Ofloxacin (Oral route)
Fluoroquinolones, including ofloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue ofloxacin and avoid use of fluoroquinolones in patients with these serious adverse reactions. Reserve use of ofloxacin for patients with no alternative treatment options for acute exacerbation of chronic bronchitis or uncomplicated cystitis. Fluoroquinolones, including ofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis .
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:
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.
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.
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.
|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.|
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.
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.
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.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Cholera Vaccine, Live
- Inotuzumab Ozogamicin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glargine, Recombinant
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
- Aminolevulinic Acid
- Lanthanum Carbonate
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.
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 12 hours for 3 to 14 days, depending on the medical problem being treated. Prostatitis is usually treated for 6 weeks. Gonorrhea is usually treated with a single oral dose of 400 mg.
- Children—Use and dose must be determined by your doctor.
- For treatment of infection:
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.
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.
Tell your doctor right away if you have any of the following symptoms while using this medicine: convulsions, 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 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:
- Less common
- Abdominal or stomach pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- body aches or pain
- chest pain
- cloudy urine
- cold sweats
- cool, pale skin
- dry mouth
- dryness or soreness of the throat
- eye pain
- fast heartbeat
- flushed, dry skin
- fruit-like breath odor
- general feeling of illness
- increased hunger
- increased thirst
- increased urination
- lower back or side pain
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pus in the urine
- runny nose
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- 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
- 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
- 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
- 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
- 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, itching, or skin rash
- increased need to urinate
- increased sensitivity of the eyes to sunlight
- increased sweating
- 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
- slow or fast heartbeat
- sores, welting, or blisters
- stopping of the heart
- sudden loss of consciousness
- swollen joints
- trembling or shaking of the hands or feet
- trouble concentrating
- trouble performing routine tasks
- trouble sleeping
- 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
- 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
- dark-colored urine
- darkening of the skin
- delusions of persecution, mistrust, suspiciousness, and/or combativeness
- diarrhea, watery and severe, which may also be bloody
- difficulty with breathing, chewing, speaking, or swallowing
- discharge or excessive tearing
- double vision
- drooping eyelids
- feeling of discomfort
- general body swelling
- high fever
- increased blood pressure
- increased menstrual flow or vaginal bleeding
- increased sensitivity of the skin to sunlight
- increased sweating
- 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
- 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
- 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
- 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
- scaly skin
- severe abdominal or stomach pain, cramping, or burning
- severe sunburn
- severe tiredness
- 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 or stomach pain
- vomiting of blood or material that looks like coffee grounds
- weakness in the arms, hands, legs, or feet
- weight gain
- yellowing of the eyes or skin
- Less common
- Change in taste
- excess air or gas in the stomach or intestines
- full feeling
- loss of taste
- passing gas
- runny nose
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:
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:
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: 9/4/2017