cefoxitin (Cefoxitin)

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Trade Name: Cefoxitin

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: SAMSON MEDICAL TECHNOLOGIES LLC

Presentation: INJECTION, POWDER, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 100 g/1

Storage and handling

CEFOXITIN SODIUM Cephalosporin Antibacterial [EPC],Cephalosporins [CS]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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PHARMACY BULK PACKAGE u2013u00a0NOT FOR DIRECT INFUSION

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefoxitin for Injection, USP and other antibacterial drugs, Cefoxitin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Cefoxitin for Injection, USP, Pharmacy Bulk Package bag SmartPaku00ae should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPaku00ae should not be used in patients who require less than the 1 gram dose of cefoxitin.
Cefoxitin for Injection, USP is a semi-synthetic, broad-spectrum cepha antibiotic for intravenous administration. It is derived from cephamycinu00a0C, which is produced by . Its chemical name is sodium ()-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate carbamate (ester).
The empirical formula is CHNNaOS, and the structural formula is:
Cefoxitin for Injection contains approximately 53.8 mg (2.3 mEq) of sodium per gram of cefoxitin.
Solutions of Cefoxitin for Injection, USP range from colorless to light amber in color. The pH of freshly constituted solutions usually ranges from 4.2 to 7.0.
BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION USING STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 MG PER ML AND FURTHER DILUTION IN 50 ML OF A COMPATIBLE SOLUTION AND INFUSED INTRAVENOUSLY.
Arrayn- THIS PRODUCT IS NOT INTENDED TO BE USED IN PEDIATRIC AND RENALLY IMPAIRED PATIENTS WHO REQUIRE LESS THAN A 1 GRAM DOSE.
Each SmartPak Pharmacy Bulk Package contains sterile Cefoxitin Sodium, USP equivalent to 100 grams of cefoxitin and is intended for intravenous infusion only.u00a0 A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses.u00a0 The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion.u00a0 FURTHER DILUTION IS REQUIRED BEFORE USE.u00a0 n
Arrayn- CEFOXITIN FOR INJECTION, USP SMARTPAK PHARMACY BULK PACKAGE SHOULD NOT BE USED IN PATIENTS WHO REQUIRE LESS THAN A 1 GRAM DOSE OF CEFOXTIN.
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefoxitin and other antibacterial drugs, Cefoxitin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefoxitin for Injection is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.n

BEFORE THERAPY WITH CEFOXITIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOXITIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFOXITIN OCCURS, DISCONTINUE THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.
Clostridium difficilen- C. difficile
C. difficile
Hypertoxin producing strains of cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary, since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of and surgical evaluation should be instituted as clinically indicated.

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Cefoxitin is generally well tolerated. The most common adverse reactions have been local reactions following intravenous injection. Other adverse reactions have been encountered infrequently.
Arrayn- Local Reactions
Arrayn- Allergic Reactions
Arrayn- Cardiovascula
Arrayn- Gastrointestinal
Arrayn- Neuromuscular
Arrayn- Blood
Arrayn- Liver Function
Arrayn- Renal Function
Cefoxitin for Injection USP, Pharmacy Bulk Package bag, SmartPak should not be used in patients with renal impairment whou00a0n- require less than the 1 gram adult dose of cefoxitin.
Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. As with the cephalosporins, acute renal failure has been reported rarely. The role of cefoxitin in changes in renal function tests is difficult to assess, since factors predisposing to prerenal azotemia or to impaired renal function usually have been present.
In addition to the adverse reactions listed above which have been observed in patients treated with Cefoxitin for Injection, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics:
Urticaria, erythema multiforme, Stevens-Johnson syndrome, serum sickness-like reactions, abdominal pain, colitis, renal dysfunction, toxic nephropathy, false-positive test for urinary glucose, hepatic dysfunction including cholestasis, elevated bilirubin, aplastic anemia, hemorrhage, prolonged prothrombin time, pancytopenia, agranulocytosis, superinfection, vaginitis including vaginal candidiasis.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See .) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

The acute intravenous LD in the adult female mouse and rabbit was about 8 grams/kg and greater than 1 gram/kg, respectively. The acute intraperitoneal LD in the adult rat was greater than 10 grams/kg.

Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak should be used only in patients who require a 1 gram dose and not any fraction thereof.
Cefoxitin for Injection USP, Pharmacy Bulk Package bag SmartPak should not be used in patients who require less than the 1 gram dose of cefoxitin.
THE INTENT OF THIS PHARMACY BULK PACKAGE IS FOR THE PREPARATION OF SOLUTIONS FOR INTRAVENOUS INFUSION ONLY. BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION OF 100 MG/ML AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION.

Cefoxitin for Injection, USP is a dry white to off-white powder available in the following SmartPak Pharmacy Bulk Package:
u00a0u00a0u00a0100 grams*
u00a0u00a0u00a0*Each 100 gram Pharmacy Bulk Package contains sterile cefoxitin sodium equivalent to 100 grams of cefoxitin.
SmartPak system components are not made with natural rubber latex.
Special storage instructions

A prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to determine the efficacy of short-term prophylaxis with cefoxitin in patients undergoing cesarean section who were at high risk for subsequent endometritis because of ruptured membranes. Patients were randomized to receive either three doses of placebo (n=58), a single dose of cefoxitin (2 grams) followed by two doses of placebo (n=64), or a three-dose regimen of cefoxitin (each dose consisting of 2 grams) (n=60), given intravenously, usually beginning at the time of clamping of the umbilical cord, with the second and third doses given 4 and 8 hours post-operatively. Endometritis occurred in 16/58 (27.6%) patients given placebo, 5/63 (7.9%) patients given a single dose of cefoxitin, and 3/58 (5.2%) patients given three doses of cefoxitin. The differences between the two groups treated with cefoxitin and placebo with respect to endometritis were statistically significant (p<0.01) in favor of cefoxitin. The differences between the one-dose and three-dose regimens of cefoxitin were not statistically significant.
Two double-blind, randomized studies compared the efficacy of a single 2u00a0gram intravenous dose of cefoxitin to a single 2u00a0gram intravenous dose of cefotetan in the prevention of surgical site-related infection (major morbidity) and non-site-related infections (minor morbidity) in patients following cesarean section. In the first study, 82/98 (83.7%) patients treated with cefoxitin and 71/95 (74.7%) patients treated with cefotetan experienced no major or minor morbidity. The difference in the outcomes in this study (95% CI: u20130.03, +0.21) was not statistically significant. In the second study, 65/75 (86.7%) patients treated with cefoxitin and 62/76 (81.6%) patients treated with cefotetan experienced no major or minor morbidity. The difference in the outcomes in this study (95% CI: u20130.08, +0.18) was not statistically significant.
In clinical trials of patients with intra-abdominal infections due to group microorganisms, eradication rates at 1 to 2u00a0weeks posttreatment for isolates were in the range of 70% to 80%. Eradication rates for individual species are listed below:u00a0
Smartpak is a registered trademark of Samson Medical Technologies, L.L.C. u2020Registered trademark of Siemens Healthcare Diagnostics Inc.

Revised 09/2019
Printed in USA
u200bC4100b
Manufactured for:Samson Medical Technologies, LLCCherry Hill, NJ 08003

PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Bag Label
NDC 66288-4100-1
Cefoxitin for Injection, USP
100 grams (ONE HUNDRED GRAMS) per Pharmacy Bulk
Package Bag
PHARMACY BULK PACKAGE -
NOT FOR DIRECT INFUSION
FOR INTRAVENOUS USE ONLY
NOT TO BE DISPENSED AS A UNIT
Rx only

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of cefoxitin (Cefoxitin) which is also known as Cefoxitin and Manufactured by SAMSON MEDICAL TECHNOLOGIES LLC. It is available in strength of 100 g/1.

cefoxitin (Cefoxitin) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.