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Ofloxacin (Oral route)

Pronunciation:

oh-FLOX-a-sin

Brand Names:

  • Floxin

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Fluoroquinolones, including ofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. Risk further increases with age over 60 years, concomitant steroid therapy, and kidney, heart, or lung transplants. Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Fluoroquinolone

Uses of This Medicine:

Ofloxacin is used to treat certain bacterial infections in many different parts of the body. It may also be used for other problems as determined by your doctor. Ofloxacin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Ofloxacin belongs to the class of drugs known as fluoroquinolone 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.

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—

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

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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—

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

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 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.

  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Sparfloxacin
  • Thioridazine

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
  • Alfuzosin
  • Alosetron
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Benfluorex
  • Bretylium
  • Chloroquine
  • Chlorpromazine
  • Chlorpropamide
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dasatinib
  • Desipramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Erythromycin
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Gatifloxacin
  • Gemifloxacin
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Granisetron
  • Guar Gum
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Insulin
  • Insulin Aspart, Recombinant
  • Insulin Glulisine
  • Insulin Lispro, Recombinant
  • Lapatinib
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Metformin
  • Methadone
  • Mifepristone
  • Miglitol
  • Moricizine
  • Moxifloxacin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ondansetron
  • Paliperidone
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Posaconazole
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Salmeterol
  • Saquinavir
  • Sematilide
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tedisamil
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Tolazamide
  • Tolbutamide
  • Toremifene
  • Trifluoperazine
  • Trimipramine
  • Troglitazone
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Warfarin
  • Ziprasidone

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.

  • Betamethasone
  • Corticotropin
  • Cortisone
  • Cosyntropin
  • Deflazacort
  • Dexamethasone
  • Didanosine
  • Fludrocortisone
  • Fluocortolone
  • Hydrocortisone
  • Iron
  • Methylprednisolone
  • Paramethasone
  • Prednisolone
  • Prednisone
  • Sucralfate
  • Triamcinolone
  • Zinc

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:

  • 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
  • Myocardial ischemia (reduced blood supply in the heart) or
  • Seizures (epilepsy), or history of—Use with caution. May make these conditions worse.
  • Brain disease (eg, hardening of the arteries) or
  • Kidney disease or
  • Liver disease (including cirrhosis) or
  • Organ transplant (eg, heart, kidney, or lung), history of or
  • Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May cause side effects to become worse.
  • Myasthenia gravis (severe muscle weakness), or history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

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.

Drink plenty of fluids while you are being treated with this medicine. Drinking extra water will help to prevent some unwanted effects of ofloxacin.

If you are also using antacids containing aluminum or magnesium (such as Maalox®, Mylanta®), multivitamins (with calcium, iron, or zinc), didanosine (Videx®), or sucralfate (Carafate®), take these medicines at least 2 hours before or 2 hours after you take ofloxacin. These medicines may keep ofloxacin 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:
      • Adults—200 to 400 milligrams (mg) every twelve hours for 3 to 14 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—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:

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.

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

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Check with your doctor right away if you have dark urine, clay-colored stools, abdominal or stomach pain, or yellow eyes or skin. These maybe symptoms of a serious liver problem.

Ofloxacin 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.

Ofloxacin may rarely cause inflammation or even tearing of a tendon (the cord that attaches muscles to bones). The risk of having tendon problems may be increased if you are over 60 years of age, using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or have received an organ (eg, heart, kidney, or lung) transplant. If you get sudden pain or swelling in a tendon after exercise (eg, in the ankle, back of the knee or leg, shoulder, elbow, or wrist), check with your doctor right away. Refrain from exercise until your doctor says otherwise.

For patients with an abnormally slow heartbeat or low potassium levels in the blood, ofloxacin may increase your risk of having a fast, slow, or irregular heartbeat. Call your doctor right away if you feel that your heart is not beating normally.

Some people who take ofloxacin 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 using 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.

Ofloxacin 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.

