Factive (Oral)

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

Gemifloxacin is a type of medicine called a quinolone antibiotic. It works by killing bacteria or stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

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

It is very important for your doctor to check your progress while you are using this medicine. This will help your doctor see if the medicine is working correctly and decide if you should keep taking 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 get worse, contact your doctor.

If you have low potassium levels in your blood, gemifloxacin may increase your risk of fast, slow, or irregular heartbeat, loss of consciousness, or fainting spells. If these symptoms happen, tell your doctor immediately.

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 taking this medicine.

Serious side effects can happen during treatment with this medicine and can occur without warning. Possible warning signs include: 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, or lower legs, unusual bleeding or bruising, or unusual weight gain. Check with your doctor right away if you notice any of these warning signs.

Gemifloxacin may cause serious liver problems, including hepatitis. Contact your doctor immediately if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while 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 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 signs 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 happen while you are taking the medicine or after you finish taking it. The risk of tendon problems may be higher if you are over 60 years old, are using steroid medicines (e.g., dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon issues (e.g., rheumatoid arthritis), or if you have received an organ transplant (e.g., heart, kidney, or lung). Contact your doctor right away if you have sudden pain or swelling in a tendon after exercise (e.g., 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. Do not exercise until your doctor says it is okay.

Tell your doctor right away if you have these symptoms while using this medicine: convulsions (seizures), 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 usual. Exposure to sunlight, even for a short time, may cause severe sunburn, skin rash, redness, itching, or discoloration. When you start taking this medicine:

• Stay out of direct sunlight, especially between 10:00 AM and 3:00 PM, if possible.
• Wear protective clothing, including a hat and sunglasses.
• Use a sunblock product with a sun protection factor (SPF) of at least 15. Some people may need a higher SPF, especially if they have fair skin. 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 to the sun, contact your doctor.

Gemifloxacin may cause some people to feel dizzy, lightheaded, drowsy, or less alert than usual. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.

If you are a diabetic patient taking diabetes medicine by mouth: Gemifloxacin may cause hypoglycemia (low blood sugar) in some patients. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. If you experience symptoms of low blood sugar, contact your doctor immediately.

• Symptoms of low blood sugar can include: anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.

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

In deciding to use a medication, the risks of using 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:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues 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 serious tendon issues (such as tendon rupture), which may require caution in patients receiving gemifloxacin.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances before using this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medications 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 using this medicine, it is especially essential that your healthcare professional know if you are using any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• 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 physician may change the dose or how frequently you use one or both of the drugs.

• Acarbose
• Acecainide
• Adagrasib
• Ajmaline
• Albiglutide
• Alfuzosin
• Alogliptin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Betamethasone
• Bretylium
• Budesonide
• Buprenorphine
• Buserelin
• Canagliflozin
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Chlorpropamide
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Corticotropin
• Cortisone
• Cosyntropin
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dapagliflozin
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Dulaglutide
• Efavirenz
• Empagliflozin
• Encorafenib
• Entrectinib
• Ertugliflozin
• Erythromycin
• Escitalopram
• Etrasimod
• Exenatide
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fludrocortisone
• Fluocortolone
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gatifloxacin
• Gepirone
• Glasdegib
• Glimepiride
• Glipizide
• 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 Glulisine
• Insulin Lispro, Recombinant
• Isradipine
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomethadyl
• Lidoflazine
• Linagliptin
• Liraglutide
• Lixisenatide
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Magnesium Sulfate
• Mefloquine
• Metformin
• Methadone
• Methylprednisolone
• Metronidazole
• Mifepristone
• Miglitol
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nateglinide
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Phenobarbital
• Pimavanserin
• Pioglitazone
• Pirmenol
• Pitolisant
• Ponesimod
• Porfimer
• Posaconazole
• Prajmaline
• Pramlintide
• Prednisolone
• Prednisone
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Repaglinide
• Ribociclib
• Risperidone
• Rosiglitazone
• Saxagliptin
• Selpercatinib
• Semaglutide
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• 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
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voglibose
• Voriconazole
• Warfarin
• Zolmitriptan
• Zotepine
• Zuclopenthixol

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

• 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

Interactions with Food/Tobacco/Alcohol

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 medications may additionally cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Issues

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

• Bradycardia (slow heartbeat) or
• Diabetes 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
• Mental illness, history of 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, moderate to severe—Use with caution. The effects may be increased since 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 raise the risk of tendon issues.

Along with its necessary effects, a medicine may cause some unwanted effects. While not all side effects may occur, if they do happen, they might need medical attention.

Check with your doctor right away if any of the following side effects occur:

Less common

• Rash

Rare

• Body aches or pain
• Burning, numbness, tingling, or painful sensations
• Chest pain or tightness
• Chills
• Fever
• Hives or welts, itching skin
• Lightheadedness
• Painful or difficult urination
• Muscle aching or cramping
• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen glands
• Trembling or shaking of the hands or feet
• Unsteadiness or awkwardness
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Weakness in the arms, hands, legs, or feet
• Yellow eyes or skin

Incidence not known

• Bleeding gums
• Blistering, peeling, or loosening of the skin
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody urine
• Blurred or double vision or other changes in vision
• Bone pain
• Confusion
• Cough
• Coughing up blood
• Decreased frequency or amount of urine
• Difficulty with breathing or swallowing
• Difficulty with chewing or talking
• Dizziness
• Drooping eyelids
• Fainting
• Fast, pounding, or irregular heartbeat or pulse
• Headache
• Increased blood pressure
• Increased menstrual flow or vaginal bleeding
• Increased sensitivity of the skin to sunlight
• Increased thirst
• Irregular heartbeat, recurrent
• Loss of appetite
• Lower back or side pain
• Muscle pain or weakness
• Nausea
• Numbness or tingling in the face, arms, or legs
• Nosebleeds
• Painful, swollen joints
• Paralysis
• Prolonged bleeding from cuts
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Red or black, tarry stools
• Red or dark brown urine
• Redness or other discoloration of the skin
• Sensation of skin burning
• Severe sunburn
• Severe tiredness
• Stomach cramps or tenderness
• Swelling of the face, fingers, or lower legs
• Trouble speaking, thinking, or walking
• Unusual weight gain or loss
• Vomiting
• Watery or bloody diarrhea

Some side effects 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:

Rare

• Bad, unusual, or unpleasant taste
• Difficulty having a bowel movement
• Dryness or soreness of the throat
• Feeling of constant movement of self or surroundings
• Hoarseness
• Redness of the face, neck, arms, and occasionally, upper chest
• Sudden sweating
• Voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Factive

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

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.

You may take this medicine with or without food. Swallow the tablet whole with liquid. Do not break, crush, or chew it.

Drink plenty of fluids while you are using 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 use this medicine. It is best to take these medicines 3 hours before or 2 hours after using 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.

Dosing

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 lung infections: Adults— 320 milligrams (mg) once a day for 5 or 7 days. Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

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.