Cipro 750mg Tablets

Manufacturer SCHERING 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 various bacterial infections, such as those of the urinary tract, skin, bones, joints, and respiratory tract.
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How to Use This Medicine

Taking Your Medication Correctly

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

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions closely.
Take your medication at the same time every day.
You can take your medication with or without food.
Drink a full glass of water with your medication.
Avoid taking your medication with dairy products, such as milk or yogurt, or calcium-rich juices. However, if you are taking a full meal that contains these products, you can take your medication with the meal.
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 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 feel well.
Swallow your medication whole. Do not chew or crush it.
Some tablet strengths may have a score line. If your dose requires splitting the tablet, only split it along the score line.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Check with your pharmacist for guidance on the best way to dispose of medications. You may also have access to drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember.
If it is less than 6 hours until your next scheduled dose, skip the missed dose and return to your regular dosing 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 or stop early, even if you feel better.
  • Avoid taking with dairy products (milk, yogurt) or calcium-fortified juices alone. You can take it with a meal that includes dairy, but not dairy as the only food.
  • Avoid antacids, sucralfate, iron, and zinc supplements for at least 2 hours before and 6 hours after taking ciprofloxacin.
  • Drink plenty of fluids to prevent kidney stone formation.
  • Avoid excessive exposure to sunlight or artificial UV light (tanning beds) as ciprofloxacin can make your skin more sensitive to light. 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.
  • Report any new or worsening muscle pain, joint pain, numbness, tingling, or weakness immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. For complicated urinary tract infections or pyelonephritis: 500 mg every 12 hours for 7-14 days or 1000 mg extended-release once daily for 7-14 days. For complicated intra-abdominal infections: 500 mg every 12 hours for 7-14 days (in combination with metronidazole). For severe or complicated infections (e.g., bone and joint, severe respiratory tract, skin and skin structure): 750 mg every 12 hours for 7-14 days or longer.
Dose Range: 250 - 750 mg

Condition-Specific Dosing:

Complicated UTI/Pyelonephritis: 500 mg every 12 hours or 1000 mg XR once daily
Bone and Joint Infections: 500-750 mg every 12 hours
Intra-abdominal Infections: 500 mg every 12 hours (with metronidazole)
Anthrax (post-exposure): 500 mg every 12 hours for 60 days
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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: Generally not recommended due to arthropathy risk, but may be used for specific severe infections (e.g., complicated UTI, pyelonephritis, inhalational anthrax, cystic fibrosis exacerbations) when benefits outweigh risks. Dosing for complicated UTI/pyelonephritis (1-17 years): 10-20 mg/kg (max 750 mg per dose) orally every 12 hours for 10-21 days.
Adolescent: Generally not recommended due to arthropathy risk, but may be used for specific severe infections (e.g., complicated UTI, pyelonephritis, inhalational anthrax, cystic fibrosis exacerbations) when benefits outweigh risks. Dosing for complicated UTI/pyelonephritis (1-17 years): 10-20 mg/kg (max 750 mg per dose) orally every 12 hours for 10-21 days.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for CrCl > 50 mL/min.
Moderate: CrCl 30-50 mL/min: Administer 250-500 mg every 12 hours (depending on severity of infection).
Severe: CrCl < 30 mL/min: Administer 250-500 mg every 18-24 hours (depending on severity of infection).
Dialysis: Hemodialysis/Peritoneal Dialysis: Administer 250-500 mg every 24 hours after dialysis. Monitor clinical response and drug levels if possible.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended, but caution is advised due to potential for liver injury. Monitor liver function tests.

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: 70-80%
Tmax: 0.5-2 hours (oral)
FoodEffect: Food delays Tmax but does not significantly alter Cmax or AUC. Dairy products and calcium-fortified juices can significantly reduce absorption.

Distribution:

Vd: 2.1-2.7 L/kg
ProteinBinding: 20-40%
CnssPenetration: Limited (CSF concentrations are 6-10% of serum concentrations in non-inflamed meninges, higher with inflamed meninges)

Elimination:

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

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Within 1-2 hours of oral administration
DurationOfAction: 12-24 hours (depending on dosing frequency)

Safety & Warnings

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BLACK BOX WARNING

Fluoroquinolones, including Cipro, 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 Cipro 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 Cipro in patients with a known history of myasthenia gravis. Fluoroquinolones, including Cipro, have been associated with an increased risk of aortic aneurysm and dissection. Consider the risk-benefit in patients at risk for aortic aneurysm or dissection. Hypoglycemia and dysglycemia have been reported with fluoroquinolones, including Cipro. 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 while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Chest pain or pressure
Shortness of breath
Shakiness
Difficulty walking
Vaginal itching or discharge
White patches in the mouth (oral thrush)
Sunburn
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Muscle pain or weakness
Difficulty focusing
Memory problems or loss
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 (may be a sign of C. difficile-associated diarrhea, a potentially life-threatening condition)
Sudden, severe pain in the stomach, chest, or back (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

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience 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
Vomiting
Headache

Reporting Side Effects

If you have questions about side effects or experience any unusual symptoms, contact your doctor for medical advice. 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:

  • Sudden pain, swelling, or bruising around a joint (especially ankle, heel, or shoulder) - could be tendon rupture.
  • Numbness, tingling, burning pain, or weakness in your arms or legs - could be peripheral neuropathy.
  • Severe dizziness, confusion, hallucinations, or seizures.
  • Severe or persistent diarrhea, especially with fever or blood in stool - could be C. difficile infection.
  • Sudden, severe chest, back, or abdominal pain - could be aortic aneurysm/dissection.
  • Signs of low blood sugar (shakiness, sweating, confusion, hunger) or high blood sugar (increased thirst, frequent urination).
  • Yellowing of skin or eyes, dark urine, severe stomach pain - signs of liver problems.
  • Rash, hives, swelling of face/throat, difficulty breathing - signs of allergic reaction.
  • Palpitations or feeling of a racing heart.
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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:
+ 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
Medications that can cause abnormal heart rhythms (prolonged QT interval). Many drugs can cause this condition, 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 your last dose.

This is not an exhaustive list of all 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. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Caution with Daily Activities

Until you know how this medication affects you, avoid driving and engaging in other activities that require you to be alert. This will help prevent accidents and ensure your safety.

Lab Tests and Monitoring

This medication may affect the results of certain lab tests. Be sure to inform all of your healthcare providers and lab personnel that you are taking this medication. If you are taking this medication long-term, your doctor may recommend regular blood work to monitor your condition.

Blood Sugar Control

Medications like this one can cause changes in blood sugar levels. If you have diabetes and are taking medications to lower your blood sugar, such as insulin, you may be at risk for low blood sugar. Symptoms of high or low blood sugar include breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, unusual thirst or hunger, passing urine more often, shaking, or sweating. Check your blood sugar levels as directed by your doctor, and report any concerns or symptoms to your doctor immediately. In rare cases, very low blood sugar can lead to coma or even death.

Duration of Use

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

Caffeine Interactions

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

Sun Protection

This medication can increase your risk of sunburn. To protect yourself, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when spending time outdoors.

Fluid Intake

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

Rare but Serious Side Effects

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

Abnormal Heartbeat

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

Liver Problems

If you experience symptoms 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.

Special Considerations

If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects. If you are a child, your doctor will carefully weigh the benefits and risks of using this medication, as there may be a higher risk of joint problems.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the potential benefits and risks of taking 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:

Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. Gastric lavage may be performed. Maintain adequate hydration. Hemodialysis or peritoneal dialysis removes only small amounts of ciprofloxacin.

Drug Interactions

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Contraindicated Interactions

  • Tizanidine (concomitant use significantly increases tizanidine Cmax and AUC, leading to hypotension and somnolence)
  • Pimozide (risk of QT prolongation and arrhythmias)
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Major Interactions

  • Antacids containing aluminum, magnesium, or calcium; sucralfate; iron supplements; zinc supplements; dairy products; calcium-fortified juices (reduce ciprofloxacin absorption)
  • Theophylline (increased theophylline levels and toxicity due to CYP1A2 inhibition)
  • Warfarin (increased anticoagulant effect and bleeding risk)
  • Methotrexate (increased methotrexate levels and toxicity)
  • Cyclosporine (increased cyclosporine levels and nephrotoxicity)
  • Phenytoin (altered phenytoin levels)
  • Sildenafil (increased sildenafil exposure)
  • Duloxetine (increased duloxetine exposure)
  • Clozapine (increased clozapine levels and adverse effects)
  • Ropinirole (increased ropinirole exposure)
  • Omeprazole (increased omeprazole exposure)
  • NSAIDs (increased risk of CNS stimulation and seizures)
  • Class IA and Class III antiarrhythmics (e.g., quinidine, procainamide, amiodarone, sotalol) and other drugs that prolong QT interval (increased risk of QT prolongation)
  • Oral hypoglycemic agents/Insulin (risk of dysglycemia, including severe hypoglycemia)
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Moderate Interactions

  • Caffeine (decreased caffeine clearance)
  • Metoclopramide (accelerated ciprofloxacin absorption)
  • Didanosine (DDI) (reduced ciprofloxacin absorption due to buffering agents)
  • Probenecid (increased ciprofloxacin levels)
  • Fosfomycin (potential antagonism)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To adjust dose in patients with impaired renal function.

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic status, especially in patients with pre-existing liver disease or those at risk for hepatotoxicity.

Timing: Prior to initiation of therapy

ECG

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

Timing: Prior to initiation of therapy for high-risk patients

Blood glucose

Rationale: To assess baseline glucose levels, especially in diabetic patients or those at risk for dysglycemia.

Timing: Prior to initiation of therapy

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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

Adverse effects (e.g., GI, CNS, musculoskeletal pain, rash)

Frequency: Daily

Target: Absence or mild, tolerable side effects

Action Threshold: Severe or persistent adverse effects

Blood glucose

Frequency: Periodically, especially in diabetic patients or those with risk factors for dysglycemia

Target: Within normal limits or patient's target range

Action Threshold: Hypoglycemia (<70 mg/dL) or hyperglycemia (>200 mg/dL)

INR (if on warfarin)

Frequency: More frequently (e.g., 2-3 times per week initially)

Target: Patient's therapeutic range

Action Threshold: INR above or below target range

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Symptom Monitoring

  • Tendinitis/Tendon rupture (pain, swelling, inflammation, or rupture of a tendon, especially Achilles)
  • Peripheral neuropathy (pain, burning, tingling, numbness, weakness in extremities)
  • CNS effects (dizziness, headache, confusion, hallucinations, seizures, tremors, anxiety, depression, insomnia)
  • Hypoglycemia/Hyperglycemia (sweating, shakiness, confusion, hunger, increased thirst, frequent urination)
  • Aortic aneurysm/dissection (sudden, severe pain in chest, back, or abdomen)
  • C. difficile-associated diarrhea (severe, persistent diarrhea, abdominal pain, fever)
  • QT prolongation/Arrhythmias (palpitations, dizziness, syncope)
  • Photosensitivity (severe sunburn reaction)
  • Hypersensitivity reactions (rash, itching, hives, swelling, difficulty breathing)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for arthropathy in the developing fetus, though human data are limited and do not consistently show this risk.
Second Trimester: Similar theoretical risks as first trimester. Use only if clearly needed.
Third Trimester: Similar theoretical risks as first trimester. Use only if clearly needed.
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Lactation

Ciprofloxacin is excreted into human breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., arthropathy, disruption of gut flora), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderate risk). Potential for arthropathy, gastrointestinal disturbances (diarrhea, candidiasis), and alteration of gut flora in the infant. Monitor infant for adverse effects.
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Pediatric Use

Generally not recommended for routine use in pediatric patients (<18 years) due to the risk of irreversible arthropathy (damage to cartilage in weight-bearing joints) observed in immature animals. However, it is approved for specific severe infections where the benefits outweigh the risks, such as complicated urinary tract infections, pyelonephritis, and inhalational anthrax (post-exposure) in children. Close monitoring for musculoskeletal adverse events is crucial.

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Geriatric Use

Elderly patients may be at increased risk for severe tendon disorders (including rupture), peripheral neuropathy, and QT prolongation. Renal function should be assessed, and dosage adjusted accordingly. Increased risk of aortic aneurysm/dissection. Exercise caution and monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Always consider the Black Box Warnings for fluoroquinolones before prescribing, especially for uncomplicated infections where alternatives exist.
  • Counsel patients extensively on the risk of tendinitis/tendon rupture and peripheral neuropathy, and to discontinue the drug immediately if symptoms occur.
  • Ensure patients separate ciprofloxacin administration from antacids, sucralfate, iron, zinc, and dairy products by at least 2 hours before and 6 hours after.
  • Monitor blood glucose closely in diabetic patients due to the risk of dysglycemia (both hypo- and hyperglycemia).
  • Ciprofloxacin is a strong CYP1A2 inhibitor; carefully review concomitant medications, especially theophylline, tizanidine (contraindicated), clozapine, and warfarin.
  • Advise patients about photosensitivity and to use sun protection.
  • Not effective against viral infections; avoid inappropriate use to prevent resistance.
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Alternative Therapies

  • Other fluoroquinolones (e.g., Levofloxacin, Moxifloxacin, Ofloxacin - chosen based on spectrum and indication)
  • Beta-lactam antibiotics (e.g., Cephalosporins, Penicillins, Carbapenems)
  • Aminoglycosides (e.g., Gentamicin, Tobramycin)
  • Macrolides (e.g., Azithromycin, Clarithromycin)
  • Tetracyclines (e.g., Doxycycline)
  • Sulfonamides (e.g., Trimethoprim/Sulfamethoxazole)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$100+ per 30 tablets (750mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. 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 crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication, the amount taken, and the time it occurred.