Epocelin

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Epocelin uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• References
• Epocelin reviews

Indications and Usage

Epocelin (ceftizoxime for injection, USP) is indicated in the treatment of infections due to susceptible strains of the microorganisms listed below.

Lower Respiratory Tract Infections caused by Klebsiella spp.; Proteus mirabilis; Escherichia coli; Haemophilus influenzae including ampicillin­resistant strains; Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); Serratia spp.; Enterobacter spp.; Bacteroides spp.; and Streptococcus spp. including S. pneumoniae, but excluding enterococci. Urinary Tract Infections caused by Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); Escherichia coli; Pseudomonas spp. including P.aeruginosa; Proteus mirabilis; P. vulgaris; Providencia rettgeri (formerly Proteus rettgeri) and Morganella morganii (formerly Proteus morganii); Klebsiella spp.; Serratia spp. including S. marcescens; and Enterobacter spp. Gonorrhea including uncomplicated cervical and urethral gonorrhea caused by Neisseria gonorrhoeae.Pelvic Inflammatory Disease caused by Neisseria gonorrhoeae, Escherichia coli or Streptococcus agalactiae. NOTE: Ceftizoxime, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti­chlamydial coverage should be added. Intra­Abdominal Infections caused by Escherichia coli; Staphylococcusepidermidis; Streptococcus spp. (excluding enterococci); Enterobacter spp.; Klebsiella spp.; Bacteroides spp. including B. fragilis; and anaerobic cocci, including Peptococcus spp. and Peptostreptococcus spp. Septicemia caused by Streptococcus spp. including S. pneumoniae (but excluding enterococci); Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); Escherichia coli; Bacteroides spp. including B. fragilis; Klebsiella spp.; and Serratia spp. Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); Staphylococcus epidermidis; Escherichia coli; Klebsiella spp.; Streptococcus spp. including Streptococcus pyogenes (but excluding enterococci); Proteus mirabilis; Serratia spp.; Enterobacter spp.; Bacteroides spp. including B. fragilis; and anaerobic cocci, including Peptococcus spp. and Peptostreptococcus spp. Bone and Joint Infections caused by Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); Streptococcus spp. (excluding enterococci); Proteusmirabilis; Bacteroides spp.; and anaerobic cocci, including Peptococcus spp. and Peptostreptococcus spp. Meningitis caused by Haemophilus influenzae. Epocelin has also been used successfully in the treatment of a limited number of pediatric and adult cases of meningitis caused by Streptococcus pneumoniae.Cefizox has been effective in the treatment of seriously ill, compromised patients, including those who were debilitated, immunosuppressed, or neutropenic. Infections caused by aerobic gram­negative and by mixtures of organisms resistant to other cephalosporins, aminoglycosides, or penicillins have responded to treatment with Epocelin. Because of the serious nature of some urinary tract infections due to P. aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Epocelin, higher dosage is recommended. Other therapy should be instituted if the response is not prompt. Susceptibility studies on specimens obtained prior to therapy should be used to determine the response of causative organisms to Epocelin. Therapy with Epocelin may be initiated pending results of the studies; however, treatment should be adjusted according to study findings. In serious infections, Epocelin has been used concomitantly with aminoglycosides. Before using Epocelin concomitantly with other antibiotics, the prescribing information for those agents should be reviewed for contraindications, warnings, precautions, and adverse reactions. Renal function should be carefully monitored. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Epocelin and other antibacterial drugs, Epocelin 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.

CONTRAINDICATIONS

Epocelin (ceftizoxime for injection, USP) is contraindicated in patients who have known allergy to the drug.

WARNINGS

BEFORE THERAPY WITH Epocelin IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Epocelin, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN­SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG BETA­LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO Epocelin OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ceftizoxime, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic­associated” colitis. After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Precautions

General

As with all broad­spectrum antibiotics, Epocelin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Although Epocelin has not been shown to produce an alteration in renal function, renal status should be evaluated, especially in seriously ill patients receiving maximum dose therapy. As with any antibiotic, prolonged use may result in overgrowth of nonsusceptible organisms. Careful observation is essential; appropriate measures should be taken if superinfection occurs. Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated. Prescribing Epocelin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Drug Interactions

Although the occurrence has not been reported with Epocelin, nephrotoxicity has been reported following concomitant administration of other cephalosporins and aminoglycosides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long­term studies in animals to evaluate the carcinogenic potential of ceftizoxime have not been conducted.

In an in vitro bacterial cell assay, there was no evidence of mutagenicity at ceftizoxime concentrations of 0.001­0.5 mcg/plate. Ceftizoxime did not produce increases in micronuclei in the in vivo mouse micronucleus test when given to animals at doses up to 7500 mg/kg, approximately six times greater than the maximum human daily dose on a mg/M² basis. Ceftizoxime had no effect on fertility when administered subcutaneously to rats at daily doses of up to 1000 mg/kg/day, approximately two times the maximum human daily dose on a mg/M² basis. Ceftizoxime produced no histological changes in the sexual organs of male and female dogs when given intravenously for thirteen weeks at a dose of 1000 mg/kg/day, approximately five times greater than the maximum human daily dose on a mg/M² basis.

Pregnancy

Teratogenic Effects: Pregnancy Category B.

Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to Epocelin. There are, however, no adequate and well­controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human effects, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Safety of Epocelin use during labor and delivery has not been established.

Nursing Mothers

Epocelin is excreted in human milk in low concentrations. Caution should be exercised when Epocelin is administered to a nursing woman.

Pediatric Use

Safety and efficacy in pediatric patients from birth to six months of age have not been established. In pediatric patients six months of age and older, treatment with Epocelin has been associated with transient elevated levels of eosinophils, AST, ALT (SGPT), and CPK (creatine phosphokinase). The CPK elevation may be related to IM administration.

The potential for the toxic effect in pediatric patients from chemicals that may leach from the single­dose IV preparation in plastic has not been determined.

Geriatric Use

Clinical studies of ceftizoxime did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Information for Patients

Patients should be counseled that antibacterial drugs including Epocelin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Epocelin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Epocelin or other antibacterial drugs in the future.

ADVERSE REACTIONS

Epocelin^® (ceftizoxime for injection, USP) is generally well tolerated. The most frequent adverse reactions (greater than 1% but less than 5%) are:

Hypersensitivity--Rash, pruritus, fever. Hepatic--Transient elevation in AST (SGOT), ALT (SGPT), and alkaline phosphatase. Hematologic--Transient eosinophilia, thrombocytosis. Some individuals have developed a positive Coombs test. Local--Injection site--Burning, cellulitis, phlebitis with IV administration, pain, induration, tenderness, paresthesia. The less frequent adverse reactions (less than 1%) are:Hypersensitivity--Numbness and anaphylaxis have been reported rarely. Hepatic--Elevation of bilirubin has been reported rarely. Renal--Transient elevations of BUN and creatinine have been occasionally observed with Epocelin. Hematologic--Anemia, including hemolytic anemia with occasional fatal outcome, leukopenia, neutropenia, and thrombocytopenia have been reported rarely. Urogenital--Vaginitis has occurred rarely. Gastrointestinal--Diarrhea; nausea and vomiting have been reported occasionally. Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment (see WARNINGS).In addition to the adverse reactions listed above which have been observed in patients treated with ceftizoxime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin­class antibiotics:Stevens­Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, serum­sickness like reaction, toxic nephropathy, aplastic anemia, hemorrhage, prolonged prothrombin time, elevated LDH, pancytopenia, and agranulocytosis. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION.) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

DOSAGE AND ADMINISTRATION

The usual adult dosage is 1 or 2 grams of Epocelin every 8 to 12 hours. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organisms.

Type of Infection	Daily Dose(Grams)	Frequencyand Route
Uncomplicated Urinary Tract	1	500 mg q12h IM or IV
Other Sites	2-3	1 gram q8-12h IM or IV
Severe or Refractory	3-6	1 gram q8h IM or IV2 grams q8-12h IMWhen administering 2 gram IM doses, the dose should be divided and given in different large muscle masses. or IV
PIDIf C. trachomatis is a suspected pathogen, appropriate anti­chlamydial coverage should be added, because ceftizoxime has no activity against this organism.	6	2 grams q8h IV
Life-Threatening In life­threatening infections, dosages up to 2 grams every 4 hours have been given.	9-12	3-4 grams q8h IV

______________________________________________________________________________

Because of the serious nature of urinary tract infections due to P. aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Epocelin, higher dosage is recommended. Other therapy should be instituted if the response is not prompt. A single, 1 gram IM dose is the usual dose for treatment of uncomplicated gonorrhea. The IV route may be preferable for patients with bacterial septicemia, localized parenchymal abscesses (such as intra­abdominal abscess), peritonitis, or other severe or life­threatening infections. In those with normal renal function, the IV dosage for such infections is 2 to 12 grams of Epocelin (ceftizoxime for injection, USP) daily. In conditions such as bacterial septicemia, 6 to 12 grams/day may be given initially by the IV route for several days, and the dosage may then be gradually reduced according to clinical response and laboratory findings.

	Unit Dose	Frequency
Pediatric patients 6 months or older	50 mg/kg	q6-8h

Dosage may be increased to a total daily dose of 200 mg/kg (not to exceed the maximum adult dose for serious infection).

Impaired Renal Function

Modification of Epocelin dosage is necessary in patients with impaired renal function. Following an initial loading dose of 500 mg-1 gram IM or IV, the maintenance dosing schedule shown below should be followed. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organisms.

When only the serum creatinine level is available, creatinine clearance may be calculated from the following formula. The serum creatinine level should represent current renal function at the steady state. Males     Clcr =Weight (kg) x (140 ­ age)                  72 x serum creatinine                  (mg/100 mL)Females are 0.85 of the calculated clearance values for males. In patients undergoing hemodialysis, no additional supplemental dosing is required following hemodialysis; however, dosing should be timed so that the patient receives the dose (according to the table below) at the end of the dialysis.

Creatinine Clearance mL/min	Renal Function	Less Severe Infections	Life-Threatening Infections
79-50	Mild Impairment	500 mg q8h	0.75-1.5 gramsq8h
49-5	Moderate to severeimpairment	250-500 mgq12h	0.5-1 gramq12h
4-0	Dialysis Patients	500 mg q48hor250 mg q24h	0.5-1 gramq48hor0.5 gram q24h

Preparation of Parenteral Solution

RECONSTITUTION

IM Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.

Vial Size	Diluent to Be Added	Approx. Avail. Vol.	Approx. Avg. Concentration	Room Temp. Stability
500 mg	1.5 mL	1.8 mL	280 mg/mL	16 hours
1 gram	3.0 mL	3.7 mL	270 mg/mL	16 hours
2 gramsWhen administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.	6.0 mL	7.4 mL	270 mg/mL	16 hours

IV Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.

Vial Size	Diluent to Be Added	Approx. Avail. Vol.	Approx. Avg. Concentration	Room Temp. Stability
500 mg	5 mL	5.3 mL	95 mg/mL	24 hours
1 gram	10 mL	10.7 mL	95 mg/mL	24 hours
2 grams	20 mL	21.4 mL	95 mg/mL	24 hours

These solutions of Epocelin are stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).

Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, then the drug solution should be discarded. Reconstituted solutions may range from yellow to amber without changes in potency. Piggyback Vials: Reconstitute with 50 to 100 mL of Sodium Chloride Injection or any other IV solution listed below. SHAKE WELL.Administer with primary IV fluids, as a single dose. These Piggyback vial solutions of Epocelin are stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).A solution of 1 gram Epocelin in 13 mL Sterile Water for Injection is isotonic. IM InjectionInject well within the body of a relatively large muscle. Aspiration is necessary to avoid inadvertent injection into a blood vessel. When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses. IV AdministrationDirect (bolus) injection, slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids. Intermittent or continuous infusion, dilute reconstituted Epocelin in 50 to 100 mL of one of the following solutions:

• Sodium Chloride Injection
• 5% or 10% Dextrose Injection
• 5% Dextrose and 0.9%, 0.45%, or 0.2% Sodium Chloride Injection
• Ringer’s Injection
• Lactated Ringer’s Injection
• Invert Sugar 10% in Sterile Water for Injection
• 5% Sodium Bicarbonate in Sterile Water for Injection
• 5% Dextrose in Lactated Ringer’s Injection (only when reconstituted with 4% Sodium Bicarbonate Injection)

In these fluids, Epocelin is stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).

HOW SUPPLIED

Epocelin^® (ceftizoxime for injection, USP)

NDC 0469­7250­01     Product No. 725001           Equivalent to 500 mg ceftizoxime in 10 mL, single­dose, flip­top vials, individually packagedNDC 0469­7251­01     Product No. 725101            Equivalent to 1 gram ceftizoxime in 20 mL, single­dose, flip­top vials, individually packagedNDC 0469­7252­01     Product No. 725201          Equivalent to 1 gram ceftizoxime in 100 mL, single­dose, Piggyback, flip­top vials, packaged in tensNDC 0469­7253­02     Product No. 725302         Equivalent to 2 grams ceftizoxime in 20 mL, single­dose, flip­top vials, individually packagedNDC 0469­7254­02     Product No. 725402          Equivalent to 2 grams ceftizoxime in 100 mL, single­dose, Piggyback, flip­top vials, packaged in tensUnreconstituted Epocelin should be protected from excessive light, and stored at controlled room temperature (59º­86ºF) in the original package until used.Rx only

REFERENCES

• National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January 2000.
• National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests – Seventh Edition. Approved Standard NCCLS Document M2-A7, Vol. 20, No. 1, NCCLS, Wayne, PA, January 2000.
• National Committee for Clinical Laboratory Standards. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – Fourth Edition. Approved Standard NCCLS Document M11-A4, Vol. 17, No. 22, NCCLS, Wayne, PA, December 1997.
• National Committee for Clinical Laboratory Standards. MIC Testing Supplemental Tables. NCCLS Document M100-S10 (M7), NCCLS, Wayne, PA, January 2000.

Product of Japan

Manufactured for:Fujisawa Healthcare, Inc.Deerfield, IL 60015-2548

Epocelin pharmaceutical active ingredients containing related brand and generic drugs:

• Ceftizoxime Sodium

Epocelin available forms, composition, doses:

• Injectable; Injection; Ceftizoxime Sodium 1 g

Epocelin destination | category:

• Human:
• Cephalosporins third-generation

Epocelin Anatomical Therapeutic Chemical codes:

• J01DD07 - Ceftizoxime

Epocelin pharmaceutical companies:

• BJC Trading
• CEPA Schwartz Pharma
• Fujisawa
• Orion Pharma

References

1. Dailymed."CEFIZOX (CEFTIZOXIME SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FUJISAWA HEALTHCARE, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. "ceftizoxime". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
3. "ceftizoxime". http://www.drugbank.ca/drugs/DB0133... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Epocelin?

Depending on the reaction of the Epocelin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Epocelin 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 Epocelin 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.

Review

sdrugs.com conducted a study on Epocelin, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Epocelin consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology