Cipro 500mg/5ml Suspension
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.
Drug Class
Fluoroquinolone antibiotic
Pharmacologic Class
DNA gyrase inhibitor; Topoisomerase IV inhibitor
Pregnancy Category
Category C
FDA Approved
Mar 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciprofloxacin is an antibiotic used to treat various bacterial infections. It works by stopping the growth of bacteria. It's important to take it exactly as prescribed and finish the entire course of medication, even if you feel better, to prevent the infection from coming back and to reduce the risk of antibiotic resistance.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of 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.
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.
Avoid taking 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, you may need 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.
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 medication 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.
What to Do If You Miss a Dose
Take a missed dose 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.
To ensure you get the most out of 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.
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.
Avoid taking 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, you may need 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.
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 medication 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.
What to Do If You Miss a Dose
Take a missed dose 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.
Lifestyle & Tips
- Shake the oral suspension well before each use.
- Do not chew the microcapsules in the suspension.
- Take with plenty of fluids to prevent crystal formation in the urine.
- Avoid taking with dairy products (milk, yogurt) or calcium-fortified juices, as they can reduce absorption. Take ciprofloxacin at least 2 hours before or 6 hours after consuming these products.
- Avoid taking with antacids containing magnesium, aluminum, or calcium, 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.
- Do not drive or operate machinery if you experience dizziness or lightheadedness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication and severity. Common doses include 250 mg to 750 mg orally every 12 hours.
Dose Range:
250 - 750 mg
Condition-Specific Dosing:
Uncomplicated UTI:
250 mg (2.5 mL of 500mg/5mL suspension) orally every 12 hours for 3 days
Complicated UTI/Pyelonephritis:
500 mg (5 mL of 500mg/5mL suspension) orally every 12 hours for 7-14 days
Lower Respiratory Tract Infections:
500 mg (5 mL of 500mg/5mL suspension) orally every 12 hours for 7-14 days
Skin and Skin Structure Infections:
500 mg (5 mL of 500mg/5mL suspension) orally every 12 hours for 7-14 days
Bone and Joint Infections:
500 mg to 750 mg (5 mL to 7.5 mL of 500mg/5mL suspension) orally every 12 hours for 4-6 weeks or longer
Infectious Diarrhea:
500 mg (5 mL of 500mg/5mL suspension) orally every 12 hours for 5-7 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:
Complicated UTI/Pyelonephritis: 10-20 mg/kg orally every 12 hours (max 750 mg/dose) for 10-21 days. Anthrax (post-exposure): 15 mg/kg orally every 12 hours (max 500 mg/dose) for 60 days. Cystic Fibrosis (pulmonary exacerbations): 20 mg/kg orally every 12 hours (max 750 mg/dose) for 10-14 days. Use generally restricted to specific indications where benefits outweigh risks.
Adolescent:
Dosing similar to adult for specific indications (e.g., complicated UTI, anthrax, CF exacerbations) or 10-20 mg/kg orally every 12 hours (max 750 mg/dose).
Dose Adjustments
Renal Impairment:
Mild:
CrCl 30-50 mL/min: No adjustment needed for standard doses, 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 250-500 mg (2.5-5 mL of 500mg/5mL suspension) orally every 24 hours after dialysis session. Monitor clinical response and drug levels if available.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No specific dose adjustment recommended, but monitor for increased adverse effects due to potential accumulation in severe impairment.
Pharmacology
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.
Pharmacokinetics
Absorption:
Bioavailability:
70-80%
Tmax:
1-2 hours (oral suspension may be slightly faster)
FoodEffect:
Food delays Tmax and slightly decreases Cmax, but overall absorption (AUC) is largely unaffected. Dairy products and calcium-fortified juices significantly reduce absorption.
Distribution:
Vd:
2-3 L/kg
ProteinBinding:
20-40%
CnssPenetration:
Limited, but achieves therapeutic concentrations in CSF in inflamed meninges; concentrations are typically 10% of plasma levels in non-inflamed meninges.
