mean that the bacteria causing your infection may be resistant to levofloxacin tablets. If your infection does not get better, call your healthcare provider. If your infection does not get better, levofloxacin tablets and other similar antibiotic medicines may not work for you in the future.
• If you take too much levofloxacin, call your healthcare provider or get medical help right away.
What should I avoid while taking levofloxacin tablets?
• Levofloxacin tablets can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how levofloxacin tablets affects you.
• Avoid sunlamps, tanning beds, and try to limit your time in the sun. Levofloxacin tablets can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take levofloxacin tablets, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.
What are the possible side effects of levofloxacin tablets?
Levofloxacin tablets may cause serious side effects, including:
• See “What is the most important information I should know about levofloxacin tablets?”
• Serious allergic reactions.
Allergic reactions can happen in people taking fluoroquinolones, including levofloxacin tablets, even after only 1 dose. Stop taking levofloxacin tablets and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:
o trouble breathing or swallowing
o swelling of the lips, tongue, face
o throat tightness, hoarseness
o rapid heartbeat
o skin rash
Skin rash may happen in people taking levofloxacin tablets, even after only 1 dose. Stop taking levofloxacin tablets at the first sign of a skin rash and immediately call your healthcare provider. Skin rash may be a sign of a more serious reaction to levofloxacin tablets.
• Liver damage(hepatotoxicity): Hepatotoxicity can happen in people who take levofloxacin tablets. Call your healthcare provider right away if you have unexplained symptoms such as:
o nausea or vomiting
o stomach pain
o abdominal pain or tenderness
o unusual tiredness
o loss of appetite
o light colored bowel movements
o dark colored urine
o yellowing of your skin or the whites of your eyes
Stop taking levofloxacin tablets and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to levofloxacin tablets (a liver problem).
• Aortic aneurysm and dissection
People who take fluoroquinolone medicines, including levofloxacin tablets, have an increased risk of swelling of the large artery that carries blood from the heart to the body (aortic aneurysm) and tearing (dissection) of this artery. Tell your healthcare provider if you have ever been told that you have an aortic aneurysm. Get emergency medical help right away if you have sudden chest, stomach, or back pain.
• Intestine infection (Pseudomembranous colitis)
Pseudomembranous colitis can happen with many antibiotics, including levofloxacin tablets. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.
• Serious heart rhythm changes (QT prolongation and torsades de pointes)
Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Levofloxacin tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:
o who are elderly
o with a family history of prolonged QT interval
o with low blood potassium (hypokalemia)
o who take certain medicines to control heart rhythm (antiarrhythmics)
• Joint Problems
Increased chance of problems with joints and tissues around joints in children can happen. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with levofloxacin tablets.
• Changes in blood sugar
People who take levofloxacin tablets and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider’s instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking levofloxacin tablets, stop taking levofloxacin tablets and call your healthcare provider right away. Your antibiotic medicine may need to be changed.
• Sensitivity to sunlight (photosensitivity)
See “What should I avoid while taking levofloxacin tablets?”
The most common side effects of levofloxacin tablets include:
In children 6 months and older who take levofloxacin tablets to treat anthrax disease or plague, vomiting is also common.
Levofloxacin tablets 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 tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store levofloxacin tablets?
• Store levofloxacin tablets at 20° to 25°C (68° to 77°F)
• Keep levofloxacin tablets in a tightly closed container.
General information about the safe and effective use of levofloxacin tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levofloxacin tablets for a condition for which it is not prescribed. Do not give levofloxacin tablets 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 tablets. If you would like more information about levofloxacin tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about levofloxacin tablets that is written for healthcare professionals.
What are the ingredients in levofloxacin tablets?
Active ingredient: levofloxacin, USP
Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.
Levofloxacin Tablets USP, 250 mg also contains iron oxide red.
Levofloxacin Tablets USP, 500 mg also contains iron oxide red and iron oxide yellow.
For more information, call 1-866-495-1995.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication Guide available at http://camberpharma.com/medication-guides
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
Hetero Labs Limited, Unit V, Polepally, Jadcherla,
Mahabubnagar — 509 301, India. Revised: January 2019
Repackaged By: Preferred Pharmaceuticals Inc.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
500 mg 50s Label:
| LEVOFLOXACIN levofloxacin tablet, film coated |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:68788-6938(NDC:31722-722) |
|Route of Administration ||ORAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) ||LEVOFLOXACIN ANHYDROUS ||500 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| CROSCARMELLOSE SODIUM || |
| HYPROMELLOSE, UNSPECIFIED || |
| MAGNESIUM STEARATE || |
| MICROCRYSTALLINE CELLULOSE || |
| POLYETHYLENE GLYCOL, UNSPECIFIED || |
| POLYSORBATE 80 || |
| POVIDONE, UNSPECIFIED || |
| TITANIUM DIOXIDE || |
| FERRIC OXIDE RED || |
| FERRIC OXIDE YELLOW || |
|Product Characteristics |
|Color ||ORANGE ||Score ||no score |
|Shape ||CAPSULE ||Size ||18mm |
|Flavor || ||Imprint Code ||I;26 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:68788-6938-7 ||7 TABLET, FILM COATED in 1 BOTTLE ||None |
| 2 ||NDC:68788-6938-1 ||10 TABLET, FILM COATED in 1 BOTTLE ||None |
| 3 ||NDC:68788-6938-4 ||14 TABLET, FILM COATED in 1 BOTTLE ||None |
| 4 ||NDC:68788-6938-2 ||20 TABLET, FILM COATED in 1 BOTTLE ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|ANDA ||ANDA202801 ||04/04/2017 || |
|Labeler — Preferred Pharmaceuticals, Inc.
|Registrant — Preferred Pharmaceuticals, Inc. (791119022) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Preferred Pharmaceuticals, Inc. || ||791119022 ||REPACK (68788-6938) |
Revised: 06/2020 Preferred Pharmaceuticals, Inc.
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.