Factive

Factive is a prescription medication used to treat certain infections. It belongs to a class of drugs known as fluoroquinolone antibiotics, which work by stopping the growth of certain bacteria.

It comes in tablet form and is usually taken once a day by mouth, with or without food.

Common side effects include diarrhea, rash, and headache. Factive can also cause dizziness. Do not drive or operate heavy machinery until you know how Factive affects you.
 

Factive is used to treat certain infections caused by bacteria such as pneumonia and bronchitis.

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

• Cornerstone Therapeutics, Inc.

• Merus Labs International Inc.

• Oscient Pharmaceuticals Corporation

Serious side effects have been reported. See the “Drug Precautions” section.

Common side effects include:

• diarrhea
• nausea
• stomach pain
• vomiting
• headache
• rash
• dizziness
• itching

This is not a complete list of Factive side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• over-the-counter supplements that contain magnesium, zinc, or aluminum
• sucralfate (Carafate)
• didanosine (Videx)
• probenecid (Benemid, Probalan)
• aspirin and other NSAIDs (nonsteroidal anti-inflammatory drugs) such as
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• warfarin (Coumadin, Jantoven)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• steroids such as prednisone (Cortan, Deltasone, Orasone, Sterapred), budesonide (Entocort), dexamethasone (Decadron), triamcinolone (Kenacort, Aristocort), flunisolide (AeroBid, Aerospan), ciclesonide (Alvesco), mometasone (Asmanex, Dulera), fluticasone (Flovent), methylprednisolone (Medrol, Solu-Medrol), fludrocortisone (Florinef), and hydrocortisone (Cortef, Hydrocortone)
• antipsychotics such as paliperidone (Invega), lurasidone (Latuda), olanzapine (Zyprexa), aripiprazole (Abilify), asenapine (Saphris), iloperidone (Fanapt), haloperidol (Haldol), prochlorperazine (Compazine), chlorpromazine (Thorazine), clozapine (Clozaril), risperidone (Risperdal), quetiapine (Seroquel), and ziprasidone (Geodon)

This is not a complete list of Factive drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported including:

• tendon problems. This can happen in people of all ages who take Factive. Tell your healthcare provider right away if you have the following symptoms of tendon problems:
  • 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
• worsening of myasthenia gravis (a disease which causes muscle weakness). Factive 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. This is a condition of nerve damage that may occur. Tell your healthcare provider right away if you experience 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 Factive, but do not do so without first talking with your health care professional.
• serious heart rhythm changes (QTc prolongation and torsades de pointes). Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint. Factive 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).
• intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including Factive. 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.
• sensitivity to sunlight. Avoid sunlamps, tanning beds, and try to limit your time in the sun. Factive 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 Factive, 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.
• central nervous system effects. Seizures have been reported in people who take fluoroquinolone antibiotics, including Factive. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Factive will change your risk of having a seizure.  Central Nervous System (CNS) side effects may occur as soon as after taking the first dose of Factive. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
  • feel dizzy
  • seizures
  • hear voices, see things, or sense things that are not there (hallucinations)
  • feel restless
  • tremors
  • feel anxious or nervous
  • confusion
  • depression
  • trouble sleeping
  • feel more suspicious (paranoia)
  • suicidal thoughts or acts
  • nightmares 
• serious allergic reactions. Allergic reactions can happen in people taking fluoroquinolones, including Factive, even after only one dose. Stop taking Factive 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 Factive and call 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 Factive (a liver problem).
• skin rash. Skin rash may happen in people taking Factive. Stop taking Factive 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 Factive. Rash happens more often with Factive in:
  • women, especially women who take hormone replacement therapy
  • people under 40 years of age
  • people who take Factive for longer than 5 days.
• joint problems

Factive can cause dizziness or lightheadedness. Do not drive or operate heavy machinery until you know how Factive affects you.

Do not take Factive if you are allergic to any ingredient in it.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Factive there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Factive , tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Factive or any other medication
• 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 “QT prolongation”
• have low blood potassium (hypokalemia) or magnesium (hypomagnesemia)
• have a slow heartbeat (bradycardia)
• have a history of seizures
• have kidney problems
• have rheumatoid arthritis (RA) or other history of joint problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal 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.

Factive 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 doctor if you are breastfeeding or plan to breastfeed.

Factive has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Factive, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Take Factive exactly as prescribed by your healthcare provider.
• Take Factive at about the same time each day.
• Factive tablets should be swallowed.
• Factive can be taken with or without food.
• Factive should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
• Drink plenty of fluids while taking Factive. 
• Do not skip any doses, or stop taking Factive 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 Factive. If this happens, Factive and other antibiotic medicines may not work in the future.
• If you miss a dose of Factive, take it as soon as you remember. Do not take more than 1 dose of Factive in one day.
• If you take too much, call your healthcare provider or get medical help immediately.

Take Factive exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Factive dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose range of Factive is 160 to 320 mg once daily.

If you take too much Factive, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store between 15º-30ºC (59º-86ºF).
• Protect from light.
• Keep this and all medications out of the reach of children.

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