Elimination:
HalfLife:
3-5 hours (prolonged in renal impairment)
Clearance:
Approximately 30-40 L/hour (total body clearance)
ExcretionRoute:
Renal (glomerular filtration and tubular secretion) and fecal (biliary/intestinal)
Unchanged:
50-70% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within 1-2 hours of oral administration)
PeakEffect:
1-2 hours post-dose
DurationOfAction:
Approximately 12 hours (supports twice-daily dosing)
Safety & Warnings
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 have been associated with serious adverse reactions, reserve Ciprofloxacin for use in patients who have no alternative treatment options for uncomplicated urinary tract infections, acute bacterial exacerbation of chronic bronchitis, and acute sinusitis.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Chest pain or pressure
Shortness of breath
Shakiness
Difficulty walking
Vaginal itching or discharge
White patches in the mouth
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), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur)
Sudden, severe pain in the stomach, chest, or back, which may be a sign of a rare but severe problem with the aorta (the main blood vessel that comes out of the heart)
Other Possible Side Effects
Most people experience either no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Upset stomach
Vomiting
Headache
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Chest pain or pressure
Shortness of breath
Shakiness
Difficulty walking
Vaginal itching or discharge
White patches in the mouth
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), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur)
Sudden, severe pain in the stomach, chest, or back, which may be a sign of a rare but severe problem with the aorta (the main blood vessel that comes out of the heart)
Other Possible Side Effects
Most people experience either no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Upset stomach
Vomiting
Headache
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening pain, swelling, or inflammation of a tendon (especially in the heel, shoulder, or elbow). Stop taking the medication and contact your doctor immediately.
- Numbness, tingling, burning, pain, or weakness in your arms or legs. Stop taking the medication and contact your doctor immediately.
- Severe or persistent diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection).
- Rash, hives, itching, swelling of the face, lips, tongue, or throat, or difficulty breathing (signs of a severe allergic reaction). Seek emergency medical attention.
- Dizziness, confusion, hallucinations, or seizures.
- Muscle weakness, especially if you have myasthenia gravis.
- Changes in vision.
- Yellowing of the skin or eyes, dark urine, or severe stomach pain (signs of liver problems).
- Fainting or irregular heartbeat.
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:
+ Long QTc on electrocardiogram (ECG) or other abnormal 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, the main blood vessel that comes out of the heart) or risk factors for this condition, including:
+ Other blood vessel problems
+ High blood pressure
+ Certain health conditions like Marfan syndrome or Ehlers-Danlos syndrome
Concurrent use of 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.
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 all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Do not start, stop, or change the dose of any medication without consulting 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:
+ Long QTc on electrocardiogram (ECG) or other abnormal 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, the main blood vessel that comes out of the heart) or risk factors for this condition, including:
+ Other blood vessel problems
+ High blood pressure
+ Certain health conditions like Marfan syndrome or Ehlers-Danlos syndrome
Concurrent use of 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.
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 all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Do not start, stop, or change the dose of any medication without consulting your doctor.
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 alertness. Additionally, be aware that this drug may interfere with certain laboratory tests. 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. Discuss this with your doctor to determine the best course of action.
Drugs similar to this one have been associated with high and low blood sugar levels. Low blood sugar has primarily occurred in people with diabetes who are taking medications that lower blood sugar, such as insulin. In severe cases, very low blood sugar can lead to coma or even death. Monitor your blood sugar levels as directed by your doctor.
Be aware of the signs of high or low blood sugar, which may include:
- 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
If you experience any of these symptoms, notify your doctor promptly.
Do not use this medication for longer than prescribed, as this can increase the risk of a second infection. Inform your doctor if you are taking any medications that contain caffeine or if you consume products with caffeine, such as tea, coffee, cola, or chocolate.
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.
Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.
Although rare, this medication can cause severe and potentially life-threatening effects, including muscle or joint problems, kidney or liver damage, blood disorders, and other complications. If you have any questions or concerns, discuss them with your doctor.
One potential side effect of this medication is 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.
If you notice any signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored 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 prone to side effects.
When administering this medication to children, use caution, as they may be at a higher risk of developing joint problems.
If you are pregnant or planning to become pregnant, discuss the benefits and risks of using this medication with your doctor.
Until you know how this medication affects you, avoid driving and other activities that require alertness. Additionally, be aware that this drug may interfere with certain laboratory tests. 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. Discuss this with your doctor to determine the best course of action.
Drugs similar to this one have been associated with high and low blood sugar levels. Low blood sugar has primarily occurred in people with diabetes who are taking medications that lower blood sugar, such as insulin. In severe cases, very low blood sugar can lead to coma or even death. Monitor your blood sugar levels as directed by your doctor.
Be aware of the signs of high or low blood sugar, which may include:
- 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
If you experience any of these symptoms, notify your doctor promptly.
Do not use this medication for longer than prescribed, as this can increase the risk of a second infection. Inform your doctor if you are taking any medications that contain caffeine or if you consume products with caffeine, such as tea, coffee, cola, or chocolate.
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.
Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.
Although rare, this medication can cause severe and potentially life-threatening effects, including muscle or joint problems, kidney or liver damage, blood disorders, and other complications. If you have any questions or concerns, discuss them with your doctor.
One potential side effect of this medication is 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.
If you notice any signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored 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 prone to side effects.
When administering this medication to children, use caution, as they may be at a higher risk of developing joint problems.
If you are pregnant or planning to become pregnant, discuss the benefits and risks of using this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Acute renal failure
- Crystalluria
- Reversible renal toxicity
- Seizures
- Confusion
- Dizziness
- Tremor
- Hallucinations
What to Do:
In case of overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is symptomatic and supportive. Gastric lavage may be performed. Maintain adequate hydration to prevent crystalluria. Hemodialysis or peritoneal dialysis removes only a small amount of ciprofloxacin.
Drug Interactions
Contraindicated Interactions
- Tizanidine (concomitant use significantly increases tizanidine plasma concentrations, leading to hypotension and somnolence)
Major Interactions
- Antacids (containing magnesium, aluminum, calcium), sucralfate, iron, zinc, multivitamins (form insoluble complexes, significantly reducing ciprofloxacin absorption; administer ciprofloxacin 2 hours before or 6 hours after these agents)
- Theophylline (ciprofloxacin inhibits CYP1A2, increasing theophylline levels and risk of toxicity)
- Warfarin (enhances anticoagulant effect, increasing bleeding risk; monitor INR closely)
- Methotrexate (may increase methotrexate levels, increasing toxicity)
- Cyclosporine (may increase cyclosporine levels, increasing nephrotoxicity)
- Phenytoin (may alter phenytoin levels, monitor closely)
- QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics; increased risk of QT prolongation and Torsades de Pointes)
- Sildenafil (may increase sildenafil exposure)
- Duloxetine (may increase duloxetine exposure due to CYP1A2 inhibition)
Moderate Interactions
- NSAIDs (may increase risk of CNS stimulation and convulsive seizures when co-administered with fluoroquinolones)
- Glyburide (may enhance hypoglycemic effect)
- Caffeine (may decrease caffeine clearance, leading to increased caffeine effects)
- Ropinirole (may increase ropinirole exposure due to CYP1A2 inhibition)
- Clozapine (may increase clozapine exposure due to CYP1A2 inhibition)
- Omeprazole (may increase ciprofloxacin absorption slightly)
Minor Interactions
- Probenecid (decreases renal clearance of ciprofloxacin, increasing its plasma levels)
- Metoclopramide (accelerates ciprofloxacin absorption, leading to earlier Tmax but no change in AUC)
Monitoring
Baseline Monitoring
Culture and Susceptibility
Rationale: To confirm bacterial pathogen and its susceptibility to ciprofloxacin, guiding appropriate therapy.
Timing: Prior to initiation of therapy
Renal Function (CrCl, BUN, Creatinine)
Rationale: To determine appropriate dosing adjustments in patients with impaired renal function.
Timing: Prior to initiation of therapy
Electrolytes (Potassium, Magnesium)
Rationale: To assess for baseline abnormalities that could predispose to QT prolongation.
Timing: Prior to initiation of therapy, especially in patients at risk for arrhythmias
Routine Monitoring
Clinical Response to Therapy
Frequency: Daily
Target: Resolution of signs and symptoms of infection
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or adverse effects.
Renal Function (CrCl, BUN, Creatinine)
Frequency: Periodically, especially in prolonged therapy or renal impairment
Target: Stable or improving renal function
Action Threshold: Significant decline may require dose adjustment or discontinuation.
INR (if on Warfarin)
Frequency: Frequently (e.g., 2-3 times per week initially, then as needed)
Target: Therapeutic INR range for indication
Action Threshold: INR outside target range requires warfarin dose adjustment.
