Saptaz

Saptaz

Manufacturer:

Makcur Laboratories

Distributor:

Bell-Kenz Pharma

Marketer:

SRS Pharma Phils
Full Prescribing Info
Contents
Cefepime hydrochloride, tazobactam sodium.
Description
Each combipack contains: Each vial contains: Cefepime Hydrochloride USP eq. to Cefepime 1,000 mg and Tazobactam Sodium eq. to Tazobactam 125 mg.
One 10 mL ampoule of Sterilised Water for Injections BP.
Action
Pharmacology: Cefepime is a fourth-generation cephalosporin and is active against a wide range of Gram-positive and Gram-negative aerobic organisms. Against Gram-positive cocci, its activity is similar to that of other cephalosporin and includes staphylococci (but not methicillin-resistant Staphylococcus aureus) and streptococci.
It is active against Enterobacteriaceae, it has a broader spectrum of activity than other cephalosporins, including activity against organisms producing chromosomally mediated beta-lactamases such as Enterobacter spp. and Proteus vulgaris, Pseudomonas aeruginosa. Tazobactam is a penicillanic acid sulfone derivative with beta-lactamases inhibitory properties. It has the potential to enhance the activity of beta-lactam antibacterials against beta-lactamases-producing bacteria.
Pharmacokinetics: Cefepime is almost completely absorbed following IM administration. In healthy adult males who received single 500 mg, 1 g or 2 g IM doses of cefepime, peak plasma concentrations of the drug were attained within 1.4-1.6 hours and averaged 13.9, 29.6 or 57.5 mcg/mL, respectively; plasma concentrations averaged 1.9, 4.5, or 8.7 mcg/mL, respectively.
Following IV infusion, over 30 minutes of a single 500 mg, 1 g or 2 g dose of cefepime in healthy adult males, peak plasma concentrations of the drug average 31.6-39.1, 65.9-81.7 or 126-163.9 mcg/mL respectively. Following parenteral administration, cefepime is widely distributed into tissues and fluids, including blister fluid, bronchial mucosa, sputum, bile, peritoneal fluid, appendix, gallbladder and prostate. Cefepime is distributed into cerebro-spinal fluid (CSF) following parenteral administration. Cefepime is distributed into human milk. Cefepime is approximately 20% bound to serum proteins.
After a 30 min infusion of 500 mg tazobactam alone, peak blister fluid levels of tazobactam are achieved at 0.94 h & mean maximum level of 6.4 mg/L is achieved. The plasma half-life of cefepime averages 2-2.3 hours.
Cefepime is partially metabolized in vivo to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide). The drug is eliminated principally unchanged in urine by glomerular filtration, 80-82% of a single dose of cefepime is excreted unchanged in urine.
The elimination of tazobactam from plasma is rapid, with a mean half life of 0.35 to 0.67 h, the half-life increasing with dose.
Indications/Uses
Cefepime with Tazobactam is used for the treatment of: Intra-abdominal Infections; Pneumonia; Skin & Skin Structure Infections; Urinary Tract Infections; Empiric Therapy in Febrile Neutropenic Patients.
Dosage/Direction for Use
Route of Administration: For IM & IV use.
For IM Injection: Reconstitute with 2.4 mL of sterile water for injection.
For IV Infusion: Reconstitute with 10 mL of sterile water for injection & added to compatible IV solution (5% Dextrose, 10% Dextrose, 0.9% NaCl Injection & 5% Dextrose and 0.9% Sodium Chloride Injection for further dilution). Cefepime with Tazobactam preferably is administered by IV infusion but also can be given by deep IM injection when indicated.
Cefepime with Tazobactam should be administered intravenously over 30 minutes. The recommended dosage are expressed as Cefepime as per the following.
Intra-abdominal Infections: The usual adult dosage is 2 g given IV every 12 hours for 7-10 days.
Pneumonia: For the treatment of moderate to severe pneumonia caused by Streptococcus pneumoniae (including those with concurrent bacteremia), the usual adult dosage is 1-2 g given IV every 12 hours for 10 days.
For initial therapy of hospital-acquired pneumonia, ventilator-associated pneumonia or health-care associated pneumonia, some clinicians recommend that adults receive dosage of 1-2 g every 8-12 hours.
Skin and Skin Structure Infections: For the treatment of moderate to severe uncomplicated skin and skin structure infections caused by Staphylococcus aureus or Streptococcus pyogenes, the usual adult dosage is 2 g IV every 12 hours for 10 days.
Urinary Tract Infections: For the treatment of mild to moderate uncomplicated or complicated urinary tract infections (including those associated with pyelonephritis and/or with concurrent bacteremia), the usual adult dosage of cefepime is 500 mg-1 g administered IV or IM every 12 hours for 7-10 days.
For the treatment of severe uncomplicated or complicated urinary tract infections (including those associated with pyelonephritis and/or concurrent bacteremia), adults should received 2 g IV every 12 hours for 10 days.
Empiric Therapy in Febrile Neutropenic Patients: For empiric anti-infective therapy in febrile neutropenic patients, adults should receive a dosage of 2 g IV every 8 hours for 7 days or until neutropenia resolves. The need for continued anti-infective therapy in patients whose fever resolves but who remain neutropenic for longer than 7 days should be frequently re-evaluated.
Paediatric Patients (2 months up to 16 years): The maximum dose for paediatric patients should not exceed the recommended adult dose. The usual recommended dosage in paediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given previously.
Renal Impairment: Dosage adjustments necessary in patients with CLcr=60 mL/minute.
Adults with Clcr=60 mL/minute (not undergoing hemodialysis): Give an initial dose using usually recommended adult dosage followed by maintenance dosage based on Clcr. (See Tables 1 and 2.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Adults undergoing hemodialysis: 1 g on the first day of treatment followed by 500 mg every 24 hours for treatment of infections or 1 g on the first day followed by 1 g every 24 hours for empiric therapy in febrile neutropenic patients. Administer the dose at the same time each day (given at completion of procedure on hemodialysis days).
Adults undergoing CAPD: Give usually recommended dose once every 48 hours.
Paediatric patients with renal impairment: Dosage adjustments required proportional to those recommended for adults.
Hepatic Impairment: Dosage adjustments not required.
Overdosage
In case of overdosage treatment should be symptomatic.
Contraindications
Cefepime with Tazobactam is contraindicated in patients who are hypersensitive to the drug or other cephalosporins and should be used with caution in patients with a history of hypersensitivity to penicillins.
Special Precautions
Prior to initiation of cefepime with tazobactam therapy, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins or other drugs.
If a hypersensitivity reaction occurs during cefepime with tazobactam therapy, the drug should be discontinued. Serious acute hypersensitivity reactions may require treatment with Epinephrine and other emergency measures including oxygen, corticosteroids, intravenous fluids, intravenous antihistamines, pressor amines, and airway management, as clinically indicated.
In patients with creatinine clearance less than or equal to 60 mL/min, the dose of cefepime hydrochloride should be adjusted to compensate for the slower rate of renal elimination.
Use In Pregnancy & Lactation
Pregnancy: The drug should be used during pregnancy only when clearly needed.
Lactation: Cefepime is distributed into milk in low concentrations following parenteral administration and the drug should be used with caution in nursing women.
Adverse Reactions
Adverse effect with cefepime and tazobactam are similar to those reported with cefepime alone and generally are transient and mild to moderate in severity.
Adverse event reported for Cefepime are: Incidence equal to or greater than 1%: Local reactions (3.0%), including phlebitis (1.3%), pain and/or inflammation (0.6%)*; rash (1.1%).
Incidence less than 1% but greater than 0.1%: Colitis (including pseudomembranous colitis), diarrhea, fever, headache, nausea, oral moniliasis, pruritus, urticaria, vaginitis, vomiting.
At the higher dose of 2 g every 8 hours, the incidence of probably-related adverse events was higher among the 795 patients who received this dose of cefepime. They consisted of rash (4%), diarrhea (3%), nausea (2%), vomiting (1%), pruritus (1%), fever (1%), and headache (1%).
The following adverse laboratory changes, irrespective of relationship to therapy with cefepime, were reported as: Incidence equal to or greater than 1%: Positive Coombs' test (without hemolysis) (16.2%); decreased phosphorus (2.8%); increased ALT/SGPT (2.8%), AST/SGOT (2.4%), eosinophils (1.7%); abnormal PTT (1.6%), PT (1.4%).
Incidence less than 1% but greater than 0.1%: Increased alkaline phosphatase, BUN, calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calcium*, hematocrit, neutrophils, platelets, WBC.
Postmarketing Experience: The following adverse experiences have been reported during worldwide postmarketing experience (survey) of Cefepime injection.
As with some other drugs in this class, encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures have been reported. Although most cases occurred in patients with renal impairment who received doses of cefepime that exceeded the recommended dosage schedules, some cases of encephalopathy occurred in patients receiving a dosage adjustment for their renal function. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Precautions should be taken to adjust daily dosage in patients with renal insufficiency or other conditions that may compromise renal function to reduce antibiotic concentrations that can lead or contribute to these and other serious adverse events, including renal failure. As with other cephalosporins, anaphylaxis including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia have been reported.
Cephalosporin-class Adverse Reactions: In addition to the adverse reactions listed previously that have been observed in patients treated with cefepime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Stevens-Johnson syndrome, erythematic multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, and pancytopenia.
Drug Interactions
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with cefepime for injection because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
ATC Classification
J01DE - Fourth-generation cephalosporins ; Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj [20 mL (vial) + 10 mL (amp) diluent] 1's.
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