Tavanic
Levofloxacin
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 the fluoroquinolones, the
following should be considered:
Allergies
Tell your doctor if you have ever had any
unusual or allergic reaction to any of the fluoroquinolones or to any
related medicines such as cinoxacin (e.g., Cinobac) or nalidixic acid
(e.g., NegGram). Also tell your health care professional if you are
allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy
Studies have not been done in humans.
However, use is not recommended during pregnancy since fluoroquinolones
have been reported to cause bone development problems in young animals.
Breast-feeding
Some of the fluoroquinolones are known to
pass into human breast milk. Since fluoroquinolones have been reported to
cause bone development problems in young animals, breast-feeding is not
recommended during treatment with these medicines.
Children
Use is not recommended for infants or
children since fluoroquinolones have been shown to cause bone development
problems in young animals. However, your doctor may choose to use one of
these medicines if other medicines cannot be used.
Teenagers
Use is not recommended for teenagers
younger than 18 years of age since fluoroquinolones have been shown to
cause bone development problems in young animals. However, your doctor may
choose to use one of these medicines if other medicines cannot be used.
Older adults
These medicines have been tested and, in
effective doses, have not been shown to cause different side effects or
problems in older people than they do in younger adults.
Other medicines
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 a fluoroquinolone, it is especially important that your
health care professional know if you are taking any of the following:
• Aminophylline or
• Oxtriphylline (e.g., Choledyl) or
• Theophylline (e.g., Elixophyllin, Theo-Dur)—Ciprofloxacin, enoxacin, and
norfloxacin may increase the chance of side effects of aminophylline,
oxtriphylline, or theophylline
• Amiodarone (e.g., Cordarone) or
• Astemizole (e.g., Hismanal) or
• Bepridil (e.g., Vascor) or
• Cisapride (e.g., Propulsid) or
• Disopyramide (e.g., Norpace) or
• Erythromycin (e.g., E-Mycin) or
• Pentamidine (e.g., NebuPent) or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,
Ormazine, Thorazine Spansule, Thor-Prom], fluphenazine [e.g., Permitil,
Prolixin], mesoridazine [e.g., Serentil], methotrimeprazine [e.g.,
Nozinan], pericyazine [e.g., Neuleptil], perphenazine [e.g., Trilafon],
prochlorperazine [e.g., Compazine], promazine [e.g., Primazine, Sparine],
thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine],
triflupromazine [e.g., Vesprin]) or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Sotalol (e.g., Sotacor) or
• Terfenadine (e.g., Seldane) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil, Endep],
amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine
[e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Norfranil,
Tipramine, Tofranil], nortriptyline [e.g., Aventyl, Pamelor],
protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Use of
these medicines with gatifloxacin, levofloxacin, moxifloxacin or
sparfloxacin may cause heart problems, such as an irregular heartbeat
• Antacids, aluminum-, calcium-, and/or magnesium-containing, or
• Didanosine (e.g., Videx, ddI) or
• Iron supplements or
• Sucralfate (e.g., Carafate)—Antacids, didanosine, iron, or sucralfate
may keep any of the fluoroquinolones from working properly. Ciprofloxacin
may be taken 2 hours before or 6 hours after these medicines. Moxifloxacin
may be taken 4 hours before or 8 hours after these medicines.
• Caffeine—Ciprofloxacin, enoxacin, and norfloxacin may increase the
chance of side effects of caffeine; caffeine should not be taken during
treatment with enoxacin
• Phenytoin (e.g., Dilantin)—Ciprofloxacin may keep phenytoin from working
properly
• Warfarin (e.g., Coumadin)—Ciprofloxacin and norfloxacin may increase the
effect of warfarin, increasing the chance of bleeding
Other medical problems—The presence of other medical problems may affect
the use of fluoroquinolones. Make sure you tell your doctor if you have
any other medical problems, especially:
• Brain or spinal cord disease, including hardening of the arteries in the
brain or epilepsy or other seizures—Fluoroquinolones may cause nervous
system side effects
• Diabetes mellitus (sugar diabetes)—Levofloxacin may cause changes in
blood sugar, which could lead to problems in controlling blood sugar
• Diarrhea—May be a sign of colon problems and taking fluoroquinolones
could make this problem worse. Your doctor will want to check you before
you begin taking your medicine.
• Glucose-6-phosphate dehydrogenase activity defect (problem with an
enzyme that your body makes)—If you have this condition and you take a
fluoroquinolone, you could have problems with anemia.
• Heart disease— Gatifloxacin, moxifloxacin or sparfloxacin may make this
problem worse
• Kidney disease or
• Liver disease—Patients with kidney disease or liver disease may have an
increased chance of side effects with any of the fluoroquinolones
• Myasthenia gravis (muscle disease)—This condition may become worse when
taking a fluoroquinolone and cause your respiratory muscles to become weak
which is life-threatening. Be sure and tell your doctor if you have this
condition.
