Ofloxacin 300mg Tablets
WARNING: This drug may cause severe side effects like irritated or torn tendons; nerve problems in the arms, hands, legs, or feet; and nervous system problems. These can happen alone or at the same time. They can happen within hours to weeks after starting this drug. Some of these effects may not go away, and may lead to disability or death.The chance of irritated or torn tendons is greater in people over the age of 60; heart, kidney, or lung transplant patients; or people taking steroid drugs. Tendon problems can happen as long as several months after treatment. Call your doctor right away if you have pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints. Call your doctor right away if you are not able to move or bear weight on a joint or if you hear or feel a snap or pop.Call your doctor right away if you have signs of nerve problems. These may include not being able to handle heat or cold; change in sense of touch; or burning, numbness, tingling, pain, or weakness in the arms, hands, legs, or feet.Call your doctor right away if you have signs of nervous system problems. These may include anxiety, bad dreams, trouble sleeping, change in eyesight, dizziness, feeling confused, feeling nervous or agitated, feeling restless, hallucinations (seeing or hearing things that are not there), new or worse behavior or mood changes like depression or thoughts of suicide, seizures, or very bad headaches.Do not take if you have myasthenia gravis. Very bad and sometimes deadly breathing problems have happened with this drug in people who have myasthenia gravis.For some health problems, this drug is only for use when other drugs cannot be used or have not worked. Talk with the doctor to be sure that the benefits of this drug are more than the risks. @ COMMON USES: It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Fluoroquinolone Antibiotic; DNA Gyrase Inhibitor; Topoisomerase IV Inhibitor
Pregnancy Category
Category C
FDA Approved
Dec 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ofloxacin is an antibiotic medication used to treat various bacterial infections, such as infections of the lungs, skin, urinary tract, and reproductive organs. It works by stopping the growth of bacteria.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
However, do not take dairy products, antacids, didanosine, sucralfate, multivitamins, or other products that contain calcium, magnesium, aluminum, iron, or zinc within 2 hours before or 2 hours after taking your medication.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
However, do not take dairy products, antacids, didanosine, sucralfate, multivitamins, or other products that contain calcium, magnesium, aluminum, iron, or zinc within 2 hours before or 2 hours after taking your medication.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed and complete the full course of treatment, even if you feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
- Drink plenty of fluids while taking this medication to help prevent kidney problems.
- Avoid excessive exposure to sunlight or artificial UV light (e.g., tanning beds) as this medication can make your skin more sensitive to the sun. Use sunscreen and wear protective clothing when outdoors.
- Avoid taking antacids, sucralfate, or mineral supplements (like iron or zinc) within 2 hours before or 2 hours after taking ofloxacin, as they can interfere with its absorption.
- Do not drive or operate machinery if you experience dizziness, lightheadedness, or confusion.
Available Forms & Alternatives
Available Strengths:
- Ofloxacin 0.3% Otic Soln 5ml (ear)
- Ofloxacin 0.3% Otic Soln 10ml (ear)
- Ofloxacin 0.3% Oph Soln 10ml (eye)
- Ofloxacin 0.3% Otic Soln 10ml (ear)
- Ofloxacin 0.3% Oph Sol 10ml (eye)
- Ofloxacin 0.3% Oph Soln 5ml (eye)
- Ofloxacin 400mg Tablets
- Ofloxacin 300mg Tablets
- Ofloxacin 300mg Tablets
- Ofloxacin 0.3% Oph Sol 10ml (eye)
- Ofloxacin 0.3% Oph Soln 5ml (eye)
Dosing & Administration
Adult Dosing
Standard Dose:
200 mg to 400 mg orally every 12 hours
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
Community-acquired pneumonia:
400 mg orally every 12 hours for 10 days
Acute bacterial exacerbation of chronic bronchitis:
400 mg orally every 12 hours for 10 days
Acute uncomplicated cystitis:
200 mg orally every 12 hours for 3 days
Complicated urinary tract infections:
200 mg orally every 12 hours for 10 days
Prostatitis:
300 mg orally every 12 hours for 6 weeks
Uncomplicated urethral and cervical gonorrhea:
400 mg orally as a single dose
Non-gonococcal urethritis/cervicitis:
300 mg orally every 12 hours for 7 days
Pelvic inflammatory disease:
400 mg orally every 12 hours for 10-14 days (often with metronidazole)
Pediatric Dosing
Neonatal:
Not established (generally avoided due to arthropathy risk)
Infant:
Not established (generally avoided due to arthropathy risk)
Child:
Not routinely recommended due to risk of arthropathy; use only when benefits outweigh risks in severe infections (e.g., cystic fibrosis exacerbations) and no other suitable alternatives. Dosing is highly individualized and based on weight and infection type, typically 15 mg/kg/day divided every 12 hours, max 800 mg/day.
Adolescent:
Not routinely recommended due to risk of arthropathy; use only when benefits outweigh risks in severe infections (e.g., cystic fibrosis exacerbations) and no other suitable alternatives. Dosing is highly individualized and based on weight and infection type, typically 15 mg/kg/day divided every 12 hours, max 800 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: No dosage adjustment needed.
Moderate:
CrCl 20-50 mL/min: Administer usual initial dose, then 200 mg every 24 hours.
Severe:
CrCl <20 mL/min: Administer usual initial dose, then 200 mg every 24 hours (or 100 mg every 24 hours for severe infections).
Dialysis:
Hemodialysis/CAPD: Administer usual initial dose, then 100 mg every 24 hours. Supplemental dose after dialysis is generally not needed as only a small amount is removed.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; monitor for adverse effects. Dosage adjustment may be considered in severe cases, but specific guidelines are not well-established.
Pharmacology
Mechanism of Action
Ofloxacin is a broad-spectrum fluoroquinolone antibiotic. It exerts its bactericidal effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. Inhibition of these enzymes leads to DNA strand breaks, ultimately resulting in bacterial cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98%
Tmax:
1-2 hours
FoodEffect:
Food has minimal effect on the extent of absorption, but may slightly delay Tmax.
Distribution:
Vd:
Approximately 1.5-2.5 L/kg
ProteinBinding:
Approximately 20-32%
CnssPenetration:
Limited (achieves therapeutic concentrations in CSF, but lower than in serum)
Elimination:
HalfLife:
5-8 hours (prolonged in renal impairment)
Clearance:
Approximately 150-200 mL/min
ExcretionRoute:
Primarily renal (glomerular filtration and tubular secretion)
Unchanged:
Approximately 65-80% in urine
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 1-2 hours of dosing
DurationOfAction:
Approximately 12 hours (allows for twice-daily dosing)
Safety & Warnings
BLACK BOX WARNING
Fluoroquinolones, including ofloxacin, are associated with an increased risk of disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Discontinue ofloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid fluoroquinolones in patients with a known history of myasthenia gravis. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions, reserve ofloxacin for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis, acute uncomplicated cystitis, and acute sinusitis.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Chest pain or pressure
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Shakiness
Difficulty walking
Shortness of breath
Vaginal itching or discharge
Redness or white patches in the mouth or throat
Muscle pain or weakness
Difficulty focusing
Memory problems or loss
Important: Antibiotic-Associated Diarrhea
Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.
Rare but Serious Vascular Problem
In rare cases, a severe problem with the aorta (the main blood vessel that comes out of the heart) has been reported in patients taking medications like this one, especially in older adults. This condition can cause tears or bursting of the aorta, leading to severe bleeding and even death. If you experience sudden, severe pain in the stomach, chest, or back that does not go away, contact your doctor immediately.
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Diarrhea
Upset stomach or vomiting
* Changes in taste
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Chest pain or pressure
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Shakiness
Difficulty walking
Shortness of breath
Vaginal itching or discharge
Redness or white patches in the mouth or throat
Muscle pain or weakness
Difficulty focusing
Memory problems or loss
Important: Antibiotic-Associated Diarrhea
Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.
Rare but Serious Vascular Problem
In rare cases, a severe problem with the aorta (the main blood vessel that comes out of the heart) has been reported in patients taking medications like this one, especially in older adults. This condition can cause tears or bursting of the aorta, leading to severe bleeding and even death. If you experience sudden, severe pain in the stomach, chest, or back that does not go away, contact your doctor immediately.
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Diarrhea
Upset stomach or vomiting
* Changes in taste
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden pain, swelling, or bruising around a joint (especially the ankle, heel, or shoulder) â this could be a sign of tendon rupture. Stop taking the medication and seek immediate medical attention.
- Numbness, tingling, burning pain, or weakness in your arms or legs â these are symptoms of peripheral neuropathy. Stop taking the medication and contact your doctor immediately.
- Severe or persistent diarrhea, especially if it contains blood or mucus, which may occur even weeks after stopping the medication.
- New or worsening muscle weakness, especially if you have myasthenia gravis.
- Dizziness, confusion, hallucinations, seizures, or severe headache.
- Rash, hives, difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat (signs of an allergic reaction).
- Palpitations or a feeling of your heart racing or skipping beats.
- Sudden, severe pain in your chest, back, or stomach (possible aortic aneurysm/dissection).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain heart conditions, such as:
+ Long QTc on electrocardiogram (ECG) or other abnormal heart rhythms
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (a weakened heart)
+ Recent heart attack
Nerve problems or tendon problems, including:
+ Previous irritation or tearing of tendons when taking this medication or similar drugs
Aortic aneurysm (a bulging or ballooning of the aorta, the main blood vessel that comes out of the heart) or risk factors for this condition, including:
+ Other blood vessel problems
+ High blood pressure
+ Certain health conditions, such as Marfan syndrome or Ehlers-Danlos syndrome
Use of medications that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can interact with this drug, so it is crucial to ask your doctor or pharmacist if you are unsure.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain heart conditions, such as:
+ Long QTc on electrocardiogram (ECG) or other abnormal heart rhythms
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (a weakened heart)
+ Recent heart attack
Nerve problems or tendon problems, including:
+ Previous irritation or tearing of tendons when taking this medication or similar drugs
Aortic aneurysm (a bulging or ballooning of the aorta, the main blood vessel that comes out of the heart) or risk factors for this condition, including:
+ Other blood vessel problems
+ High blood pressure
+ Certain health conditions, such as Marfan syndrome or Ehlers-Danlos syndrome
Use of medications that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can interact with this drug, so it is crucial to ask your doctor or pharmacist if you are unsure.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness.
Duration of Use
Do not use this medication for longer than prescribed, as this may increase the risk of a second infection.
Blood Sugar Monitoring
Drugs like this one can cause high or low blood sugar levels. This is more common in people with diabetes who take medications that lower blood sugar, such as insulin. In rare cases, very low blood sugar can lead to coma or death. Monitor your blood sugar levels as directed by your doctor, and report any signs of high or low blood sugar, including:
- Breath that smells like fruit
- Dizziness
- Fast breathing
- Fast heartbeat
- Feeling confused, sleepy, or weak
- Flushing
- Headache
- Unusual thirst or hunger
- Passing urine more often
- Shaking or sweating
Long-Term Use and Lab Tests
If you are taking this medication for an extended period, your doctor may recommend regular blood work to monitor its effects. This medication may also affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this medication.
Sun Protection
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
Hydration
Drink plenty of non-caffeinated liquids every day, unless your doctor advises you to limit your fluid intake.
Rare but Serious Side Effects
Although rare, this medication can cause severe and potentially life-threatening effects, including muscle or joint problems, kidney or liver damage, blood disorders, and other complications. If you have any concerns or questions, discuss them with your doctor.
Severe Skin Reactions
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can lead to serious health problems or death. Seek immediate medical attention if you experience:
- Red, swollen, blistered, or peeling skin (with or without fever)
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes
Abnormal Heartbeat
This medication can also cause a type of abnormal heartbeat known as prolonged QT interval. If you experience a fast or irregular heartbeat, or if you pass out, call your doctor right away.
Special Considerations
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects.
Pediatric Use
This medication is not approved for use in children under 18 years old. If you have any questions or concerns, discuss them with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to you and your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness.
Duration of Use
Do not use this medication for longer than prescribed, as this may increase the risk of a second infection.
Blood Sugar Monitoring
Drugs like this one can cause high or low blood sugar levels. This is more common in people with diabetes who take medications that lower blood sugar, such as insulin. In rare cases, very low blood sugar can lead to coma or death. Monitor your blood sugar levels as directed by your doctor, and report any signs of high or low blood sugar, including:
- Breath that smells like fruit
- Dizziness
- Fast breathing
- Fast heartbeat
- Feeling confused, sleepy, or weak
- Flushing
- Headache
- Unusual thirst or hunger
- Passing urine more often
- Shaking or sweating
Long-Term Use and Lab Tests
If you are taking this medication for an extended period, your doctor may recommend regular blood work to monitor its effects. This medication may also affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this medication.
Sun Protection
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
Hydration
Drink plenty of non-caffeinated liquids every day, unless your doctor advises you to limit your fluid intake.
Rare but Serious Side Effects
Although rare, this medication can cause severe and potentially life-threatening effects, including muscle or joint problems, kidney or liver damage, blood disorders, and other complications. If you have any concerns or questions, discuss them with your doctor.
Severe Skin Reactions
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can lead to serious health problems or death. Seek immediate medical attention if you experience:
- Red, swollen, blistered, or peeling skin (with or without fever)
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes
Abnormal Heartbeat
This medication can also cause a type of abnormal heartbeat known as prolonged QT interval. If you experience a fast or irregular heartbeat, or if you pass out, call your doctor right away.
Special Considerations
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects.
Pediatric Use
This medication is not approved for use in children under 18 years old. If you have any questions or concerns, discuss them with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- CNS symptoms (confusion, dizziness, seizures, tremors)
- Nausea, vomiting
- Gastric irritation
- QT prolongation
What to Do:
In case of overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Maintain adequate hydration.
Drug Interactions
Contraindicated Interactions
- Tizanidine (increased tizanidine concentrations and hypotension)
Major Interactions
- Antacids containing aluminum, magnesium, or calcium
- Sucralfate
- Didanosine (buffered tablets/powder for oral solution)
- Iron supplements
- Zinc supplements
- Multivitamins containing minerals (decreased ofloxacin absorption)
- Corticosteroids (increased risk of tendon rupture)
- QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (increased risk of QT prolongation and Torsades de Pointes)
- Warfarin (enhanced anticoagulant effect, increased bleeding risk)
- NSAIDs (increased risk of CNS stimulation and seizures)
Moderate Interactions
- Theophylline (increased theophylline levels, though less pronounced than with ciprofloxacin)
- Glyburide (potential for severe hypoglycemia)
- Cyclosporine (increased cyclosporine levels)
- Probenecid (decreased renal clearance of ofloxacin)
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To guide dosage adjustment in patients with impaired renal function.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease.
Timing: Prior to initiation of therapy.
Electrocardiogram (ECG)
Rationale: To assess baseline QTc interval, especially in patients with risk factors for QT prolongation (e.g., known prolonged QT, uncorrected hypokalemia/hypomagnesemia, bradycardia, concomitant QT-prolonging drugs).
Timing: Prior to initiation of therapy, if risk factors present.
Blood glucose
Rationale: For diabetic patients, due to risk of dysglycemia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of tendonitis/tendon rupture
Frequency: Daily during therapy and for several months post-therapy
Target: Absence of pain, swelling, inflammation, or inability to bear weight.
Action Threshold: Discontinue ofloxacin immediately and avoid exercise if symptoms occur; consider alternative antibiotic.
Signs and symptoms of peripheral neuropathy
Frequency: Daily during therapy
Target: Absence of pain, burning, tingling, numbness, or weakness.
Action Threshold: Discontinue ofloxacin immediately if symptoms occur to prevent irreversible damage.
Signs and symptoms of CNS effects
Frequency: Daily during therapy
Target: Absence of dizziness, confusion, hallucinations, seizures, tremors, or insomnia.
Action Threshold: Discontinue ofloxacin if severe CNS effects occur.
Blood glucose
Frequency: Regularly, especially in diabetic patients
Target: Within normal limits (or patient's target range)
Action Threshold: Monitor closely for hypo- or hyperglycemia; adjust antidiabetic therapy if needed; discontinue ofloxacin if severe dysglycemia occurs.
Renal function (CrCl)
Frequency: Periodically, especially in patients with pre-existing renal impairment or on prolonged therapy.
Target: Stable or improving
Action Threshold: Adjust dose if renal function declines.
Fluid intake
Frequency: Daily
Target: Adequate hydration
Action Threshold: Encourage adequate fluid intake to prevent crystalluria.
Symptom Monitoring
- Tendon pain, swelling, inflammation (especially Achilles tendon)
- Numbness, tingling, burning, pain, or weakness in extremities (peripheral neuropathy)
- Dizziness, lightheadedness, confusion, hallucinations, anxiety, depression, insomnia, tremors, seizures
- Severe or persistent diarrhea (Clostridioides difficile-associated diarrhea)
- Rash, itching, hives, swelling of face/throat (hypersensitivity reaction)
- Palpitations, fainting (QT prolongation)
- Muscle weakness (exacerbation of myasthenia gravis)
- Sudden, severe pain in chest, back, or abdomen (aortic aneurysm/dissection)
Special Patient Groups
Pregnancy
Ofloxacin is classified as Pregnancy Category C. Animal studies have shown adverse effects on fetal development (e.g., arthropathy in immature animals). There are no adequate and well-controlled studies in pregnant women. Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and when no safer alternative antibiotics are available.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on cartilage development, though human data are limited. Avoid if possible.
Second Trimester:
Potential for adverse effects on cartilage development. Avoid if possible.
Third Trimester:
Potential for adverse effects on cartilage development. Avoid if possible.
Lactation
Ofloxacin is excreted into human breast milk. Due to the potential for serious adverse reactions in breastfed infants, including arthropathy and other effects observed with fluoroquinolones, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The American Academy of Pediatrics considers fluoroquinolones to be compatible with breastfeeding with caution (L3).
Infant Risk:
Potential for arthropathy, gastrointestinal disturbances (e.g., diarrhea, candidiasis), and alteration of gut flora in the infant. Monitor infant for adverse effects.
Pediatric Use
Ofloxacin is generally not recommended for use in pediatric patients (under 18 years of age) due to the risk of irreversible arthropathy (damage to cartilage in weight-bearing joints) observed in immature animals. Use in children should be reserved for situations where the benefits outweigh the risks, such as severe infections (e.g., complicated urinary tract infections, pyelonephritis, or cystic fibrosis exacerbations) where other safer alternatives are not effective or available. Close monitoring for musculoskeletal adverse effects is crucial.
Geriatric Use
Elderly patients may be at increased risk for certain adverse reactions associated with fluoroquinolones, including tendinitis and tendon rupture, QT prolongation, and CNS effects (e.g., hallucinations, confusion). Renal function should be assessed prior to dosing, and dosage adjustments made as necessary. Increased caution is advised in elderly patients, especially those on concomitant corticosteroids or with pre-existing renal impairment or cardiac conditions.
Clinical Information
Clinical Pearls
- Always complete the full course of therapy, even if symptoms improve, to prevent resistance and relapse.
- Educate patients about the Black Box Warnings, especially the risk of tendinitis/rupture and peripheral neuropathy, and instruct them to discontinue the drug and seek medical attention immediately if these symptoms occur.
- Advise patients to stay well-hydrated to prevent crystalluria.
- Remind patients to avoid concomitant administration with antacids, sucralfate, or mineral supplements.
- Monitor diabetic patients closely for dysglycemia (both hypo- and hyperglycemia).
- Ofloxacin has relatively minimal CYP450 interaction compared to ciprofloxacin, making it a safer choice in patients on medications metabolized by CYP1A2 (e.g., theophylline).
- Consider alternative antibiotics for uncomplicated infections where fluoroquinolones are not first-line due to the risk of serious adverse effects.
Alternative Therapies
- Other fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin)
- Beta-lactam antibiotics (e.g., Penicillins, Cephalosporins)
- Macrolide antibiotics (e.g., Azithromycin, Clarithromycin)
- Tetracyclines (e.g., Doxycycline)
- Sulfonamides (e.g., Trimethoprim/Sulfamethoxazole)
- Aminoglycosides (for specific severe infections)
Cost & Coverage
Average Cost:
$20 - $100 per 30 tablets (300mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the medication taken, the quantity, and the time it occurred.