Cipro 250mg/5ml Suspension

Manufacturer BAYER Active Ingredient Ciprofloxacin Oral Suspension(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
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.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. 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 it with or without food.
Drink a full glass of water with your medication.
Before each use, shake the liquid suspension well for about 15 seconds.
Measure liquid doses carefully using the measuring device provided with your medication.
Do not chew the mixture.
Keep the lid tightly closed when not in use.
Do not administer the liquid suspension through a feeding tube.
After using the measuring spoon, wash it with soap and water, and make sure it is completely dry before using it again.

Important Interactions to Consider

Do not take your medication with dairy products, such as milk or yogurt, or calcium-rich juices. However, you can take it with a full meal that includes these products.
If you take certain other medications, your doctor may advise you to take this medication at a different time. Take this medication at least 2 hours before or 6 hours after any antacids, didanosine, lanthanum, sucralfate, quinapril, bismuth, sevelamer, multivitamins, or 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 feel well.

Storing and Disposing of Your Medication

Store the liquid suspension at room temperature or in the refrigerator. Do not freeze.
Discard any unused portion after 2 weeks.
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 medications. You may also have access to drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember.
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 exactly as prescribed, do not skip doses, and complete the full course of treatment even if you feel better.
  • Shake the oral suspension well before each use.
  • Do not take with dairy products (milk, yogurt) or calcium-fortified juices, as these can reduce absorption. Separate by at least 2 hours before or 6 hours after.
  • Avoid antacids, sucralfate, iron, or zinc supplements for at least 2 hours before or 6 hours after taking ciprofloxacin.
  • Stay well-hydrated by drinking plenty of fluids.
  • 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 driving or operating machinery until you know how this medication affects you, as it can cause dizziness or lightheadedness.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For uncomplicated UTI: 250 mg every 12 hours for 3 days. For complicated UTI/pyelonephritis: 500 mg every 12 hours for 7-14 days. For lower respiratory tract infections: 500-750 mg every 12 hours for 7-14 days.
Dose Range: 250 - 750 mg

Condition-Specific Dosing:

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

Neonatal: Not established (generally not recommended due to arthropathy risk)
Infant: Not established (generally not recommended due to arthropathy risk)
Child: Complicated UTI and Pyelonephritis (1 to 17 years): 10-20 mg/kg (max 750 mg per dose) orally every 12 hours for 10-21 days. Inhalational Anthrax (post-exposure): 15 mg/kg (max 500 mg per dose) orally every 12 hours for 60 days.
Adolescent: Complicated UTI and Pyelonephritis (1 to 17 years): 10-20 mg/kg (max 750 mg per dose) orally every 12 hours for 10-21 days. Inhalational Anthrax (post-exposure): 15 mg/kg (max 500 mg per dose) orally every 12 hours for 60 days.
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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: Administer usual dose, but reduce frequency to every 18 hours or reduce dose by 25-50%. CrCl 5-29 mL/min: Administer usual dose, but reduce frequency to every 24 hours or reduce dose by 50%.
Severe: CrCl <30 mL/min: Administer usual dose, but reduce frequency to every 24 hours or reduce dose by 50%.
Dialysis: Hemodialysis/Peritoneal Dialysis: Administer dose after dialysis. For most indications, 250-500 mg every 24 hours. Supplemental dose after dialysis is generally not needed for oral formulation.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed (pharmacokinetics are not significantly altered in patients with stable chronic liver cirrhosis).

Pharmacology

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Mechanism of Action

Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic. 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 ultimately cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-80%
Tmax: Oral suspension: 1-2 hours
FoodEffect: Food delays Tmax but does not significantly alter Cmax or AUC. Dairy products or calcium-fortified juices significantly decrease absorption.

Distribution:

Vd: 2-3 L/kg
ProteinBinding: 20-40%
CnssPenetration: Limited (approximately 10% of plasma concentrations in non-inflamed meninges; higher with inflamed meninges)

Elimination:

HalfLife: 3-5 hours (normal renal function)
Clearance: Approximately 30-40 L/hr
ExcretionRoute: Renal (primarily glomerular filtration and tubular secretion) and fecal (biliary/intestinal)
Unchanged: Approximately 40-50% (renal), 15% (fecal)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for susceptible organisms)
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: 12 hours (based on dosing frequency)

Safety & Warnings

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BLACK BOX WARNING

Fluoroquinolones, including Ciprofloxacin, 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 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. Ciprofloxacin is also associated with an increased risk of aortic aneurysm and dissection.
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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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or 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 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
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause severe health problems and potentially 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 your mouth, throat, nose, or eyes
Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem. Contact your doctor immediately if you experience:
+ Stomach pain or 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 potentially be fatal. Seek medical help immediately if you experience:
+ Sudden, severe pain in the stomach, chest, or back that does not go away

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 symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach or vomiting
* Headache

This is not an exhaustive 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.
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Seek Immediate Medical Attention If You Experience:

  • Any pain, swelling, or inflammation of a tendon (especially in the heel, shoulder, or hand). Stop taking the medication and call your doctor immediately.
  • Numbness, tingling, burning pain, or weakness in your arms or legs. Stop taking the medication and call your doctor immediately.
  • Confusion, hallucinations, seizures, severe dizziness, or unusual thoughts/behaviors.
  • Severe or watery diarrhea, especially if it occurs after you finish your medication.
  • Sudden chest, stomach, or back pain (could be a sign of aortic aneurysm/dissection).
  • Signs of low blood sugar (shakiness, sweating, confusion, hunger) or high blood sugar (increased thirst, frequent urination).
  • Yellowing of the skin or eyes, dark urine, severe stomach pain (signs of liver problems).
  • Any signs of an allergic reaction (rash, hives, swelling of face/throat, 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 to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Certain heart conditions, such as:
+ Abnormal heartbeat (Long QTc on ECG) or other irregular heart rhythms
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (weak heart)
+ Recent heart attack
Nerve problems or tendon problems, including:
+ Previous tendon irritation or tears when taking this medication or similar drugs
Aortic aneurysm (ballooning or bulging of the aorta) or risk factors for this condition, including:
+ 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). Many drugs can interact with this medication, so ask 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 the last dose.

This is not an exhaustive list of potential interactions. To ensure your safety, inform your doctor and pharmacist about:

All prescription and over-the-counter medications
Natural products
Vitamins
* Health problems

Verify that it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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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 they are aware of any potential interactions or effects.

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. Additionally, be aware that this drug may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and laboratory 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. It is also important to be aware of the risk of high and low blood sugar associated with this medication. Low blood sugar has occurred in people with diabetes who are taking medications that lower blood sugar, such as insulin, and can lead to coma or even death in severe cases. Your doctor will advise you on how to monitor your blood sugar levels. If you experience symptoms of high or low blood sugar, such as fruity-smelling breath, dizziness, rapid breathing, rapid heartbeat, confusion, sleepiness, weakness, flushing, headache, increased thirst or hunger, frequent urination, shaking, or sweating, notify your doctor promptly.

Do not use this medication for longer than prescribed, as this can increase the risk of a second infection. If you consume products containing caffeine, such as tea, coffee, cola, or chocolate, or take medications that contain caffeine, inform your doctor.

You may be more susceptible to sunburn while taking this medication, so it is essential to avoid excessive sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize your risk. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.

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.

This medication can also cause a type of abnormal heartbeat known as prolonged QT interval. If you experience a rapid or irregular heartbeat, or if you faint, seek medical attention immediately. Additionally, if you notice signs of liver problems, such as dark urine, fatigue, loss of appetite, nausea, stomach pain, pale stools, vomiting, or yellowing of the skin or eyes, 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. Similarly, if the patient is a child, use this medication with caution, as the risk of joint problems may be higher in children.

If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Tremor
  • Headache
  • Tiredness
  • Seizures
  • Hallucinations
  • Confusion
  • Abdominal discomfort
  • Renal and hepatic impairment
  • Crystalluria

What to Do:

In case of overdose, seek immediate medical attention or call a poison control center. The national poison control center number is 1-800-222-1222. Treatment is symptomatic and supportive. Gastric lavage may be performed. Maintain adequate hydration to prevent crystalluria. Hemodialysis or peritoneal dialysis removes only a small amount of ciprofloxacin.

Drug Interactions

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Contraindicated Interactions

  • Tizanidine (increased tizanidine levels, 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
  • Theophylline (increased theophylline levels, toxicity)
  • Warfarin (increased anticoagulant effect, bleeding risk)
  • Methotrexate (increased methotrexate levels, toxicity)
  • Phenytoin (altered phenytoin levels)
  • Cyclosporine (increased cyclosporine levels, nephrotoxicity)
  • Oral hypoglycemics (e.g., glyburide) - severe hypoglycemia
  • Sildenafil (increased sildenafil exposure)
  • Duloxetine (increased duloxetine exposure)
  • Clozapine (increased clozapine levels, toxicity)
  • Ropinirole (increased ropinirole levels)
  • Omeprazole (increased omeprazole levels)
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Moderate Interactions

  • Antacids containing aluminum, magnesium, calcium, sucralfate, iron, zinc, multivitamins with minerals (decreased ciprofloxacin absorption - administer ciprofloxacin 2 hours before or 6 hours after)
  • Didanosine (DDI) - decreased ciprofloxacin absorption
  • Probenecid (increased ciprofloxacin levels)
  • Metoclopramide (accelerated ciprofloxacin absorption, but no change in AUC)
  • Caffeine (decreased caffeine clearance, increased caffeine effects)
  • NSAIDs (increased risk of CNS stimulation and convulsions, especially with high doses of NSAIDs)
  • Corticosteroids (increased risk of tendon rupture)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (SCr, CrCl)

Rationale: To guide dosing adjustments in patients with impaired renal function.

Timing: Prior to initiation of therapy

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

Rationale: Although rare, ciprofloxacin can cause hepatic dysfunction. Baseline assessment is prudent.

