Noroxin

Noroxin is a prescription medication used to treat certain bacterial infections including urinary tract and prostate infections. Noroxin belongs to a group of antibiotics called fluoroquinolones, which work by killing the bacteria that cause the infections.

This medication comes in tablet form and is taken twice a day. It is taken on an empty stomach, either one hour before or 2 hours after a meal or ingestion of milk and/or dairy products. Length of treatment depends on the infection being treated.

Common side effects of Noroxin include dizziness, nausea, and diarrhea. 

Noroxin is a prescription medication used to treat certain bacterial infections including urinary tract and prostate infections. Noroxin may be used to treat gonorrhea.

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

• Merck & Co., Inc.

Noroxin can cause side effects that may be serious. See "Drug Precautions".

The most common side effects of Noroxin include:

• dizziness
• nausea
• diarrhea
• heartburn
• headache
• stomach (abdominal) cramping
• weakness
• changes in certain liver function tests

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

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal and dietary supplements. Noroxin and other medicines can affect each other causing side effects.

Especially tell your healthcare provider if you take:

• an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take Noroxin or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
• glyburide (Micronase, Glynase, Diabeta, Glucovance)
• a blood thinner (warfarin, Coumadin, Jantoven)
• a medicine to control your heart rate or rhythm (antiarrhythmics)
• an anti-psychotic medicine
• a tricyclic antidepressant
• erythromycin
• a water pill (diuretic)
• a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury.
• probenecid (Probalan, Col-probenecid)
• cyclosporine (Gengraf, Sandimmune, Neoral)
• products that contain caffeine
• clozapine (Fazaclo ODT, Clozaril)
• ropinirole (Requip, Requip XL)
• tacrine (Cognex)
• tizanidine (Zanaflex)
• theophylline (Theo-24, Elixophyllin, Theochron, Uniphyl, Theolair)
• cisapride (Propulsid)

Certain medicines may keep Noroxin from working correctly. Take it either 2 hours before or 2 hours after taking these products:

• an antacid, multivitamin or other product that has iron or zinc
• sucralfate (Carafate)
• didanosine (Videx, Videx EC)

You should not take the medicine nitrofurantoin (Furadantin, Macrodantin, Macrobid) while taking Noroxin.

Noroxin belongs to a class of antibiotics called fluoroquinolones. Noroxin can cause side effects that may be serious or even cause death. If you develop any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take Noroxin.

Tendon rupture or swelling of the tendon (tendinitis). Tendon problems can happen in people of all ages who take Noroxin. Tendons are tough cords of tissue that connect muscle to bones. Symptoms of tendon problems may 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 Noroxin 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 Noroxin. 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 Noroxin 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 Noroxin. 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 Noroxin. 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 incident in a tendon area
  • unable to move the affected area or bear weight

Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like Noroxin 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.

Peripheral neuropathy may occur. Tell your healthcare provider right away if you experience the following:

• pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature. These symptoms can occur early in treatment and may be permanent. It may be necessary to stop Noroxin, but do not do so without first talking with your health care professional.

Other serious side effects of Noroxin include:

• Central Nervous System Effects: Seizures have been reported in people who take fluoroquinolone antibiotics including Noroxin. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Noroxin 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 Noroxin. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
  • feel lightheaded
  • seizures
  • hear voices, see things, or sense things that are not there (hallucinations)
  • feel restless
  • tremors
  • feel anxious or nervous
  • confusion
  • feel more suspicious (paranoia)
• Serious allergic reactions: Allergic reactions can happen in people who take fluoroquinolones, including Noroxin, even after only one dose. Stop taking Noroxin 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
  • skin rash accompanied by fever and feeling unwell
  • yellowing of the skin or eyes. Stop taking Noroxin 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 Noroxin (a liver problem).
• Skin rash: Skin rash may happen in people taking Noroxin, even after only one dose. Stop taking Noroxin at the first sign of a skin rash and call your healthcare provider. Skin rash may be sign of a more serious reaction to Noroxin.
• Serious heart rhythm changes (QTc prolongation and torsade 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. Noroxin may cause a rare heart problem known as prolongation of the QTc 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 QTc interval
  • with low blood potassium (hypokalemia)
  • who take certain medicines to control heart rhythm (antiarrhythmics)
• Intestine infection (Pseudomembranous colitis): Pseudomembranous colitis can happen with most antibiotics, including Noroxin. 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 Noroxin. 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
  • weakness

• Low blood sugar (hypoglycemia): People taking Noroxin and other fluoroquinolone medicines with the oral anti-diabetes medicine glyburide (Micronase, Glynase, Diabeta, Glucovance) can get low blood sugar (hypoglycemia) which can sometimes be severe. Tell your healthcare provider if you get low blood sugar while taking Noroxin. Your antibiotic medicine may need to be changed.
• Sensitivity to sunlight (photosensitivity).

Do not take Noroxin if you:

• have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in Noroxin. Ask your healthcare provider if you are not sure. See the list of ingredients in Noroxin at the end of this Medication Guide.
• have had tendinitis or tendon rupture with the use of Noroxin or another fluoroquinolone antibiotic.

Food and dairy can decrease the body's ability to fully absorb this medication. Take Noroxin on an empty stomach, either one hour before or 2 hours after eating dairy products or drinking milk.

Tell your healthcare provider about all your medical conditions, including if you:

• have tendon problems
• have a disease that causes muscle weakness (myasthenia gravis)
• 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 "QTc prolongation"
• have low potassium (hypokalemia)
• have a slow heartbeat called bradycardia
• have a history of seizures
• have kidney problems. You may need a lower dose of Noroxin if your kidneys do not work well.
• have rheumatoid arthritis (RA) or other history of joint problems
• are pregnant or planning to become pregnant. It is not known if Noroxin will harm your unborn child.
• are breastfeeding or planning to breastfeed. It is not known if Noroxin passes into breast milk. You and your healthcare provider should decide whether you will take Noroxin or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal and dietary supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Noroxin falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. It is not known if Noroxin passes into breast milk. You and your healthcare provider should decide whether you will take Noroxin or breastfeed.

• Take Noroxin exactly as prescribed by your healthcare provider.
• Noroxin is usually taken every 12 hours for patients with normal kidney function.
• Take Noroxin with a glass of water.
• Drink plenty of fluids while taking Noroxin .
• Take Noroxin at least one hour before or 2 hours after a meal or having milk or other dairy products.
• Do not skip any doses, or stop taking Noroxin even if you begin to feel better, until you finish your prescribed treatment, unless:
  • you have tendon effects,
  • you have a serious allergic reaction, 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 Noroxin. If this happens, Noroxin and other antibiotic medicines may not work in the future.
• If you miss a dose of Noroxin, take it as soon as you remember. Do not take two doses of Noroxin at the same time. Do not take more than 2 doses of Noroxin in one day.
• If you take too much, call your healthcare provider or get medical help immediately.

What to avoid while taking :

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

The dose your doctor recommends will depend on the infection being treated as well as your kidney function and your age. 

The recommended dose for urinary tract infections is 400 mg every 12 hours (twice daily) for 3 to 21 days.

The recommended dose for sexually transmitted diseases (gonorrhea) is a single dose of 800 mg.

For prostatitis, the recommended dose is 400 mg every 12 hours for 28 days.

If you take too much Noroxin, call your healthcare provider or get medical help immediately.

• Store between 59-86°F (15-30°C).
• Keep container closed tightly.
• Keep Noroxin and all medicines out of the reach of children.

WARNING:

Fluoroquinolones, including Noroxin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Fluoroquinolones, including Noroxin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Noroxin in patients with known history of myasthenia gravis.