Ofloxacin 400mg 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
Fluoroquinolone Antibiotic
Pharmacologic Class
DNA Gyrase Inhibitor; Topoisomerase IV Inhibitor
Pregnancy Category
Category C
FDA Approved
Dec 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ofloxacin is an antibiotic medication used to treat various bacterial infections, such as those affecting the lungs, skin, urinary tract, and certain sexually transmitted infections. It works by stopping the growth of bacteria.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. However, avoid taking dairy products, antacids, didanosine, sucralfate, multivitamins, or any other products containing 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 feeling better. It's essential to complete the full course of treatment as directed.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe and secure location, out of reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about any local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. However, avoid taking dairy products, antacids, didanosine, sucralfate, multivitamins, or any other products containing 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 feeling better. It's essential to complete the full course of treatment as directed.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe and secure location, out of reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about any local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing 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, even if you feel better, to ensure the infection is fully cleared and prevent resistance.
- Drink plenty of fluids while taking this medication to help prevent kidney problems.
- Avoid excessive exposure to sunlight or artificial UV light (tanning beds) as this medication can make your skin more sensitive to the sun, leading to severe sunburn. Use sunscreen and wear protective clothing.
- Avoid taking antacids, sucralfate, iron, or zinc supplements within 2 hours before or 2 hours after taking ofloxacin, as they can interfere with its absorption.
- Report any new or worsening symptoms to your doctor immediately.
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:
400 mg every 12 hours
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
Acute Bacterial Exacerbation of Chronic Bronchitis:
400 mg every 12 hours for 10 days
Community-Acquired Pneumonia:
400 mg every 12 hours for 10 days
Uncomplicated Skin and Skin Structure Infections:
400 mg every 12 hours for 10 days
Uncomplicated Urinary Tract Infections:
200 mg every 12 hours for 3-7 days
Complicated Urinary Tract Infections:
200 mg every 12 hours for 10 days
Prostatitis:
300 mg every 12 hours for 6 weeks
Acute Uncomplicated Urethral and Cervical Gonorrhea:
400 mg as a single dose
Non-gonococcal Urethritis and Cervicitis (Chlamydia):
300 mg every 12 hours for 7 days
Pediatric Dosing
Neonatal:
Not established (generally not recommended due to risk of arthropathy)
Infant:
Not established (generally not recommended due to risk of arthropathy)
Child:
Not established (generally not recommended due to risk of arthropathy, use only when benefits outweigh risks and no other suitable options)
Adolescent:
Not established (generally not recommended due to risk of arthropathy, use only when benefits outweigh risks and no other suitable options)
Dose Adjustments
Renal Impairment:
Mild:
CrCl > 50 mL/min: No adjustment needed
Moderate:
CrCl 20-50 mL/min: Initial dose as per indication, then 200 mg every 24 hours
Severe:
CrCl < 20 mL/min: Initial dose as per indication, then 200 mg every 48 hours
Dialysis:
Hemodialysis or CAPD: Initial dose as per indication, then 200 mg every 48 hours. Administer after dialysis session.
Hepatic Impairment:
Mild:
No specific adjustment, use with caution
Moderate:
No specific adjustment, use with caution
Severe:
No specific adjustment, use with caution
Pharmacology
Mechanism of Action
Ofloxacin is a broad-spectrum fluoroquinolone antibiotic that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This inhibition leads to DNA strand breaks and bacterial cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 98%
Tmax:
1-2 hours
FoodEffect:
Minimal effect on absorption; can be taken with or without food.
Distribution:
Vd:
1.5-2.5 L/kg
ProteinBinding:
Approximately 20-30%
CnssPenetration:
Yes (achieves therapeutic concentrations in CSF)
Elimination:
HalfLife:
5-8 hours (average 6 hours)
Clearance:
Primarily renal clearance
ExcretionRoute:
Primarily renal (glomerular filtration and tubular secretion)
Unchanged:
70-80% excreted unchanged in urine
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of first dose)
PeakEffect:
Within 1-2 hours of dosing
DurationOfAction:
Approximately 12 hours (consistent with 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 the use of fluoroquinolones in patients who experience any of these serious adverse reactions. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Ofloxacin in patients with a known history of myasthenia gravis. Fluoroquinolones have been associated with an increased risk of aortic aneurysm and dissection. Consider the risk-benefit in patients at risk. Dysglycemia, including both hypoglycemia and hyperglycemia, has been reported with fluoroquinolone use.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately:
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
Diarrhea, especially if it is severe, bloody, or watery (a rare but serious condition called C. diff-associated diarrhea, or CDAD, may occur)
If you experience any of these symptoms, contact your doctor immediately. Additionally, be aware of a rare but severe problem that can occur with the main blood vessel that comes out of the heart (aorta), especially in older patients. This can include tears or bursting of the aorta, which can lead to severe bleeding and even death. If you experience sudden, severe pain in the stomach, chest, or back that does not go away, seek medical help right away.
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness or headache
Diarrhea
Upset stomach or vomiting
Changes in taste
This is not a comprehensive list of all possible 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 immediately:
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
Diarrhea, especially if it is severe, bloody, or watery (a rare but serious condition called C. diff-associated diarrhea, or CDAD, may occur)
If you experience any of these symptoms, contact your doctor immediately. Additionally, be aware of a rare but severe problem that can occur with the main blood vessel that comes out of the heart (aorta), especially in older patients. This can include tears or bursting of the aorta, which can lead to severe bleeding and even death. If you experience sudden, severe pain in the stomach, chest, or back that does not go away, seek medical help right away.
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness or headache
Diarrhea
Upset stomach or vomiting
Changes in taste
This is not a comprehensive list of all possible 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 in a joint or tendon (especially Achilles tendon)
- Numbness, tingling, burning, or weakness in your arms or legs
- Confusion, hallucinations, severe dizziness, or seizures
- Severe or watery diarrhea that does not stop, with or without fever and stomach cramps
- New or worsening muscle weakness, especially if you have myasthenia gravis
- Sudden, severe chest, back, or abdominal pain
- Yellowing of the skin or eyes (jaundice), dark urine, or pale stools
- Severe rash, hives, or swelling of the face, lips, or tongue
- Palpitations, irregular heartbeat, or fainting spells
- Signs of low blood sugar (e.g., sweating, shaking, confusion, hunger) or high blood sugar (e.g., increased thirst, frequent urination)
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:
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 health conditions, such as:
+ Abnormal heartbeat patterns, including a prolonged QTc interval on an electrocardiogram (ECG), slow heartbeat, or low potassium or magnesium levels.
+ Heart failure, which is a condition where the heart is not pumping blood efficiently.
+ Recent heart attack.
+ Nerve problems or tendon problems, including a history of tendon irritation or tears, especially if you have experienced these issues while taking this medication or similar drugs in the past.
+ Aortic aneurysm, which is a bulging or ballooning of the aorta, the main blood vessel that carries blood from the heart. This includes individuals with a history of blood vessel problems, high blood pressure, or certain genetic conditions like Marfan syndrome or Ehlers-Danlos syndrome.
If you are taking any medications that can cause abnormal heartbeat patterns, such as prolonged QT interval. There are numerous medications that can have this effect, so it is crucial to consult with 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.
Any natural products, vitamins, or supplements you are using.
Your complete medical history, including any health problems you have or have had in the past.
Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to verify that it is safe to do so. This will help prevent potential interactions and ensure the best possible treatment outcome.
It is essential to inform your doctor about the following:
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 health conditions, such as:
+ Abnormal heartbeat patterns, including a prolonged QTc interval on an electrocardiogram (ECG), slow heartbeat, or low potassium or magnesium levels.
+ Heart failure, which is a condition where the heart is not pumping blood efficiently.
+ Recent heart attack.
+ Nerve problems or tendon problems, including a history of tendon irritation or tears, especially if you have experienced these issues while taking this medication or similar drugs in the past.
+ Aortic aneurysm, which is a bulging or ballooning of the aorta, the main blood vessel that carries blood from the heart. This includes individuals with a history of blood vessel problems, high blood pressure, or certain genetic conditions like Marfan syndrome or Ehlers-Danlos syndrome.
If you are taking any medications that can cause abnormal heartbeat patterns, such as prolonged QT interval. There are numerous medications that can have this effect, so it is crucial to consult with 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.
Any natural products, vitamins, or supplements you are using.
Your complete medical history, including any health problems you have or have had in the past.
Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to verify that it is safe to do so. This will help prevent potential interactions and ensure the best possible treatment outcome.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. Additionally, do not take this medication for a longer period than prescribed, as this may increase the risk of a second infection.
Be aware that medications like this one can cause changes in blood sugar levels, including high and low blood sugar. This is particularly important for people with diabetes who are taking medications that lower blood sugar, such as insulin. In rare cases, very low blood sugar can lead to coma or even death. Monitor your blood sugar levels as directed by your doctor, and report any signs of high or low blood sugar, such as:
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
If you are taking this medication for an extended period, your doctor may recommend regular blood tests to monitor your condition. This medication may affect certain lab tests, so it is crucial to inform all your healthcare providers and lab workers that you are taking this medication.
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside. It is also essential to drink plenty of non-caffeinated liquids every day, unless your doctor advises you to limit your fluid intake.
Although rare, this medication can cause severe and potentially life-threatening side 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.
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems and even death. Seek immediate medical attention if you experience any of the following symptoms:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
* Sores in your mouth, throat, nose, or eyes
This medication can also cause a type of abnormal heartbeat known as prolonged QT interval. If you experience a fast heartbeat, an irregular heartbeat, or fainting, contact your doctor right away.
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for use in children under 18 years old. If you are a parent or guardian, discuss the potential risks and benefits with your child's doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. Additionally, do not take this medication for a longer period than prescribed, as this may increase the risk of a second infection.
Be aware that medications like this one can cause changes in blood sugar levels, including high and low blood sugar. This is particularly important for people with diabetes who are taking medications that lower blood sugar, such as insulin. In rare cases, very low blood sugar can lead to coma or even death. Monitor your blood sugar levels as directed by your doctor, and report any signs of high or low blood sugar, such as:
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
If you are taking this medication for an extended period, your doctor may recommend regular blood tests to monitor your condition. This medication may affect certain lab tests, so it is crucial to inform all your healthcare providers and lab workers that you are taking this medication.
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside. It is also essential to drink plenty of non-caffeinated liquids every day, unless your doctor advises you to limit your fluid intake.
Although rare, this medication can cause severe and potentially life-threatening side 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.
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems and even death. Seek immediate medical attention if you experience any of the following symptoms:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
* Sores in your mouth, throat, nose, or eyes
This medication can also cause a type of abnormal heartbeat known as prolonged QT interval. If you experience a fast heartbeat, an irregular heartbeat, or fainting, contact your doctor right away.
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for use in children under 18 years old. If you are a parent or guardian, discuss the potential risks and benefits with your child's doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Confusion
- Seizures
- QT prolongation
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Management is primarily supportive, including gastric lavage, activated charcoal, and maintaining hydration. ECG monitoring is recommended due to the risk of QT prolongation.
Drug Interactions
Contraindicated Interactions
- Tizanidine (concurrent use significantly increases tizanidine plasma concentrations, leading to hypotension and somnolence)
Major Interactions
- Antacids (containing magnesium, aluminum, calcium), sucralfate, iron, zinc (form chelation complexes, significantly reducing ofloxacin absorption)
- Warfarin (may enhance anticoagulant effects, increasing INR and bleeding risk)
- Class IA and Class III antiarrhythmics (e.g., quinidine, procainamide, amiodarone, sotalol), tricyclic antidepressants, macrolides, antipsychotics (increased risk of QT prolongation and Torsades de Pointes)
- NSAIDs (may increase risk of CNS stimulation and convulsive seizures)
- Cyclosporine (may increase cyclosporine plasma concentrations, leading to nephrotoxicity)
- Glibenclamide (may cause severe hypoglycemia)
Moderate Interactions
- Corticosteroids (increased risk of tendon rupture)
- Probenecid (decreases renal tubular secretion of ofloxacin, increasing its plasma levels)
- Theophylline (ofloxacin may increase theophylline levels, leading to toxicity, though less pronounced than with ciprofloxacin)
- Cimetidine (may slightly increase ofloxacin levels)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Culture and Susceptibility
Rationale: To confirm bacterial pathogen and its susceptibility to ofloxacin, guiding appropriate therapy.
Timing: Prior to initiating therapy
Renal Function (CrCl, BUN, Creatinine)
Rationale: Ofloxacin is primarily renally eliminated; dose adjustment is required in renal impairment.
Timing: Prior to initiating therapy
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: Although minimally metabolized, caution is advised in hepatic impairment; baseline assessment is prudent.
Timing: Prior to initiating therapy, especially in patients with pre-existing liver disease
Electrolytes (Potassium, Magnesium)
Rationale: Hypokalemia or hypomagnesemia can increase the risk of QT prolongation.
Timing: Prior to initiating therapy, especially in patients at risk for electrolyte imbalances
ECG
Rationale: To assess baseline QT interval, especially in patients with cardiac conditions or on other QT-prolonging drugs.
Timing: Prior to initiating therapy, if risk factors for QT prolongation are present
Routine Monitoring
Clinical Response to Therapy
Frequency: Daily
Target: Resolution of infection symptoms (e.g., fever, pain, inflammation)
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or alternative diagnosis.
Adverse Effects Monitoring (e.g., GI upset, CNS effects, musculoskeletal pain)
Frequency: Daily
Target: Absence or mild, tolerable side effects
Action Threshold: Development of severe or persistent adverse effects (e.g., severe diarrhea, tendon pain, numbness/tingling, confusion, hallucinations) requires immediate evaluation and potential discontinuation.
Renal Function (CrCl, BUN, Creatinine)
Frequency: Periodically, especially in prolonged therapy or worsening renal function
Target: Stable or improving renal function
Action Threshold: Significant decline in renal function may necessitate dose adjustment or discontinuation.
INR (for patients on Warfarin)
Frequency: More frequently (e.g., 2-3 times per week initially)
Target: Therapeutic INR range for indication
Action Threshold: Significant increase in INR requires warfarin dose adjustment.
Blood Glucose (for diabetic patients, especially on oral hypoglycemics)
Frequency: Regularly, especially at initiation
Target: Target glycemic control
Action Threshold: Hypoglycemia or hyperglycemia requires immediate intervention and potential drug adjustment.
Symptom Monitoring
- Tendon pain, swelling, or inflammation (especially Achilles, shoulder, hand)
- Numbness, tingling, burning, or weakness in extremities (peripheral neuropathy)
- Dizziness, lightheadedness, confusion, hallucinations, anxiety, depression, insomnia, seizures
- Severe or persistent diarrhea, abdominal pain, fever (Clostridioides difficile-associated diarrhea)
- Chest, back, or abdominal pain (aortic aneurysm/dissection)
- Sudden severe headache, visual disturbances, or other signs of increased intracranial pressure
- Rash, itching, hives, swelling of face/lips/tongue (hypersensitivity reaction)
- Yellowing of skin or eyes, dark urine, pale stools (liver injury)
- Palpitations, fainting, shortness of breath (QT prolongation/arrhythmia)
- Muscle weakness, difficulty breathing (exacerbation of myasthenia gravis)
Special Patient Groups
Pregnancy
Category C. Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal cartilage development.
Trimester-Specific Risks:
First Trimester:
Potential for cartilage damage in the developing fetus, though human data are limited.
Second Trimester:
Potential for cartilage damage in the developing fetus.
Third Trimester:
Potential for cartilage damage in the developing fetus.
Lactation
L3 (Moderate risk). Ofloxacin is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, including arthropathy and other effects observed in juvenile animals, 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.
Infant Risk:
Potential for arthropathy (cartilage damage), gastrointestinal disturbances (diarrhea, candidiasis), and alteration of gut flora.
Pediatric Use
Generally not recommended for use in pediatric patients (<18 years of age) due to the risk of irreversible arthropathy (cartilage damage) in weight-bearing joints. Use is restricted to situations where the benefit outweighs the risk and no other suitable alternative antibiotics are available (e.g., severe infections like complicated UTIs or anthrax exposure where other agents are ineffective or contraindicated).
Geriatric Use
Elderly patients may be at increased risk for severe tendon disorders (including rupture), peripheral neuropathy, and QT prolongation. Renal function should be assessed, and dose adjusted accordingly. Increased susceptibility to CNS effects and dysglycemia may also occur.
Clinical Information
Clinical Pearls
- Counsel patients extensively on the Black Box Warnings, especially the risk of tendinitis/tendon rupture and peripheral neuropathy. Advise immediate discontinuation and medical attention if these symptoms occur.
- Emphasize the importance of hydration to prevent crystalluria, although this is less common with ofloxacin than older quinolones.
- Avoid co-administration with multivalent cations (antacids, iron, zinc, sucralfate) due to significant reduction in absorption. Separate administration by at least 2 hours before or 2 hours after.
- Monitor blood glucose closely in diabetic patients, as fluoroquinolones can cause both hypoglycemia and hyperglycemia.
- Ofloxacin has good penetration into various tissues and fluids, including prostate, lungs, and CSF, making it useful for a range of infections.
- Consider ECG monitoring in patients with known QT prolongation, uncorrected hypokalemia/hypomagnesemia, or those on other QT-prolonging medications.
Alternative Therapies
- Other Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin, Moxifloxacin)
- Beta-lactam antibiotics (e.g., Penicillins, Cephalosporins, Carbapenems)
- Macrolides (e.g., Azithromycin, Clarithromycin)
- Tetracyclines (e.g., Doxycycline, Minocycline)
- Aminoglycosides (e.g., Gentamicin, Tobramycin)
- Sulfonamides (e.g., Trimethoprim/Sulfamethoxazole)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
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 safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 details about the medication taken, the quantity, and the time it occurred.