Timing: Prior to initiation of therapy

ECG

Rationale: Consider 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)

Blood glucose

Rationale: For diabetic patients, as ciprofloxacin can cause dysglycemia.

Timing: Prior to initiation of therapy

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Routine Monitoring

Signs/symptoms of tendonitis/tendon rupture

Frequency: Daily during therapy and for several months post-therapy

Target: Absence of pain, swelling, inflammation in tendons

Action Threshold: Discontinue ciprofloxacin immediately if tendon pain, swelling, or inflammation occurs.

Signs/symptoms of peripheral neuropathy

Frequency: Daily during therapy

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

Action Threshold: Discontinue ciprofloxacin immediately if symptoms of peripheral neuropathy occur.

Signs/symptoms of CNS effects

Frequency: Daily during therapy

Target: Absence of dizziness, confusion, hallucinations, seizures, tremors

Action Threshold: Discontinue ciprofloxacin if severe CNS effects occur.

Blood glucose

Frequency: Regularly in diabetic patients

Target: Maintain euglycemia

Action Threshold: Monitor closely for hypoglycemia or hyperglycemia; adjust antidiabetic therapy if needed.

Renal function (SCr, CrCl)

Frequency: Periodically during prolonged therapy or if renal function changes

Target: Stable renal function

Action Threshold: Adjust dose if renal function declines.

Liver function tests

Frequency: Periodically during prolonged therapy or if symptoms of liver injury occur

Target: Normal LFTs

Action Threshold: Discontinue if significant elevation or signs of liver injury.

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Symptom Monitoring

  • Tendon pain, swelling, inflammation (especially Achilles, shoulder, hand)
  • Numbness, tingling, burning, pain, or weakness in extremities (peripheral neuropathy)
  • Dizziness, lightheadedness, confusion, hallucinations, anxiety, depression, insomnia, nightmares, paranoia, suicidal thoughts/actions
  • Seizures, tremors
  • Severe or persistent diarrhea, abdominal pain, fever (C. difficile-associated diarrhea)
  • Rash, itching, hives, swelling of face/throat, difficulty breathing (hypersensitivity reaction)
  • Chest pain, shortness of breath, back pain (aortic aneurysm/dissection)
  • Vision changes, photophobia
  • Joint pain or swelling (in pediatric patients)

Special Patient Groups

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Pregnancy

Category C. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown arthropathy and skeletal abnormalities. Human data are limited but generally reassuring, though caution is advised.

Trimester-Specific Risks:

First Trimester: Limited human data, but no clear evidence of increased major birth defects. Animal studies show potential for cartilage damage.
Second Trimester: Limited human data, no clear evidence of increased major birth defects.
Third Trimester: Limited human data, no clear evidence of increased major birth defects. Theoretical risk of cartilage damage in the fetus, though less likely to be clinically significant in humans compared to animals.
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Lactation

L3 (Moderately Safe). Ciprofloxacin is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (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: Potential for arthropathy, disruption of infant gut flora, and theoretical risk of cartilage damage. Monitor infant for gastrointestinal disturbances (diarrhea, candidiasis) and rare but serious effects.
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Pediatric Use

Use in pediatric patients (under 18 years) is generally restricted due to the risk of arthropathy (damage to weight-bearing joints). It is approved for complicated urinary tract infections and pyelonephritis, and for inhalational anthrax (post-exposure) where the benefits outweigh the risks. Close monitoring for musculoskeletal adverse events is essential.

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Geriatric Use

Elderly patients may be at increased risk for tendon rupture, QT prolongation, and CNS effects. 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

  • Always advise patients to complete the full course of therapy, even if symptoms improve, to prevent resistance.
  • Emphasize the importance of separating ciprofloxacin from polyvalent cations (dairy, antacids, iron, zinc) by at least 2 hours before or 6 hours after to ensure adequate absorption.
  • Counsel patients on the black box warnings, particularly the signs of tendonitis/rupture and peripheral neuropathy, and to discontinue the drug immediately if these occur.
  • Advise patients about photosensitivity and to use sun protection.
  • Monitor blood glucose closely in diabetic patients due to the risk of dysglycemia.
  • Ciprofloxacin suspension should be shaken well before each use and not be administered through feeding tubes due to potential for clogging.
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Alternative Therapies

  • Other fluoroquinolones (e.g., Levofloxacin, Moxifloxacin - chosen based on spectrum and indication)
  • Beta-lactam antibiotics (e.g., Penicillins, Cephalosporins - depending on susceptibility and infection site)
  • Macrolides (e.g., Azithromycin, Clarithromycin - for respiratory infections, atypical pathogens)
  • Tetracyclines (e.g., Doxycycline - for certain skin, respiratory, or atypical infections)
  • Aminoglycosides (e.g., Gentamicin - for severe gram-negative infections, often in combination)
  • Sulfonamides (e.g., Trimethoprim/Sulfamethoxazole - for UTIs, certain respiratory infections)
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Cost & Coverage

Average Cost: $20 - $100 per 100ml (250mg/5ml) suspension
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 and effective treatment, 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.