PIPRACILLIN ELSaad -2

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PIPRACILLIN ELSaad -2

Chemical Name:

Piperacillin
Therapeutic Category:

Antimicrobial
Pharmacologic Category:

Antibiotic, Penicillin
Pharmaceutical Form:

Vial
Composition:

Piperacillin 2000mg

Leaflet

PIPRACILLIN ELSaad

For Injection (Vial)

Piperacillin (Sodium)

Broad Spectrum Antibiotic

1-PHARMACOLOGY:

Piperacillin Sodium is an antibiotic which exerts its bactericidal activity by inhibiting both septum and cell wall synthesis. It is active against a variety of gram – positive and gram-negative aerobic and anaerobic bacteria. After I.V. infusion, mean peak serum concentration occurs within two to three minutes, and after I.M. administration it is rapidly absorbed and the mean peak serum concentration occurs approximately 30 minutes after a single dose of 2 g. Piperacillin Sodium is widely distributed in human tissues and body fluids, including bone, prostate, heart, and bile, it is also penetrates into the cerebrospinal fluid in the presence of inflamed meningis. Because Piperacillin Sodium is excreted by the biliary route as well as by the renal route, it can be used safely in appropriate dosage in patients with severely restricted kidney function, and can be used effectively in treatment of hepatobiliary infections.

2-INDICATIONS:

PIPRACILLIN is indicated for the treatment of infections caused by susceptible strains as listed below:

-Intra-abdominal infections including hepatobiliary surgical infections caused by E.coli, pseudomonas aeruginosa, enterococci, clostridium sp., anaerobic cocci, and bacteroides fragilis.

-Urinary tract infections caused by E.coli, klebsiella, pseudomonas aeruginosa, proteus mirabilis, and enterococci.

-Gynecologic infections including endometritis, pelvic inflammatory disease, pelvic cellulitis by bacteroides B fragilis, anaerobic cocci, neisseria gonorrhea and enterococcus faecalis.

-Septicemia including bateremia by E.coli, klebsiella, enterobacter, enterococci serratia, proteus mirabilis, streptococcus pneumonia, pseudomonas aeruginosa, bacteroides and anaerobic cocci.

-Skin and skin structure infectins caused by E . coli, klebsiella, serratia acinetobacter, enterobacter, pseudomonas aeruginosa, proteus mirabilis, bacteroides sp., anaerobic cocci and enterococci.

-Bone and joint infections caused by pseudomonas aeruginosa, enterococci bateroides and anaerobic cocci.

-Gonococcal infections: PIPRACILLIN has been effective in the treatment of uncomplicated gonococcal urethritis.

-Also PIPRACILLIN is particularly useful for the treatment of mixed infections and presumptive therapy prior to the identification of the causative organisms.

- PIPRACILLIN has been successfully used with aminoglycosides , especially in patients with impaired host defenses, and both drug should be used in full therapeutic doses.

-PIPRACILLIN is indicated for prophylactic use in surgery including intra-abdominal gastrointestinal and biliary procedures, vaginal or abdominal hysterectomy, and cesarean section, PIPRACILLIN should be given one-half to one hour before the operation.

3-CONTRA-INDICATIONS:

A history of allergic reactions to any of the penicillins and/or cephalosporins.

4-ADVERSE REACTIONS:

Piperacillin Sodium is well tolerated, and the most common adverse reactions have been local in nature such as erythema, and/or induration at the injection site, diarrhea and loose stools were noted, nausea, hyperbilirubinemia, elevations of plasma creatinine have been reported but rarely. Headache, dizziness,

neutropenia also have been seen.

5-PRECAUTIONS:

Before initiating therapy with Piperacillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins and/or cephalosporins if an allergic reaction occurs the drug must be discontinued and emergency treatment must carried out. Periodic assessment of organ system functions including renal, hepatic, and hematopoietic, during prolonged therapy is advisable.

If higher than recommended doses are given intravenously, neuromuscular excitability may occur. The possibility of hypokalemia should be kept in mind with patients who have low potassium reserves and who are receiving diuretics, therefore periodic electrolyte determinations should be made in these patients.

6-DRUG INTERACTIONS:

The mixing of Piperacillin Sodium with aminoglycoside in vitro can result in substantial inactivation of the aminoglycosides. Piperacillin is reported to prolong the action of vecuronium.

7-PREGNANCY , LACTATION & PEDIATRIC:

PREGNANCY: CATEGORY B.

This drug should be used during pregnancy only if clearly needed, and caution should be exercised when administrated to nursing mothers because it is excreted in low concentration in milk, dosage for children under the age of 12 and neonates have not been established.

8-DOSAGE & ADMINISTRATION:

PIPRACILLIN may be administrated by the I.M. or I.V. route which must be used for serious infections. The maximum daily dose for adults is usually 24g/day, although higher doses have been used. Intramuscular injections should be limited to 2g per injection site, and this route of administration has been used primarily in the treatment of patients with uncomplicated gonorrhea and urinary tract infections.

DOSAGE RECOMMENDATIONS:

Type of infections	Usual total daily dose
Serious infections such as septicemia, nosocomial pneumonia, intra-abdominal aerobic and anaerobic gynecologic infections and skin and soft tissue infections.	12 to 18 g/d I.V. (200 to 300 mg/kg/day) in divided doses every 4 to 6 h.
Complicated urinary tract infections	8 to 16 g/d I.V. (125 to 200 mg/kg/day) in divided doses every 16 to 12 h.
Uncomplicated gonorrhea infections	2g I.M. as a one-time dose *

* One gram of probenecid is given orally one-half hour prior to injection

DOSAGE IN RENAL IMPAIRMENT:

Creatinine Clearance ml/min	Urinary tract infection (uncomplicated)	Urinary tract infection (complicated)	Serious systemic Infection
> 40	No dosage adjustment necessary
20 to 40	No dosage Adjustment necessary	9 g/day 3 g every 8h	12 g/day 4 g every 8h
< 20	6 g/day 3 g every 12 h	6 g/day 3 g every 12h	8 g/day 4 g every 12h

PROPHYLAXIS:

PIPRACILLIN should be administered as a 20 to 30 minutes infusion just prior to anaesthesia while the patient is awake.

Indication	1st dose	2nd dose		3rd dose
Intra-abdominal surgery	2 g I.V. just prior to surgery	2 g during surgery	2 g every 6 h –Pos-surgery for or no more than 24 h
Vaginal hysterectomy	2 g I.V. just prior to surgery	2 g 6 h after 1st dose	2 g 12 h after 1st dose
Cesarean section	2 g I.V. after cord is clamped	2 g 4 h after 1st dose	2 g 8 h after 1st dose
Abdominal hysterectomy	2 g I.V. just prior to surgery	2 g on retum to recovery room	g after 6 h