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Ciprofloxacin I.V. 400mg Sol, 200ml

Manufacturer SAGENT Active Ingredient Ciprofloxacin Injection(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 fights bacteria in your body. It's given through a vein (IV) to treat serious infections like those in the lungs, skin, bones, or urinary tract. It works by stopping bacteria from growing and multiplying.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered as an intravenous infusion, which means it is given through a vein over a specified period of time.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Report any new or worsening side effects immediately to your doctor or nurse.
  • Stay well-hydrated unless otherwise instructed by your doctor.
  • Avoid excessive sun exposure or use sunscreen, as this medication can increase sun sensitivity.
  • Do not take antacids, iron, or zinc supplements at the same time as oral ciprofloxacin (not applicable for IV, but good general knowledge if transitioning to oral).
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication, e.g., 400 mg IV every 8 to 12 hours for severe infections.
Dose Range: 200 - 400 mg

Condition-Specific Dosing:

complicatedUTI_pyelonephritis: 400 mg IV every 8 hours
lowerRespiratoryTract_skin_bone_joint_intraAbdominal: 400 mg IV every 8 to 12 hours
acuteSinusitis: 400 mg IV every 12 hours
nosocomialPneumonia: 400 mg IV every 8 hours
anthrax_postExposure: 400 mg IV every 12 hours
plague: 400 mg IV every 8 to 12 hours
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Pediatric Dosing

Neonatal: Not established (generally avoided due to arthropathy risk)
Infant: Not established (generally avoided due to arthropathy risk)
Child: 10 mg/kg IV every 8 hours (max 400 mg/dose) for complicated UTI/pyelonephritis; 10 mg/kg IV every 12 hours (max 400 mg/dose) for anthrax/plague.
Adolescent: Similar to adult dosing for specific indications (e.g., complicated UTI, anthrax, plague) where benefits outweigh risks.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 50-80 mL/min)
Moderate: Dose reduction (e.g., 200-400 mg IV every 18-24 hours or 50% of standard dose) for CrCl 30-50 mL/min
Severe: Further dose reduction (e.g., 200-400 mg IV every 24 hours or 25-50% of standard dose) for CrCl < 30 mL/min
Dialysis: Administer after dialysis on dialysis days. For hemodialysis/peritoneal dialysis, 200-400 mg IV every 24 hours (or 25-50% of standard dose).

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed (monitor for adverse effects due to potential for reduced clearance in severe cases)

Pharmacology

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Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibacterial that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to DNA strand breaks and bacterial cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV administration)
Tmax: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

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

Elimination:

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

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: End of infusion
DurationOfAction: Dose-dependent, typically allows for q8-12h dosing

Safety & Warnings

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BLACK BOX WARNING

Fluoroquinolones, including Ciprofloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Discontinue Ciprofloxacin immediately and avoid 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. Consider the risk-benefit in patients at risk for aortic aneurysm or dissection. Fluoroquinones, including Ciprofloxacin, have been associated with dysglycemia (both hypoglycemia and hyperglycemia).
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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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ 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 or tremors
 Difficulty walking
Vaginal itching or discharge
 White patches in the mouth (oral thrush)
Sunburn or increased sensitivity to the sun
 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

Additional Serious Side Effects

 Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) can occur, which may lead to life-threatening bowel problems. If you experience:
+ Stomach pain or cramps
+ Very loose, watery, or bloody stools
contact your doctor immediately.
A rare but severe problem with the aorta (the main blood vessel that comes out of the heart) has been reported in some patients, especially older adults, within 2 months of taking this medication. This can cause severe bleeding and even death. If you experience:
+ Sudden, severe pain in the stomach, chest, or back that does not go away
contact your doctor immediately.

Common Side Effects

 Diarrhea
Upset stomach or vomiting
 Headache
* Irritation at the injection site (if applicable)

Reporting Side Effects

If you experience any side effects that bother you or do not go away, contact your doctor for 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:

  • New or worsening pain, swelling, or bruising around a joint (especially ankle, heel, shoulder, elbow, wrist, or hand) – could be tendon problems.
  • Numbness, tingling, burning, or weakness in your arms or legs – could be nerve damage.
  • Dizziness, confusion, hallucinations, or seizures.
  • Severe, watery diarrhea or bloody stools, even weeks after stopping the medication.
  • Sudden chest, back, or stomach pain.
  • Significant changes in blood sugar levels (feeling shaky, sweaty, very hungry, or very thirsty, frequent urination).
  • Any new or worsening muscle weakness, especially if you have myasthenia gravis.
  • Severe skin rash, blistering, or peeling.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and circumstances to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
 Certain heart conditions, including:
+ Abnormal heartbeat patterns, such as a prolonged QTc interval on an electrocardiogram (ECG)
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (a weakened heart)
+ Recent heart attack
Nerve problems or tendon problems, including:
+ Previous irritation or tearing of tendons while taking this medication or similar drugs
 Aortic aneurysm (a bulging or ballooning of the aorta, the main blood vessel that carries blood from the heart) or risk factors for this condition, such as:
+ Other blood vessel problems
+ High blood pressure
+ Certain health conditions, including Marfan syndrome or Ehlers-Danlos syndrome
Concurrent use of medications that can cause abnormal heartbeat patterns (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
* Breastfeeding status: Do not breastfeed while taking this medication and for at least 2 days after the last dose.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and 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 your safety and prevent potential interactions with other treatments.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness. This will help prevent accidents and ensure your safety.

Lab Tests and Monitoring
This medication may interfere with certain lab tests. Be sure to inform all 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 (hypoglycemia). In rare cases, very low blood sugar can lead to coma or even death. Monitor your blood sugar levels as directed by your doctor, and report any signs of high or low blood sugar, including:
- Breath that smells like fruit
- Dizziness
- Fast breathing
- Fast heartbeat
- Feeling confused or sleepy
- Feeling weak
- Flushing
- Headache
- Unusual thirst or hunger
- Passing urine more often
- Shaking or sweating

Duration of Treatment
Do not take this medication for longer than prescribed. If you do, you may be at risk for 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.

Sun Protection
This medication can increase your risk of sunburn. To protect yourself, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.

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

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

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

Liver Problems
If you notice any signs of liver problems, such as dark urine, tiredness, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor right away.

Age-Related Precautions
If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects. If you are a child, your doctor will use caution when prescribing this medication, as the risk of joint problems may be higher in children.

Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

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

What to Do:

In case of suspected overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and includes maintaining hydration to prevent crystalluria, and monitoring renal function and vital signs. Hemodialysis or peritoneal dialysis removes only a small amount of ciprofloxacin.

Drug Interactions

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Contraindicated Interactions

  • Tizanidine (concurrent use significantly increases tizanidine Cmax and AUC, leading to hypotension and somnolence)
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Major Interactions

  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) - increased risk of QT prolongation and Torsades de Pointes
  • Warfarin (increased anticoagulant effect, monitor INR)
  • Theophylline (increased theophylline levels, monitor for toxicity)
  • Methotrexate (increased methotrexate levels, monitor for toxicity)
  • Cyclosporine (increased cyclosporine levels, monitor for nephrotoxicity)
  • Phenytoin (altered phenytoin levels, monitor)
  • Sildenafil (increased sildenafil exposure)
  • Duloxetine (increased duloxetine exposure)
  • Clozapine (increased clozapine levels, monitor for adverse effects)
  • Ropinirole (increased ropinirole exposure)
  • NSAIDs (increased risk of CNS stimulation and convulsive seizures)
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Moderate Interactions

  • Caffeine (decreased caffeine clearance)
  • Oral hypoglycemics (potential for dysglycemia, monitor blood glucose)
  • Probenecid (decreased renal clearance of ciprofloxacin)
  • Omeprazole (decreased ciprofloxacin absorption if given orally, not relevant for IV)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: Ciprofloxacin is primarily renally eliminated; dose adjustment is required in renal impairment.

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: Although primarily renal, some hepatic metabolism occurs; monitor for rare hepatotoxicity.

Timing: Prior to initiation of therapy, especially in patients with pre-existing hepatic disease

Electrolytes (Potassium, Magnesium)

Rationale: Baseline assessment, especially if patient is at risk for QT prolongation or on concomitant medications affecting electrolytes.

Timing: Prior to initiation of therapy

ECG

Rationale: Baseline assessment for QT interval, especially in patients with cardiac risk factors or on QT-prolonging drugs.

Timing: Prior to initiation of therapy

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Routine Monitoring

Renal function (BUN, creatinine)

Frequency: Periodically, especially in patients with pre-existing renal impairment or prolonged therapy

Target: Within patient's baseline or normal limits

Action Threshold: Significant increase in creatinine or BUN may require dose adjustment or discontinuation.

Blood glucose

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

Target: Within target range for diabetic control

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

INR (if on warfarin)

Frequency: Frequently (e.g., 2-3 times per week initially, then as needed)

Target: Therapeutic range for indication

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

Signs/symptoms of adverse reactions (e.g., tendon pain, neuropathy, CNS effects)

Frequency: Daily patient assessment

Target: Absence of symptoms

Action Threshold: New onset or worsening of these symptoms requires immediate discontinuation.

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Symptom Monitoring

  • Tendon pain, swelling, inflammation, or rupture (especially Achilles, shoulder, hand)
  • Numbness, tingling, burning, pain, or weakness in extremities (peripheral neuropathy)
  • Dizziness, confusion, hallucinations, seizures, tremors, restlessness, insomnia, depression, suicidal thoughts (CNS effects)
  • Severe, persistent diarrhea (Clostridioides difficile-associated diarrhea)
  • Chest, back, or abdominal pain (aortic aneurysm/dissection)
  • Sudden onset of severe rash, blistering, or peeling skin (severe cutaneous adverse reactions)
  • Palpitations, fainting (QT prolongation, Torsades de Pointes)
  • Muscle weakness, difficulty breathing (exacerbation of myasthenia gravis)
  • Hypoglycemia (sweating, tremor, hunger, confusion) or hyperglycemia (increased thirst, urination)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show some evidence of arthropathy, but human data are limited and do not consistently show increased risk of major birth defects.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies show arthropathy. Generally avoided unless no safer alternative.
Second Trimester: Limited human data, animal studies show arthropathy. Generally avoided unless no safer alternative.
Third Trimester: Limited human data, animal studies show arthropathy. Generally avoided unless no safer alternative.
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Lactation

L3 (Moderately Safe). Ciprofloxacin is excreted into breast milk. Potential for serious adverse reactions in the infant (e.g., alteration of gut flora, arthropathy). Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for ciprofloxacin and any potential adverse effects on the breastfed infant.

Infant Risk: Low to moderate risk. Monitor infant for gastrointestinal disturbances (diarrhea, candidiasis) and theoretical risk of arthropathy (though not observed in human infants).
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Pediatric Use

Generally not recommended for routine use in pediatric patients due to the risk of arthropathy (damage to cartilage in weight-bearing joints) observed in immature animals. Use is reserved for specific severe infections (e.g., complicated UTI, pyelonephritis, anthrax, plague) where the benefits outweigh the risks and no safer alternative exists. Close monitoring for musculoskeletal adverse events is crucial.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients are more likely to have renal impairment, requiring dose adjustment. They may also be at higher risk for tendon disorders, QT prolongation, and CNS effects. Monitor renal function and for adverse reactions closely.

Clinical Information

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Clinical Pearls

  • Always consider the Black Box Warning for fluoroquinolones; reserve use for situations where benefits clearly outweigh risks, especially for less severe infections.
  • Ensure adequate hydration during therapy to prevent crystalluria, although this is rare with ciprofloxacin.
  • Infuse IV ciprofloxacin slowly over 60 minutes to minimize local irritation and infusion-related reactions.
  • Be vigilant for signs of tendinitis/tendon rupture, peripheral neuropathy, and CNS effects, and discontinue the drug immediately if these occur.
  • Monitor blood glucose closely in diabetic patients due to the risk of dysglycemia (both hypo- and hyperglycemia).
  • Avoid co-administration with tizanidine due to severe hypotension and somnolence risk.
  • Counsel patients on the importance of reporting any new or unusual symptoms promptly.
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Alternative Therapies

  • Other fluoroquinolones (e.g., Levofloxacin, Moxifloxacin - chosen based on spectrum and specific infection)
  • Beta-lactam antibiotics (e.g., Ceftriaxone, Piperacillin/Tazobactam)
  • Aminoglycosides (e.g., Gentamicin, Tobramycin)
  • Carbapenems (e.g., Meropenem, Imipenem/Cilastatin)
  • Other classes depending on the specific pathogen and site of infection (e.g., Trimethoprim/Sulfamethoxazole, Doxycycline)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 400mg/200ml IV bag per 400mg/200ml IV bag
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 or 4 (Brand) for most commercial and government plans. Often covered for approved indications.
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs that provide a safe and responsible way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides important information about its safe use. It is crucial to read this guide carefully and review it again each time your prescription is refilled. 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 contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare professionals provide appropriate treatment.