#tazobactam

Common Brand Names: Zosyn

Therapeutic Class: A penicillinase-resistant extended spectrum penicillin antibiotic

Common Injectable Dosage Forms:

Powder for Injection: 2 g piperacillin/0.25 g tazobactam, 3 g piperacillin/0.375 g tazobactam, and 4 g piperacillin/0.5 g tazobactam in vials and ADD-Vantage; 36 g piperacillin/4.5 g tazobactam in bulk vials *ADD-Vantage is a trademark of Abbott Labs.

Dosage Ranges:

Treatment of infections due to penicillinase-producing, piperacillin-resistant susceptible organisms in infections including appendicitis, peritonitis, skin and skin structure infections, postpartum endometritis or pelvic inflammatory disease, and moderately severe pneumonia: Usual adult dose is 2.25-4.5 g every 6-8 hours for up to 10 days. Maximum of 18 g per day of piperacillin. Dosage for treating appendicitis in children <40 kg is 80-100 mg/kg every 8 hours. Dosage reductions may be necessary in renal impairment (CrCl <40 mL).

Administration and Stability: Dilute with 5 mL of a compatible solution (Sterile Water, NS) per 1 g piperacillin. For intermittent IV infusion, dilute as described above and further dilute in the desired volume (minimum 50 mL). Administer as IV infusion over 30 minutes. Stability of these concentrations is acceptable for 24 hours at room temperature and 7 days if refrigerated. pH 4.5-6.8

Pharmacology/Pharmacokinetics: Piperacillin acts by inhibiting bacterial wall synthesis via acylation of the transpeptidase enzyme. Piperacillin is susceptible to cleavage by beta-lactamase. It is however active against beta-lactamase-producing gonococci. It is active against many anaerobic, Gram-negative, and non-penicillinase producing strains of Gram-positive bacteria. It is particularly useful for Pseudomonas and Klebsiella, as well as certain indole-positive Proteus species. Tazobactam is an inhibitor of beta-lactamase penicillinase. Peak concentration occurs immediately after an IV infusion and in 30 minutes after an IM injection. The plasma half-life of piperacillin is approximately 1 hour. Up to 30% is bound to plasma proteins. Distribution to the meninges occurs during inflammation. Excretion occurs predominantly through the urine by glomerular filtration and tubular secretion.

Drug and Lab Interactions: May inactivate aminoglycosides when mixed in the same solution. TETRACYCLINES may inhibit actions. May potentiate the actions of warfarin or heparin. May cause false-positive urine glucose tests if Clinitest, Benedict’s Solution or Fehling’s Solution is used. Large doses may cause a positive direct antiglobulin test (DAT).

Contraindications/Precautions: Contraindicated in patients hypersensitive to penicillins and/or cephalosporins. Use bacteriologic studies to determine optimum therapy. Severe neurovascular damage occurred after administration of other penicillins so prompt attention must be given to any sign of a compromise of the blood supply distal, proximal, or at the injection site. Use decreased dose in patients with renal impairment. As with all antibiotics, the possibility superinfections should be considered. Pregnancy Category B.

Monitoring Parameters: Cr, BUN, CBC, PT, signs of bleeding.

Adverse Effects: Common adverse effects in order of decreasing incidence: diarrhea, constipation, headache, insomnia, rash, vomiting, dyspepsia, and pruritus. Large doses may cause reversible neurotoxicity or nephrotoxicity. May cause an increase in prothrombin time. If hypersensitivity reactions occur, manifested by urticaria, edema, laryngospasm, bronchospasm, or hypotension, discontinue use and institute supportive treatment.

Introduction

A diabetic foot is a non-healing ulcer due to the presence of diabetes in a patient. [2] The most important and serious foot complications in diabetes are:

a) Ulceration (an estimate shows lifetime incidence of foot ulcers among people affected by diabetes is around 15-25%] “A Diabetic foot ulcer (DFU] affects around 15% of all the people suffering from diabetes along the course of their life and is a major factor in predisposing amputations in almost 15% of all cases [3-6]. b) Neuropathic osteoarthropathy.

These are the significant risk factors for lower extremity amputation. Administration of antimicrobial agents, to which they are sensitive to, is very important part of the management of these patients. “Of all the methods that are proposed for the prevention of DFU, the only beneficial therapy in RCTs was foot temperature-guided avoidance therapy “a meta-analysis shows [7].Treating DFIs with broad spectrum antibiotics is practiced worldwide; however, because of infections with resistant organisms, treating with a narrow spectrum antibiotic may be more appropriate, due to low resistance rates and high bacteriological and clinical cure rates. The fact that antibiotic sensitivity changes with time [8,9], therefore knowledge of common bacteria involved and their current sensitivity pattern will help us not only in providing the best initial empirical therapy but also in preventing the emergence of resistance [10] when taken properly and to prevent long term morbidity. Records of 2013 show that around 382 million people worldwide suffer from diabetes [11]. About 90% of these are type 2 [12,13]. International Diabetes Federation (IDF] in 2014 audited that diabetes resulted in 4.9 million deaths [14]. World Health Organization (WHO] in 2012 estimated that diabetes resulted in 1.5 million deaths, what makes it the 8th leading cause of death [15]. Modeling is used by IDF to estimate the deaths amounting to diabetes [16]. Low and middle-income countries amounted for around 80% deaths due to diabetes [17]. Within this backdrop we propose to study the most common organisms responsible for Diabetic Foot Infection and their sensitivity to antimicrobial agents for the prevention of sepsis/amputation by the administration of empirical treatment.

