LEVAQUIN ®
(levofloxacin)

Description

What is LEVAQUIN? LEVAQUIN (levofloxacin) is a synthetic broad spectrum antibacterial agent for oral and intravenous administration.

LEVAQUIN is a quinolone antibiotic used in adults as a lung, sinus, skin, and urinary tract infection treatment when such infections are caused by certain bacteria. LEVAQUIN kills many of the types of bacteria that can infect the lungs, sinuses, skin, and urinary tract and has been shown in a large number of clinical trials to be safe and effective for the treatment of many bacterial infections.

LEVAQUIN

LEVAQUIN, like other antibiotics, does not kill viruses.
You should contact your health care professional if you think that your condition is not improving while taking LEVAQUIN. LEVAQUIN Tablets are terra cotta pink for the 250 mg tablet, peach colored for the 500 mg tablet, or white for the 750 mg tablet.

 

LEVAQUIN Tablets are available as film-coated tablets and contain the following inactive ingredients:

250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide,
polysorbate 80 and synthetic red iron oxide.

500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide,
polysorbate 80 and synthetic red and yellow iron oxides.

750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide,
polysorbate 80 and synthetic red and yellow iron oxides.

How and when should I take LEVAQUIN?

levofloxacin

LEVAQUIN should be taken once a day for 3, 5, 7, 10, 14 or 28 days depending on your prescription. LEVAQUIN® tablets should be swallowed and may be taken with or without. LEVAQUIN® oral solution is recommended to be taken 1 hour before, or 2 hours after, eating. Try to take the tablet and oral solution at the same time each day and drink fluids liberally.

You may begin to feel better quickly; however, in order to make sure that all bacteria are killed, you should complete the full course of medication. Do not take more than the prescribed dose of LEVAQUIN even if you missed a dose by mistake. You should not take a double dose.

Who should not take LEVAQUIN?

You should not take LEVAQUIN if you have ever had a severe allergic reaction to any of the group of antibiotics known as “quinolones” such as ciprofloxacin. Serious and occasionally fatal allergic reactions have been reported in patients receiving therapy with quinolones, including LEVAQUIN.

If you are pregnant or are planning to become pregnant while taking LEVAQUIN, talk to your health care professional before taking this medication. LEVAQUIN is
not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

LEVAQUIN is not recommended for children.

What are possible side effects of LEVAQUIN?

LEVAQUIN is generally well tolerated. The most common side effects caused by LEVAQUIN, which are usually mild, include nausea, diarrhea, itching, abdominal pain, dizziness, flatulence, rash and vaginitis in women.

You should be careful about driving or operating machinery until you are sure LEVAQUIN is not causing dizziness.

Allergic reactions have been reported in patients receiving quinolones including LEVAQUIN, even after just one dose. If you develop hives, skin rash or other symptoms of an allergic reaction, you should stop taking this medication and call your health care professional.

Ruptures of shoulder, hand, or Achilles tendons have been reported in patients receiving quinolones, including LEVAQUIN. If you develop pain, swelling, or rupture of a tendon you should stop taking LEVAQUIN and contact your health care professional.

Some quinolone antibiotics have been associated with the development of phototoxicity (“sunburns” and “blistering sunburns”) following exposure to sunlight or other sources of ultraviolet light such as artificial ultraviolet light used in tanning salons. LEVAQUIN has been infrequently associated with phototoxicity. You should avoid excessive exposure to sunlight or artificial ultraviolet light while you are taking LEVAQUIN.

If you have diabetes and you develop a hypoglycemic reaction while on LEVAQUIN, you should stop taking LEVAQUIN and call your health care professional.

Convulsions have been reported in patients receiving quinolone antibiotics including LEVAQUIN. If you have experienced convulsions in the past, be sure to let your physician know that you have a history of convulsions.

Quinolones, including LEVAQUIN, may also cause central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts.

If you notice any side effects not mentioned in this leaflet or you have concerns about the side effects you are experiencing, please inform your health care professional.

For more complete information regarding levofloxacin, please refer to the full prescribing information, which may be obtained from your health care professional, pharmacist, or the Physicians Desk Reference (PDR).

What about other medicines I am taking?

Taking warfarin (Coumadin) and LEVAQUIN together can further predispose you to the development of bleeding problems. If you take warfarin, be sure to tell your health care professional.

Many antacids and multivitamins may interfere with the absorption of LEVAQUIN and may prevent it from working properly. You should take LEVAQUIN either 2 hours before or 2 hours after taking these products.

It is important to let your health care professional know all of the medicines you are using.

Other information

Take your dose of LEVAQUIN once a day.

Complete the course of medication even if you are feeling better.

Keep this medication out of the reach of children.

This information does not take the place of discussions with your doctor or health care professional about your medical condition or your treatment.

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