• Sensitivity of the skin to sunlight (previous)—Patients taking
sparfloxacin or any of the other fluoroquinolones may have an increased
risk of severe reactions to sunlight
• Tendinitis (previous)—Fluoroquinolones may increase the risk of tendon
injury
Proper Use of This Medicine
Do not take fluoroquinolones if you are
pregnant. Do not give fluoroquinolones to infants, children, or teenagers
unless otherwise directed by your doctor. These medicines have been shown
to cause bone development problems in young animals.
Fluoroquinolones should be used only to treat bacterial infections and not
viral infections like the common cold.
To help clear up your infection completely, keep taking your medicine for
the full time of treatment, even if you begin to feel better after a few
days. If you stop taking this medicine too soon, your symptoms may return.
Fluoroquinolones are best taken with a full
glass (8 ounces) of water. Several additional glasses of water should be
taken every day, unless you are otherwise directed by your doctor.
Drinking extra water will help to prevent some unwanted effects of
ciprofloxacin and norfloxacin.
Enoxacin or norfloxacin should be taken on an empty stomach.
Ciprofloxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin,
ofloxacin, or sparfloxacin may be taken with meals or on an empty stomach.
Ciprofloxacin should NOT be taken with dairy products or calcium-fortified
juices alone, but may be taken with a meal that contains these products
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 two doses a day, the
doses should be spaced about 12 hours apart. If this interferes with your
sleep or other daily activities, or if you need help in planning the best
times to take your medicine, check with your health care professional.
Dosing
The dose of fluoroquinolones 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 fluoroquinolones. Your dose may be different if you have
kidney disease. If your dose is different, do not change it unless your
doctor tells you to do so.
The number of tablets or amount of oral
suspension 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 a fluoroquinolone.
For ciprofloxacin
• For oral dosage form (oral suspension or
tablets):
- Adults: 100 to 750 milligrams (mg) every twelve hours for three to
twenty-eight days, depending on the medical problem being treated. Bone
and joint infections are usually treated for at least four to six weeks.
Gonorrhea is usually treated with a single oral dose of 250 mg.
Inhalational anthrax is usually treated for sixty days with 500 mg every
twelve hours.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers, except in the case of inhalational
anthrax. Inhalational anthrax is usually treated for sixty days with 15 mg
per kilogram (kg) (6.8 mg per pound) of body weight every twelve hours.
• For injection dosage form:
- Adults: 200 to 400 mg every eight to twelve hours.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers, except in the case of inhalational
anthrax. Inhalational anthrax is usually treated for sixty days with 10 mg
per kg (4.5 mg per pound) of body weight every twelve hours.
For enoxacin
• For oral dosage form (tablets):
- Adults: 200 to 400 mg every twelve hours for seven to fourteen days,
depending on the medical problem being treated. Gonorrhea is usually
treated with a single oral dose of 400 mg.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
For gatifloxacin
• For oral dosage form (tablets):
- Adult: 200 to 400 mg every twenty four hours for seven to fourteen days,
depending on the medical problems being treated. Gonorrhea and certain
bladder infection are usually treated with a single oral dose of 400 mg.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
• For injection dosage form:
- Adults: 200 to 400 mg every twenty four
hours for seven to fourteen days, depending on the medical problems being
treated. Gonorrhea and certain bladder infection are usually treated with
a single oral dose of 400 mg.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
For levofloxacin
• For oral dosage form (tablets):
- Adults: 250 to 750 mg once a day for seven to fourteen days, depending
on the medical problem being treated.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
• For injection dosage form:
- Adults: 250 to 750 mg, injected slowly into a vein, once a day for seven
to fourteen days, depending on the medical problem being treated.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
For lomefloxacin
• For oral dosage form (tablets):
- Adults: 400 mg once a day for three to fourteen days, depending on the
medical problem being treated.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
For moxifloxacin
• For oral dosage form (tablets):
- Adult: 400 mg once a day for five to fourteen days, depending on the
medical problem being treated.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
• For injection dosage form:
- Adult: 400 mg injected in a vein once a day for five to fourteen days,
depending on the medical problem being treated.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
For norfloxacin
• For oral dosage form (tablets):
- Adults: 400 mg every twelve hours for three to twenty-eight days,
depending on the medical problem being treated. Gonorrhea is usually
treated with a single oral dose of 800 mg.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
For ofloxacin
• For oral dosage form (tablets):
- Adults: 200 to 400 mg every twelve hours for three to fourteen days,
depending on the medical problem being treated. Prostatitis is usually
treated for six weeks. Gonorrhea is usually treated with a single oral
dose of 400 mg.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
• For injection dosage form:
- Adults: 200 to 400 mg, injected slowly into a vein, every twelve hours
for three to fourteen days, depending on the medical problem being
treated. Prostatitis is usually treated for six weeks. Gonorrhea is
usually treated with a single dose of 400 mg.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
For sparfloxacin
• For oral dosage form (tablets):
- Adults: 400 mg on the first day, then 200 mg once a day for an
additional nine days.