Material and Methods

This study was carried out at the 3 major Tertiary care hospitals of the province which receives patients from across the province. Convenient sampling technique was used and the sample size was calculated to be 100 using WHO sample size calculator. Patients who were resident of KPK and were admitted to KTH, HMC or LRH for diabetic foot treatment were included in the study and those who refused to participate in the study, patients with documented anatomical abnormalities of lower limbs (based on history and past medical record] and those without a confirm diagnosis of diabetes were excluded from the study. Diabetes was defined as symptoms of diabetes plus random blood sugar ≥ 11.1 mmol/ L or fasting blood sugar ≥ 7mmol/L and/or HbA1c ≥ 6.5% [18]. A semi structured questionnaire was used for this purpose having open-ended as well as close-ended questions. In most cases data was collected by person to person interviews with respondents. Study was conducted after approval from ethical & research committee.

Results

This section revolves around meaningful facts and figures derived computational statistics of our research work. Our sample size was 100 people belonging to different walks of life with different occupations. 58 were males and 42 were females. Marital status: 64 were married, 14 were single, 12 were divorced and 10 were widowed. If we talk about their educational background then 37 were uneducated, 26 studied up to primary, 17 were matriculate and 20 had done higher education. Demographically, out of the 100 there were 24 from Peshawar region, 5 from DI Khan, 6 each from Chitral and Charsadda, 7 from Nowshera, 8 from Kohat, 9 from Bannu, 10 each from Sawabi and Sawat, 15 from FATA.

Occupationally, out of 100 there were 8 who were students, 8 others were self-employed, 10 were unemployed, 38 were employed, 36 were house workers. 87 presented with Type 2 diabetes and 13 presented with Type 1diabetes 90 (Figure 1]. Amputation: 35 had no amputation, 35 with amputation below ankle, 16 with below knee amputation and 14 with above knee amputation (Figures 2&3].

a) The three most frequently found Aerobic bacteria E.coli (19%), Staph. Aureus (9%), Pseudomonas (7%) (Table 1). b) The most frequently found Gram positive bacteria are Staph. Aureus (9%), MRSA (6%). The most common Gram negative bacteria are E.coli (19%), Pseudomonas(7%), and Proteus (4%).

c) Most effective drugs against Gram positive are Cephalosporin's {Generation ll and lll (100%)}, Vancomycin (100%), Imipenem (100%), piperacillin/Tazobactam (100%) (Table 2).i. Cefoperazone/Sulbactam (94.4%) d) Most effective drugs against Gram negative are Cefoperazone/Sulbactam (94.4%), Vancomycin (92.3%), Imipenem (89.4%), and Piperacillin/Tazobactam (89.4%). e) Most effective drugs against MRSA are Vancomycin (100%), Chloramphenicol (100%), Amikacin (100%), and Minocycline (100%). f) Most effective drug against polymicrobial infection is Vancomycin (100%), Chloramphenicol (80%), and amikacin (50%).

Conclusion

a) Staph. Aureus and E.coli are the most common Gram positive and Gram negative organisms, respectively, in KPK. b) Anaerobes are still the most common cause for this infection, although the prevalence is less. c) These ulcers and infections may require use of combined antimicrobial therapy for initial management, repeated dressing and wound debridement may be required. d) This study helps us to choose empirical treatment for patients with diabetic foot infection and also in the management of patient who comes with sepsis that is caused from diabetic foot.

Recommendations

From our study, we can concoct the following recommendations which show us the most common organism involved in the diabetic foot and help us in preventing the amputation and sepsis. Since the most common organism appears to be

E.coli

and it is most sensitive to drugs such as;

i. Cefoperazone/Sulbactam (94.4%) ii. Vancomycin (92.3%) iii. Imipenem (89.4%) iv. piperacillin/Tazobactam (89.4%) a) Therefore, patients presenting with diabetic foot should be directly put on empirical treatment, to prevent further damage to the body and better recovery. b) The patients should be educated to keep their feet clean and healthy. c) The attendants of the patients should be advised to take proper care of their patient. d) The patient should be compelled to check their limbs specially, lower extremities for any ulcers, wounds or cuts. e) Good compliance to therapy will yield positive results and would eradicate the complications before it causes further damage to health.

To read more articles in Journal of Orthopedic & Orthoplastic Surgery

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BPOM Rilis “Safety Alert” Untuk Piperacillin Tunggal dan Kombinasi Tazobactam Terkait DRESS

farmasetika.com – Badan Pengawas Obat Makanan (Badan POM) mengeluarkan “safety alert” atau peringatan keamanan produk obat Piperacillin tunggal atau kombinasi dengan Tazobactam berupa potensi risiko Drug Reaction with Eosinophilia and systernic Symptoms (DRESS) kemarin (23/11/2016).

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