TAZOTER

                          TAZOTER

     Piperacillin and Tazobactam             Injection IP

COMPOSITION:

  Tazoter 2.25gm

  Each vial contain;

  Piperacillin sodium.                          2.0gm

  Tazobactam sodium.                       0.25gm

  Tazoter 4.5gm

   Each vial contain;

   Piperacillin sodium.                          4.0gm  

   Tazobactam sodium.                         0.5gm

 DESCRIPTION:

     Piperacillin-Tazobactam is an injectable antibacterial combination product consisting of the semisynthetic antibiotic piperacillin sodium and the beta-lactamase inhibitor Tazobactam sodium for intravenous administration. Piperacillin sodium exerts bactericidal activity by inhibiting septum formation and cell wall synthesis of susceptible bacteria. In vitro, piperacillin is active against a variety of gram-positive and gram-negative aerobic and anaerobic bacteria. Tazobactam sodium has little clinically relevant in vitro activity against bacteria due to its reduced affinity to piperacillin binding proteins. Tazobactam is a beta-lactamase inhibitor.

PHARMACOLOGICAL ACTION

      Mechanism / Pharmacodynamic:

               Piperacillin exerts bactericidal activity by inhibition of septum and cell wall synthesis. Tazobactum, a beta-lactam   structurally related to penicillin, is an inhibitor of many beta-lactamases, which commonly cause resistance to penicillins and cephalosporins, but it does not inhibit AmpC enzyme or Metallo beta-lactamases. Tazobactam extends the antibiotic spectrum of piperacillin to include many beta-lactamase-producing bacteria that have acquired resistance to piperacillin alone.

          Pharmacokinetic:

                Absorption- The peak piperacillin and tazobactam concentration after 4g/0.5g administered over 30 minutes by intravenous infusion are 298microgram/ml and 34microgram/ml respectively.

               Distribution-Both piperacillin and tazobactam are approximately 30% bound to plasma proteins. The protein binding of either piperacillin or tazobactam is unaffected by the presence of the other compound. Protein binding of tazobactam metabolite is negligible. Piperacillin / Tazobactam is widely distributed in tissues and body fluid including intestinal mucosa, gall bladder, lungs, bile, and bone. Mean tissue concentration is generally 50 to 100% of those in plasma. Distribution into cerebrospinal fluid is low in subjects with non-inflamed meninges, as with other penicillins.

           Biotransformation- Piperacillin is metabolized to a minor microbiologically active desethyl metabolite. Tazobactam is metabolized to a single metabolite that has been found to be microbiologically inactive.

           Elimination- Piperacillin, and Tazobactam are eliminated in the kidney by glomerular filtration and tubular secretion. Piperacillin is excreted rapidly as an unchanged substance, with 68% of the administered dose appearing in the urine. Tazobactam and its metabolite are eliminated primarily by renal excretion, with 80% of the administered dose.

ADVERSE REACTION:

1. The most commonly reported adverse reaction is diarrhea (occurring in 1 patient out of 10)
2.Constipation

3.Nausea

4.Vomiting

5.Heartburn

6.Stomach pain

7.Fever

8.Headache

9.Mouth sores

10. Difficulty falling asleep or staying asleep

11.Rash

12.Itching

13.Hives

14.Difficulty breathing or swallowing

15.wheezing

SPECIAL PRECAUTION:

• Before using piperacillin and tazobactam injection to inform your doctor and pharmacist if you are allergic to piperacillin, tazobactam, cephalosporin antibiotics such as cefaclor, cefadroxil,  cefuroxime and  beta-lactam antibiotics such as penicillin r amoxicillin .
• To inform your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to ta. 
• To inform  your doctor if you have  kidney dise e.
• To inform  your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. 
• if you are having  dental surg y, to inform  the doctor or dentist that you are receiving piperacillin and tazobactam injection.

STORAGE:

    Temperature 15 -30-degree celsius.