Iquix

Do not use this medicine while wearing contact lenses. Levofloxacin ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

It is not likely that other drugs you take orally or inject will have an effect on levofloxacin used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

• Vistakon Pharmaceuticals, LLC

Levofloxacin can cause side effects that may be serious or even cause death (see "Drug Precautions").

Levofloxacin can cause severe allergic reactions. Allergic reactions can happen in people taking fluoroquinolones, including levofloxacin, even after only 1 dose. Stop taking levofloxacin and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:

• hives
• trouble breathing or swallowing
• swelling of the lips, tongue, face
• throat tightness or hoarseness
• rapid heartbeat
• faint
• skin rash

Skin rash may happen in people taking levofloxacin, even after only 1 dose. Stop taking levofloxacin 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 levofloxacin.

Liver damage (hepatotoxicity) can happen in people who take levofloxacin. Call your doctor right away if you have unexplained symptoms such as:

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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

Seizures have been reported in people who take fluoroquinolone antibiotics including levofloxacin. Tell your doctor if you have a history of seizures. Ask your doctor whether taking levofloxacin 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 levofloxacin. Talk to your doctor right away if you get any of these side effects, or other changes in mood or behavior:

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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

Intestine infection (Pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including levofloxacin. Call your doctor 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 levofloxacin. Talk with your doctor right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:.

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pain
•  
burning
•  
tingling
•  
numbness
•  
weakness
  • Levofloxacin may need to be stopped to prevent permanent nerve damage.


Serious heart rhythm changes (QT prolongation and torsades de pointes). 
Tell your doctor right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Levofloxacin 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)

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.

Changes in blood sugar can occur. People who take levofloxacin 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, stop taking levofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

Sensitivity to sunlight (photosensitivity). 

The most common side effects of levofloxacin include:

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dizziness
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headache
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constipation
•  
nausea
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diarrhea

Levofloxacin, a fluoroquinolone antibiotic, 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.

• Tendon problems can happen in people of all ages who take levofloxacin. Tendons are tough cords of tissue that connect muscles to bones.
  Some tendon problems include pain, swelling, tears, and inflammation 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 is higher if you:
  • are over 60 years of age
  • are taking steroids (corticosteroids)
  • 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.
• Other reasons that can increase your risk of tendon problems 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 pain, swelling or inflammation. Stop taking levofloxacin 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 levofloxacin. 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. Tendon ruptures have happened up to several months after people 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

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 any of the ingredients in levofloxacin. Ask your doctor if you are not sure. 

Levofloxacin 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 affects you.

Avoid sunlamps, tanning beds, and try to limit your time in the sun. Levofloxacin 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 levofloxacin, call your doctor right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

Tell your doctor 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 levofloxacin 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 levofloxacin will harm your unborn child.
• are breast-feeding or planning to breast-feed. Levofloxacin is thought to pass into breast milk. You and your doctor should decide whether you will take levofloxacin or breast-feed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal and dietary supplements. Levofloxacin and other medicines can affect each other causing side effects. Especially tell your doctor if you take:

• an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take levofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures. 
• an oral anti-diabetes medicine or insulin
• a blood thinner (warfarin, Coumadin, Jantoven)
• a medicine to control your heart rate or rhythm (antiarrhythmics). 
• an anti-psychotic medicine
• a tricyclic antidepressant
• a water pill (diuretic)
• a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. 
• theophylline (Theo-24, Elixophyllin, Theochron, Uniphyl, Theolair)
• Certain medicines may keep levofloxacin from working correctly. Take levofloxacin tablets or oral solution either 2 hours before or 2 hours after taking these products: an antacid, multivitamin, or other product that has magnesium, aluminum, iron, or zinc, sucralfate (Carafate), didanosine (Videx,Videx EC).

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use levofloxacin ophthalmic to treat any eye condition that has not been checked by your doctor.

The number of times per day that you use this medicine may change throughout your treatment. Follow your doctor's dosing instructions very carefully.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

NDC 68669-145-05

Iquix®
(levofloxacin ophthalmic
solution) 1.5%

Sterile

5mL

VISTAKON®
PHARMACEUTICALS, LLC

Applies to levofloxacin ophthalmic: ophthalmic solution

Along with its needed effects, levofloxacin ophthalmic (the active ingredient contained in Iquix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of levofloxacin ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• voice changes

• body aches or pain
• congestion
• dryness or soreness of throat
• runny nose
• swelling of the eyelid
• tender, swollen glands in neck
• trouble in swallowing

• Itching, pain, redness or swelling of eye or eyelid
• watering of eyes
• decreased vision
• fever
• feeling of having something in the eye
• headache
• hoarseness
• eye burning, dryness, itching, or pain
• increased sensitivity of eyes to light

Animal studies have failed to reveal evidence of teratogenicity at oral doses up to 50 mg/kg/day or when dosed IV at 25 mg/kg/day (about 250 to 2250 and 120 to 1000 times the systemic exposure of the maximum recommended human ophthalmic dose, respectively). Oral doses of 810 mg/kg/day in rats showed decreased fetal body weight and increased mortality. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C