Ciprofloxacin 750mg Tablets

Manufacturer AUROBINDO PHARMA 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
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 that belongs to a group of medicines called fluoroquinolones. It works by stopping the growth of bacteria that cause infections. It is used to treat many different types of bacterial infections, such as infections of the urinary tract, skin, bones, joints, and lungs.
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How to Use This Medicine

Taking Your Medication Correctly

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

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

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store it at room temperature in a dry place, away from the bathroom.
Keep all medications out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist to see if there are any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

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

  • Take exactly as prescribed, even if you feel better. Do not skip doses or stop early.
  • Avoid taking antacids, sucralfate, iron, zinc, or calcium supplements, and dairy products (milk, yogurt) or calcium-fortified juices within 2 hours before or 6 hours after taking ciprofloxacin, as they can reduce its effectiveness.
  • Drink plenty of fluids to prevent kidney stones.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) as ciprofloxacin can make your skin more sensitive to light, leading to severe sunburn. Use sunscreen and wear protective clothing.
  • Avoid driving or operating machinery until you know how this medicine affects you, as it can cause dizziness or lightheadedness.
  • Limit caffeine intake, as ciprofloxacin can increase caffeine's effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For severe or complicated infections (e.g., complicated UTI, chronic bacterial prostatitis, bone and joint infections, complicated intra-abdominal infections): 750 mg orally every 12 hours.
Dose Range: 250 - 750 mg

Condition-Specific Dosing:

complicated_uti: 500 mg orally every 12 hours for 7-14 days or 750 mg orally every 12 hours for 5-10 days (depending on severity/pathogen)
bone_joint_infections: 500-750 mg orally every 12 hours for 4-6 weeks or longer
chronic_bacterial_prostatitis: 500 mg orally every 12 hours for 28 days
complicated_intra_abdominal_infections: 500 mg orally every 12 hours for 7-14 days (in combination with metronidazole)
anthrax_post_exposure_prophylaxis: 500 mg orally every 12 hours for 60 days
plague: 500-750 mg orally every 12 hours for 10-14 days
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Pediatric Dosing

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

Renal Impairment:

Mild: CrCl 30-50 mL/min: No adjustment for 250-500 mg doses. For 750 mg dose, reduce to 500 mg every 12 hours.
Moderate: CrCl 5-29 mL/min: Administer usual single dose, then half the usual dose every 12 hours (e.g., 250-500 mg every 12 hours). For 750 mg dose, reduce to 500 mg every 24 hours.
Severe: CrCl <5 mL/min: Administer usual single dose, then half the usual dose every 12 hours (e.g., 250-500 mg every 12 hours). For 750 mg dose, reduce to 500 mg every 24 hours.
Dialysis: Hemodialysis/Peritoneal Dialysis: Administer dose after dialysis. For 750 mg dose, reduce to 500 mg every 24 hours. Supplemental dose not typically needed after routine hemodialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended. Ciprofloxacin is primarily renally eliminated; hepatic impairment is not expected to significantly alter clearance.

Pharmacology

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Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibacterial. It exerts its bactericidal effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for 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 affect Cmax or AUC. Dairy products or calcium-fortified juices can significantly decrease absorption.

Distribution:

Vd: 2.1-2.7 L/kg
ProteinBinding: 20-40%
CnssPenetration: Limited (CSF concentrations are 10% of serum in non-inflamed meninges, 14-37% in inflamed meninges)

Elimination:

HalfLife: 3-5 hours (normal renal function)
Clearance: 30-48 L/hr (renal and non-renal)
ExcretionRoute: Renal (primarily unchanged drug and metabolites), fecal (minor)
Unchanged: 50-70% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: 12 hours (due to twice-daily dosing)

Safety & Warnings

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BLACK BOX WARNING

Fluoroquinolones, including ciprofloxacin, have been 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. Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of aortic aneurysm and dissection. In patients at increased risk for these events, use ciprofloxacin only when there are no other treatment options available. Fluoroquinolones, including ciprofloxacin, have been associated with dysglycemia, including both hypoglycemia and hyperglycemia. Monitor blood glucose in diabetic patients.
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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 when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
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 or memory problems
Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Diarrhea, especially if it is severe, bloody, or watery (may be a sign of C. difficile-associated diarrhea, a potentially life-threatening condition)
Sudden, severe stomach, chest, or back pain (may be a sign of a rare but serious problem with the aorta, the main blood vessel that comes out of the heart)

