2g/250mg Powder for Injection (IM/IV) Antibacterial

Here’s a detailed overview of Piperacillin + Tazobactam (Tazobet) 2g/250mg Powder for Injection (IM/IV) Antibacterial Vial 1's:

Product Description:

Piperacillin + Tazobactam (Tazobet) is a combination of Piperacillin, a broad-spectrum penicillin antibiotic, and Tazobactam, a β-lactamase inhibitor. The 2g/250mg powder is reconstituted and administered via intravenous (IV) or intramuscular (IM) injection. The combination is designed to combat a wide range of bacterial infections, particularly those caused by Gram-positive, Gram-negative, and anaerobic bacteria.

Piperacillin works by inhibiting the synthesis of bacterial cell walls, while Tazobactam protects Piperacillin from degradation by β-lactamase enzymes produced by some bacteria, thereby extending the range of pathogens that can be effectively treated.

Indications:

Piperacillin + Tazobactam (Tazobet) is indicated for the treatment of a variety of bacterial infections, including:

• Respiratory tract infections, such as:

  • Pneumonia (community-acquired and hospital-acquired)

  • Acute exacerbations of chronic bronchitis

• Urinary tract infections (UTIs), including complicated UTIs.

• Intra-abdominal infections, including conditions like:

  • Peritonitis

  • Intra-abdominal abscesses

• Skin and soft tissue infections, such as cellulitis, wound infections, and diabetic foot infections.

• Gynecological infections, such as pelvic inflammatory disease (PID).

• Sepsis (bacteremia): Bloodstream infections caused by susceptible bacteria.

• Bone and joint infections, such as osteomyelitis.

This combination antibiotic is also used to treat complicated infections where a broad spectrum of activity against various bacteria is needed, including resistant strains like Pseudomonas aeruginosa.

Dosage:

The dosage of Piperacillin + Tazobactam (Tazobet) depends on the severity of the infection, the patient’s clinical condition, and their renal function.

For Adults (General Dosage):

• Typical dose: 2g/250mg every 6-8 hours by IV or IM injection.

• Duration of treatment: Treatment typically lasts from 7 to 14 days, depending on the severity of the infection.

For Severe Infections:

• Higher doses may be given, typically 4g/500mg every 6 hours or as directed by a healthcare provider.

For Renal Impairment:

• Dosing adjustments are required for patients with impaired renal function:

  • Creatinine clearance <40 mL/min: A reduced dose or extended dosing interval is required.

  • Patients with severe renal impairment (e.g., creatinine clearance <10 mL/min) may require a dose adjustment.

For Pediatric Patients:

• The dosing for children depends on weight and the specific infection. Generally, pediatric dosing is based on 80-100 mg/kg/day of Piperacillin in divided doses every 6-8 hours.

Note: Always follow the specific dosing instructions provided by a healthcare provider or as indicated on the prescribing information.

Side Effects:

While Piperacillin + Tazobactam (Tazobet) is generally well tolerated, side effects can occur. These include both common and serious side effects:

Common Side Effects:

• Gastrointestinal symptoms:

  • Diarrhea

  • Nausea

  • Vomiting

  • Abdominal pain

  • Dyspepsia (indigestion)

• Rash or itching, particularly with allergic reactions.

• Injection site reactions, such as pain, redness, or swelling.

Serious Side Effects:

• Allergic reactions: Severe reactions, such as anaphylaxis, with symptoms like difficulty breathing, swelling of the throat, or a severe rash. This requires immediate medical attention.

• Clostridium difficile-associated diarrhea (C. difficile): Antibiotic treatment can lead to overgrowth of C. difficile, causing severe and potentially life-threatening diarrhea.

• Liver damage: Elevated liver enzymes, jaundice (yellowing of the skin or eyes), and hepatitis. Liver function should be monitored during treatment.

• Kidney damage: Acute renal failure can occur, particularly in patients with pre-existing kidney problems or those receiving high doses.

• Hematological reactions: Blood disorders, including thrombocytopenia (low platelet count), leukopenia (low white blood cell count), and anemia (low red blood cell count).

• Severe skin reactions: Stevens-Johnson syndrome (a life-threatening skin condition) and toxic epidermal necrolysis (TEN), though rare.

• Seizures: Rare but may occur in patients with pre-existing kidney disease or in those receiving high doses.

If any serious side effects occur, treatment should be discontinued and medical attention should be sought immediately.

Contraindications:

Piperacillin + Tazobactam (Tazobet) is contraindicated in the following situations:

• Hypersensitivity to Piperacillin, Tazobactam, or any of the excipients in the formulation.

• History of severe allergic reactions to penicillin or cephalosporins (cross-allergy may occur).

• Mononucleosis: Patients with mononucleosis (often caused by the Epstein-Barr virus) should avoid Piperacillin, as they may be more prone to develop rashes.

• Severe renal impairment: In patients with severely impaired kidney function, the drug may accumulate in the body, increasing the risk of toxicity. Dose adjustments are needed for these patients.

• Pregnancy: Category B (FDA): Although animal studies have not shown any harm to the fetus, there is limited data on the use of Piperacillin + Tazobactam in pregnant women. It should only be used during pregnancy if the benefit outweighs the potential risk.

• Breastfeeding: Both Piperacillin and Tazobactam pass into breast milk in small amounts. While generally considered safe for breastfeeding mothers, consult a healthcare provider before use.

Precautions:

• Renal function monitoring: Since Piperacillin and Tazobactam are primarily excreted by the kidneys, kidney function should be monitored during treatment, especially in elderly patients or those with renal impairment.

• Electrolyte imbalance: This medication can affect fluid balance and may require adjustments in patients with electrolyte disturbances.

• Superinfection: Prolonged use of broad-spectrum antibiotics can lead to the development of superinfections (e.g., fungal infections or infections by resistant organisms), which may require alternative treatments.

• Severe diarrhea: If severe diarrhea occurs, particularly during or after treatment, Clostridium difficile should be considered, and appropriate treatment should be initiated.

• Drug interactions: Piperacillin + Tazobactam may interact with other medications, such as blood thinners (e.g., warfarin), other antibiotics, and nephrotoxic drugs. Always inform your healthcare provider of any other medications you are taking.

• Injection site reactions: For IM injections, ensure proper technique to avoid tissue damage and minimize discomfort.

Note: Piperacillin + Tazobactam (Tazobet) should be administered by a healthcare professional, and it is important to complete the full prescribed course of therapy to ensure the infection is fully treated and to prevent antibiotic resistance. If you have any concerns or experience any side effects, consult your healthcare provider immediately.