Blood Glucose (in diabetic patients)
Frequency: Regularly
Target: Target glycemic control
Action Threshold: Hypoglycemia or hyperglycemia may occur; adjust antidiabetic medications as needed.
Signs of Tendinopathy/Tendon Rupture
Frequency: Daily throughout therapy and for several months post-therapy
Target: Absence of pain, swelling, or inflammation in tendons
Action Threshold: Any tendon pain or swelling requires immediate discontinuation and medical evaluation.
Signs of Peripheral Neuropathy
Frequency: Daily throughout therapy
Target: Absence of numbness, tingling, burning, pain, or weakness
Action Threshold: Onset of these symptoms requires immediate discontinuation.
ECG (in patients at risk for QT prolongation)
Frequency: Baseline and periodically as clinically indicated
Target: Normal QT interval
Action Threshold: Significant QT prolongation (>500 ms or >60 ms increase from baseline) may require discontinuation.
Symptom Monitoring
- Tendon pain or swelling (especially Achilles tendon)
- Numbness, tingling, burning, pain, or weakness in extremities (signs of peripheral neuropathy)
- Severe or persistent diarrhea (may indicate C. difficile-associated diarrhea)
- Rash, hives, itching, swelling of face/throat, difficulty breathing (signs of hypersensitivity reaction)
- Dizziness, lightheadedness, confusion, hallucinations, seizures (CNS effects)
- Muscle weakness (especially in patients with myasthenia gravis)
- Vision changes
- Joint pain or swelling (especially in pediatric patients)
- Chest pain, palpitations, fainting (signs of cardiac arrhythmia)
Special Patient Groups
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 definitive safety has not been established.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal studies show potential for arthropathy. Use only if clearly needed.
Second Trimester:
Limited human data, animal studies show potential for arthropathy. Use only if clearly needed.
Third Trimester:
Limited human data, animal studies show potential for arthropathy. Use only if clearly needed.
Lactation
L3 (Moderate risk). Ciprofloxacin is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, including arthropathy and effects on 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 (cartilage damage), alteration of infant gut flora, and theoretical risk of tendinopathy. Monitor infant for gastrointestinal disturbances (diarrhea, candidiasis) and musculoskeletal issues.
Pediatric Use
Use in pediatric patients is generally restricted due to the risk of arthropathy (damage to weight-bearing joints). It is reserved for specific, severe infections where other safer alternatives are not available or effective (e.g., complicated UTI, pyelonephritis, anthrax, cystic fibrosis exacerbations). Close monitoring for musculoskeletal adverse events is crucial.
Geriatric Use
Elderly patients are at increased risk for serious adverse reactions, including tendinopathy/tendon rupture, QT prolongation, and CNS effects (e.g., hallucinations, confusion). Dose adjustment is necessary for age-related decline in renal function. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Always shake the oral suspension well before each dose.
- Ensure patients understand the importance of avoiding dairy products, calcium-fortified juices, antacids, and mineral supplements around dosing times.
- Educate patients on the Black Box Warning symptoms (tendon pain, neuropathy, CNS effects) and to discontinue the drug immediately if they occur.
- Advise patients to stay well-hydrated to prevent crystalluria.
- Ciprofloxacin can cause photosensitivity; advise patients to use sunscreen and protective clothing.
- Complete the full course of therapy, even if symptoms improve, to prevent resistance and relapse.
- Be aware of the potential for C. difficile-associated diarrhea, which can occur during or even months after therapy.
Alternative Therapies
- Other fluoroquinolones (e.g., Levofloxacin, Moxifloxacin - chosen based on spectrum and indication)
- Beta-lactam antibiotics (e.g., Amoxicillin, Cephalexin, Ceftriaxone - depending on infection type and susceptibility)
- Macrolide antibiotics (e.g., Azithromycin, Clarithromycin - for respiratory or atypical infections)
- Tetracyclines (e.g., Doxycycline - for certain skin, respiratory, or atypical infections)
- Aminoglycosides (e.g., Gentamicin - often used in combination for severe Gram-negative infections)
Cost & Coverage
Average Cost:
Variable, typically $20-$100 per 100 mL of 500mg/5mL suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health problems 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, a patient fact sheet that provides important information. 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 with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.