Pronunciation:

je-mi-FLOX-a-sin

Brand Names:

• Factive

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antibiotic

Chemical—

Fluoroquinolone

Uses of This Medicine:

Gemifloxacin belongs to the class of medicines known as antibiotics. 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.

Before Using This Medicine:

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.

Children—

Studies on this medicine have only been done in adult patients and there is no specific information comparing the use of gemifloxacin in children with use in other age groups. It is not recommended to use gemifloxacin in children up to 18 years of age because this medicine has been shown to cause bone development problems in young animals.

Older adults—

There is no specific information comparing use of gemifloxacin in the elderly with use in other age groups. However, it has been used in older people and has not been found to cause different side effects or other problems than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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

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, epilepsy or other seizures— Gemifloxacin may increase the chance of making these problems worse.

• Heart rhythm problems— Gemifloxacin should be used with caution in patients with these conditions.

• Hypokalemia (not enough potassium in your blood) or
• Hypomagnesemia (not enough magnesium in your blood)— These conditions can increase your risk of having a fast, slow or irregular heartbeat when you are taking gemifloxacin.

• QTc prolongation (rare heart rhythm problem)—Gemifloxacin may cause this condition to become worse, especially with higher doses of gemifloxacin.

Proper Use of This Medicine:

Gemifloxacin may be taken with or without food. Tablet must be swallowed whole. Do not chew the tablet.

Drink plenty of fluids while you are being treated with this medicine. Drinking extra water will help to 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. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day.

It is important that you take this medicine exactly as prescribed by your doctor. It is important for you to take this medicine for as long as the doctor tells you to, even if you begin to feel better after a few days.

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
    • Adults— 320 milligrams (mg) once a day for five to seven 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.

Precautions While Using This Medicine:

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

Make sure your doctor knows if you recently had an episode of chest pain.

Tell your doctor right away if you have palpitations (pounding heartbeat) or fainting spells while taking this medicine.

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; or vision changes. When you begin taking this medicine use caution when you are in the sun and do not use a tanning bed, booth or sunlamp. If you have a severe reaction from the sun, check with your doctor.

If you get a skin rash or other signs of an allergic reaction, stop taking gemifloxacin and check with your doctor immediately .

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 are not alert. If these reactions are especially bothersome, check with your doctor.

This medicine may rarely cause inflammation or even tearing of a tendon (the cord that attaches muscles to bones). If you get sudden pain in a tendon after exercise (for example, in your ankle, back of the knee or leg, shoulder, elbow, or wrist), stop taking gemifloxacin and check with your doctor. Rest and do not exercise until the doctor has made sure that you have not injured or torn the tendon.

Tell your doctor if you have severe diarrhea that does not go away while taking this medicine or after you finish taking this medicine.

Side Effects of This Medicine:

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 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

pale skin

painful or difficult urination

pinpoint red spots on skin

redness of skin

runny nose

shortness of breath

skin rash

sneezing

sore throat

sores, ulcers, or white spots on lips or in mouth

swollen glands

tightness in chest

trouble in swallowing

troubled breathing

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

voice changes

weakness in arms, hands, legs, or feet

wheezing

yellow eyes or skin

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:

Less Common

Diarrhea

headache

nausea

Rare

Abnormal urine

acid or sour stomach

back pain

bad unusual or unpleasant taste

belching

blistering, crusting, irritation, itching, or reddening of skin

blurred vision

change in taste

change in vision

cracked, dry, scaly skin

difficulty having a bowel movement (stool)

difficulty in moving

dizziness or light-headedness

dry mouth

dryness or soreness of throat

feeling of constant movement of self or surroundings

feeling of warmth

fruit like breath odor

heartburn

hoarseness

increased hunger and thirst

increased sensitivity of skin to sunlight

increased urination

indigestion

lack or loss of strength

leg cramps

loss of appetite

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 legs, arms, hands, feet

sleepiness or drowsiness

sleeplessness

stomach discomfort, upset or pain

sudden sweating

swelling

swollen joints

trembling or shaking of hands or feet

trouble in swallowing

voice changes

vomiting

weight loss

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