- Children up to 18 years of age: This medicine is not recommended for use
in infants, children, or teenagers.
Missed dose
If you miss a dose of this medicine, take
it as soon as possible. This will help to keep a constant amount of
medicine in the blood or urine. 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
To store this medicine:
• Keep out of the reach of children.
• Store away from heat and direct light.
• Ciprofloxacin oral suspension may be refrigerated. However, keep this
medicine from freezing.
• Do not store in the bathroom, near the kitchen sink, or in other damp
places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that
any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
If your symptoms do not improve within a
few days, or if they become worse, check with your doctor.
If you are taking aluminum- or magnesium-containing antacids, or
sucralfate, do not take them at the same time that you take this medicine.
It is best to take these medicines at least 6 hours before or 2 hours
after taking ciprofloxacin; at least 8 hours before or 2 hours after
taking enoxacin; at least 4 hours after taking gatifloxacin; at least 4
hours before or 4 hours after taking sparfloxacin; at least 2 hours before
or 2 hours after taking levofloxacin, norfloxacin, or ofloxacin; at least
4 hours before or 2 hours after taking lomefloxacin, and at least 8 hours
before and 4 hours after taking moxifloxacin. These medicines may keep
fluoroquinolones from working properly.
If you are taking metal cations such as
iron, and multivitamin preparations with zinc, or didanosine (Videx®)
chewable/buffered tablets or the pediatric powder for oral solutiontake
moxifloxacin at least 4 hours before or 8 hours after and take
ciprofloxacin at least 2 hours before or 6 hours after taking these
medicines.
If you are taking levofloxacin, you should
not take certain medications which correct a fast, slow or irregular
heartbeat. Check with your physician to determine whether you are taking
one of these medications.
If you are taking enoxacin, you should not
take any caffeine-containing products (e.g., coffee, tea, chocolate,
certain carbonated beverages). Taking any of these caffeine-containing
products while you are taking enoxacin may increase the effects of
caffeine.
Some people who take fluoroquinolones, especially sparfloxacin, may become
more sensitive to sunlight than they are normally. Exposure to sunlight,
even for brief periods of time, may cause severe sunburn, or 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 patients 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 health care professional.
• Do not use a sunlamp or tanning bed or booth.
Stay out of direct sunlight and artificial
light (e.g., sunlamp, tanning bed or booth) for the next 5 days or until
the reaction has stopped.
If you get a skin rash or other signs of an allergic reaction, stop taking
the fluoroquinolone and check with your doctor.
Fluoroquinolones may also 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 can be dangerous if you are dizzy or are not alert. If these
reactions are especially bothersome, check with your doctor.
Fluoroquinolones 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 the fluoroquinolone 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.
If you have pain, burning, tingling,
numbness and/or weakness, stop taking the fluoroquinolone and check with
your doctor.
For patients with diabetes taking insulin or diabetes medicine by mouth:
Levofloxacin 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, stop taking levofloxacin and check with your doctor right away:
• Symptoms of low blood sugar can include:
Anxious feeling, behavior change similar to being drunk, blurred vision,
cold sweats, confusion, cool pale skin, difficulty in concentrating,
drowsiness, excessive hunger, headache, nausea, nervousness, rapid
heartbeat, shakiness, unusual tiredness or weakness.
For patients with low potassium levels:
levofloxacin may increase your risk of experiencing a fast, slow or
irregular heartbeat.
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:
• More common--For sparfloxacin and moxifloxacin (less common)
- Fainting; irregular or slow heart rate
• Less common--More common for lomefloxacin and sparfloxacin
- Bloating or swelling of face, arms, hands, lower legs, or feet;
blistering of skin; blurred vision; dizziness; headache; nervousness ;
pounding in the ears; rapid weight gain; sensation of skin burning; slow
or fast heartbeat; skin itching, rash, redness, or swelling; tingling of
hands or feet; unusual weight gain or loss
• Rare
- Abdominal or stomach cramps and pain (severe); abdominal pain; abdominal
tenderness; agitation; area rash; black, tarry stools; bleeding; blisters
on mucous membranes, with fever; blistering, itching, loosening, peeling,
or redness of skin; bloody or cloudy urine; coldness; burning, crawling,
itching, numbness, prickling, "pins and needles" , or tingling feelings;
chills; chest pain; clay-colored stools; confusion; cough; dark or amber
urine; diarrhea (watery and severe, which may also be bloody); difficulty
breathing; difficulty swallowing; discoloration of skin; dizziness; dry
mouth; excessive muscle tone; fainting; faintness, dizziness, or
lightheadedness when getting up from a lying or sitting position suddenly;
fast, pounding, or irregular heartbeat or pulse; fatigue; flushed, dry
skin; feeling of pressure; feeling of unreality; feeling of warmth or
heat; fever; flushing or redness of skin especially on face and neck;
fruit-like breath odor; hallucinations (seeing, hearing, or feeling things
that are not there); hives or welts; incoordination; increased hunger;
increased thirst; increased urination; inflammation; infection; irregular
or fast heart rate ; itching; joint pain; lack or loss of strength; large
amount of fat in the blood; loss of appetite; loss of memory; lower back,
side, or stomach pain; lumps; muscle stiffness; muscle tension or
tightness; nausea; noisy breathing; numbness; pain; pain at site of
injection—for ciprofloxacin or ofloxacin injection; pain in calves,
radiating to heels; pain, warmth, or burning in fingers, toes and legs;
painful or difficult urination; pale stools; palpitations; peeling of the
skin; problems with memory; problems with speech or speaking; problems
with vision or hearing ; rash; rash with flat lesions or small raised
lesions on the skin; redness ; redness of skin; redness, swelling, or
soreness of tongue; scarring; seizures; sense of detachment from self or
body; shakiness or tremors; shortness of breath skin rash; sore throat;
sores, ulcers, or white spots on lips or in mouth; soreness; stomach pain;
stinging; sweating; swelling; swelling of face or neck; swelling of
calves, feet, or lower legs; swelling or inflammation of the mouth;
swelling or puffiness of face; tenderness; tightness in chest; tingling;
troubled breathing; ulceration; unpleasant breath odor; unusual tiredness
or weakness ; vomiting; vomiting of blood; warmth; wheezing ; yellow eyes
or skin
• Incidence not determined--—Observed during clinical practice with
levofloxacin; estimates of frequency cannot be determined
- Abnormal brain wave patterns; black, tarry stools ; bleeding gums;
blurred vision; coma; confusion ; difficult breathing; failure of the
heart, lungs, kidneys and/or liver; fatigue; general body swelling; hives;
inability to move arms and legs; increased bleeding time; irregular
reading on a electrocardiogram (heart test); joint or muscle pain; sharp
drop in blood pressure; sore throat; sudden numbness and weakness in the
arms and legs; swollen glands; unsteadiness or awkwardness; unusual
bleeding or bruising; weakness in arms, hands, legs, or feet
Other 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. However, check with your doctor if any of the following side
effects continue or are bothersome:
• More common
- Abdominal or stomach pain or discomfort (mild); diarrhea (mild);
drowsiness; lightheadedness; nervousness; trouble in sleeping; vaginal
pain and discharge
• Less frequent or rare
- Abnormal dream; acid or sour stomach ; back pain; bad, unusual or
unpleasant (after) taste; belching; bloated full feeling; burning,
crawling, itching, numbness, prickling, "pins and needles" , or tingling
feelings; burning feeling in chest or stomach; change in sense of taste;
change in sense of smell ; change in taste; change in vision;
constipation; continuing ringing or buzzing or other unexplained noise in
ears; crying; depersonalization; depression; difficulty in moving;
difficulty in sleeping; difficulty in speaking; difficulty in urination;
dysphoria; euphoria; excess air or gas in stomach or intestines; fear;
feeling of constant movement of self or surroundings; general feeling of
discomfort or illness; hearing loss; heartburn; impaired vision; increased
sensitivity of skin to sunlight; indigestion; mental depression; muscle
pain; pain, swelling, or redness in joints; paranoia; passing gas; pelvic
pain; pinpoint red or purple spots on skin; puffiness or swelling of the
eyelids or around the eyes, face, lips or tongue ; quick to react or
overreact emotionally; rapidly changing moods; sensation of spinning;
shortness of breath; sleeplessness; sleepiness or unusual drowsiness; sore
mouth or tongue, or white patches in mouth and/or on tongue ; spots on
skin resembling a blister or pimple; stomach discomfort, upset or pain;
tenderness in stomach area; thinking, abnormal; tongue discoloration;
unable to sleep ; vaginal yeast infection; vision problems; weight loss
Other side effects not listed above may also occur in some patients. If
you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved for
marketing for a certain use, experience may show that it is also useful
for other medical problems. Although these uses are not included in
product labeling, fluoroquinolones are used in certain patients with the
following medical conditions:
• Chancroid
• Pulmonary exacerbations (airway infections) in cystic fibrosis
Other than the above information, there is
no additional information relating to proper use, precautions, or side
effects for these uses.
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