DRUGS & SUPPLEMENTS

Pozineg

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Pozineg uses


1 INDICATIONS AND USAGE

Pozineg for Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms:

  • Pneumonia.
  • Empiric therapy for febrile neutropenic patients. (1.2)
  • Uncomplicated and complicated urinary tract infections (including pyelonephritis). (1.3)
  • Uncomplicated skin and skin structure infections. (1.4)
  • Complicated intra-abdominal infections (used in combination with metronidazole) in adults. (1.5)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Pozineg for Injection and other antibacterial drugs, Pozineg for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)

1.1 Pneumonia

Pozineg for Injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.

1.2 Empiric Therapy for Febrile Neutropenic Patients

Pozineg as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection, antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of Pozineg monotherapy in such patients [see Clinical Studies (14.1)].

1.3 Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis)

Pozineg is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these bacteria.

1.4 Uncomplicated Skin and Skin Structure Infections

Pozineg is indicated in the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus or Streptococcus pyogenes.

1.5 Complicated Intra-abdominal Infections (used in combination with metronidazole)

Pozineg is indicated in the treatment of complicated intra-abdominal infections (used in combination with metronidazole) in adults caused by susceptible isolates of Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis [see Clinical Studies (14.2)].

1.6 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Pozineg for Injection and other antibacterial drugs, Pozineg for Injection should be used only to treat 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.

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2 DOSAGE AND ADMINISTRATION

§For Pseudomonas aeruginosa, use 2 g IV every 8 hours.

*Or until resolution of neutropenia. (2.1)

**Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli. (2.1)


Recommended Dosage in Adults with Creatinine Clearance (CrCL)

Greater Than 60 mL/min (2.1)


Site and Type of Infection


Dose


Frequency


Duration (days)


Moderate to Severe Pneumonia§


1to2 g IV


Every 8to12 hours


10


Empiric Therapy for Febrile Neutropenic Patients


2 g IV


Every 8 hours


7*


Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections


0.5to1 g IV/IM**


Every 12 hours


7to10


Severe Uncomplicated or Complicated Urinary Tract Infections


2 g IV


Every 12 hours


10


Moderate to Severe Uncomplicated Skin and Skin Structure Infections


2 g IV


Every 12 hours


10


Complicated Intra-abdominal Infections§ (used in combination with metronidazole)


2 g IV


Every 12 hours


7to10


Pediatric Patients (2 months to 16 years)

Recommended dosage in pediatric with CrCL greater than 60 mL/min. (2.2)

  • The usual recommended dosage in pediatric patients is 50 mg per kg per dose administered every 12 hours (every 8 hours for febrile neutropenia). (2.2)
  • Patients with Renal Impairment: Adjust dose in patients with CrCL less than or equal to 60 mL/min. (2.3)

2.1 Dosage for Adults

The recommended adult dosages and routes of administration are outlined in Table 1 below for patients with creatinine clearance greater than 60 mL/min. Administer Pozineg for Injection intravenously over approximately 30 minutes.

*or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently.

**Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli.

§For P. aeruginosa, use 2 g IV every 8 hours.


Site and Type of Infection


Dose


Frequency


Duration

(days)


Adults


Intravenous (IV)/Intramuscular (IM)



Moderate to Severe Pneumonia§


1 to 2 g IV


Every 8 to 12 hours


10


Empiric therapy for febrile neutropenic patients


2 g IV


Every 8 hours


7*


Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis


0.5 to 1 g

IV/IM**


Every 12 hours


7 to 10


Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis


2 g IV


Every 12 hours


10


Moderate to Severe Uncomplicated Skin and Skin Structure Infections


2 g IV


Every 12 hours


10


Complicated Intra-abdominal Infections§ (used in combination with metronidazole)


2 g IV


Every 8 to 12 hours


7 to 10

2.2 Pediatric Patients

The maximum dose for pediatric patients should not exceed the recommended adult dose.

The usual recommended dosage in pediatric patients up to 40 kg in weight for durations as given above for adults is:

  • 50 mg per kg per dose, administered every 12 hours for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia.
  • For moderate to severe pneumonia due to P. aeruginosa give 50 mg per kg per dose, every 8 hours.
  • 50 mg per kg per dose, every 8 hours for febrile neutropenic patients.

2.3 Dosage Adjustments in Patients with Renal Impairment

Adult Patients

Adjust the dose of Pozineg for injection in patients with creatinine clearance less than or equal to 60 mL/min to compensate for the slower rate of renal elimination. In these patients, the recommended initial dose of Pozineg for injection should be the same as in patients with CrCL greater than 60 mL/min except in patients undergoing hemodialysis. The recommended doses of Pozineg for injection in patients with renal impairment are presented in Table 2.

