Ciprofloxacin 250mg Tablets

Manufacturer SOLCO HEALTHCARE 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
Antibiotic
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Pharmacologic Class
Fluoroquinolone
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Pregnancy 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, skin, bones, joints, and lungs. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication Correctly

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

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions closely.
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 calcium-rich juices, unless you are taking it with a full meal that contains these products.

Interactions with Other Medications

If you take certain other medications, you may need to take your medication at a different time. Be sure to take your medication at least 2 hours before or 6 hours after taking any of the following:
Antacids
Didanosine
Lanthanum
Sucralfate
Quinapril
Bismuth
Sevelamer
Multivitamins
Other products that contain magnesium, calcium, aluminum, iron, or zinc

Continuing Your Medication

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.

Swallowing Your Medication

Swallow your medication whole.
Do not chew or crush your medication.
Some strengths of the tablets may have a score line, which allows you to split the tablet in half if needed for your dose. If you need to split the tablet, only split it along the score line.

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 place, 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. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also be able to participate in a drug take-back program in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is less than 6 hours until your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take with plenty of water to prevent crystal formation in the urine.
  • Avoid taking with dairy products (milk, yogurt) or calcium-fortified juices, as they can reduce absorption. Separate by at least 2 hours.
  • Avoid taking with antacids, sucralfate, iron, or zinc supplements. Take ciprofloxacin at least 2 hours before or 6 hours after these products.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) as ciprofloxacin can increase sensitivity to light. Use sunscreen and wear protective clothing.
  • Complete the full course of medication, even if you feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Stay well-hydrated during therapy.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. E.g., Uncomplicated UTI: 250 mg orally every 12 hours for 3 days. Complicated UTI: 500 mg orally every 12 hours for 7-14 days. Lower Respiratory Tract/Skin/Bone & Joint Infections: 500-750 mg orally every 12 hours for 7-14 days.
Dose Range: 250 - 750 mg

Condition-Specific Dosing:

Uncomplicated UTI: 250 mg orally every 12 hours for 3 days
Complicated UTI: 500 mg orally every 12 hours for 7-14 days
Acute Sinusitis: 500 mg orally every 12 hours for 10 days
Chronic Bacterial Prostatitis: 500 mg orally every 12 hours for 28 days
Lower Respiratory Tract/Skin/Bone & Joint Infections: 500-750 mg orally every 12 hours for 7-14 days
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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: Generally not first-line due to risk of arthropathy. Used for specific severe infections (e.g., complicated UTI, pyelonephritis, inhalational anthrax post-exposure, cystic fibrosis exacerbations) when benefits outweigh risks. Dosing is weight-based, e.g., 10-20 mg/kg orally every 12 hours (max 750 mg/dose).
Adolescent: Similar considerations as child, weight-based dosing.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 30-50 mL/min: No adjustment for most indications, but consider lower end of dosing range.
Moderate: CrCl 30-50 mL/min: For most indications, administer usual dose every 12 hours, but consider lower end of dosing range. For severe infections, 500 mg every 12 hours. CrCl 5-29 mL/min: Administer usual dose every 18-24 hours or half the usual dose every 12 hours.
Severe: CrCl < 30 mL/min: Administer usual dose every 18-24 hours or half the usual dose every 12 hours. E.g., 250-500 mg every 18-24 hours.
Dialysis: Hemodialysis/Peritoneal Dialysis: Administer dose after dialysis. E.g., 250-500 mg every 24 hours (after dialysis on dialysis days).
Confidence: High

Hepatic Impairment:

Mild: No adjustment generally needed.
Moderate: No adjustment generally needed.
Severe: Not well studied; use with caution. No specific dose adjustment recommendations, but monitor for adverse effects.
Confidence: Medium

Pharmacology

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Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibacterial. It exerts its bactericidal action by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to inhibition of bacterial DNA synthesis and ultimately bacterial cell death.
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Pharmacokinetics

Absorption:

Bioavailability: 70-80%
Tmax: 1-2 hours
FoodEffect: Food delays Tmax but does not significantly alter the extent of absorption (AUC). Dairy products or calcium-fortified juices can significantly decrease absorption.

Distribution:

Vd: 2-3 L/kg
ProteinBinding: 20-40%
CnssPenetration: Limited, but achieves therapeutic concentrations in CSF in inflamed meninges. Penetrates well into tissues and body fluids (e.g., bone, prostate, lung, bile, macrophages).

