What is Factive?

Fluoroquinolones, including gemifloxacin mesylate, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue gemifloxacin mesylate and avoid use of fluoroquinolones in patients with these serious adverse reactions. Reserve use of gemifloxacin mesylate for patients with no alternative treatment options for acute bacterial exacerbation of chronic bronchitis. Fluoroquinolones, including gemifloxacin mesylate, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis .

Gemifloxacin is used to treat bronchitis and pneumonia caused by bacterial infections.

Gemifloxacin belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Gemifloxacin may be taken with or without food. The tablet must be swallowed whole. Do not break, crush, or chew the tablet.

Drink plenty of fluids while you are taking this medicine. Drinking extra water will help prevent some unwanted effects of gemifloxacin.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Try to take the medicine at the same time each day.

Do not take this medicine alone with milk, yogurt, or other dairy products. Do not drink any juice with calcium added when you take this medicine. It is okay to have dairy products or juice as part of a larger meal when you take this medicine.

If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take this medicine. It is best to take these medicines 3 hours before or 2 hours after taking gemifloxacin. These medicines may keep gemifloxacin from working properly.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of lung infections:
    • Adults— 320 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of gemifloxacin in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemifloxacin in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems, or develop severe tendon problems (including tendon rupture), which may require caution in patients receiving gemifloxacin.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Acecainide
• Acetohexamide
• Ajmaline
• Alfuzosin
• Alogliptin
• Amiodarone
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azimilide
• Azithromycin
• Benfluorex
• Betamethasone
• Bretylium
• Budesonide
• Buprenorphine
• Buserelin
• Canagliflozin
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Chlorpropamide
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Corticotropin
• Cortisone
• Cosyntropin
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dapagliflozin
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Efavirenz
• Encorafenib
• Ertugliflozin
• Erythromycin
• Escitalopram
• Exenatide
• Fingolimod
• Flecainide
• Fluconazole
• Fludrocortisone
• Fluocortolone
• Fluoxetine
• Foscarnet
• Gatifloxacin
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocortisone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Isradipine
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Levomethadyl
• Lidoflazine
• Linagliptin
• Liraglutide
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Mefloquine
• Metformin
• Methadone
• Methylprednisolone
• Metronidazole
• Mifepristone
• Miglitol
• Moxifloxacin
• Nafarelin
• Nateglinide
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Osimertinib
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pentamidine
• Pimavanserin
• Pioglitazone
• Pirmenol
• Pitolisant
• Posaconazole
• Prajmaline
• Pramlintide
• Prednisolone
• Prednisone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Rasagiline
• Repaglinide
• Ribociclib
• Risperidone
• Rosiglitazone
• Salmeterol
• Saxagliptin
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Sitagliptin
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sulfamethizole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolazamide
• Tolbutamide
• Toremifene
• Trazodone
• Triamcinolone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vasopressin
• Vemurafenib
• Vildagliptin
• Vinflunine
• Voriconazole
• Warfarin
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Aminolevulinic Acid
• Calcium Carbonate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Lanthanum Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Sucralfate

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heartbeat) or
• Diarrhea or
• Heart disease or
• Heart rhythm problems (eg, prolonged QT interval), or family history of or
• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected or
• Liver disease (including hepatitis) or
• Myocardial ischemia (reduced blood supply in the heart) or
• Seizures (epilepsy), or history of—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of gemifloxacin from the body.

• Myasthenia gravis (severe muscle weakness), or history of—Should not be used in patients with this condition.

• Organ transplant (eg, kidney, heart, or lung), history of or
• Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May increase the risk of tendon problems.

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

If you have low potassium levels in the blood, gemifloxacin may increase your risk of having a fast, slow or irregular heartbeat, loss of consciousness, or fainting spells. If these symptoms occur, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without warning. However, possible warning signs are including black, tarry stools, blistering, peeling, or loosening of the skin, bloody or cloudy urine, chills, decreased urination, diarrhea, fever, joint or muscle pain, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, severe stomach pain, skin rash, swelling of the face, fingers, feet, and/or lower legs, unusual bleeding or bruising, or unusual weight gain. Check with your doctor immediately if you notice any of these warning signs.

Gemifloxacin may cause serious liver problems, including hepatitis. Check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while you are using this medicine.

Gemifloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

Gemifloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can occur while you are taking the medicine or after you finish taking it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant (eg, heart, kidney, or lung). Check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.

Tell your doctor right away if you have the following symptoms while using this medicine: convulsions, feeling anxious, confused, or depressed, seeing, hearing, or feeling things that are not there, severe headache, trouble sleeping, or unusual thoughts or behaviors.

Some people who take gemifloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn, skin rash, redness, itching, or discoloration. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 AM and 3:00 PM, if possible.
• Wear protective clothing, including a hat and sunglasses.
• Apply a sun block product that has a sun protection factor (SPF) of at least 15. Some people may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
• Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Gemifloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If these reactions are especially bothersome, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.