When only serum creatinine is available, the following formula 4 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:


Males: Creatinine Clearance (mL/min) =


Weight (kg) x (140 – age)


72 × serum creatinine (mg/dL)


Females: 0.85 × above value


Creatinine

Clearance (mL/min)


Recommended Maintenance Schedule


Greater than 60


500 mg every 12 hours


1 g every 12 hours


2 g every 12 hours


2 g every

8 hours


30 to 60


500 mg

every 24 hours


1 g

every 24 hours


2 g

every 24 hours


2 g

every 12 hours


11 to 29


500 mg

every 24 hours


500 mg

every 24 hours


1 g

every 24 hours


2 g

every 24 hours


Less than 11


250 mg

every 24 hours


250 mg

every 24 hours


500 mg

every 24 hours


1 g

every 24 hours


Continuous Ambulatory Peritoneal Dialysis (CAPD)


500 mg

every 48 hours


1 g

every 48 hours


2 g

every 48 hours


2 g

every 48 hours


HemodialysisOn hemodialysis days, Pozineg should be administered following hemodialysis. Whenever possible, Pozineg should be administered at the same time each day.


1 g on day 1, then 500 mg every 24 hours thereafter


1 g

every 24 hours


In patients undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD), Pozineg for injection may be administered at the recommended doses at a dosage interval of every 48 hours.

In patients undergoing hemodialysis, approximately 68% of the total amount of Pozineg present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of Pozineg for injection for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours.

Pozineg for Injection should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days.

Pediatric Patients

Data in pediatric patients with impaired renal function are not available; however, since Pozineg pharmacokinetics are similar in adults and pediatric patients [see Clinical Pharmacology (12.3)], changes in the dosing regimen proportional to those in adults are recommended for pediatric patients.

2.4 Preparation of Pozineg for Intravenous Infusion

Vials

  • Constitute the 0.5 gram, 1 gram, or 2 grams vial, of Pozineg with the one of the following diluents:
    • Sterile Water for Injection
    • 0.9% Sodium Chloride Injection
    • 5% Dextrose Injection
    • 0.5% or 1% Lidocaine Hydrochloride Injection
    • Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol
  • Dilute reconstituted solution with one of the following compatible infusion solutions prior to intravenous infusion (Refer to Table 3 below for the amount of diluent to be added to each vial):
    • 0.9% Sodium Chloride Injection
    • 5% and 10% Dextrose Injection
    • M/6 Sodium Lactate Injection
    • 5% Dextrose and 0.9% sodium Chloride Injection
    • Lactated Rings and 5% Dextrose Injection
    • Normosol -R and Normosol -M in 5% Dextrose Injection
  • Parenteral drugs should be inspected visually for particulate matter before administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.
  • Administer the resulting intravenous infusion over approximately 30 minutes.
  • Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing Pozineg, it is desirable to discontinue the other solution.

2.5 Preparation for Intramuscular Administration

Constitute Pozineg for injection vials 0.5 gram, 1 gram and 2 grams with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1% Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol. Refer to Table 3 below for the amount of diluent to be added to each vial.

Parenteral drugs should be inspected visually for particulate matter before administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.


Single-Dose Vials for Intravenous /Intramuscular (IM)Administration


Amount of Diluent

to be added (mL)


Approximate Available Volume (mL)


Approximate Pozineg Concentration

(mg/mL)


Pozineg vial content


500 mg (IV)


5


5.6


100


500 mg (IM)


1.3


1.8


280


1 g (IV)


10


11.3


100


1 g (IM)


2.4


3.6


280


2 g (IV)


10


12.5


160

2.6 Compatibility and Stability

Intravenous Pozineg for Injection

Intravenous Infusion Compatibility

Pozineg for Injection vials are compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection, Normosol -R, and Normosol -M in 5% Dextrose Injection. These solutions may be stored up to 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) or 7 days in a refrigerator 2°C to 8°C (36°F to 46°F).

Admixture Compatibility

Pozineg for Injection admixture compatibility information is summarized in Table 4.

NS = 0.9% Sodium Chloride Injection.

D5W = 5% Dextrose Injection.

na = not applicable.

RT/L = Ambient room temperature and light.


Stability Time for


Pozineg Concentration


Admixture and Concentration


Intravenous (IV) Infusion

Solutions


RT/L

(20° to 25°C)


Refrigeration

(2° to 8°C)


40 mg/mL


Amikacin

6 mg/mL


NS or D5W


24 hours


7 days


40 mg/mL


Ampicillin

1 mg/mL


D5W


8 hours


8 hours


40 mg/mL


Ampicillin

10 mg/mL


D5W


2 hours


8 hours


40 mg/mL


Ampicillin

1 mg/mL


NS


24 hours


48 hours


40 mg/mL


Ampicillin

10 mg/mL


NS


8 hours


48 hours


4 mg/mL


Ampicillin

40 mg/mL


NS


8 hours


8 hours


4 to 40 mg/mL


Clindamycin

Phosphate

0.25 to 6 mg/mL


NS or D5W


24 hours


7 days


4 mg/mL


Heparin

10 to 50 units/mL


NS or D5W


24 hours


7 days


4 mg/mL


Potassium Chloride

10 to 40 mEq/L


NS or D5W


24 hours


7 days


4 mg/mL


Theophylline

0.8 mg/mL


D5W


24 hours


7 days


1 to 4 mg/mL


na


Aminosyn  II

4.25% with

electrolytes and calcium


8 hours


3 days


0.125 to

0.25 mg/mL


na


Inpersol

with 4.25% dextrose


24 hours


7 days


Pozineg for Injection Admixture Incompatibility

Do not add solutions of Pozineg for injection, to solutions of ampicillin at a concentration greater than 40 mg per mL, or to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin sulfate, or aminophylline because of potential interaction. However, if concurrent therapy with Pozineg for injection is indicated, each of these antibiotics can be administered separately.

Intramuscular Pozineg for Injection

Pozineg for injection constituted as directed is stable for 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) or for 7 days in a refrigerator 2°C to 8°C (36°F to 46°F) with the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5% or 1% Lidocaine Hydrochloride.

Intramuscular and Intravenous Pozineg for Injection

As with other cephalosporins, the color of Pozineg powder, as well as its solutions tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

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3 DOSAGE FORMS AND STRENGTHS

Pozineg for Injection, USP is a sterile white to pale yellow powder of Pozineg in single-dose vials for reconstitution and it is available in the following strengths:

  • 0.5 gram per vial
  • 1 g per vial
  • 2 g per vial

Pozineg for injection, USP is a sterile powder of Pozineg in vials for reconstitution, available in the following strengths:

  • 0.5 gram per vial, 1 gram per vial and 2 grams per vial. (3)

4 CONTRAINDICATIONS

Pozineg for injection is contraindicated in patients who have shown immediate hypersensitivity reactions to Pozineg or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.

Patients with known immediate hypersensitivity reactions to Pozineg or other cephalosporins, penicillins or other beta-lactam antibacterial drugs. (4)

5 WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions: Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Pozineg for Injection occurs, discontinue the drug.
  • Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with Pozineg for Injection therapy occurs, discontinue the drug. (5.2)
  • Clostridium difficile Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. (5.3)

5.1 Hypersensitivity Reactions

Before therapy with Pozineg for injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to Pozineg, cephalosporins, penicillins, or other beta-lactams. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Pozineg for injection occurs, discontinue the drug and institute appropriate supportive measures.

5.2 Neurotoxicity

Serious adverse reactions have been reported including life-threatening or fatal occurrences of the following: encephalopathy, aphasia, myoclonus, seizures, and nonconvulsive status epilepticus [see Adverse Reactions (6.2)]. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment. However, some cases of neurotoxicity occurred in patients receiving a dosage adjustment appropriate for their degree of renal impairment. In the majority of cases, symptoms of neurotoxicity were reversible and resolved after discontinuation of Pozineg and/or after hemodialysis. If neurotoxicity associated with Pozineg therapy occurs, discontinue Pozineg and institute appropriate supportive measures.

5.3 Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Pozineg, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile 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 antibacterial drug 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 antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.4 Development of Drug-Resistant Bacteria

Prescribing Pozineg for injection in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antimicrobials, prolonged use of Pozineg may result in overgrowth of nonsusceptible microorganisms. Repeated evaluation of the patient's condition is essential. Should superinfection occur during therapy, appropriate measures should be taken.

5.5 Drug/Laboratory Test Interactions

Urinary Glucose

The administration of Pozineg may result in a false-positive reaction for glucose in the urine when using some methods (e.g. Clinitest tablets) [see Drug Interactions (7.1)].

Coombs' Tests

Positive direct Coombs' tests have been reported during treatment with Pozineg. In patients who develop hemolytic anemia, discontinue the drug and institute appropriate therapy. Positive Coombs' test may be observed in newborns whose mothers have received cephalosporin antibiotics before parturition.

Prothrombin Time

Many cephalosporins, including Pozineg, have been 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. Prothrombin time should be monitored in patients at risk, and exogenous vitamin K administered as indicated.

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in the Warnings and Precautions section and below:

  • Hypersensitivity Reactions [see Warnings and Precautions ]
  • Neurotoxicity [see Warnings and Precautions (5.2)]
  • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.3)]
  • The most common adverse reactions (incidence ≥ 1%) were local reactions, positive Coombs' test, decreased phosphorous, increased ALT and AST, increased PT and PTT and rash. (6.1)
  • At the highest dose (2 g every 8 hours), incidence of adverse reactions was ≥1% for rash, diarrhea, nausea, vomiting, pruritis, fever, and headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at-1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials using multiple doses of Pozineg, 4137 patients were treated with the recommended dosages of Pozineg (500 mg to 2 g intravenous every 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. Sixty-four (1.5%) patients discontinued medication due to adverse reactions. Thirty-three (51%) of these 64 patients who discontinued therapy did so because of rash. The percentage of cefepime-treated patients who discontinued study drug because of drug-related adverse reactions was similar at daily doses of 500 mg, 1 g, and 2 g every 12 hours (0.8%, 1.1%, and 2%, respectively). However, the incidence of discontinuation due to rash increased with the higher recommended doses.

The following adverse reactions (Table 5) were identified in clinical trials conducted in North America (n=3125 cefepime-treated patients).


Incidence equal to or greater than 1%


Local adverse reactions (3%), 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, erythema, fever, headache, nausea, oral moniliasis, pruritus, urticaria, vaginitis, vomiting, anemia


At the higher dose of 2 g every 8 hours, the incidence of adverse reactions was higher among the 795 patients who received this dose of Pozineg. They consisted of rash (4%), diarrhea (3%), nausea (2%), vomiting (1%), pruritus (1%), fever (1%), and headache (1%).

The following (Table 6) adverse laboratory changes, with Pozineg, were seen during clinical trials conducted in North America.


Incidence equal to or greater than 1%


Positive Coombs' test (without hemolysis) (16.2%); decreased phosphorus (2.8%); increased Alanine Transaminase (ALT) (2.8%), Aspartate Transaminase (AST) (2.4%), eosinophils (1.7%); abnormal PTT (1.6%), Prothrombin Time (PT) (1.4%)


Incidence less than 1% but greater than 0.1%


Increased alkaline phosphatase, Blood Urea Nitrogen (BUN), calcium, creatinine, phosphorus, potassium, total bilirubin; decreased calciumHypocalcemia was more common among elderly patients. Clinical consequences from changes in either calcium or phosphorus were not reported., hematocrit, neutrophils, platelets, White Blood Cells (WBC)


A similar safety profile was seen in clinical trials of pediatric patients

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Pozineg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In addition to the adverse reactions reported during the North American clinical trials with Pozineg, the following adverse reactions have been reported during worldwide postmarketing experience. Encephalopathy, aphasia, myoclonus, seizures, and nonconvulsive status epilepticus have been reported. [see Warnings and Precautions (5.2)]

Anaphylaxis including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia, have been reported.

6.3 Cephalosporin-Class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with Pozineg, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterial drugs:

Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic dysfunction including cholestasis, and pancytopenia.

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7 DRUG INTERACTIONS

  • Aminoglycosides: increased potential of nephrotoxicity and ototoxicity. Monitor renal function.
  • Diuretics: nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function. (7.3)

7.1 Drug/Laboratory Test Interactions

The administration of Pozineg may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

7.2 Aminoglycosides

Monitor renal function if aminoglycosides are to be administered with Pozineg because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs.

7.3 Diuretics

Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function when Pozineg is concomitantly administered with potent diuretics.

8 USE IN SPECIFIC POPULATIONS

  • Geriatric Use: Serious neurologic adverse reactions have occurred in geriatric patients with renal insufficiency given unadjusted doses of Pozineg.

8.1 Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies of Pozineg use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pozineg was not teratogenic or embryocidal when administered during the period of organogenesis to rats at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose calculated on a body surface area basis) or to mice at doses up to 1200 mg/kg (approximately equal to the recommended maximum human dose calculated on a body surface area basis) or to rabbits at a dose level of 100 mg/kg (0.3 times the recommended maximum human dose calculated on a body surface area basis).

8.2 Labor and Delivery

Pozineg has not been studied for use during labor and delivery. Treatment should only be given if clearly indicated.

8.3 Nursing Mothers

Pozineg is excreted in human breast milk. Caution should be exercised when Pozineg is administered to a nursing woman [see Clinical Pharmacology ].

8.4 Pediatric Use

The safety and effectiveness of Pozineg in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years. Use of Pozineg in these age groups is supported by evidence from adequate and well-controlled studies of Pozineg in adults with additional pharmacokinetic and safety data from pediatric trials [see Clinical Pharmacology (12.3)].

Safety and effectiveness in pediatric patients below the age of 2 months have not been established. There are insufficient clinical data to support the use of Pozineg for injection in pediatric patients for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is H. influenzae type b. In those patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented, an alternate agent with demonstrated clinical efficacy in this setting should be used.

8.5 Geriatric Use

Of the more than 6400 adults treated with Pozineg for injection in clinical studies, 35% were 65 years or older while 16% were 75 years or older. When geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in non-geriatric adult patients.

Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of Pozineg, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures [see Warnings and Precautions, Adverse Reactions (6.2)].

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored [see Clinical Pharmacology (12.3), Warnings and Precautions (5.2), Dosage and Administration (2.3)].

8.6 Renal Impairment

Adjust the dose of Pozineg for injection in patients with creatinine clearance less than or equal to 60 mL/min to compensate for the slower rate of renal elimination. [See Dosage Adjustments in Patients with Renal Impairment (2.3)]

10 OVERDOSAGE

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of Pozineg from the body. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability and nonconvulsive status epilepticus [see Warnings and Precautions (5.2), Adverse Reactions (6.2), Dosage and Administration (2.3)].

11 DESCRIPTION

Pozineg hydrochloride, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula:

Pozineg hydrochloride is a white to pale yellow powder. Pozineg hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of Pozineg (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water.

Pozineg for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of Pozineg. Pozineg for injection, USP is a sterile, dry mixture of Pozineg hydrochloride and L-arginine. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of Pozineg (C19H24N6O5S2). The L-arginine, at an approximate concentration of 725 mg/g of Pozineg, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Pozineg for Injection, USP will range in color from pale yellow to amber.

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Pozineg is a cephalosporin antibacterial drug [See Microbiology ].

12.2 Pharmacodynamics

Similar to other beta-lactam antimicrobial agents, the time that the unbound plasma concentration of Pozineg exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in animal models of infection. However, the pharmacokinetic/pharmacodynamics relationship for Pozineg has not been evaluated in patients.

12.3 Pharmacokinetics

Pharmacokinetic parameters for Pozineg in healthy adult male volunteers following single 30-minute infusions (IV) of Pozineg 500 mg, 1 g, and 2 g are summarized in Table 7. Elimination of Pozineg is principally via renal excretion with an average (±SD) half-life of 2 (±0.3) hours and total body clearance of 120 (±8) mL/min in healthy volunteers. Pozineg pharmacokinetics are linear over the range 250 mg to 2 g. There is no evidence of accumulation in healthy adult male volunteers (n=7) receiving clinically relevant doses for a period of 9 days.


Pozineg


Parameter


500 mg IV


1 g IV


2 g IV


Cmax, mcg/mL


39.1 (3.5)


81.7 (5.1)


163.9 (25.3)


AUC, h-mcg/mL


70.8 (6.7)


148.5 (15.1)


284.8 (30.6)


Number of subjects


9


9


9


(male)


Pharmacokinetic parameters for Pozineg following a single intramuscular injection are summarized in Table 8. The pharmacokinetics of Pozineg are linear over the range of 500 mg to 2 g intramuscularly and do not vary with respect to treatment duration.


Pozineg


Parameter


500 mg IM


1 g IM


2 g IM


Cmax, mcg/mL


13.9 (3.4)


29.6 (4.4)


57.5 (9.5)


Tmax, h


1.4 (0.9)


1.6 (0.4)


1.5 (0.4)


AUC, h-mcg/mL


60 (8)


137 (11)


262 (23)


Number of subjects


6


6


12


(male)


Absorption

Following intramuscular (IM) administration, Pozineg is completely absorbed.

Distribution

The average steady-state volume of distribution of Pozineg is 18 (±2) L. The serum protein binding of Pozineg is approximately 20% and is independent of its concentration in serum.

Pozineg is excreted in human milk at a concentration of 0.5 mcg/mL. A nursing infant consuming approximately 1000 mL of human milk per day would receive approximately 0.5 mg of Pozineg per day [see Use in Specific Populations (8.3)].

Concentrations of Pozineg achieved in specific tissues and body fluids are listed in Table 9.


Tissue or Fluid


Dose/Route


# of Patients


Mean Time of Sample Post-Dose

(h)


Mean Concentration


Blister Fluid


2 g IV


6


1.5


81.4 mcg/mL


Bronchial Mucosa


2 g IV


20


4.8


24.1 mcg/g


Sputum


2 g IV


5


4


7.4 mcg/mL


Urine


500 mg IV


8


0 to 4


292 mcg/mL


1 g IV


12


0 to 4


926 mcg/mL


2 g IV


12


0 to 4


3120 mcg/mL


Bile


2 g IV


26


9.4


17.8 mcg/mL


Peritoneal Fluid


2 g IV


19


4.4


18.3 mcg/mL


Appendix


2 g IV


31


5.7


5.2 mcg/g


Gallbladder


2 g IV


38


8.9


11.9 mcg/g


Prostate


2 g IV


5


1


31.5 mcg/g


Data suggest that Pozineg does cross the inflamed blood-brain barrier. The clinical relevance of these data is uncertain at this time.

Metabolism and Excretion

Pozineg is metabolized to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide). Urinary recovery of unchanged Pozineg accounts for approximately 85% of the administered dose. Less than 1% of the administered dose is recovered from urine as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of Pozineg. Because renal excretion is a significant pathway of elimination, patients with renal dysfunction and patients undergoing hemodialysis require dosage adjustment [see Dosage and Administration (2.3)].

Specific Populations

Patients with Renal impairment

Pozineg pharmacokinetics have been investigated in patients with various degrees of renal impairment (n=30). The average half-life in patients requiring hemodialysis was 13.5 (±2.7) hours and in patients requiring continuous peritoneal dialysis was 19 (±2) hours. Pozineg total body clearance decreased proportionally with creatinine clearance in patients with abnormal renal function, which serves as the basis for dosage adjustment recommendations in this group of patients [see Dosage and Administration (2.3)].

Patients with Hepatic impairment

The pharmacokinetics of Pozineg were unaltered in patients with hepatic impairment who received a single 1 g dose (n=11).

Geriatric patients

Pozineg pharmacokinetics have been investigated in elderly (65 years of age and older) men (n=12) and women (n=12) whose mean (SD) creatinine clearance was 74 (±15) mL/min. There appeared to be a decrease in Pozineg total body clearance as a function of creatinine clearance. Therefore, dosage administration of Pozineg in the elderly should be adjusted as appropriate if the patient's creatinine clearance is 60 mL/min or less [see Dosage and Administration (2.3)].

Pediatric patients

Pozineg pharmacokinetics have been evaluated in pediatric patients from 2 months to 11 years of age following single and multiple doses on every 8 hours (n=29) and every 12 hours (n=13) schedules. Following a single intravenous dose, total body clearance and the steady-state volume of distribution averaged 3.3 (±1) mL/min/kg and 0.3 (±0.1) L/kg, respectively. The urinary recovery of unchanged Pozineg was 60.4 (±30.4)% of the administered dose, and the average renal clearance was 2 (±1.1) mL/min/kg. There were no significant effects of age or gender (25 male vs. 17 female) on total body clearance or volume of distribution, corrected for body weight. No accumulation was seen when Pozineg was given at 50 mg per kg every 12 hours (n=13), while Cmax, AUC, and t½ were increased about 15% at steady state after 50 mg per kg every 8 hours. The exposure to Pozineg following a 50 mg per kg intravenous dose in a pediatric patient is comparable to that in an adult treated with a 2 g intravenous dose. The absolute bioavailability of Pozineg after an intramuscular dose of 50 mg per kg was 82.3 (±15)% in eight patients.

12.4 Microbiology

Mechanism of Action

Pozineg is a bactericidal drug that acts by inhibition of bacterial cell wall synthesis. Pozineg has a broad spectrum of in vitro activity that encompasses a wide range of Gram-positive and Gram-negative bacteria. Within bacterial cells, the molecular targets of Pozineg are the penicillin binding proteins (PBP).

Antimicrobial Activity

Pozineg has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the Indications and Usage section (1).

Gram-negative Bacteria

Enterobacter spp.

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

Pseudomonas aeruginosa

Gram-positive Bacteria

Staphylococcus aureus (methicillin-susceptible isolates only)

Streptococcus pneumoniae

Streptococcus pyogenes

Viridans group streptococci

The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for Pozineg against isolates of similar genus or organism group. However, the efficacy of Pozineg in treating clinical infections due to these bacteria has not been established in adequate and well-controlled clinical trials.

Gram-positive Bacteria

Staphylococcus epidermidis (methicillin-susceptible isolates only)

Staphylococcus saprophyticus

Streptococcus agalactiae

NOTE: Most isolates of enterococci, e.g., Enterococcus faecalis, and methicillin-resistant staphylococci are resistant to Pozineg.

Gram-negative Bacteria

Acinetobacter calcoaceticus subsp. lwoffii

Citrobacter diversus

Citrobacter freundii

Enterobacter agglomerans

Haemophilus influenzae

Hafnia alvei

Klebsiella oxytoca

Moraxella catarrhalis

Morganella morganii

Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Serratia marcescens

NOTE: Pozineg is inactive against many isolates of Stenotrophomonas maltophilia.

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide cumulative reports of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug for treatment.

Dilution techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method 1,2 (broth and/or agar). The MIC should be interpreted according to criteria provided in Table 10.

Diffusion techniques

Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method 2,3. This procedure uses paper discs impregnated with 30 mcg Pozineg to test the susceptibility of microorganisms to Pozineg. The disk diffusion interpretive criteria are provided in Table 10.