Elimination:

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

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Within 1-2 hours (plasma concentration)
DurationOfAction: 12 hours (based on BID dosing)

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 the use of fluoroquinolones in patients who experience any of these serious adverse reactions. Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ciprofloxacin in patients with a known history of myasthenia gravis.
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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
+ 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
Rarely, allergic reactions can be fatal.
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
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
Memory problems or loss
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, causing severe health problems that may not resolve and can be fatal. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) can occur, which may lead to a life-threatening bowel problem. Contact your doctor immediately if you experience:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
A rare but severe problem with the aorta (the main blood vessel that comes out of the heart) has been reported in some patients, especially older adults, within 2 months of taking this medication. This can cause severe bleeding and death. Seek medical help immediately if you experience:
+ Sudden, severe pain in the stomach, chest, or back that does not subside

Other Side Effects

Most people do not experience significant side effects or only have minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Diarrhea
Upset stomach
Vomiting
* Headache

This is not an exhaustive list of possible side effects. If you have concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • New or worsening pain, swelling, or bruising around a joint (especially ankle, heel, shoulder, elbow, wrist) - could be tendon rupture.
  • Numbness, tingling, burning, or weakness in arms or legs - could be nerve damage.
  • Dizziness, confusion, hallucinations, seizures, or severe headaches.
  • Severe, watery diarrhea or bloody stools, with or without fever and stomach cramps (may occur up to several months after stopping treatment) - could be C. difficile infection.
  • Sudden chest pain, shortness of breath, or fainting - could be heart rhythm problems.
  • Severe rash, blistering, or peeling skin.
  • Yellowing of skin or eyes, dark urine, severe stomach pain (signs of liver problems).
  • Any signs of an allergic reaction: rash, itching, swelling of face/lips/tongue, difficulty breathing.
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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 heartbeat or Long QTc on an electrocardiogram (ECG)
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (a weakened heart)
+ Recent heart attack
History of nerve problems or tendon problems
Previous experiences with tendon irritation or tears while taking this medication or similar drugs
Presence of an 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
Concurrent use of medications that can cause abnormal heart rhythms (prolonged QT interval). Many drugs can have this effect, so consult your doctor or pharmacist if you are unsure.
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 the last dose.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

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 any 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 you to be alert. This will help prevent accidents and ensure your safety.

Lab Tests and Monitoring

This medication may affect the results of certain lab tests. Be sure to inform all your healthcare providers and lab workers that you are taking this medication. If you are taking this medication long-term, your doctor may recommend regular blood work 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. Check 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 or sleepy
Feeling weak
Flushing
Headache
Unusual thirst or hunger
Passing urine more often
* Shaking or sweating

Duration of Treatment

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

Caffeine Interactions

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

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 effects, including muscle or joint problems, kidney or liver damage, blood disorders, and other complications. If you have any questions or concerns, 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 heartbeat, an irregular heartbeat, or fainting, seek medical attention immediately.

Liver Problems

If you notice any signs of liver problems, such as dark urine, tiredness, decreased appetite, stomach pain, 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 you are a child, your doctor will use caution when prescribing this medication, 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:

  • Acute renal failure
  • Crystalluria
  • Reversible renal toxicity
  • CNS effects (e.g., confusion, dizziness, tremor, hallucinations, seizures)

What to Do:

In case of overdose, call your local poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention immediately. Treatment is supportive, including gastric emptying (emesis or gastric lavage), hydration to prevent crystalluria, and monitoring of renal function and ECG.

Drug Interactions

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Contraindicated Interactions

  • Tizanidine (concomitant use can lead to significant hypotension and sedation due to increased tizanidine plasma concentrations)
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Major Interactions

  • Antacids (containing magnesium, aluminum, calcium), sucralfate, iron, zinc, multivitamins containing minerals (form insoluble chelates, significantly reduce ciprofloxacin absorption)
  • Theophylline (ciprofloxacin inhibits CYP1A2, leading to increased theophylline levels and potential toxicity)
  • Warfarin (enhances anticoagulant effect, leading to increased 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)
  • Methotrexate (increased methotrexate plasma concentrations, potential for toxicity)
  • Cyclosporine (increased cyclosporine levels, potential for nephrotoxicity)
  • Phenytoin (altered phenytoin levels, monitor)
  • Sildenafil (increased sildenafil exposure, potential for adverse effects)
  • Duloxetine (increased duloxetine exposure)
  • Clozapine (increased clozapine levels, potential for adverse effects)
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Moderate Interactions

  • Caffeine (increased caffeine levels due to CYP1A2 inhibition)
  • Oral hypoglycemics (e.g., glyburide) (potential for severe hypoglycemia or hyperglycemia)
  • NSAIDs (increased risk of CNS stimulation and seizures, especially with high doses of NSAIDs)
  • Ropinirole (increased ropinirole exposure)
  • Omeprazole (reduced ciprofloxacin absorption, but generally not clinically significant)
  • Probenecid (decreases renal clearance of ciprofloxacin, increasing levels)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (CrCl, BUN, Creatinine)

Rationale: To determine appropriate dosing, especially in elderly or renally impaired patients.

Timing: Prior to initiation of therapy.

Liver function tests (ALT, AST, ALP, Bilirubin)

Rationale: Although hepatic metabolism is minor, severe hepatic impairment may alter pharmacokinetics. Baseline is useful if hepatic dysfunction is suspected.

Timing: Prior to initiation if clinically indicated.

Culture and Sensitivity

Rationale: To confirm susceptibility of the infecting organism to ciprofloxacin.

Timing: Prior to initiation of therapy.

ECG

Rationale: If patient has risk factors for QT prolongation (e.g., pre-existing cardiac conditions, electrolyte imbalances, concomitant QT-prolonging drugs).

Timing: Prior to initiation if clinically indicated.

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Routine Monitoring

Renal function

Frequency: Periodically, especially in prolonged therapy or in patients with changing renal status.

Target: Within patient's baseline or adjusted for age/condition.

Action Threshold: Significant decline in CrCl may require dose adjustment.

INR (if on warfarin)

Frequency: Frequently, especially at initiation and discontinuation of ciprofloxacin, and during therapy.

Target: Therapeutic range for indication.

Action Threshold: INR outside target range requires warfarin dose adjustment.

Blood glucose (in diabetic patients)

Frequency: Regularly, especially at initiation.

Target: Patient's target glucose range.

Action Threshold: Significant hypoglycemia or hyperglycemia requires intervention and potential discontinuation.

WBC count

Frequency: If prolonged therapy or signs of bone marrow suppression.

Target: Normal range.

Action Threshold: Significant leukopenia/neutropenia.

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Symptom Monitoring

  • Tendon pain, swelling, inflammation, or rupture (especially Achilles tendon)
  • Numbness, tingling, burning, or weakness (signs of peripheral neuropathy)
  • Dizziness, lightheadedness, confusion, hallucinations, seizures, tremors (CNS effects)
  • Severe or persistent diarrhea, abdominal pain, fever (signs of C. difficile-associated diarrhea)
  • Rash, itching, hives, swelling of face/lips/tongue, difficulty breathing (allergic reaction)
  • Joint pain or swelling (especially in pediatric patients)
  • Changes in vision or hearing
  • Palpitations, chest pain, fainting (signs of QT prolongation/arrhythmia)
  • Photosensitivity reactions (severe sunburn-like reaction)

Special Patient Groups

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Pregnancy

Ciprofloxacin is Pregnancy Category C. Animal studies have shown adverse effects on fetal development (arthropathy). There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for arthropathy in animal studies. Human data are limited but generally do not show a consistent pattern of major birth defects.
Second Trimester: Potential for arthropathy in animal studies. Limited human data.
Third Trimester: Potential for arthropathy in animal studies. Limited human data.
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Lactation

Ciprofloxacin is excreted into human breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., arthropathy, alteration of gut flora), 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: L3 (Moderately Safe) - Potential for arthropathy, disruption of infant gut flora, and theoretical risk of cartilage damage. Monitor infant for gastrointestinal disturbances (diarrhea, candidiasis) and rare musculoskeletal issues. Consider alternative antibiotics if possible.
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Pediatric Use

Generally not recommended as first-line therapy due to the risk of arthropathy (damage to cartilage in weight-bearing joints) observed in immature animals. Use is reserved for specific severe infections (e.g., complicated UTI, pyelonephritis, inhalational anthrax post-exposure, cystic fibrosis exacerbations) where the benefits outweigh the risks and alternative therapies are not suitable. Close monitoring for musculoskeletal adverse events is crucial.

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Geriatric Use

Elderly patients may be at increased risk for severe tendon disorders (including rupture), QT prolongation, and CNS effects (e.g., confusion, hallucinations). Renal function often declines with age, requiring dose adjustment. Monitor closely for adverse effects and ensure appropriate hydration.

Clinical Information

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Clinical Pearls

  • Ciprofloxacin is a broad-spectrum antibiotic, but its use should be guided by culture and sensitivity to minimize resistance.
  • Counsel patients extensively on the black box warnings, especially regarding tendon issues and peripheral neuropathy, and to discontinue the drug immediately if these symptoms occur.
  • Ensure patients understand the importance of separating ciprofloxacin from polyvalent cations (antacids, iron, dairy) to ensure adequate absorption.
  • Maintain adequate hydration to prevent crystalluria.
  • Be vigilant for C. difficile-associated diarrhea, which can occur during or even months after therapy.
  • Avoid in patients with a history of myasthenia gravis due to potential for exacerbation of muscle weakness.
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Alternative Therapies

  • Other fluoroquinolones (e.g., levofloxacin, moxifloxacin - note similar class warnings)
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins)
  • Macrolides (e.g., azithromycin, clarithromycin)
  • Tetracyclines (e.g., doxycycline)
  • Aminoglycosides (e.g., gentamicin)
  • Sulfonamides (e.g., trimethoprim/sulfamethoxazole)
  • Depending on the specific infection and susceptibility profile.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (250mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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. 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 amount, and the time it occurred.