Gemifloxacin (Oral Route)

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

Gemifloxacin 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.

This product is available in the following dosage forms:

• Tablet

Before Using

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:

Allergies

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.

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 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.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Bepridil


• Cisapride


• Mesoridazine


• Pimozide


• 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


• Alosetron


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Arsenic Trioxide


• Astemizole


• Azimilide


• Benfluorex


• Bretylium


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Chlorpropamide


• Clarithromycin


• Desipramine


• Dibenzepin


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Encainide


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Halofantrine


• Haloperidol


• Hydroquinidine


• Ibutilide


• Imipramine


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isradipine


• Levomethadyl


• Lidocaine


• Lidoflazine


• Mefloquine


• Metformin


• Mexiletine


• Miglitol


• Moricizine


• Nortriptyline


• Octreotide


• Pentamidine


• Pirmenol


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Risperidone


• Sematilide


• Sertindole


• Sotalol


• Spiramycin


• Sulfamethizole


• Sultopride


• Tedisamil


• Tocainide


• Tolazamide


• Tolbutamide


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Troglitazone


• Vasopressin


• Zolmitriptan


• Zotepine

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


• Betamethasone


• Calcium Carbonate


• Corticotropin


• Cortisone


• Cosyntropin


• Deflazacort


• Dexamethasone


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Fludrocortisone


• Fluocortolone


• Hydrocortisone


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Methylprednisolone


• Paramethasone


• Prednisolone


• Prednisone


• Sucralfate


• Triamcinolone

Other Interactions

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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:

• Brain or spinal cord disease, including epilepsy or other seizuresa€” Gemifloxacin may cause nervous system side effects and make these conditions worse.

• Diarrhea or


• Heart attack, recent or


• Heart rhythm problems (e.g., prolonged QT interval) or


• Hypokalemia (low potassium in the blood), uncorrected or


• Hypomagnesemia (low magnesium in the blood), uncorrected or


• Slow heartbeata€”Use with caution. May make these conditions worse.

• Kidney diseasea€”Effects may be increased because of slower removal of gemifloxacin from the body .

• Organ transplant (e.g., kidney, heart, or lung) or


• Tendon disorder, (e.g., rheumatoid arthritis), history ofa€”Use with caution. May increase the risk of tendon problems .

• Sensitivity of the skin to sunlighta€”Patients taking gemifloxacin may have an increased risk of severe reactions to sunlight.

Proper Use

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 should come with a medication guide. Read and follow these 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 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.

If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, sucralfate, 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.

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 treatment of infection:
    
    
    
    • Adultsa€” 320 milligrams (mg) once a day.
    
    
    • Childrena€”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.

Precautions

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

For patients with low potassium levels, 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 a rash; itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you take this medicine.

Gemifloxacin may cause diarrhea, and in some cases it can be severe . 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 (e.g., dexamethasone, prednisolone, prednisone, or MedrolA®), have severe kidney problems, have a history of tendon problems (e.g., rheumatoid arthritis), or if you have received an organ transplant (e.g., heart, kidney, or lung). Stop using this medicine and check with 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. Refrain from exercise until your doctor says otherwise.

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 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat and sunglasses.


• Apply a sun block product that has a skin 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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

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

Less common

• Rash

Rare

• Black, tarry stools


• Bleeding gums


• Blood in the urine or stools


• Body aches or pain


• Burning, numbness, tingling, or painful sensations


• Chest pain


• Chills


• Congestion


• Cough


• Fever


• Hives or welts


• Hoarseness


• Itching skin


• Painful or difficult urination


• Pale skin


• Pinpoint red spots on the skin


• Redness of the skin


• Runny nose


• Shortness of breath


• Sneezing


• Sore throat


• Sores, ulcers, or white spots on the lips or in the mouth


• Swollen glands


• Tightness in the chest


• Trouble with swallowing


• Troubled breathing


• Unsteadiness or awkwardness


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Voice changes


• Weakness in the arms, hands, legs, or feet


• Wheezing


• Yellow eyes or skin

Incidence not known

• Abdominal tenderness


• Bleeding gums


• Blistering, peeling, or loosening of the skin


• Bloating or swelling of the face, arms, hands, lower legs, or feet


• Confusion


• Coughing up blood


• Decreased frequency/amount of urine


• Decreased vision or other changes in vision


• Diarrhea


• Difficulty with breathing or swallowing


• Dizziness


• Facial swelling


• Fainting


• Fast, pounding, or irregular heartbeat or pulse


• Flaking and falling off of the skin


• Headache


• Hives


• Increased blood pressure


• Increased menstrual flow or vaginal bleeding


• Increased sensitivity of the skin to sunlight


• Joint or muscle pain


• Loss of appetite


• Lower back or side pain


• Nausea


• Nosebleeds


• Numbness or tingling in the face, arms, or legs


• Paralysis


• Prolonged bleeding from cuts


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Rapid weight gain


• Red or dark brown urine


• Red, irritated eyes


• Redness or other discoloration of the skin


• Severe abdominal or stomach cramps and pain


• Severe sunburn


• Swelling of the face, fingers, or lower legs


• Tingling of the hands or feet


• Trouble speaking, thinking, or walking


• Unusual weight gain or loss


• Vomiting


• Watery and severe diarrhea, which may also be bloody


• Weight gain

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

• Abnormal urine


• Acid or sour stomach


• Back pain


• Bad unusual or unpleasant taste


• Belching


• Blistering, crusting, irritation, itching, or reddening of the skin


• Blurred vision


• Change in taste


• Change in vision


• Cracked, dry, or scaly skin


• Difficulty having a bowel movement (stool)


• Difficulty in moving


• Dizziness or lightheadedness


• Dry mouth


• Dryness or soreness of the throat


• Feeling of constant movement of self or surroundings


• Feeling of warmth


• Fruit like breath odor


• Heartburn


• Hoarseness


• Increased hunger and thirst


• Increased urination


• Indigestion


• Lack or loss of strength


• Leg cramps


• Muscle aching or cramping


• Muscle pain or stiffness


• Nervousness


• Pain


• Pain in joints


• Redness of the face, neck, arms and occasionally, upper chest


• Sensation of spinning


• Shakiness in the legs, arms, hands, or feet


• Sleepiness or drowsiness


• Sleeplessness


• Stomach discomfort, upset, or pain


• Sudden sweating


• Swelling


• Swollen joints


• Trembling or shaking of the hands or feet


• 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.