Piptam Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Piperacillin Na 4 g, tazobactam Na 500 mg

Indications/Uses

Systemic &/or local bacterial infections caused by susceptible organisms eg, lower resp tract infections, complicated & uncomplicated UTI, intra-abdominal infections, skin & skin structure infections, gynecological infections including postpartum endometritis & pelvic inflammatory disease, bacterial septicemia. Polymicrobial infections (suspected aerobic & anaerobic organisms). In combination w/ aminoglycoside for the management of neutropenia in adults or childn & against certain Pseudomonas aeruginosa strains. Intra-abdominal infections (including appendicitis complicated by rupture or abscess, peritonitis & biliary infections) in hospitalized childn 2-12 yr.

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Dosage/Direction for Use

IV Administer as slow IV infusion over 30 min or slow IV inj over 3-5 min. Adult & childn >40 kg 4.5 g every 8 hr. Usual treatment duration: 7-10 days. Hospital-acquired pneumonia & bacterial infection Neutropenic patients 4.5 g every 6 hr. Max: 18 g/day. Treatment duration: 7-14 days. Acute infection 10 mg/kg every 6 hr. Max: 4.5 g every 6 hr. Complicated intra-abdominal infections Childn 2-12 yr weighing >40 kg 4.5 g every 8 hr, ≤40 kg 100 mg/12.5 mg/kg every 8 hr. Dose adjustment of piperacillin/tazobactam in renal impairment: Adult w/ CrCl 20-80 mL/min 12 g/1.5 g daily in divided doses of 4.5 g every 8 hr, <20 mL/min 8 g/1 g daily in divided doses of 4.5 g every 12 hr. Adult on hemodialysis Max daily dose: 8 g/1 g. Administer 1 additional dose of 2 g/250 mg following each dialysis period. Childn 2-12 yr w/ CrCl >50 mL/min 112.5 mg/kg every 8 hr. Max: 12 g/1.5 g daily, ≤50 mL/min 78.75 mg/kg every 8 hr. Max: 8.4 g/1.05 g daily. Childn on hemodialysis Administer 40 mg/5 mg/kg following each dialysis period.

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Overdosage

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Contraindications

Hypersensitivity to any β-lactams (including penicillins, cephalosporins & β-lactamase inhibitors) or piperacillin & tazobactam.

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Warnings

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Special Precautions

Discontinue treatment if rash, irritation or swelling; bleeding complications especially in patients w/ renal impairment; superinfections; lesions occur. Periodically evaluate hepatic, renal & hematologic systems during prolonged therapy (≥21 days). Monitor serum electrolytes in patients w/ low K reserves. Patients w/ low K reserves receiving concomitant medications that may lower K levels. Restricted Na intake. Clostridium difficile-associated diarrhea; watery & bloody stools during, or as late as ≥2 mth after the last dose. Not to be used in viral infections. Patients should complete the full course of therapy. Partial cross-allergenicity among penicillin & other β-lactam antibiotic. Leukopenia, neutropenia; neurological complications (convulsions) in high doses. Monitor closely if skin rash develops. May result in false +ve reaction in urinary glucose & Aspergillus test. Renal impairment. Pregnancy & lactation. Elderly w/ renal impairment.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, nausea, constipation, vomiting, dyspepsia, abdominal pain, ulcerative stomatitis & pseudomembranous colitis (antibiotic associated diarrhea); rash (maculopapular, bullous, urticaria), pruritus, hypersensitivity reaction, anaphylaxis, erythema multiforme, acute generalized exanthematous pustulosis, SJS, TEN & DRESS; decreased Hb & hematocrit, thrombocytopenia, increased platelet count, transient eosinophilia & leukopenia, neutropenia, agranulocytosis, prolonged prothrombin time & partial thromboplastin time; headache, insomnia, dizziness, anxiety, tremor, seizures, vertigo & confusion; increased serum conc of creatinine & BUN, proteinuria, intestinal nephritis, renal failure & hypokalemia; increased AST (SGOT), ALT (SGPT), alkaline phosphatase & bilirubin; arthralgia & myalgia; candidiasis; phlebitis, pain, inflammation, thrombophlebitis & edema; fever, hypotension, chest pain, hypoglycemia, flushing & back pain.

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Drug Interactions

Prolonged neuromuscular blockade w/ vecuronium. Prolonged t_½ & low renal clearance w/ probenecid. May decrease renal clearance of MTX. May alter serum conc of aminoglycoside in patients w/ ESRD requiring hemodialysis. Concomitant use w/ high doses of heparin, oral anticoagulants, or other drugs that affect blood coagulant or thrombocyte function. May increase risk of nephrotoxicity induced by vancomycin.

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Storage

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Description

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Action

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MIMS Class

Penicillins

ATC Classification

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

Thai FDA Category

Presentation/Packing

Form

Piptam powd for inj 4.5 g

Packing/Price

1's

Piptam

piperacillin + tazobactam

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical