Ciprofloxacin 500mg Tablets

Manufacturer PACK PHARMACEUTICALS, LLC Active Ingredient Ciprofloxacin Tablets(sip roe FLOKS a sin) Pronunciation sip-roe-FLOKS-a-sin
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 or prevent bacterial infections.
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Drug Class
Fluoroquinolone Antibiotic
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Pharmacologic Class
DNA Gyrase Inhibitor; Topoisomerase IV Inhibitor
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Pregnancy Category
Category C
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FDA Approved
Oct 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ciprofloxacin is an antibiotic used to treat various bacterial infections, such as infections of the urinary tract, lungs, skin, bones, and joints. It works by stopping the growth of bacteria. It's important to take it exactly as prescribed and finish the entire course of treatment, even if you feel better.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day.
You can take your medication with or without food, and with a full glass of water.
However, do not take your medication with dairy products like milk or yogurt, or with calcium-rich juices. If you eat a meal that contains these products, you can take your medication with the meal.
If you take other medications, your doctor may need to adjust the timing of your doses. Take your medication at least 2 hours before or 6 hours after taking antacids, didanosine, lanthanum, sucralfate, quinapril, bismuth, sevelamer, multivitamins, or other products that contain magnesium, calcium, aluminum, iron, or zinc.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Swallow your medication whole; do not chew or crush it.
Some tablet strengths may have a score line, which allows you to split the tablet in half if needed for your dose. If you need to split a tablet, only split it along the score line.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications 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.
Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
If it is less than 6 hours until your next scheduled dose, skip the missed dose and take your next dose at the regular time.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take with a full glass of water to prevent kidney stone formation.
  • Avoid taking with dairy products (milk, yogurt) or calcium-fortified juices, as they can reduce absorption. Separate by at least 2 hours before or 6 hours after.
  • Avoid taking with antacids, iron supplements, or zinc supplements. Separate by at least 2 hours before or 6 hours after.
  • Stay well-hydrated during treatment.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) as ciprofloxacin can increase sensitivity to the sun. Use sunscreen and wear protective clothing.
  • Avoid strenuous exercise during treatment and for several months after, due to the risk of tendon problems.

Dosing & Administration

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Adult Dosing

Standard Dose: 500 mg orally every 12 hours for most infections (e.g., uncomplicated UTI, respiratory tract infections)
Dose Range: 250 - 750 mg

Condition-Specific Dosing:

Uncomplicated UTI: 250 mg orally every 12 hours for 3 days
Complicated UTI/Pyelonephritis: 500 mg orally every 12 hours for 7-14 days
Lower Respiratory Tract Infections: 500-750 mg orally every 12 hours for 7-14 days
Acute Sinusitis: 500 mg orally every 12 hours for 10 days
Skin and Skin Structure Infections: 500-750 mg orally every 12 hours for 7-14 days
Bone and Joint Infections: 500-750 mg orally every 12 hours for 4-6 weeks
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Pediatric Dosing

Neonatal: Not established (generally avoided due to arthropathy risk)
Infant: Not established (generally avoided due to arthropathy risk)
Child: 10-20 mg/kg orally every 12 hours (max 750 mg/dose) for specific indications (e.g., complicated UTI, pyelonephritis, inhalational anthrax post-exposure) when benefits outweigh risks.
Adolescent: 10-20 mg/kg orally every 12 hours (max 750 mg/dose) for specific indications (e.g., complicated UTI, pyelonephritis, inhalational anthrax post-exposure) when benefits outweigh risks.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 50 mL/min)
Moderate: Reduce dose to 250-500 mg every 12 hours (CrCl 30-50 mL/min)
Severe: Reduce dose to 250-500 mg every 18-24 hours (CrCl < 30 mL/min)
Dialysis: Administer dose after dialysis; 250-500 mg every 24 hours (Hemodialysis or Peritoneal Dialysis)

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: Caution advised; monitor for adverse effects. No specific dose adjustment recommended based on current data, but impaired elimination may occur.

Pharmacology

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Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibacterial. It inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to inhibition of bacterial cell division and cell death.
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Pharmacokinetics

Absorption:

Bioavailability: 70-80%
Tmax: 0.5-2 hours
FoodEffect: Food delays Tmax but does not significantly alter bioavailability. Dairy products and calcium-fortified juices can significantly decrease absorption.

Distribution:

Vd: 2-3 L/kg
ProteinBinding: 20-40%
CnssPenetration: Limited (achieves therapeutic concentrations in CSF, but lower than in serum)

Elimination:

HalfLife: 3-5 hours (normal renal function)
Clearance: 30-40 L/hour (total body clearance)
ExcretionRoute: Renal (primarily glomerular filtration and tubular secretion), some fecal
Unchanged: 50-70% (renal), 15% (fecal)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Concentration-dependent killing; peak serum concentrations achieved within 1-2 hours post-dose.
DurationOfAction: Maintained for 12 hours due to post-antibiotic effect and concentration-dependent killing.

Safety & Warnings

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BLACK BOX WARNING

Fluoroquinolones, including ciprofloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Discontinue ciprofloxacin 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 ciprofloxacin in patients with a known history of myasthenia gravis. Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions, reserve ciprofloxacin for use in patients who have no alternative treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.
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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 or hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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
Chest pain or pressure
Shortness of breath
Shakiness or tremors
Difficulty walking
Vaginal itching or discharge
White patches in the mouth (oral thrush)
Sunburn
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Muscle pain or weakness
Difficulty focusing or memory problems
Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes

Important: Diarrhea and Antibiotic Use

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur. This condition can lead to life-threatening bowel problems. If you experience:

Stomach pain or cramps
Very 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 occurred within 2 months of taking medications like this one, especially in older patients. This 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

contact your doctor immediately.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Upset stomach or vomiting
* Headache

Reporting Side Effects

If you have questions about side effects or want to report any, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • New or worsening pain, swelling, tenderness, stiffness, or inability to move a joint (especially in the heel, shoulder, or elbow) - STOP taking and call your doctor immediately.
  • Numbness, tingling, burning, or weakness in your arms or legs - STOP taking and call your doctor immediately.
  • Severe or watery diarrhea, especially if it contains blood or mucus, occurring during or after treatment.
  • Sudden chest pain, shortness of breath, or fainting.
  • Severe dizziness or lightheadedness.
  • Rash, hives, blistering, or peeling skin.
  • Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing.
  • Any new or worsening muscle weakness, especially if you have myasthenia gravis.
  • Changes in vision or hearing.
  • Unusual mood changes, confusion, hallucinations, or seizures.
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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 and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain heart conditions, including:
+ Abnormal heart rhythms (Long QTc on ECG) or other irregular heartbeats
+ 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 while 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, such as:
+ Other blood vessel problems
+ High blood pressure
+ Certain health conditions like Marfan syndrome or Ehlers-Danlos syndrome
Medications that can cause abnormal heart rhythms (prolonged QT interval). There are many drugs that can cause this condition; consult your doctor or pharmacist if you are unsure.
Concurrent use of specific medications, including:
+ Duloxetine
+ Theophylline
+ Tizanidine
+ Zolpidem
* Breast-feeding: Do not breast-feed while taking this medication and for at least 2 days after your last dose.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. Verify that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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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. This will help ensure your safety and prevent potential interactions with other treatments.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness. This will help prevent accidents and ensure your safety.

Lab Tests and Monitoring
This medication may interfere with certain lab tests. Be sure to inform all your healthcare providers and lab personnel that you are taking this medication. If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.

Blood Sugar Control
Medications like this one can cause changes in blood sugar levels. If you have diabetes and are taking medications to lower your blood sugar, such as insulin, you may be at risk for low blood sugar (hypoglycemia). In rare cases, 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, including:
- Breath that smells like fruit
- Dizziness
- Fast breathing
- Fast heartbeat
- Feeling confused or sleepy
- Feeling weak
- Flushing
- Headache
- Unusual thirst or hunger
- Passing urine more often
- Shaking or sweating

Duration of Use
Do not take this medication for longer than prescribed. Taking it for an extended period can increase the risk of a second infection.

Caffeine Interactions
If you consume products containing caffeine, such as tea, coffee, cola, or chocolate, or take medications that contain caffeine, inform your doctor. This can help prevent potential interactions.

Sun Protection
This medication can increase your risk of sunburn. To protect yourself, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.

Fluid Intake
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Rare but Serious Side Effects
In rare cases, 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.

Abnormal Heartbeat
This medication can cause a type of abnormal heartbeat known as prolonged QT interval. If you experience a fast or irregular heartbeat, or if you faint, seek medical attention immediately.

Liver Problems
If you notice any signs of liver problems, such as dark urine, tiredness, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor right away.

Age-Related Precautions
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects. If the patient is a child, use this medication with caution, as the risk of joint problems may be higher in children.

Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Tremor
  • Headache
  • Tiredness
  • Seizures
  • Abdominal pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Renal impairment (crystalluria)

What to Do:

Call 911 or your local poison control center (1-800-222-1222 in the US) immediately. Treatment is supportive; gastric lavage may be considered. Maintain hydration to prevent crystalluria. Hemodialysis or peritoneal dialysis removes only small amounts of ciprofloxacin.

Drug Interactions

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Contraindicated Interactions

  • Tizanidine (increased tizanidine concentrations, severe hypotension, somnolence)
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Major Interactions

  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) - increased risk of QT prolongation and Torsades de Pointes
  • Warfarin - increased anticoagulant effect, risk of bleeding
  • Theophylline - increased theophylline levels, risk of toxicity (nausea, vomiting, seizures)
  • Methotrexate - increased methotrexate levels, risk of toxicity
  • Cyclosporine - increased cyclosporine levels, risk of nephrotoxicity
  • Phenytoin - altered phenytoin levels (increase or decrease)
  • Oral hypoglycemics (e.g., glyburide) - severe hypoglycemia
  • Sildenafil - increased sildenafil exposure
  • Clozapine - increased clozapine levels, risk of adverse effects
  • Duloxetine - increased duloxetine exposure
  • Ropinirole - increased ropinirole exposure
  • Omeprazole - increased omeprazole exposure
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Moderate Interactions

  • Antacids containing aluminum, magnesium, or calcium; sucralfate; iron supplements; zinc supplements; dairy products; calcium-fortified juices - decreased ciprofloxacin absorption (separate administration by at least 2 hours before or 6 hours after)
  • Caffeine - decreased caffeine clearance, increased caffeine effects
  • NSAIDs - increased risk of CNS stimulation and seizures (rare, but reported with other quinolones)
  • Probenecid - decreased ciprofloxacin renal clearance, increased ciprofloxacin levels
  • Metoclopramide - accelerated ciprofloxacin absorption, but no change in bioavailability
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: To determine appropriate dosing, especially in elderly or patients with pre-existing renal impairment.

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic status, especially in patients with pre-existing liver disease, though hepatic impairment rarely requires dose adjustment.

Timing: Prior to initiation of therapy (if clinically indicated)

ECG

Rationale: To assess QT interval, especially in patients with known QT prolongation, uncorrected hypokalemia/hypomagnesemia, or receiving other QT-prolonging drugs.

Timing: Prior to initiation of therapy (if risk factors present)

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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 ciprofloxacin immediately if symptoms occur; avoid exercise.

Signs and symptoms of peripheral neuropathy

Frequency: Daily during therapy

Target: Absence of pain, burning, tingling, numbness, or weakness

Action Threshold: Discontinue ciprofloxacin immediately if symptoms occur.

Blood glucose

Frequency: Periodically, especially in diabetic patients or those on oral hypoglycemics

Target: Normal glucose levels

Action Threshold: Monitor for hypo/hyperglycemia; adjust antidiabetic therapy if needed.

Fluid intake

Frequency: Daily

Target: Adequate hydration

Action Threshold: Ensure adequate hydration to prevent crystalluria.

INR (if on warfarin)

Frequency: Frequently, especially at initiation and discontinuation of ciprofloxacin

Target: Therapeutic range for indication

Action Threshold: Adjust warfarin dose as needed to maintain INR within target range.

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Symptom Monitoring

  • Tendon pain, swelling, inflammation, or rupture (especially Achilles tendon)
  • Numbness, tingling, burning, pain, or weakness (signs of peripheral neuropathy)
  • Severe or persistent diarrhea (possible Clostridioides difficile-associated diarrhea)
  • Rash, hives, itching, swelling of face/lips/tongue/throat (allergic reaction)
  • Dizziness, lightheadedness, fainting (hypotension, QT prolongation)
  • Palpitations, irregular heartbeat (arrhythmias)
  • Muscle weakness (exacerbation of myasthenia gravis)
  • Confusion, hallucinations, seizures, tremors, restlessness (CNS effects)
  • Vision changes, photophobia
  • Joint pain or swelling (in pediatric patients)

Special Patient Groups

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Pregnancy

Ciprofloxacin is Pregnancy Category C. It 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 development (arthropathy). While human data are limited, it is generally avoided unless no safer alternative exists for a serious infection.

Trimester-Specific Risks:

First Trimester: Potential for cartilage damage, though human data are reassuring for first-trimester exposure. Still, generally avoided.
Second Trimester: Potential for cartilage damage, generally avoided.
Third Trimester: Potential for cartilage damage, generally avoided.
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Lactation

Ciprofloxacin is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but Hale's rates it L3 (moderately safe). Potential risks to the infant include alteration of gut flora, diarrhea, and theoretical risk of cartilage damage. Monitor breastfed infants for gastrointestinal disturbances (diarrhea, candidiasis) and rash. Use with caution, or consider an alternative if available.

Infant Risk: Low to moderate risk; monitor for GI upset, candidiasis, and theoretical arthropathy.
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Pediatric Use

Generally not recommended for routine use in pediatric patients due to the risk of arthropathy (damage to weight-bearing joints) observed in immature animals. Use is restricted to specific, severe infections (e.g., complicated UTIs, pyelonephritis, inhalational anthrax post-exposure, cystic fibrosis exacerbations) where the benefits outweigh the risks and no safer alternative is available. Close monitoring for musculoskeletal adverse effects is crucial.

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Geriatric Use

Elderly patients may be at increased risk for tendon rupture, QT prolongation, and CNS effects (e.g., confusion, hallucinations). Renal function often declines with age, necessitating dose adjustments based on creatinine clearance. Increased susceptibility to C. difficile-associated diarrhea.

Clinical Information

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Clinical Pearls

  • Always complete the full course of therapy, even if symptoms improve, to prevent resistance.
  • Educate patients thoroughly on the black box warnings, especially tendon rupture and peripheral neuropathy, and instruct them to discontinue the drug immediately if symptoms occur.
  • Advise patients to separate administration from dairy products, antacids, and mineral supplements by several hours.
  • Ensure adequate hydration to prevent crystalluria.
  • Be aware of significant drug interactions, particularly with tizanidine (contraindicated), warfarin, and theophylline.
  • Monitor blood glucose closely in diabetic patients due to the risk of hypo- or hyperglycemia.
  • Counsel on photosensitivity and the need for sun protection.
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Alternative Therapies

  • Other fluoroquinolones (e.g., Levofloxacin, Moxifloxacin - note different spectrums and indications)
  • Beta-lactam antibiotics (e.g., Amoxicillin, Cephalexin, Ceftriaxone)
  • Macrolides (e.g., Azithromycin, Clarithromycin)
  • Tetracyclines (e.g., Doxycycline)
  • Sulfonamides (e.g., Trimethoprim/Sulfamethoxazole)
  • Aminoglycosides (e.g., Gentamicin, Tobramycin)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (500mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 for guidance. 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.