Ceftazidime 2gm 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. It works by killing the bacteria that cause the infection.
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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. Administer the medication as directed, which may involve:

Receiving it as an injection into a muscle
Receiving it as an infusion into a vein over a period of time
* Receiving it as an injection 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, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Report any severe or persistent diarrhea to your healthcare provider, as this could be a sign of a more serious infection (C. difficile).
  • Inform your healthcare provider about all medications you are taking, including over-the-counter drugs, supplements, and herbal products.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

Severe infections: 2 grams IV every 8 hours
Urinary tract infections: 250 mg to 500 mg IV or IM every 8 to 12 hours
Uncomplicated pneumonia/skin and skin structure infections: 500 mg to 1 gram IV or IM every 8 hours
Bone and joint infections: 2 grams IV every 12 hours
Pseudomonal infections (severe): 2 grams IV every 8 hours
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Pediatric Dosing

Neonatal: 0-4 weeks: 30 mg/kg IV every 12 hours (up to 60 mg/kg/day)
Infant: 1 month to 12 years: 30 to 50 mg/kg IV every 8 hours (max 6 grams/day)
Child: 1 month to 12 years: 30 to 50 mg/kg IV every 8 hours (max 6 grams/day)
Adolescent: 12 years and older: Same as adult dosing (1 to 2 grams IV or IM every 8 to 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 1 gram after each hemodialysis session. Peritoneal dialysis: 500 mg every 24 hours.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Ceftazidime is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs). This binding interferes with the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to inhibition of cell wall biosynthesis and ultimately bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM)
Tmax: IM: 1 hour
FoodEffect: Not applicable (parenteral administration)

Distribution:

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

Elimination:

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

OnsetOfAction: Rapid (within minutes of IV administration)
PeakEffect: Within 1 hour (IV), 1 hour (IM)
DurationOfAction: Dependent on dose and renal function, typically allows for 8-12 hour dosing intervals

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of 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
Diarrhea, especially if it is severe, bloody, or watery (a rare but potentially life-threatening condition called C. diff-associated diarrhea or CDAD may occur)
Stomach pain, cramps, or severe diarrhea (if you experience any of these symptoms, contact your doctor before treating the diarrhea)

If you have kidney problems, you may be at risk for additional side effects, such as:
Seizures
Confusion
Shakiness
Muscle twitching
Difficulty controlling body movements
Contact your doctor right away if you experience any of these symptoms, as your dosage may need to be adjusted.

Other Possible Side Effects

Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Upset stomach or vomiting
Stomach pain
Irritation at the injection site

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe allergic reactions: rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing, dizziness.
  • Severe diarrhea (watery or bloody), abdominal cramps, fever (may indicate *Clostridioides difficile* infection).
  • Seizures (rare, more common in patients with kidney problems or high doses).
  • Unusual bleeding or bruising.
  • Signs of new infection (e.g., fever, chills, sore throat, new or worsening symptoms).
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking chloramphenicol, as this may interact with the medication.
It is crucial to note that this is not an exhaustive list of all potential interactions with this medication. Therefore, it is vital to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, to your doctor and pharmacist.
You should also inform your doctor about any existing health problems, as these may affect the safety of taking this medication.
* To ensure your safety, always verify with your doctor before starting, stopping, or modifying the dose of any medication, including this one, to avoid potential interactions or adverse effects.
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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 for you, 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 impact the results of certain 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 mental status)
  • 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.

Drug Interactions

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Major Interactions

  • Aminoglycosides (e.g., gentamicin, tobramycin): Increased risk of nephrotoxicity.
  • Loop diuretics (e.g., furosemide): May increase ceftazidime serum concentrations.
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Moderate Interactions

  • Oral anticoagulants (e.g., warfarin): May enhance the anticoagulant effect, requiring INR monitoring.
  • Probenecid: Decreases renal tubular secretion of ceftazidime, leading to increased and prolonged serum concentrations (not typically co-administered due to minimal clinical benefit).

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine, CrCl)

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

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: Although not primarily hepatically metabolized, baseline assessment is prudent.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with differential

Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., eosinophilia, thrombocytopenia, leukopenia).

Timing: Prior to initiation of therapy

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Routine Monitoring

Renal function (BUN, serum creatinine)

Frequency: Every 2-3 days or as clinically indicated, especially in patients with pre-existing renal impairment or those receiving concomitant nephrotoxic drugs.

Target: Within normal limits or stable based on patient's baseline

Action Threshold: Significant increase in BUN/creatinine; consider dose adjustment or discontinuation.

Signs and symptoms of superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)

Frequency: Daily

Target: Absence of new infections

Action Threshold: Development of new infections; consider appropriate antifungal/antibiotic therapy or discontinuation.

Fluid intake and output

Frequency: Daily

Target: Adequate hydration and urine output

Action Threshold: Oliguria/anuria; investigate cause and manage fluid balance.

INR (if on oral anticoagulants)

Frequency: As per anticoagulant monitoring guidelines, potentially more frequently initially

Target: Therapeutic range for indication

Action Threshold: INR above therapeutic range; adjust anticoagulant dose.

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Symptom Monitoring

  • Rash or hives (signs of hypersensitivity)
  • Difficulty breathing or swallowing (signs of anaphylaxis)
  • Severe or persistent diarrhea, abdominal pain, fever (signs of *Clostridioides difficile*-associated diarrhea)
  • Nausea, vomiting
  • Headache, dizziness, seizures (especially in patients with renal impairment receiving high doses)
  • Injection site reactions (pain, inflammation)

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: Low risk based on animal data, but human data limited. Use only if clearly indicated.
Second Trimester: Low risk based on animal data, but human data limited. Use only if clearly indicated.
Third Trimester: Low risk based on animal data, but human data limited. Use only if clearly indicated.
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Lactation

Ceftazidime is excreted in human milk in low concentrations. The amount ingested by a nursing infant is generally considered low and unlikely to cause significant adverse effects. However, monitor the infant for potential changes in bowel flora (e.g., diarrhea, candidiasis) or allergic reactions.

Infant Risk: Low risk (L2 - Safer)
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Pediatric Use

Dosing is weight-based and adjusted for age. Neonates and infants require careful dosing due to immature renal function. Close monitoring for adverse effects is important.

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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 is a key antibiotic for treating *Pseudomonas aeruginosa* infections, especially in patients with cystic fibrosis or neutropenic fever.
  • Always confirm patient allergies, especially to penicillins or other cephalosporins, due to potential cross-reactivity.
  • Ensure proper renal dose adjustment to prevent accumulation and potential neurotoxicity (e.g., seizures).
  • Reconstituted solutions may vary in color from light yellow to amber; this does not indicate a loss of potency.
  • Administer IV doses slowly over 20-30 minutes to minimize vein irritation.
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Alternative Therapies

  • Piperacillin/tazobactam (Zosyn) - broad-spectrum penicillin/beta-lactamase inhibitor.
  • Carbapenems (e.g., meropenem, imipenem/cilastatin, doripenem) - very broad-spectrum antibiotics, often reserved for resistant infections.
  • Aminoglycosides (e.g., tobramycin, amikacin) - often used in combination with beta-lactams for severe Gram-negative infections, including *Pseudomonas*.
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) - for susceptible Gram-negative infections, including *Pseudomonas*.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 2gm vial per 2gm vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 (Brand)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or 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 the recommended 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, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.