Ceftazidime 1gm 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 (into a vein or muscle) to treat a wide range of serious bacterial infections. It works by killing the bacteria that cause the infection. It is especially effective against certain types of bacteria, including those that can cause infections in the lungs, skin, urinary tract, and blood, as well as a common type of bacteria called Pseudomonas.
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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 to you. It is essential to follow the instructions carefully. This medication can be administered in two ways: as an injection into a muscle or as an infusion into a vein over a period of time. In some cases, it may also 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 to determine the best way to store it.

Missing a Dose

If you miss a dose, contact your doctor to find out what steps to take next.
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Lifestyle & Tips

  • Complete the full course of treatment as prescribed, even if you start to feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Maintain good hydration unless otherwise instructed 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 to 2 grams IV/IM every 8 to 12 hours
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

Severe infections (e.g., febrile neutropenia, meningitis): 2 grams IV every 8 hours
Urinary tract infections: 0.5 to 1 gram IV/IM every 8 to 12 hours
Uncomplicated pneumonia, skin and soft tissue infections: 0.5 to 1 gram 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 IV every 12 hours)
Infant: 1 month to 12 years: 30-50 mg/kg IV every 8 hours (max 6 g/day); for severe infections/meningitis, 100-150 mg/kg/day divided every 8 hours (max 6 g/day)
Child: 1 month to 12 years: 30-50 mg/kg IV every 8 hours (max 6 g/day); for severe infections/meningitis, 100-150 mg/kg/day divided every 8 hours (max 6 g/day)
Adolescent: 12 years and older: Refer to adult dosing (1 to 2 grams IV/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: 0.5 gram every 24 hours
Dialysis: Hemodialysis: 1 gram loading dose, then 1 gram after each dialysis session. Peritoneal dialysis: 0.5 gram every 24 hours, or 1 gram loading dose then 0.5 gram every 24 hours.

Hepatic Impairment:

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

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, thereby inhibiting the transpeptidation step of peptidoglycan synthesis. This leads to the disruption of the cell wall, resulting in bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 0.21 L/kg
ProteinBinding: Approximately 17%
CnssPenetration: Yes (especially when meninges are inflamed)

Elimination:

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

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

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
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
+ Difficulty controlling body movements (more common in people with kidney problems)

If you experience any of these symptoms, contact your doctor immediately. Your doctor may need to adjust your dosage if you have kidney problems.

Common and Less Severe Side Effects

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

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:

  • Signs of allergic reaction: rash, itching, hives, swelling of face/lips/tongue, difficulty breathing.
  • Severe or watery diarrhea, especially if it contains blood or mucus (may be a sign of *Clostridioides difficile* infection).
  • New or worsening fever, chills, or sore throat (signs of superinfection or blood dyscrasias).
  • Seizures or changes in mental status.
  • Unusual bleeding or bruising.
  • Yellowing of the skin or eyes (jaundice).
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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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking chloramphenicol.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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 interfere with the results of some lab tests.

Do not take this medication for longer than prescribed, as this may increase the risk of a secondary infection. Older adults (65 years and older) should use this medication with caution, 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)
  • Asterixis (flapping tremor)
  • Neuromuscular excitability

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive. 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. Monitor renal function closely.
  • Loop diuretics (e.g., furosemide): May increase ceftazidime serum concentrations. Monitor for increased adverse effects.
  • Oral anticoagulants (e.g., warfarin): May enhance anticoagulant effect. Monitor INR/PT closely.
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Moderate Interactions

  • Probenecid: Decreases renal tubular secretion of ceftazidime, leading to increased and prolonged serum concentrations. Generally not co-administered unless therapeutic benefit outweighs risk.
  • Vaccines (e.g., BCG, typhoid live): Antibiotics may reduce the therapeutic effect of live bacterial vaccines. Administer vaccines at least 24 hours after antibiotic discontinuation.
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Minor Interactions

  • Laboratory tests: May cause a false-positive direct Coombs' test. May cause false-positive urine glucose tests with copper-reduction methods (e.g., Benedict's solution, Fehling's solution).

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

Rationale: Ceftazidime is primarily renally eliminated; baseline assessment is crucial for dose adjustment, especially in patients with pre-existing renal impairment.

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: Although hepatic metabolism is minimal, transient elevations have been reported. Baseline assessment helps identify pre-existing liver disease.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with differential

Rationale: To establish baseline values and monitor for potential hematologic adverse effects (e.g., eosinophilia, leukopenia, thrombocytopenia) during therapy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Renal function (BUN, serum creatinine)

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

Target: Within normal limits or stable from baseline

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

Liver function tests (ALT, AST)

Frequency: Periodically, if clinically indicated or with prolonged therapy

Target: Within normal limits or stable from baseline

Action Threshold: Significant elevation may warrant discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically, especially with prolonged therapy

Target: Within normal limits

Action Threshold: Significant changes (e.g., leukopenia, thrombocytopenia) may warrant discontinuation.

Signs and symptoms of superinfection (e.g., oral thrush, vaginal candidiasis, *Clostridioides difficile*-associated diarrhea)

Frequency: Daily throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: Development of new infections requires appropriate diagnostic workup and treatment.

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Symptom Monitoring

  • Rash
  • Hives
  • Itching
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, tongue, lips, or eyes
  • Severe diarrhea (watery or bloody)
  • Abdominal pain or cramps
  • Fever
  • Seizures
  • Unusual bleeding or bruising
  • Yellowing of skin or eyes (jaundice)
  • Dark urine

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 major birth defects based on animal data. Use if clearly indicated.
Second Trimester: No specific increased risks identified. Use if clearly indicated.
Third Trimester: No specific increased risks identified. Use if clearly indicated.
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Lactation

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

Infant Risk: Low risk (L2)
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Pediatric Use

Dosing must be carefully calculated based on age, weight, and severity of infection. Neonates and infants have immature renal function, requiring specific dosing adjustments. Close monitoring for adverse effects is important.

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Geriatric Use

Elderly patients are more likely to have decreased renal function, which may necessitate dose adjustment based on creatinine clearance. Monitor renal function closely to prevent accumulation and potential neurotoxicity (e.g., seizures).

Clinical Information

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Clinical Pearls

  • Ceftazidime is a key antibiotic for treating infections caused by *Pseudomonas aeruginosa*, including severe hospital-acquired infections and febrile neutropenia.
  • It has good penetration into various body fluids and tissues, including cerebrospinal fluid when meninges are inflamed, making it suitable for meningitis.
  • Unlike some other cephalosporins, ceftazidime has limited activity against Gram-positive bacteria and anaerobes, so it is often used in combination with other agents if broad-spectrum coverage is needed.
  • Always adjust the dose in patients with renal impairment to prevent drug accumulation and potential neurotoxicity.
  • Patients should be monitored for *Clostridioides difficile*-associated diarrhea (CDAD), which can occur with nearly all antibacterial agents, including ceftazidime.
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Alternative Therapies

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

Average Cost: Highly variable per 1gm vial
Generic Available: Yes
Insurance Coverage: Typically covered by most prescription drug plans, often as a Tier 1 or Tier 2 generic. Brand name may require prior authorization.
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General Drug Facts

If your symptoms or health problems persist or worsen, 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. 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 or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may be aware of local drug take-back programs. Additionally, some medications may have a separate 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 amount, and the time it occurred to ensure prompt and effective treatment.