¥For patients with renal impairment see Table 2 in Dosage and Administration.

*For isolates of Enterobacteriaceae with intermediate susceptibility, use a dose of 2 g every 8 hours in patients with normal renal function.

§ For P. aeruginosa, use 2 g IV every 8 hours in patients with normal renal function

bFor non-meningitis isolates, a penicillin MIC of < 0.06 mcg/ml (or oxacillin zone > 20 mm) can predict susceptibility to Pozineg.

Susceptibility of staphylococci to Pozineg may be deduced from testing only penicillin and either cefoxitin or oxacillin.


Pathogen


Minimum Inhibitory Concentrations

(mcg/ml)


Disk Diffusion Zone Diameters

(mm)


(S)

Susceptible


(I)

Intermediate


(R)

Resistant


(S)

Susceptible


(I)

Intermediate


(R)

Resistant


Enterobacteriaceae


≤2


4 to 8*


≥16


≥25


19 to 24*


≤18


Pseudomonas

aeruginosa §


≤8


-


≥16


≥18


-


≤17


Streptococcus

pneumoniae b

non-meningitis isolates


≤1


2


≥4


-


-


-


Streptococcus pyogenes


≤0.5


-


-


≥24


-


-


Viridans group streptococci


≤1


2


≥4


≥24


22 to 23


≤21


A report of Susceptible (S) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of Intermediate (I) indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of the drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individual performing the test 1,2,3. Standard Pozineg powder should provide the following range of MIC values noted in Table 11. For the diffusion technique using the 30 mcg disc, the criteria in Table 11 should be achieved.


QC Strain


Minimum Inhibitory Concentrations (mcg/mL)


Disk Diffusion (zone diameters in mm)


Escherichia coli ATCC 25922


0.015 to 0.12


31 to 37


Staphylococcus aureus

ATCC 29213


1 to 4


-


Staphylococcus aureus

ATCC 25923


-


23 to 29


Pseudomonas aeruginosa ATCC 27853


0.5 to 4


24 to 30


Streptococcus pneumoniae ATCC 49619


0.03 to 0.25


28 to 35


Haemophilus influenzae ATCC 49247


0.5 to 2


25 to 31


Neisseria gonorrhoeae

ATCC 49226


0.015 to 0.06


37 to 46

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal carcinogenicity studies have been conducted with Pozineg. In chromosomal aberration studies, Pozineg was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells. In other in vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), Pozineg was negative for genotoxic effects. Moreover, in vivo assessments of Pozineg in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity. No untoward effects on fertility were observed in rats when Pozineg was administered subcutaneously at doses up to 1000 mg/kg/day (1.6 times the recommended maximum human dose calculated on a body surface area basis).

14 CLINICAL STUDIES

14.1 Febrile Neutropenic Patients

The safety and efficacy of empiric Pozineg monotherapy of febrile neutropenic patients have been assessed in two multicenter, randomized trials comparing Pozineg monotherapy to ceftazidime monotherapy (at a dose of 2 g intravenously every 8 hours). These studies comprised 317 evaluable patients. Table 12 describes the characteristics of the evaluable patient population.

ANC = absolute neutrophil count; SBP = systolic blood pressure

Pozineg


Ceftazidime


Total


164


153


Median age (yr)


56 (range, 18 to 82)


55 (range, 16 to 84)


Male


86 (52%)


85 (56%)


Female


78 (48%)


68 (44%)


Leukemia


65 (40%)


52 (34%)


Other hematologic malignancies


43 (26%)


36 (24%)


Solid tumor


54 (33%)


56 (37%)


Median ANC nadir (cells/microliter)


20 (range, 0 to 500)


20 (range, 0 to 500)


Median duration of neutropenia (days)


6 (range, 0 to 39)


6 (range, 0 to 32)


Indwelling venous catheter


97 (59%)


86 (56%)


Prophylactic antibiotics


62 (38%)


64 (42%)


Bone marrow graft


9 (5%)


7 (5%)


SBP less than 90 mm Hg at entry


7 (4%)


2 (1%)


Table 13 describes the clinical response rates observed. For all outcome measures, Pozineg was therapeutically equivalent to ceftazidime.


% Response


Pozineg


Ceftazidime


Outcome Measures


(n=164)


(n=153)


Primary episode resolved with no treatment modification, no new febrile episodes or infection, and oral antibiotics allowed for completion of treatment


51


55


Primary episode resolved with no treatment modification, no new febrile episodes or infection and no post-treatment oral antibiotics


34


39


Survival, any treatment modification allowed


93


97


Primary episode resolved with no treatment modification and oral antibiotics allowed for completion of treatment


62


67


Primary episode resolved with no treatment modification and no post-treatment oral antibiotics


46


51


Insufficient data exist to support the efficacy of Pozineg monotherapy in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia). No data are available in patients with septic shock.

14.2 Complicated Intra-abdominal Infections

Patients hospitalized with complicated intra-abdominal infections participated in a randomized, double-blind, multicenter trial comparing the combination of Pozineg (2 g every 12 hours) plus intravenous metronidazole (500 mg every 6 hours) versus imipenem/cilastatin (500 mg every 6 hours) for a maximum duration of 14 days of therapy. The study was designed to demonstrate equivalence of the two therapies. The primary analyses were conducted on the population consisting of those with a surgically confirmed complicated infection, at least one pathogen isolated pretreatment, at least 5 days of treatment, and a 4 to 6 week follow-up assessment for cured patients. Subjects in the imipenem/cilastatin arm had higher APACHE II scores at baseline. The treatment groups were otherwise generally comparable with regard to their pretreatment characteristics. The overall clinical cure rate among the primary analysis patients was 81% (51 cured/63 evaluable patients) in the Pozineg plus metronidazole group and 66% (62/94) in the imipenem/cilastatin group. The observed differences in efficacy may have been due to a greater proportion of patients with high APACHE II scores in the imipenem/cilastatin group.

15 REFERENCES

  • Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. CLSI document M07-10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-sixth Informational Supplement, CLSI document M100-S26. CLSI document M100-S26, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2016.
  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  • Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16:31-41.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Pozineg for injection, USP is supplied as follows: Pozineg for Injection, USP in the dry state, is a white to pale yellow powder. Constituted solution of Pozineg for Injection, USP can range in color from pale yellow to amber.


Unit of Sale


Strength


Each


NDC 60505–0678–0

Carton containing 1


500 mgBased on Pozineg activity


NDC 60505–0678–0

Vial


NDC 60505–0678–4

Carton containing 10


500 mg


NDC 60505–0678–1

Vial


NDC 60505–0834–0

Carton containing 1


1 gram


NDC 60505–0834–0

Vial


NDC 60505–0834–4

Carton containing 10


1 gram


NDC 60505–0834–1

Vial


NDC 60505–0681–0

Carton containing 1


2 grams


NDC 60505–0681–0

Vial


NDC 60505–0681–4

Carton containing 10


2 grams


NDC 60505–0681–1

Vial


Storage and Handling

Pozineg for injection, USP in the dry state should be stored at 2° to 25° C (36° to 77° F) and protected from light.

17 PATIENT COUNSELING INFORMATION

  • Counsel patients that antibacterial drugs including Pozineg for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Pozineg for injection is prescribed to treat a bacterial infection, tell patients 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 Pozineg for injection or other antibacterial drugs in the future.
  • Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibiotic is discontinued. Inform patient that they may develop watery and bloody stools (with or without stomach cramps and fever) during treatment and as late as two or more months after having taken the last dose of the antibiotic. Inform patients that they should contact their physician as soon as possible if this occurs.
  • Advise patients of neurological adverse events that could occur with Pozineg for injection use. Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia (disturbance of speaking and understanding spoken and written language), myoclonus, seizures and nonconvulsive status epilepticus, for immediate treatment, dosage adjustment, or discontinuation of Pozineg for injection.

Mfg. by:                                                                                                                            Mfg. for:

Hospira Healthcare India Pvt. Ltd.                                                                              Apotex Corp.

Irungattukottai - 602 105, India                                                                                        Weston, FL 33326

LAB-1002-1.0

9491xxxxx

NDC 60505-0678

Single-Dose Vial

NDC 60505-0834-1

Pozineg

for Injection, USP

1 gram*

For IV or IM Use

after constitution.

Rx Only

APOTEX CORP.

949119364


 

949119430

Carton NDC 60505-0834-0 60505-0834-4

Single-Dose Vial

NDC 60505-0681-1

Pozineg

for Injection, USP

2 grams*

For IV Use

after constitution.

Rx Only

APOTEX CORP.

949119366

 

949119431

 

Carton NDC 60505-0681-0 60505-0681-4

Pozineg pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Pozineg available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Pozineg destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Pozineg Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Pozineg pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CEFEPIME HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "cefepime". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Pozineg?

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

sDrugs.com conducted a study on Pozineg, 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 Pozineg 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.

Visitor reports

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sDrugs.com website users shows the following figures about several people who felt the medicine Pozineg is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Expensive1
100.0%

One visitor reported time for results

What is the time duration Pozineg drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sDrugs.com website users needed 3 days to notice the result from using Pozineg drug. The time needed to show improvement in health condition after using the medicine Pozineg need not be same for all the users. It varies based on other factors.
Visitors%
3 days1
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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