部份中文Tazocin处方资料（仅供参考）
【中文名稱】特治星
【通作名称】哌拉西林钠/三唑巴坦钠
【英文名稱】Tazocin（piperacillin and tazobactam）
【類別】抗感染藥
【說明】
【別名】呱拉西林-三唑巴坦, 氧呱嗪青黴素-他唑巴坦
【外文名】Piperacillin-Tazobactam, Tazocin, Zosyn
【成分】呱拉西林4g,他佐巴坦鈉鹽Na 500mg.
【適應症】敏感細菌所致的呼吸道感染，泌尿道感染，腹腔內感染，皮膚及軟組織感染，腹腔內感染，皮膚及軟組織感染 ，細菌性敗血症，婦科感染，患中性粒性細胞減少症病人的細菌感染，骨與關節感染。
【用量用法】成人及１２歲以上的青少年4.5g/6-12 hr一次緩慢靜脈注射，靜脈滴注或肌肉注射。治療急性感染，療程至 少在5天以上，並在臨床症狀緩解或體溫恢復後繼酌情減量或延長給藥間隔時間。
【禁忌】對青黴素類，頭孢菌素類藥物或Ｂ－內醯胺酶抑制劑有過敏史的病人。１２歲以下兒童。
【不良反應】過敏反應。胃腸系統症狀。
【注意事項】定期檢查肚、腎功能，造血功能，凝血指標。妊娠和哺乳婦女慎用。
【藥物相互作用】勿與丙磺舒，妥布黴素，氨基糖甙類抗生素，非極化肌松劑合用。
【規格】
注射粉劑4g/500mg x 1瓶。
https://www.medicines.org.uk/emc/medicine/28280
Tazocin (4.5g) Injection
Active ingredient:
Piperacillin 4gm (as piperacillin sodium) and Tazobactam 0.5 g (as tazobactam sodium) per vial
Dosage Form:
sterile Lyophilized Powder for Injection
For Intravenous Use
Therapeutic category:
Antibiotic, Penicillin (antipseudomonal penicillins)/ß-lactamase Inhibitor
What is the medicine prescribed for?
Adult Formulation:
Treatment of moderate-to-severe infections caused by susceptible organisms, including infections of the lower respiratory tract (community-acquired pneumonia, nosocomial pneumonia); urinary tract; uncomplicated and complicated skin and skin structures; gynecologic (endometritis, pelvic inflammatory disease); bone and joint infections; intra-abdominal infections (appendicitis with rupture/abscess, peritonitis); and septicemia. Tazobactam expands activity of piperacillin to include beta-lactamase producing strains of S. aureus, H. influenzae, Bacteroides, and other gram-negative bacteria.
Medicines are sometimes prescribed for purposes other than those listed above. Use only for the condition for which it was prescribed. Do not give this medicine to other people even if they have the same symptoms you have, as it may not be right for them.
How to take medication?
The suitable dosage for each patient should be prescribed by a doctor.
Method of Administration:
Administration: I.V.
Administer by I.V. infusion over 30 minutes. For extended infusion administration (unlabeled dosing), administer over 3-4 hours (Kim 2007; Shea, 2009).
Extended infusion: Extended-infusion strategies have been shown to improve the pharmacodynamics of piperacillin/tazobactam as compared to traditional 30-minute intermittent-infusion regimens (Kim, 2007). For the beta-lactam antibiotics, the time in which unbound drug concentrations remain above the MIC (T>MIC) of an infecting pathogen is the pharmacodynamic parameter that predicts clinical and microbiologic efficacy.
Various strategies aimed at improving the T>MIC include increasing the dose, frequency of dosing, and/or infusion times (including utilizing continuous infusions) (Shea, 2009). However, utilizing a continuous infusion may be impractical as a dedicated intravenous catheter would be required for drug administration. On the other hand, prolonging the length of the infusion to 3-4 hours enhances drug exposure while allowing time for other drugs to be administered through the same intravenous catheter. This approach has the added benefit of lower daily doses than are required by other dose optimization strategies, thereby decreasing drug expenditures. At doses ≥3.375 g every 8 hours, 4-hour infusions of piperacillin/tazobactam achieved excellent target attainment with lower daily doses as compared to standard regimens when MICs were ≤16 μg/mL (Shea, 2009).
Dietary Consideration:
Piperacillin and Tazobactam for injection contains a total of 2.35 mEq (54 mg) of sodium (Na+ ) per gram of piperacillin in the combination product.
Adult Dosage:
Usual dosage range:
Adults: I.V.: 3.375 g every 6 hours or 4.5 g every 6-8 hours; maximum: 18 g/day
Extended infusion method (unlabeled dosing): 3.375-4.5 g I.V. over 4 hours every 8 hours (Kim, 2007; Shea, 2009); an alternative regimen of 4.5 g I.V. over 3 hours every 6 hours has also been described (Kim, 2007)
Indication-specific dosing: I.V.:
>40 kg: refer to Adult dosing
Cystic fibrosis, pseudomonal infections (unlabeled use): 350-450 mg/kg/day in divided doses
Adults:
Diverticulitis, intra-abdominal abscess, peritonitis: I.V.: 3.375 g every 6 hours; Note: Some clinicians use 4.5 g every 8 hours for empiric coverage since the %time>MIC is similar between the regimens for most pathogens; however, this regimen is NOT recommended for nosocomial pneumonia or Pseudomonas coverage.
Intra-abdominal infection, severe: I.V.: 3.375 g every 6 hours for 4-7 days (provided source controlled). Note: Increase to 3.375 g every 4 hours or 4.5 g every 6 hours if P. aeruginosa suspected. Not recommended for mild-to-moderate, community-acquired intra-abdominal infections due to risk of toxicity and the development of resistant organisms (Solomkin, 2010).
Pneumonia (nosocomial): I.V.: 4.5 g every 6 hours for 7-14 days (when used empirically, combination with an aminoglycoside or antipseudomonal fluoroquinolone is recommended; consider discontinuation of additional agent if P. aeruginosa is not isolated)
Severe infections: I.V.: 3.375 g every 6 hours for 7-10 days; Note: Some clinicians use 4.5 g every 8 hours for empiric coverage since the %time>MIC is similar between the regimens for most pathogens; however, this regimen is NOT recommended for nosocomial pneumonia or Pseudomonas coverage.
Children Dosage:
Usual dosage range:
Children: I.V.:
2-8 months: 80 mg of piperacillin component/kg every 8 hours
≥9 months and ≤40 kg: 100 mg of piperacillin component/kg every 8 hours
Indication-specific dosing: I.V.:
Children: Note: Dosing based on piperacillin component:
Appendicitis, peritonitis:
2-8 months: 80 mg/kg every 8 hours
≥9 months and ≤40 kg: 100 mg/kg every 8 hours
>40 kg: refer to Adult dosing
Cystic fibrosis, pseudomonal infections (unlabeled use): 350-450 mg/kg/day in divided doses
How does it work?
Amoxicillin:
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs); which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested. Tazobactam inhibits many beta-lactamases, including staphylococcal penicillinase and Richmond and Sykes types II, III, IV, and V, including extended spectrum enzymes; it has only limited activity against class I beta-lactamases other than class Ic types
Contraindications
Hypersensitivity to penicillins, beta-lactamase inhibitors, or any component of the formulation
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Important safety information
Warnings/Precautions
 Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity, history of sensitivity to multiple allergens, or previous IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria). Use with caution in asthmatic patients.
• Bleeding disorders: Particularly in patients with renal impairment, bleeding disorders have been observed; discontinue if thrombocytopenia or bleeding occurs.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
 Disease-related concerns:
• Cystic fibrosis: An increased frequency of fever and rash has been reported in patients with cystic fibrosis.
• Renal impairment: Use with caution in patients with renal impairment or underdeveloped kidneys; due to sodium load and to the adverse effects of high serum concentrations of penicillins. Dosage adjustment recommended.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal impairment, may increase risk of seizures.
If you miss a dose
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
Pregnancy considerations
Adverse events have not been observed in animal studies; therefore, piperacillin/tazobactam is classified as pregnancy category B. Piperacillin and tazobactam both cross the placenta and are found in the fetal serum, placenta, amniotic fluid, and fetal urine. When used during pregnancy, the clearance and volume of distribution of piperacillin/tazobactam are increased; half-life and AUC are decreased.
Breastfeeding considerations
Although no information is available on the use of piperacillin and tazobactam during breastfeeding, limited information indicates that maternal doses of piperacillin produce low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, disruption of the infant’s gastrointestinal flora, resulting in diarrhea or thrush, has been reported with penicillins, but these effects have not been adequately eva luated. Piperacillin and tazobactam is acceptable to use during breastfeeding.
Low concentrations of piperacillin are excreted in breast milk; information for tazobactam is not available. The manufacturer recommends that caution be exercised when administering piperacillin/tazobactam to nursing women. Other penicillins are considered safe for use during breast-feeding. Nondose-related effects could include modification of bowel flora. When given alone in the early postpartum period, some pharmacokinetic parameters of piperacillin may be altered (refer to Piperacillin monograph for details).
Possible side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Side effects may include:
Very common (≥10%)
>10%: Gastrointestinal: Diarrhea (7% to 11%)
Common (1%-10%)
>1% to 10%:
Cardiovascular: Hypertension (2%)
Central nervous system: Insomnia (7%), headache (8%), fever (2% to 5%), agitation (2%), pain (2%)
Dermatologic: Rash (4%), pruritus (3%)
Gastrointestinal: Constipation (1% to 8%), nausea (7%), vomiting (3% to 4%), dyspepsia (3%), stool changes (2%), abdominal pain (1% to 2%)
Hepatic: Transaminases increased
Local: Local reaction (3%), abscess (2%)
Respiratory: Pharyngitis (2%)
Miscellaneous: Moniliasis (2%), sepsis (2%), infection (2%)
Serious ADR (<1%)
≤1%, postmarketing, and/or case reports: Agranulocytosis, anaphylaxis/anaphylactoid reaction, anemia, anxiety, arrhythmia, arthralgia, atrial fibrillation, back pain, bradycardia, bronchospasm, candidiasis, cardiac arrest, cardiac failure, circulatory failure, chest pain, cholestatic jaundice, confusion, convulsions, coughing, depression, diaphoresis, dizziness, dyspnea, dysuria, edema, epistaxis, erythema multiforme, flatulence, flushing, gastritis, genital pruritus, hallucination, hematuria, hemolytic anemia, hemorrhage, hepatitis, hiccough, hypoglycemia, hypotension, ileus, incontinence, inflammation, injection site reaction, interstitial nephritis, leukorrhea, malaise, mesenteric embolism, myalgia, myocardial infarction, oliguria, pancytopenia, phlebitis, photophobia, pseudomembranous colitis, pulmonary edema, pulmonary embolism, purpura, renal failure, rhinitis, rigors, Stevens-Johnson syndrome, syncope, tachycardia (supraventricular and ventricular), taste perversion, thirst, thrombocytopenia, thrombocytosis, thrombophlebitis, tinnitus, toxic epidermal necrolysis, tremor, ulcerative stomatitis, urinary retention, vaginitis, ventricular fibrillation, vertigo
The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Interaction with other medication
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to ensure that the combination is safe.