Other Possible Side Effects

Most people experience no side effects or only mild side effects when taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Upset stomach or vomiting
Headache

Reporting Side Effects

If you have questions about side effects or experience any side effects not listed here, 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:

  • 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 your arms or legs - could be nerve damage.
  • Confusion, hallucinations, feeling restless, anxious, depressed, or having suicidal thoughts - could be serious brain effects.
  • Severe, watery diarrhea or bloody stools (even weeks after stopping the medicine) - could be C. difficile infection.
  • Sudden chest, stomach, or back pain - could be aortic aneurysm/dissection.
  • Severe dizziness, fainting, or fast/pounding heartbeats - could be heart rhythm problems or low blood sugar.
  • Any signs of an allergic reaction like rash, hives, swelling of your face/lips/tongue/throat, or trouble breathing.
  • Muscle weakness or trouble breathing if you have myasthenia gravis.
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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 while 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, 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 interact with this medication, 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 your 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

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, particularly in people with diabetes who are taking medications that lower blood sugar, such as insulin. In severe cases, low blood sugar can lead to coma or even death. Therefore, it is essential to monitor your blood sugar levels as directed by your doctor and report any signs of high or low blood sugar, such as:

Breath that smells like fruit
Dizziness
Fast breathing
Fast heartbeat
Feeling confused or sleepy
Feeling weak
Flushing
Headache
Unusual thirst or hunger
Passing urine more often
* Shaking or sweating

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

Be aware that this medication can increase your risk of sunburn, 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.

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

Although rare, this medication can cause severe and potentially life-threatening side effects, including muscle or joint problems, kidney or liver damage, blood disorders, and other complications. If you have any concerns or questions, discuss them with your doctor.

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, tiredness, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow 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. Additionally, 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:

  • Acute renal failure
  • Crystalluria
  • Reversible renal toxicity
  • Dizziness
  • Confusion
  • Headache
  • Abdominal discomfort
  • Nausea
  • Vomiting
  • Diarrhea
  • Seizures (rare)

What to Do:

In case of overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and includes 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 (increased tizanidine levels, severe hypotension)
  • Concomitant administration with Class IA and Class III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics (due to QT prolongation risk)
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Major Interactions

  • Antacids containing magnesium/aluminum, sucralfate, iron, zinc, calcium, dairy products (decreased ciprofloxacin absorption)
  • Warfarin (increased anticoagulant effect, INR)
  • Theophylline (increased theophylline levels, toxicity)
  • Cyclosporine (increased cyclosporine levels, nephrotoxicity)
  • Phenytoin (altered phenytoin levels)
  • Methotrexate (increased methotrexate levels, toxicity)
  • NSAIDs (increased risk of CNS stimulation and convulsive seizures)
  • Oral hypoglycemics/insulin (dysglycemia, including 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

  • Caffeine (decreased caffeine clearance)
  • Probenecid (increased ciprofloxacin levels)
  • Metoclopramide (accelerated ciprofloxacin absorption)
  • Didanosine (DDI) (decreased ciprofloxacin absorption)
  • Sevelamer (decreased ciprofloxacin absorption)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

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

Timing: Prior to initiation of therapy.

Liver function tests (ALT, AST, bilirubin)

Rationale: Although primarily renally eliminated, severe hepatic impairment may warrant caution. Baseline helps identify pre-existing conditions.

Timing: Prior to initiation of therapy, especially in patients with known liver disease.

Electrolytes (Potassium, Magnesium)

Rationale: To assess risk of QT prolongation, especially in patients with pre-existing electrolyte imbalances.

Timing: Prior to initiation of therapy, especially in patients at risk for arrhythmias.

ECG

Rationale: To assess baseline QTc interval, especially in patients with known cardiac disease, bradycardia, or on other QT-prolonging drugs.

Timing: Prior to initiation of therapy in high-risk patients.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily

Target: Resolution of signs/symptoms of infection

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistance.

Adverse effects (e.g., GI upset, headache, dizziness, tendon pain, rash)

Frequency: Daily

Target: Absence or mild, tolerable symptoms

Action Threshold: Severe or persistent adverse effects, new onset of tendon pain, neuropathy symptoms, or psychiatric changes require immediate evaluation and potential discontinuation.

