Best quality of Yashipiptaz is offered by us to patrons across the India. This Yashipiptaz is contains Piperacillin sodium equivalent to 4 grams of Piperacillin and Tazobactum Sodium equivalent to Tazobactum 0.5 grams. it helps to reduce the development of drug-resistant bacteria and sustain the effectiveness. It act as an effective broad spectrum antibacterial agent in injectable antibacterial combination form that consisting of the semisynthetic antibiotic Piperacillin sodium and β-lactam Tazobactam.
| Composition: |
- Each vial contains: piperacillin sodium USP, Eq. to piperacillin
4 g, tazobactam sodium, Eq. to tazobactam 0.5 g
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| Pharmacological classification: |
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| Mechanism of action: |
- Piperacillin, a broad spectrum, semisynthetic penicillin exerts
bactericidal activity by inhibition of both septum and cell wall
synthesis.
- Tazobactam, a beta-lactam structurally related to penicillins, is
an inhibitor of many beta- lactamases, which commonly cause
resistance to penicillins and cephalosporins but it does not inhibit
AmpC enzymes 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.
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| Indications and usage: |
- Yashipiptaz is used in the management of neutropenic patients
with fever suspected to be due to a bacterial infection. Yashipiptaz
is indicated for the treatment of the following infections in adults
and children over 2 years of age
- Adults and adolescents:
- Severe pneumonia including hospital-acquired and
ventilator-associated pneumonia
- Complicated urinary tract infections (including pyelonephritis)
- Complicated intra-abdominal infections
- Complicated skin and soft tissue infections (including diabetic
foot infections)
- Children 2 to 12 years of age: Complicated intra-abdominal infections
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| Dosage and administration: |
- Yashipiptaz is administered by intravenous injection (over 30
minutes). The dose and frequency of Yashipiptaz depends on the
severity and localization of the infection and expected pathogens.
- Adult and adolescent patients:
- For Infections: The usual dose of 4g piperacillin /0.5g
tazobactam is given every eight hours.
- For nosocomial pneumonia & bacterial infections in
neutropenic patients: Recommended dose of 4g piperacillin /0.5g
tazobactam is every six hours. This regimen may also be applicable
to treat patients with other indicated infections when particularly
severe.
- For patients on haemodialysis, one additional dose of
piperacillin/tazobactam 2g/0.25g should be administered following
each dialysis period. No dose adjustment is required for the elderly
with normal renal function or creatinine clearance values above 40
mL/min.
- Children: YASHIPIPTAZ is not recommended for children
below 2 years age.
- Neutropenic children with fever suspected due to bacterial
infections: 80mg
- Piperacillin/10mg tazobactam per kg body weight, every six hours;
not to exceed the maximum 4g /0.5g per dose over 30 minutes.
- Complicated intra-abdominal infections: 100mg
piperacillin/12.5mg tazobactam per kg body weight, every eight
hours; not to exceed the maximum 4g/0.5g per dose over 30 minutes.
- Creatinine Clearance = 50 mg/mL: 70mg piperacillin/8.75mg
tazobactam per kg body weight, every eight hours.
- For children on haemodialysis, one additional dose of 40mg
piperacillin /5mg tazobactam per kg should be administered following
each dialysis period.
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| Contraindications: |
- Yashipiptaz is contraindicated for patients with hypersensitivity
to piperacillin and/or tazobactam or any other
penicillin-antibacterial agent, history of acute severe allergic
reaction to any other beta-lactam active substances (e.g.
cephalosporin, monobactam or carbapenem).
|
| Warnings and precautions: |
- Before initiating therapy with piperacillin/tazobactam, careful
inquiry should be made concerning previous hypersensitivity
reactions to penicillins, other beta-lactam agents (e.g.
cephalosporin, monobactam or carbapenem) and other allergens.
- Serious and occasionally fatal hypersensitivity
(anaphylactic/anaphylactoid including shock) reactions may occur in
patients receiving therapy. These reactions are more likely to occur
in persons with a history of sensitivity to multiple allergens.
Serious hypersensitivity reactions require the discontinuation of
the antibiotic, and may require administration of epinephrine and
other emergency measures.
- Antibiotic-induced pseudomembranous colitis may be manifested by
severe, persistent diarrhoea which may be life-threatening. The
onset of pseudomembranous colitis symptoms may occur during or after
antibacterial treatment. In these cases piperacillin/tazobactam,
should be discontinued.
- Therapy with piperacillin/tazobactam may result in the emergence
of resistant organisms, which might cause super-infections.
- Bleeding manifestations may occur in patients receiving
beta-lactam antibiotics. If bleeding manifestations occur, the
antibiotic should be discontinued and appropriate therapy
instituted.
- Leukopenia and neutropenia may occur, especially during prolonged
therapy. Therefore, periodic assessment of a full blood count should
be performed.
- As with treatment with other penicillins, neurological
complications in the form of convulsions may occur when high doses
are administered, especially in patients with impaired renal
function.
- This medicinal product contains 9.44 mmol (217 mg) of sodium per
vial of powder for solution for infusion. To be taken into account
by patients on a controlled sodium diet.
- Hypokalaemia may occur in patients with low potassium reserves or
those receiving concomitant medicinal products that may lower
potassium levels; periodic electrolyte determinations may be
advisable in such patients.
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| Drug interaction: |
- Non-depolarising muscle relaxants: piperacillin when used
concomitantly with vecuronium due to their similar mechanisms of
action, it is expected that the neuromuscular blockade produced by
any of the non-depolarising muscle relaxants could prolong the
presence of piperacillin.
- Oral anticoagulants: during simultaneous administration
of heparin, oral anticoagulants and other drugs affecting the blood
coagulation system including thrombocyte function, appropriate
coagulation tests should be performed more frequently and monitored
regularly.
- Methotrexate: piperacillin may reduce the excretion of
methotrexate; therefore, serum levels of methotrexate should be
monitored in patients to avoid substance toxicity.
- Probenecid: as with other penicillins, concurrent
administration of probenecid and piperacillin/tazobactam produces a
longer half-life and lower renal clearance for both piperacillin and
tazobactam; unaffecting peak plasma concentrations of either
substance.
- Aminoglycosides: piperacillin, either alone or with
tazobactam, does not significantly alter the pharmacokinetics of
tobramycin in subjects with normal renal function and with mild or
moderate renal impairment. The pharmacokinetics of piperacillin,
tazobactam and the M1 metabolite are not significantly altered by
tobramycin administration. The inactivation of tobramycin and
gentamicin by piperacillin may occur in patients with severe renal
impairment.
- Vancomycin: No pharmacokinetic interactions occur between
piperacillin/ tazobactam and vancomycin.
- Effects on laboratory tests: piperacillin/tazobactam
therapy may lead to false-positive results for urinary glucose by
non-enzymatic methods, urine protein by chemical measurement
methods.
- Protein measurement with dip sticks is not affected. The direct
Coombs test may be positive.
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| Adverse reactions: |
- Adversed reactions may include candidal superinfection,
leucopenia, neutropenia, thrombocytopenia, purpura, epistaxis,
prolonged bleeding time, activated partial thromboplastin time,
prothrombin time; eosinophilia, haemolytic anaemia, agranulocytosis,
positive coombs' direct test, pancytopenia, thrombocythaemia,
anaphylactic/anaphylactoid reaction (including shock), decreased
blood albumin, blood glucose, blood protein total, hypokalaemia,
headache, insomnia, hypotension, phlebitis, thrombophlebitis,
flushing diarrhoea, nausea, vomiting constipation, dyspepsia,
jaundice, stomatitis, abdominal pain, pseudo-membranous colitis,
increased alanine aminotransferase, aspartate aminotransferase,
blood bilirubin, blood creatinine, blood urea, blood alkaline
phosphatase, gamma glutamyltransferase; hepatitis, maculopapular
rash pruritus, urticaria, dermatitis bullous, exanthema
Stevens-Johnson Syndrome, toxic epidermal necrolysis, arthralgia,
myalgia, tubulointerstitial nephritis, renal failure, pyrexia,
injection-site reaction, chills
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| Overdosage: |
- Symptoms include nausea, vomiting, and diarrhoea. In the event of
an overdose, piperacillin/tazobactam treatment should be
discontinued. Treatment should be supportive and symptomatic
according to the patient's clinical presentation. Excessive serum
concentrations of either piperacillin or tazobactam may be reduced
by haemodialysis.
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| Presentation: |
- One vial containing white to off white, highly hygroscopic powder
for injection and 10 mL Water for Injection.
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| Storage: |
- Do not store above 30°C.
- Reconstituted and/or diluted piperacillin/tazobactam 4g/0.5g
Powder for Injection should be used immediately.
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