For diabetic patients taking insulin or oral medicine: Ofloxacin 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 ofloxacin 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, or unusual tiredness or weakness.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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 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
Abdominal or stomach pain
anxiety
black, tarry stools
bleeding gums
blood in the urine or stools
blurred vision
body aches or pain
chest pain
chills
cloudy urine
cold sweats
coma
confusion
congestion
cool, pale skin
cough
depression
diarrhea
dry mouth
dryness or soreness of the throat
eye pain
fast heartbeat
fever
flushed, dry skin
fruit-like breath odor
general feeling of illness
headache
hoarseness
increased hunger
increased thirst
increased urination
lower back or side pain
nausea
nervousness
nightmares
painful or difficult urination
pale skin
pinpoint red spots on the skin
pus in the urine
runny nose
seizures
shakiness
shortness of breath
slurred speech
sore throat
sores, ulcers, or white spots on the lips or in the mouth
sweating
swollen glands
tender, swollen glands in the neck
trouble with swallowing
troubled breathing with exertion
unexplained weight loss
unusual bleeding or bruising
unusual tiredness or weakness
voice changes
vomiting
Rare
Burning while urinating
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
change in color vision
continuing ringing or buzzing or other unexplained noise in the ears
convulsions
decrease in frequency of urination
decrease in urine volume
decreased hearing or any change in hearing
difficult or painful urination
difficulty in passing urine (dribbling)
difficulty seeing at night
difficulty with moving
discouragement
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
false or unusual sense of well-being
fast, irregular, pounding, or racing heartbeat or pulse
fear or nervousness
feeling of constant movement of self or surroundings
feeling of warmth or heat
feeling sad or empty
flushing or redness of the skin, especially on the face and neck
hearing loss
hives or welts
increased need to urinate
increased sensitivity of the eyes to sunlight
increased sweating
irritability
itching
joint pain
lack of appetite
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of bladder control
loss of interest or pleasure
muscle aching or cramping
muscle pains or stiffness
muscle spasm or jerking of all extremities
no blood pressure or pulse
no breathing
passing urine more often
pounding in the ears
redness, soreness, or itching skin
seeing, hearing, or feeling things that are not there
sensation of spinning
shakiness in the legs, arms, hands, or feet
skin rash
slow or fast heartbeat
sores, welting, or blisters
stopping of the heart
sudden loss of consciousness
swelling
swollen joints
trembling or shaking of the hands or feet
trouble concentrating
trouble performing routine tasks
trouble sleeping
unconsciousness
Incidence not known
Abdominal or stomach tenderness
actions that are out of control
back, leg, or stomach pains
blistering, peeling, or loosening of the skin
bloating
blue lips and fingernails
burning, dry, or itching eyes
changes in behavior
confusion about identity, place, and time
coughing that sometimes produces a pink frothy sputum
coughing up blood
cracks in the skin
crying
dark-colored urine
darkening of the skin
delusions of persecution, mistrust, suspiciousness, and/or combativeness
depersonalization
diarrhea, watery and severe, which may also be bloody
difficulty with breathing, chewing, or talking
difficulty with speaking
difficulty with swallowing
discharge or excessive tearing
double vision
drooling
drooping eyelids
dysphoria
euphoria
feeling of discomfort
general body swelling
heartburn
high fever
hyperventilation
increased blood pressure
increased menstrual flow or vaginal bleeding
increased sensitivity of the skin to sunlight
increased sweating
indigestion
inflammation of the joints
irregular heartbeats
irregular or slow heart rate
itching of the vagina or outside the genitals
loss of ability to use or understand speech or language
loss of appetite
loss of balance control
loss of heat from the body
mental depression
mood or mental changes
muscle weakness
noisy breathing
nosebleeds
numbness of the hands
pain during sexual intercourse
pain in the ankles or knees
pain, inflammation, or swelling in the calves, shoulders, or hands
painful, red lumps under the skin, mostly on the legs
paralysis
prolonged bleeding from cuts
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
quick to react or overreact emotionally
rapidly changing moods
rash
red or black, tarry stools
red or dark brown urine
red skin lesions, often with a purple center
red, irritated eyes
red, swollen skin
redness or other discoloration of the skin
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
restlessness
scaly skin
severe abdominal pain, cramping, or burning
severe sunburn
severe tiredness
shaking
shuffling walk
stiffness of the limbs
stomach pain, continuing
swelling of the face, fingers, or lower legs
swollen lymph glands
talking, feeling, and acting with excitement
thick, white, curd-like vaginal discharge without odor or with mild odor
thoughts of killing oneself
twisting movements of the body
uncontrolled eye movements
uncontrolled movements, especially of the face, neck, and back
unexplained bleeding or bruising
unpleasant breath odor
unsteadiness or awkwardness
unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness, especially in children using 2% cyclopentolate
unusual weight loss
upper right abdominal pain
vomiting of blood or material that looks like coffee grounds
weakness in the arms, hands, legs, or feet
weight gain
wheezing
yellowing of the 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:

More common
Sleeplessness
unable to sleep
Less common
Change in taste
excess air or gas in the stomach or intestines
full feeling
loss of taste
passing gas
runny nose

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.


Last Updated: 4/4/2014

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