Blood glucose (in diabetic patients or those at risk)

Frequency: Periodically during therapy

Target: Within target glycemic range

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

INR (for patients on warfarin)

Frequency: Frequently, especially at initiation and discontinuation of ciprofloxacin

Target: Therapeutic INR range for indication

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

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Symptom Monitoring

  • Tendon pain, swelling, inflammation, or rupture (especially Achilles tendon)
  • Numbness, tingling, burning, or weakness (signs of peripheral neuropathy)
  • Confusion, hallucinations, depression, suicidal thoughts, anxiety, insomnia, nightmares (CNS effects)
  • Severe diarrhea (possible C. difficile infection)
  • Rash, hives, swelling of face/throat, difficulty breathing (allergic reaction)
  • Severe dizziness, fainting (hypotension, dysglycemia, QT prolongation)
  • Muscle weakness, difficulty breathing (exacerbation of myasthenia gravis)
  • Chest, back, or abdominal pain (aortic aneurysm/dissection)

Special Patient Groups

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Pregnancy

Ciprofloxacin is generally not recommended during pregnancy due to potential risks to the fetus, particularly cartilage damage observed in juvenile animals. It should only be used if the potential benefit justifies the potential risk to the fetus, and when safer alternatives are not available.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal studies show potential for cartilage damage. Avoid if possible.
Second Trimester: Limited human data. Avoid if possible.
Third Trimester: Limited human data. Avoid if possible. Risk of arthropathy in the fetus/neonate.
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Lactation

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. The American Academy of Pediatrics considers it compatible with breastfeeding with caution.

Infant Risk: L3 (Moderately safe). Potential for GI upset (diarrhea, candidiasis), and theoretical risk of cartilage damage. Monitor infant for adverse effects.
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Pediatric Use

Generally not recommended for routine use in pediatric patients due to the risk of irreversible arthropathy (damage to cartilage in weight-bearing joints) observed in juvenile animals. Use is restricted to specific severe infections where the benefits outweigh the risks (e.g., complicated UTI/pyelonephritis, inhalational anthrax, plague). Close monitoring for musculoskeletal adverse events is crucial.

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Geriatric Use

Elderly patients may be at increased risk for severe tendinitis and tendon rupture, peripheral neuropathy, and QT prolongation. Renal function should be assessed and dosing adjusted accordingly. Increased risk of CNS effects (e.g., confusion, hallucinations) and dysglycemia. Use with caution and monitor closely.

Clinical Information

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Clinical Pearls

  • Always counsel patients on the Black Box Warning risks, especially tendinopathy/rupture, peripheral neuropathy, and CNS effects. Instruct them to discontinue the drug and seek medical attention immediately if these symptoms occur.
  • Ensure patients avoid concomitant administration with polyvalent cations (antacids, iron, calcium, dairy) due to significant reduction in absorption. Separate administration by at least 2 hours before or 6 hours after.
  • Ciprofloxacin is a strong CYP1A2 inhibitor; carefully review concomitant medications, especially theophylline, tizanidine, and clozapine, which can have serious interactions.
  • Advise patients about photosensitivity and the need for sun protection.
  • Hydration is important to prevent crystalluria.
  • Monitor blood glucose closely in diabetic patients due to the risk of dysglycemia (both hypo- and hyperglycemia).
  • Ciprofloxacin is not effective against anaerobic bacteria; for mixed infections (e.g., intra-abdominal), it often needs to be combined with an anaerobic agent (e.g., metronidazole).
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Alternative Therapies

  • Other fluoroquinolones (e.g., Levofloxacin, Moxifloxacin, Ofloxacin) - chosen based on spectrum, indication, and patient factors.
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems) - for susceptible infections.
  • Aminoglycosides (e.g., Gentamicin, Tobramycin) - often in combination for severe infections.
  • Trimethoprim/sulfamethoxazole (Bactrim) - for UTIs and other susceptible infections.
  • Macrolides (e.g., Azithromycin, Clarithromycin) - for respiratory or atypical infections.
  • Tetracyclines (e.g., Doxycycline) - for various infections including atypical pathogens.
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Cost & Coverage

Average Cost: $20 - $100 per 30 tablets (750mg)
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 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 consumed, and the time it occurred.