Prazitam 4.5

Piperacillin sodium, tazobactam sodium.

Each vial contains: Piperacillin Sodium Eq. to Piperacillin 4 g and Tazobactam Sodium Eq. to Tazobactam 500 mg.

Pharmacology: Pharmacokinetics: Both Piperacillin and Tazobactam are not well absorbed in the GIT but have a good bioavailability after an IM injection. They are both widely distributed into different body compartments but penetration into the meninges of Tazobactam is poor when meninges are inflamed. Tazobactam is metabolized to a single inactive metabolite while Piperacillin is metabolized to the desethyl metabolite, which has minor activity. Approximately 68% and 80% of an administered dose of Piperacillin and Tazobactam, respectively are excreted unchanged in the urine.

For documented multidrug resistant Gram-negative infections due to organisms proven or suspected to be susceptible to Piperacillin/Tazobactam except CNS infections; and for polymicrobial infections (e.g., mixed aerobic and anaerobic infections in which other agents have insufficient activity or are contraindicated due to toxic potential.

Piperacillin/Tazobactam (PRAZITAM) should be administered by intravenous infusion over 30 minutes.
Adults: The usual total daily dose of Piperacillin/Tazobactam is 3.375 g every six hours totaling 13.5 g (12.0 g Piperacillin/1.5 g Tazobactam). Initial presumptive treatment of patients with nosocomial pneumonia should start with (16.0 g Piperacillin/2.0 g Tazobactam). Treatment with aminoglycoside should be continued in patients from whom Pseudomonas aeruginosa is isolated. If Pseudomonas aeruginosa is not isolated, the aminoglycoside may be discontinued at the discretion of the treating physician.
Pediatrics: Piperacillin/Tazobactam (PRAZITAM) can be administered in pediatric patients from 2 months of age. The dosage and indications in pediatric patients with normal renal function are as follows: See Table 1.

Click on icon to see table/diagram/image

Duration of Therapy: The usual duration of Piperacillin/Tazobactam (PRAZITAM) treatment is from seven to ten days. However, the recommended duration of treatment of nosocomial pneumonia is 7 to 14 days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriological progress.
Renal Insufficiency: In patients with renal insufficiency (creatinine clearance < mL/min), the intravenous dose of Piperacillin/Tazobactam (PRAZITAM) should be adjusted to the degree of actual renal function impairment. In patients with nosocomial pneumonia receiving concomitant aminoglycoside therapy, the aminoglycoside dosage should be adjusted according to the recommendation of the manufacturer.
The recommended daily doses of Piperacillin/Tazobactam (PRAZITAM) for patients with renal insufficiency are as follows: Adults: See Table 2.

Click on icon to see table/diagram/image

For patients on haemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since haemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g Piperacillin/Tazobactam (PRAZITAM) should be administered following each dialysis period on haemodialysis days. No additional dosage of Piperacillin/Tazobactam (PRAZITAM) is necessary for CAPD patients.
Pediatrics: There are no dosage recommendation for Piperacillin/Tazobactam in pediatric patients with impaired renal function.

Piperacillin/Tazobactam (PRAZITAM) is contraindicated in patients with a history of allergic reactions to any of the active ingredients, penicillins, cephalosporins, beta-lactamase antibiotics, tetracycline antibiotics, or beta-lactamase inhibitors.

If the patient is pregnant, planning to become pregnant, or is breast-feeding, if the patient is taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement, if the patient has allergies to medicines, food, or other substances, if the patient has cystic fibrosis, bowel inflammation, bleeding problems, congestive heart failure, or kidney problems, if the patient is on dialysis, or if the patient has a history of severe diarrhea or bowel problems due to an antibiotics, and if the patient is on a salt-restricted diet or has low blood potassium levels.

Agitation; constipation; diarrhea; dizziness; headache; indigestion; nausea; pain; swelling or redness at the injection site; sleeplessness; vomiting. Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools;chest pain; decreased urination; depression; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucination; inflammation at the injection site; prolonged muscle relaxation; red, swollen, or blistered skin; seizure; severe diarrhea, vomiting, or stomach pain; shortness of breath; swelling of the hands, ankles, or feet; tremor; unusual tiredness or weakness; vaginal irritation or discharge; vein inflammation or tenderness; yellowing of the eyes or skin.

Aminoglycosides (e.g., tobramycin) or oral contraceptives (birth control pills) because their effectiveness may be decreased by Piperacillin/Tazobactam. Anticoagulants (e.g., warfarin) because their effectiveness may be decreased or the risk of their side effects may be decreased or the risk of their side effects may be increased by Piperacillin/Tazobactam chemotherapy or diuretics (e.g., furosemide, hydrochlorothiazide) because the risk of side effects, such as low blood potassium levels, may be increased. Heparin, methotrexate, or nondepolarizing muscle relaxants (e.g., vecuronium) because the risk of their side effects may be increased by Piperacillin/Tazobactam. Probenecid because may increase the risk of Piperacillin/Tazobactam's side effects Tetracyclines (e.g., doxycycline) because they may decrease Piperacillin/Tazobactam's effectiveness.

Direction for Reconstitution: Dissolve the contents of a vial in 20 mL water for injection. The reconstituted solution should be used immediately after preparation and discard the unused remaining portion. It should not be allowed to freeze.

Store at temperatures not exceeding 30°C.

Penicillins

J01CR05 - piperacillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

Rx