DRUGS & SUPPLEMENTS
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PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fucef for Injection, USP and other antibacterial drugs, Fucef for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Fucef for Injection, USP is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:
The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4.
Fucef for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of Fucef activity.
Fucef for Injection, USP in sterile crystalline form is supplied in Pharmacy Bulk Package equivalent to 7.5 g of Fucef as Fucef sodium. Solutions of Fucef for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5.
A pharmacy bulk package is a container of a sterile powder for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE.
Following IV doses of 750 mg and 1.5 g, serum concentrations were approximately 50 and 100 mcg/mL, respectively, at 15 minutes. Therapeutic serum concentrations of approximately 2 mcg/mL or more were maintained for 5.3 hours and 8 hours or more, respectively. There was no evidence of accumulation of Fucef in the serum following IV administration of 1.5 g doses every 8 hours to normal volunteers. The serum half-life after IV injections is approximately 80 minutes.
Approximately 89% of a dose of Fucef is excreted by the kidneys over an 8-hour period, resulting in high urine concentrations.
Intravenous doses of 750 mg and 1.5 g produced urinary levels averaging 1,150 and 2,500 mcg/mL, respectively, during the first 8-hour period.
The concomitant oral administration of probenecid with Fucef slows tubular secretion, decreases renal clearance by approximately 40%, increases the peak serum level by approximately 30%, and increases the serum half-life by approximately 30%. Fucef is detectable in therapeutic concentrations in pleural fluid, joint fluid, bile, sputum, bone and aqueous humor.
Fucef is detectable in therapeutic concentrations in cerebrospinal fluid of adults and pediatric patients with meningitis. The following table shows the concentrations of Fucef achieved in cerebrospinal fluid during multiple dosing of patients with meningitis.
|Patients||Dose||Number of Patients|| |
Mean (Range) CSF Fucef
Within 8 Hours
(4 weeks to 6.5 years)
divided q 6 hours
(7 months to 9 years)
|200 to 230 mg/kg/day, divided q 8 hours||6|| |
|Adults||1.5 grams q 8 hours||2|| |
|Adults||1.5 grams q 6 hours||10|| |
Fucef is approximately 50% bound to serum protein.
Fucef has in vitro activity against a wide range of gram-positive and gram-negative organisms, and it is highly stable in the presence of beta-lactamases of certain gram-negative bacteria. The bactericidal action of Fucef results from inhibition of cell-wall synthesis.
Fucef is usually active against the following organisms in vitro.
Aerobes, Gram-positive: Staphylococcus aureus; Staphylococcus epidermidis; Streptococcus pneumoniae; and Streptococcus pyogenes (and other streptococci). NOTE: Most strains of enterococci, e.g., Enterococcus faecalis (formerly Streptococcus faecalis), are resistant to Fucef. Methicillin-resistant staphylococci and Listeria monocytogenes are resistant to Fucef.
Aerobes, Gram-negative: Citrobacter spp., Enterobacter spp., Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella (Branhamella) catarrhalis (including ampicillin- and cephalothin-resistant strains), Morganella morganii (formerly Proteus morganii), Neisseria gonorrhoeae (including penicillinase- and non-penicillinase-producing strains), Neisseria meningitidis, Proteus mirabilis, Providencia rettgeri (formerly Proteus rettgeri), Salmonella spp., and Shigella spp.
NOTE: Some strains of Morganella morganii, Enterobacter cloacae, and Citrobacter spp. have been shown by in vitro tests to be resistant to Fucef and other cephalosporins. Pseudomonas and Campylobacter spp., Legionella spp., Acinetobacter calcoaceticus, and most strains of Serratia spp. and Proteus vulgaris are resistant to most first- and second-generation cephalosporins.
Anaerobes: Gram-positive and gram-negative cocci (including Peptococcus and Peptostreptococcus spp.), gram-positive bacilli (including Clostridium spp.), and gram-negative bacilli (including Bacteroides and Fusobacterium spp.).
NOTE: Clostridium difficile and most strains of Bacteroides fragilis are resistant to Fucef.
Diffusion Techniques: Quantitative methods that require measurement of zone diameters give an estimate of antibiotic susceptibility. One such standard procedure1 that has been recommended for use with disks to test susceptibility of organisms to Fucef uses the 30 mcg Fucef disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration for Fucef.
A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of “Moderately Susceptible” suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissues and fluids in which high antibiotic levels are attained. A report of “Intermediate” suggests an equivocable or indeterminate result. A report of “Resistant” indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected.
Reports from the laboratory giving results of the standard single-disk susceptibility test for organisms other than Haemophilus spp. and Neisseria gonorrhoeae with a 30 mcg Fucef disk should be interpreted according to the following criteria:
|>20||750 mg-1.5 grams||q8h|
|<10||750 mg||q24h |
When only serum creatinine is available, the following formula2 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
|Males:||clearance (mL/min) =||Weight (kg) x (140 – age)|
|72 x serum creatinine (mg/dL)|
|Females:||0.85 x male value|
NOTE: As with antibiotic therapy in general, administration of Fucef for Injection, USP should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.
Pediatric Patients Above 3 Months of Age: Administration of 50 to 100 mg/kg per day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to Fucef. The higher dosage of 100 mg/kg per day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.
In bone and joint infections, 150 mg/kg per day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of Fucef for Injection, USP.
In cases of bacterial meningitis, a larger dosage of Fucef for Injection, USP is recommended, 200 to 240 mg/kg per day intravenously in divided doses every 6 to 8 hours.
In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.
Pharmacy Bulk Package – Not for Direct Infusion: The pharmacy bulk package is for use in a pharmacy admixture service only under a laminar flow hood. Entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and the contents dispensed in aliquots using aseptic technique, the closure should be penetrated only one time using a suitable sterile dispensing set; which allows measured dispensing of the contents. The use of a syringe and needle is not recommended as it may cause leakage. AFTER INITIAL WITHDRAWAL USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS.
Pharmacy Bulk Package – Not for Direct Infusion: This pharmacy bulk package is designed for use in the pharmacy in preparing admixtures for intravenous infusion only. Use of this product is restricted to a suitable work area, such as a laminar flow hood. The 7.5 grams pharmacy bulk package should be constituted with 77 mL of Sterile Water for Injection; each 8 mL of the resulting solution contains 750 mg of Fucef; 16 mL of solution contains 1.5 grams of Fucef.
THIS PACKAGE IS NOT TO BE DISPENSED AS A UNIT.
After constitution, the intent of this pharmacy bulk package is for the preparation of solutions for IV infusion only.
Intravenous Administration: The IV route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.
For intermittent IV infusion with a Y-type administration set , dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Fucef for Injection, USP, it is advisable to temporarily discontinue administration of any other solutions at the same site.
For continuous IV infusion , a solution of Fucef for Injection, USP may be added to an IV infusion pack containing one of the following fluids: 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; or 1/6 M Sodium Lactate Injection.
Solutions of Fucef for Injection, USP, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.
However, if concurrent therapy with Fucef for Injection, USP and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.
Intravenous: When the 7.5 g pharmacy bulk package is constituted as directed with Sterile Water for Injection the contents should be withdrawn without delay. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. More dilute solutions, such as 750 mg or 1.5 g plus 100 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, also maintain satisfactory potency for 24 hours at room temperature and for 7 days under refrigeration.
These solutions may be further diluted to concentrations of between 1 and 30 mg/mL in the following solutions and will lose not more than 10% activity for 24 hours at room temperature or for at least 7 days under refrigeration: 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; Ringer’s Injection, USP; Lactated Ringer’s Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 10% Dextrose Injection; and 10% Invert Sugar in Water for Injection.
Unused solutions should be discarded after the time periods mentioned above.
Fucef for Injection, USP has also been found compatible for 24 hours at room temperature when admixed in IV infusion with heparin (10 and 50 U/mL) in 0.9% Sodium Chloride Injection and Potassium Chloride (10 and 40 mEq/L) in 0.9% Sodium Chloride Injection. Sodium Bicarbonate Injection, USP is not recommended for the dilution of Fucef for Injection, USP.
Frozen Stability: Constitute the 7.5 g pharmacy bulk package vial as directed for IV administration. Immediately withdraw 8 mL or 16 mL from the 7.5 g pharmacy bulk package vial and add to a minibag containing 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection and freeze. Frozen solutions are stable for 6 months when stored at -20°C. Frozen solutions should be thawed at room temperature and not refrozen. Do not force thaw by immersion in water baths or by microwave irradiation. Thawed solutions may be stored for up to 24 hours at room temperature or for 7 days in a refrigerator.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
As with other cephalosporins, Fucef for Injection, USP powder as well as solutions and suspensions tend to darken, depending on storage conditions, without adversely affecting product potency.
The container may be hung by the attached bail band during dispensing of the contents.
Store Fucef for Injection, USP at 20° to 25°C (68° to 77°F). Protect From Light. Fucef for Injection, USP is a dry, white to off-white powder supplied in vials and infusion packs as follows:
Fucef for Injection, USP. Fucef sodium equivalent to 7.5 grams of Fucef per Pharmacy Bulk Package.
NDC 44567-712-10 7.5 gram vial Pharmacy Bulk Pack (Carton of 10)
Fucef for Injection, USP. Fucef sodium equivalent to 750 mg or 1.5 grams Fucef per vial or infusion pack.
NDC 44567-710-10 750 mg vial (Carton of 10)
NDC 44567-711-10 1.5 gram vial (Carton of 10)
NDC 44567-720-10 750 mg infusion pack (Carton of 10)
NDC 44567-722-10 1.5 gram infusion pack (Carton of 10)
CLINITEST® is a registered trademark of Ames Division, Miles Laboratories, Inc.
WG Critical Care, LLC
Paramus, New Jersey 07652
Revised: October 2012
Depending on the reaction of the Fucef after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fucef not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Fucef addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology