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Levaquin

Infectious Disease News

Levaquin
May 12, 2012 12:40PM

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May 11, 2012 06:08AM

Infections Cause 1 in 6 Cancers

Millions of people around the world are diagnosed with cancer after being infected with a virus, bacteria or parasite. That accounts for one in six cancers.

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May 10, 2012 11:03AM

Taking Charge: Getting Tested for HIV

As you're boarding the bus, you see an ad that asks you to “Take Charge. Take the Test.” The test is free, and you don't have to study. The results are simple: Your HIV status.

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May 09, 2012 09:46PM

Pills That Prevents HIV?

For decades, researchers have struggled to find medical defenses against HIV infection. Now, an effective option is on the table: Popping a preventative pill called Truvada.

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May 09, 2012 03:44PM

Interferon and Depression

Depressive symptoms may be present in patients with hepatitis C before they begin treatment. But research suggests that the hepatitis C drug, interferon, also contributes to depression.

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May 08, 2012 02:31PM

Gene Therapy Safe for HIV Patients

It's hoped that gene therapy – altering the genetic code in a patient's cells – will someday cure disease. But today, it's enough to know that it's not causing additional illness.

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May 07, 2012 11:05AM

Common Cold Remedy May Not be Best

Zinc is commonly sold as a remedy for the common cold, but whether its effective is controversial. A recent review of research shed some light on this debated treatment.

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May 06, 2012 06:46PM

More Meningitis Protection on the Way

The tricky thing about protecting people against bacterial meningitis is that so many different strains exist and the current vaccines protects against only a couple.

A couple vaccines exist for specific strains of meningococcal serogroup B, which causes bacterial meningitis, but a vaccine that protects against this whole class of strains is not yet available.

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May 05, 2012 07:16PM

Pfizer Stops Phase 3 Trial Of Lyrica

Pfizer Inc. announced that it has stopped a Phase 3 clinical trial of Lyrica (pregabalin) in patients with neuropathic pain associated with HIV neuropathy, a form of nerve damage characterized by burning pain usually beginning in the feet.

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May 03, 2012 04:24AM

High Infection Risk in Kids with RA

For many children with rheumatoid arthritis, drug treatment is one of the few ways to stop the pain. Some of these medications, however, may be raising patients' risk of infection.

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May 02, 2012 09:58AM

Germs Living in Your Sandcastles

Going to the beach means digging in the sand, building sandcastles, being buried in sand… But most health departments have no way of determining how "clean" that sand is.

A new research article by two scientists attempts to come up with a marker of what a clean enough beach would be.

It would mean low enough levels of microbes and germs that the sand's risk to a person's health is no greater than the water when the water is deemed appropriately safe.

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Warning

Click here for more information.

Fluoroquinolone products affected by the labeling changes include ciprofloxacin (Cipro, Bayer; and generics), extended-release ciprofloxacin (Cipro XR, Bayer; Proquin XR, Depomed), gemifloxacin (Factive, Oscient), levofloxacin (Levaquin, Ortho McNeil), moxifloxacin (Avelox, Bayer), norfloxacin (Noroxin, Merck), and ofloxacin (Floxin, Ortho McNeil; and generic).

Using levofloxacin injection increases the risk that you will develop tendinitis (swelling of a fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of a fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. These problems may affect tendons in your shoulder, your hand, the back of your ankle, or in other parts of your body. Tendinitis or tendon rupture may happen to people of any age, but the risk is highest in people over 60 years of age. Tell your doctor if you have or have ever had a kidney, heart, or lung transplant; kidney disease; a joint or tendon disorder such as rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); or if you participate in regular physical activity. Tell your doctor and pharmacist if you are taking oral or injectable steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), or prednisone (Sterapred). If you experience any of the following symptoms of tendinitis, stop using levofloxacin injection, rest, and call your doctor immediately: pain, swelling, tenderness, stiffness, or difficulty in moving a muscle. If you experience any of the following symptoms of tendon rupture, stop using levofloxacin injection and get emergency medical treatment: hearing or feeling a snap or pop in a tendon area, bruising after an injury to a tendon area, or inability to move or to bear weight on an affected area.

Using levofloxacin injection may worsen muscle weakness in people with myasthenia gravis (a disorder of the nervous system that causes muscle weakness) and cause severe difficulty breathing or death. Tell your doctor if you have myasthenia gravis. Your doctor may tell you not to use levofloxacin injection. If you have myasthenia gravis and your doctor tells you that you should use levofloxacin injection, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.

Talk to your doctor about the risks of using levofloxacin injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with levofloxacin injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide 

Fluoroquinolone products affected by the labeling changes include ciprofloxacin (Cipro, Bayer; and generics), extended-release ciprofloxacin (Cipro XR, Bayer; Proquin XR, Depomed), gemifloxacin (Factive, Oscient), levofloxacin (Levaquin, Ortho McNeil), moxifloxacin (Avelox, Bayer), norfloxacin (Noroxin, Merck), and ofloxacin (Floxin, Ortho McNeil; and generic).

What is LEVAQUIN?

LEVAQUIN is a fluoroquinolone antibiotic medicine used in adults, 18 years or older, to treat certain infections caused by certain germs called bacteria. Children have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking LEVAQUIN. In children 6 months and older who have breathed the anthrax bacteria germ: LEVAQUIN is used to prevent anthrax disease (inhalation anthrax). It is not known if it is safe to use LEVAQUIN in children for more than 14 days. It is not known if LEVAQUIN is safe and works in children under the age of 6 months. Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including LEVAQUIN, do not kill viruses

What should I tell my healthcare provider before taking LEVAQUIN?

Tell your healthcare provider about all your medical conditions, including if you:
  • have tendon problems
  • have central nervous system problems (such as epilepsy)
  • have nerve problems
  • have or anyone in your family has an irregular heartbeat, especially a condition called "QT prolongation."
  • have low blood potassium (hypokalemia)
  • have a history of seizures
  • have bone and joint problems
  • have kidney problems. You may need a lower dose of LEVAQUIN if your kidneys do not work well.
  • have liver problems
  • have rheumatoid arthritis (RA) or other history of joint problems are pregnant or planning to become pregnant. It is not known if LEVAQUIN will harm your unborn child.
  • are breast-feeding or planning to breast-feed. LEVAQUIN is thought to pass into breast milk. You and your healthcare provider should decide whether you will take LEVAQUIN or breast-feed.

What are the possible side effects of LEVAQUIN?

Other serious side effects of LEVAQUIN include:
Liver damage (hepatotoxicity) can happen in people who take LEVAQUIN. Call your healthcare provider right away if you have unexplained symptoms such as:
  •  
nausea or vomiting
  •  
stomach pain
  •  
fever
  •  
weakness
  •  
abdominal pain or tenderness
  •  
itching,
  •  
unusual tiredness,
  •  
loss of appetite
  •  
light colored bowel movements
  •  
dark colored urine or yellowing of your skin or the whites of your eyes
Central Nervous System Effects
Seizures have been reported in people who take fluoroquinolone antibiotics including LEVAQUIN. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking LEVAQUIN will change your risk of having a seizure.
Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of LEVAQUIN. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
  •  
seizures
  •  
hear voices, see things, or sense things that are not there (hallucinations)
  •  
feel restless
  •  
tremors
  •  
feel anxious or nervous
  •  
confusion
  •  
depression
  •  
trouble sleeping
  •  
nightmares
  •  
feel lightheaded
  •  
feel more suspicious (paranoia)
  •  
suicidal thoughts or acts

Serious allergic reactions
Allergic reactions can happen in people taking fluoroquinolones, including LEVAQUIN, even after only one dose. Stop taking LEVAQUIN and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
  •  
hives
  •  
trouble breathing or swallowing
  •  
swelling of the lips, tongue, face
  •  
throat tightness, hoarseness
  •  
rapid heartbeat
  •  
faint
  •  
Yellowing of the skin or eyes. Stop taking LEVAQUIN and tell your healthcare provider right away if you get 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 LEVAQUIN (a liver problem).
Skin rash

Skin rash may happen in people taking LEVAQUIN, even after only one dose. Stop taking LEVAQUIN at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to LEVAQUIN.
Intestine infection (Pseudomembranous colitis)
Pseudomembranous colitis can happen with most antibiotics, including LEVAQUIN. 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.
Changes in sensation and possible nerve damage (Peripheral Neuropathy)
Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including LEVAQUIN. Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:.
  •  
pain
  •  
burning
  •  
tingling
  •  
numbness
  •  
weaknessv LEVAQUIN may need to be stopped to prevent permanent nerve damage

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. LEVAQUIN 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:
  •  
who are elderly
  •  
with a family history of prolonged QT interval
  •  
with low blood potassium (hypokalemia)
  •  
who take certain medicines to control heart rhythm (antiarrhythmics)
The most common side effects of LEVAQUIN include:
  •  
dizziness
  •  
headache
  •  
constipation
  •  
nausea
  •  
diarrhea

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

LEVAQUIN belongs to a class of antibiotics called fluoroquinolones. LEVAQUIN can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take LEVAQUIN.
  • Tendon rupture or swelling of the tendon (tendinitis)..
  • Tendons are tough cords of tissue that connect muscles to bones.
  • Pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including LEVAQUIN. 
The risk of getting tendon problems is higher if you:
  • are over 60 years of age
  • are taking steroids (corticosteroids)
  • have had a kidney, heart or lung transplant.
  • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
Other reasons for tendon ruptures can include:
  • physical activity or exercise
  • kidney failure
  • tendon problems in the past, such as in people with rheumatoid arthritis (RA).
  • Call your healthcare provider right away at the first sign of tendon p8ain, swelling or inflammation. Stop taking LEVAQUIN until tendinitis or tendon rupture has been ruled out by your healthcare provider. 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. Talk to your healthcare provider about the risk of tendon rupture with continued use of LEVAQUIN. 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 LEVAQUIN. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
  • Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
  • hear or feel a snap or pop in a tendon area
  • bruising right after an injury in a tendon area
  • unable to move the affected area or bear weight

How should I take LEVAQUIN?

Take LEVAQUIN® exactly as prescribed by your healthcare provider.
Take LEVAQUIN® at about the same time each day.
Drink plenty of fluids while taking LEVAQUIN.
LEVAQUIN® Tablets can be taken with or without food.
Take LEVAQUIN Oral Solution 1 hour before or 2 hours after eating.
If you miss a dose of LEVAQUIN, take it as soon as you remember. Do not take more than one dose in one day.
LEVAQUIN® for Injection is given to you by intravenous (I.V.) infusion into your vein, slowly, over 60 or 90 minutes, as prescribed by your healthcare provider. See "What are the possible side effects of LEVAQUIN?"
Do not skip any doses, or stop taking LEVAQUIN even if you begin to feel better, until you finish your prescribed treatment, unless:
you have tendon effects (see "What is the most important information I should know about LEVAQUIN?"),
you have a serious allergic reaction (see "What are the possible side effects of LEVAQUIN?"), or
your healthcare provider tells you to stop.
This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to LEVAQUIN. If this happens, LEVAQUIN and other antibiotic medicines may not work in the future.
If you take too much, call your healthcare provider or get medical help immediately.

If you have been prescribed LEVAQUIN after being exposed to anthrax:

  • LEVAQUIN has been approved to lessen the chance of getting anthrax disease or worsening of the disease after you are exposed to the anthrax bacteria germ.
  • Take LEVAQUIN exactly as prescribed by your healthcare provider. Do not stop taking LEVAQUIN without talking with your healthcare provider. If you stop taking LEVAQUIN too soon, it may not keep you from getting the anthrax disease.
  • Side effects may happen while you are taking LEVAQUIN. When taking LEVAQUIN to prevent anthrax infection, you and your healthcare provider should talk about whether the risks of stopping your medicine too soon are more important than the risks of side effects with LEVAQUIN. It is not known if it is safe to use LEVAQUIN for more than 28 days in adults and for more than 14 days in children 6 months of age and older.
  • If you are pregnant, or plan to become pregnant while taking LEVAQUIN, you and your healthcare provider should decide whether the benefits of taking LEVAQUIN for anthrax are more important than the risks.

What should I avoid while taking LEVAQUIN®?

  • LEVAQUIN® 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 LEVAQUIN® affects you.
  • Avoid sunlamps, tanning beds, and try to limit your time in the sun. LEVAQUIN® 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 taking LEVAQUIN®, 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 ingredients in LEVAQUIN?

250 mg LEVAQUIN Film-Coated Tablets:
  • Active ingredient: levofloxacin.
  • Inactive ingredients: hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide.
500 mg LEVAQUIN Film-Coated Tablets:
  • Active ingredient: levofloxacin.
  • Inactive ingredients: hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides.
750 mg LEVAQUIN Film-Coated Tablets:
  • Active ingredient: levofloxacin.
  • Inactive ingredients: hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.
LEVAQUIN Oral Solution (25 mg/mL):
  • Active ingredient: levofloxacin.
  • Inactive ingredients: sucrose, glycerin, sucralose, hydrochloric acid, purified water, propylene glycol, artificial and natural flavors, benzyl alcohol, ascorbic acid, and caramel color. It may also contain a solution of sodium hydroxide for pH adjustment.
LEVAQUIN Oral Solution may look clear yellow to clear greenish-yellow in color.
LEVAQUIN Injection in Single-Use Vials:
  • Active ingredient: levofloxacin.
  • Inactive ingredients: water for injection. LEVAQUIN for Injection Single Use Vials do not contain any preservatives.
LEVAQUIN Injection Premix in Single-Use Flexible Containers:
  • Active ingredient: levofloxacin.
  • Inactive ingredients: Dextrose (D5W). Solutions of hydrochloric acid and sodium hydroxide may have been added to adjust the pH.
Reviewed by:
Review Date:
Joseph V. Madia, MD
Friday, June 17, 2011

Source: FDA