Ceftazidime 6gm Inj, 1 Vial

Manufacturer SAGENT PHARMACEUTICAL Active Ingredient Ceftazidime(SEF tay zi deem) Pronunciation SEF tay zi deem
It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Third-generation Cephalosporin
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Pregnancy Category
Category B
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FDA Approved
Jul 1985
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ceftazidime is an antibiotic medication given by injection to treat serious bacterial infections, including those of the lungs, skin, urinary tract, and blood. It works by killing the bacteria that cause these infections.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered either as an injection into a muscle or as an infusion into a vein over a period of time. In some cases, it may be given as an injection directly into a vein.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missing a Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Complete the full course of treatment as prescribed, even if you start feeling better. Stopping early can lead to resistant bacteria.
  • Stay well-hydrated unless otherwise advised by your doctor.
  • Report any new or worsening symptoms to your healthcare provider immediately.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 grams IV/IM every 8-12 hours
Dose Range: 1 - 6 mg

Condition-Specific Dosing:

uncomplicatedUTI: 250-500 mg IV/IM every 8-12 hours
complicatedUTI: 500 mg IV/IM every 8-12 hours
pneumonia: 1-2 grams IV/IM every 8-12 hours
severeInfections: 2 grams IV/IM every 8 hours
pseudomonalInfections: 2 grams IV/IM every 8 hours
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Pediatric Dosing

Neonatal: 0-4 weeks: 30 mg/kg IV every 12 hours (for meningitis, 50 mg/kg every 12 hours)
Infant: 1 month to 12 years: 30-50 mg/kg IV every 8 hours (max 6g/day)
Child: 1 month to 12 years: 30-50 mg/kg IV every 8 hours (max 6g/day)
Adolescent: Same as adult dosing (1-2 grams IV/IM every 8-12 hours)
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Dose Adjustments

Renal Impairment:

Mild: CrCl 31-50 mL/min: 1 gram every 12 hours
Moderate: CrCl 16-30 mL/min: 1 gram every 24 hours
Severe: CrCl 6-15 mL/min: 500 mg every 24 hours
Dialysis: CrCl <5 mL/min: 500 mg every 48 hours. Administer loading dose of 1 gram, then 500 mg after each hemodialysis session. Peritoneal dialysis: 500 mg every 24 hours.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

Pharmacology

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Mechanism of Action

Ceftazidime is a bactericidal antibiotic that acts by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, which interferes with the transpeptidation step of peptidoglycan synthesis, leading to cell lysis and bacterial death.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV), 90-95% (IM)
Tmax: 1 hour (IM)
FoodEffect: Not applicable (administered parenterally)

Distribution:

Vd: 0.21-0.28 L/kg
ProteinBinding: Approximately 10%
CnssPenetration: Yes (especially with inflamed meninges)

Elimination:

HalfLife: Approximately 1.8-2 hours (normal renal function)
Clearance: Approximately 100-120 mL/min (renal clearance)
ExcretionRoute: Renal (primarily glomerular filtration)
Unchanged: 80-90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV administration)
PeakEffect: End of infusion (IV), 1 hour (IM)
DurationOfAction: 8-12 hours (based on dosing frequency)
Confidence: High

Safety & Warnings

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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 a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), such as:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Dark urine or yellow skin and eyes
Difficulty urinating or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Redness or white patches in the mouth or throat
Vaginal itching or discharge
Severe diarrhea (C. diff-associated diarrhea, or CDAD), which may cause:
+ Stomach pain
+ Cramps
+ Loose, watery, or bloody stools
Neurological symptoms, such as:
+ Seizures
+ Confusion
+ Shakiness
+ Muscle twitching
+ Trouble controlling body movements (more common in people with kidney problems)

If you experience any of these symptoms, contact your doctor right away. Your doctor may need to adjust your dosage or provide additional guidance.

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's essential to discuss any concerns with your doctor. Common side effects include:

Diarrhea
Upset stomach
Vomiting
Stomach pain
Irritation at the injection site

If you experience any of these side effects or have concerns about other symptoms, 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:

  • Signs of a severe allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, dizziness.
  • Severe or watery diarrhea, especially if it contains blood or mucus, which may occur during or even several months after treatment.
  • Unusual bleeding or bruising.
  • Seizures or confusion (rare, more likely in patients with kidney problems).
  • Signs of a new infection (e.g., fever, sore throat, oral thrush, vaginal yeast infection).
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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:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking chloramphenicol, as this may interact with the medication.

This is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method, as this medication may affect the accuracy of certain tests. Additionally, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication, as it may interfere with the results of some lab tests.

Do not take this medication for longer than prescribed, as this can increase the risk of developing a second infection. Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Seizures
  • Encephalopathy (confusion, altered consciousness)
  • Neuromuscular excitability
  • Asterixis

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Hemodialysis may be useful in removing ceftazidime from the body, especially in patients with impaired renal function.

Drug Interactions

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Major Interactions

  • Aminoglycosides (increased risk of nephrotoxicity)
  • Loop diuretics (increased risk of nephrotoxicity with aminoglycosides)
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Moderate Interactions

  • Probenecid (decreased renal tubular secretion of ceftazidime, leading to increased and prolonged plasma concentrations)
  • Oral anticoagulants (e.g., warfarin - potential for increased INR/bleeding risk, though less common than with other cephalosporins)
  • Live bacterial vaccines (e.g., typhoid vaccine - antibiotics may reduce therapeutic effect)

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine, CrCl)

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

Timing: Prior to initiation of therapy

Culture and susceptibility testing

Rationale: To confirm the causative organism and its susceptibility to ceftazidime.

Timing: Prior to initiation of therapy

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Routine Monitoring

Renal function (BUN, serum creatinine)

Frequency: Periodically, especially in patients with pre-existing renal impairment or those receiving concomitant nephrotoxic drugs

Target: Within normal limits or stable for patient's baseline

Action Threshold: Significant increase in creatinine or BUN; consider dose adjustment or alternative therapy

Clinical response to therapy

Frequency: Daily

Target: Resolution of signs/symptoms of infection

Action Threshold: Lack of improvement or worsening of infection; consider re-evaluation of diagnosis, susceptibility, or alternative therapy

Complete Blood Count (CBC) with differential

Frequency: Periodically, especially with prolonged therapy

Target: Within normal limits

Action Threshold: Significant changes (e.g., eosinophilia, leukopenia, thrombocytopenia); may indicate drug-induced hematologic effects

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, especially with prolonged therapy

Target: Within normal limits

Action Threshold: Significant elevation; may indicate drug-induced hepatotoxicity (rare)

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Symptom Monitoring

  • Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
  • Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
  • Seizures or other central nervous system effects (especially in patients with renal impairment not adequately dosed)
  • Signs of superinfection (new fever, persistent sore throat, oral thrush, vaginal yeast infection)
  • Injection site reactions (pain, inflammation, phlebitis)

Special Patient Groups

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Pregnancy

Ceftazidime is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of congenital anomalies.
Second Trimester: No specific risks identified.
Third Trimester: No specific risks identified.
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Lactation

Ceftazidime is excreted in human milk in low concentrations. It is generally considered compatible with breastfeeding. Monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low risk. Potential for alteration of bowel flora, candidiasis, or allergic sensitization.
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Pediatric Use

Dosing must be carefully calculated based on weight and age, especially in neonates and infants. Renal function should be monitored, as neonates and young infants have immature renal function. Safety and efficacy are established for various infections.

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Geriatric Use

No specific dose adjustment is needed based solely on age, but elderly patients are more likely to have decreased renal function, which necessitates dose adjustment based on creatinine clearance. Monitor renal function closely.

Clinical Information

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Clinical Pearls

  • Ceftazidime has excellent activity against Pseudomonas aeruginosa, making it a crucial agent for suspected or confirmed pseudomonal infections.
  • It has good CNS penetration, making it suitable for treating bacterial meningitis caused by susceptible organisms.
  • Always adjust the dose in patients with renal impairment to prevent accumulation and potential neurotoxicity (e.g., seizures).
  • Ceftazidime is often used empirically in febrile neutropenia due to its broad-spectrum activity against Gram-negative bacteria, including Pseudomonas.
  • While generally well-tolerated, monitor for C. difficile-associated diarrhea, which can occur during or after therapy.
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Alternative Therapies

  • Other anti-pseudomonal beta-lactams (e.g., Piperacillin/Tazobactam, Cefepime, Meropenem, Imipenem/Cilastatin, Doripenem)
  • Aminoglycosides (e.g., Gentamicin, Tobramycin, Amikacin - often used in combination with beta-lactams for severe pseudomonal infections)
  • Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin - for susceptible infections)
  • Polymyxins (e.g., Colistin, Polymyxin B - for highly resistant Gram-negative infections)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 1g vial (generic) per 1g vial
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, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, 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 quantity, and the time of ingestion.