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Complicated skin and skin structure infections (adult patients and pediatric patients ? 3 months only). (1. 1) • Complicated intra-abdominal infections (adult patients and pediatric patients ? 3 months only). (1. 2) • Bacterial meningitis (pediatric patients ? 3 months only). (1. 3) – – – – – – – – – – – – – – – – – DOSAGE AND ADMINISTRATION – – – – – – – – – – – – – – – – • 500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for skin and skin structure infections for adult patients. (2. 1) • 1 g every 8 hours by intravenous infusion over 15 to 30 minutes for intra-abdominal infections for adult patients.

(2. 1) • 1 g every 8 hours by intravenous bolus injection (5 to 20 mL) over 3 to 5 minutes for adult patients. (2. 1) • Dosage should be reduced in adult patients with renal impairment. (2. 2) Recommended MERREM I. V. Dosage Schedule for Adult Patients with Renal Impairment Creatinine Dose Dosing Interval Clearance (dependent on type of infection) (mL/min) >50 Recommended dose Every 8 hours (500 mg cSSSI and 1 g Intra-abdominal) >25-50 Recommended dose Every 12 hours 10-25 One-half recommended dose Every 12 hours 50 Recommended dose (500 mg cSSSI and 1 g Intra-abdominal) Every 8 hours.

Recommended dose Every 12 hours 10-25 One-half recommended dose Every 12 hours 25-50 There is inadequate information regarding the use of MERREM I. V. in patients on hemodialysis or peritoneal dialysis. 2. 3 Use in Pediatric Patients (? 3 Months only) For pediatric patients from 3 months of age and older, the MERREM I. V. dose is 10, 20 or 40 mg/kg every 8 hours (maximum dose is 2 g every 8 hours), depending on the type of infection (complicated skin and skin structure, intra-abdominal or meningitis). (See dosing table below. ) Pediatric patients weighing over 50 kg should be administered MERREM I.

V. at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 g every 8 hours for intra-abdominal infections and 2 g every 8 hours for meningitis. MERREM I. V. should be given as intravenous infusion over approximately 15 to 30 minutes or as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes. Recommended MERREM I. V. Dosage Schedule for Pediatric Patients With Normal Renal Function Type of Infection Dose Up to a (mg/kg) Maximum Dose Complicated skin and 10 500 mg skin structure Intra-abdominal 20 1g Meningitis 40 2g.

There is no experience in pediatric patients with renal impairment. Dosing Interval Every 8 hours Every 8 hours Every 8 hours 2. 4 Preparation of Solution For Intravenous Bolus Administration Constitute injection vials (500 mg and 1 g) with sterile Water for Injection. (See table below. ) Shake to dissolve and let stand until clear. Amount of Approximate Approximate Diluent Withdrawable Average Added Volume Concentration Vial Size (mL) (mL) (mg/mL) 500 mg 10 10 50 1g 20 20 50 For Infusion Infusion vials (500 mg and 1 g) may be directly constituted with a compatible infusion fluid.

Alternatively, an injection vial may be constituted, then the resulting solution added to an I. V. container and further diluted with an appropriate infusion fluid [see Dosage and Administration (2. 5) and (2. 6)]. WARNING: Do not use flexible container in series connections. 2. 5 Compatibility Compatibility of MERREM I. V. with other drugs has not been established. MERREM I. V. should not be mixed with or physically added to solutions containing other drugs. 2. 6 Stability and Storage Freshly prepared solutions of MERREM I. V. should be used whenever possible.

However, constituted solutions of MERREM I. V. maintain satisfactory potency at controlled room temperature 15-25°C (59-77°F) or under refrigeration at 4°C (39°F) as described below. Solutions of intravenous MERREM I. V. should not be frozen. Intravenous Bolus Administration MERREM I. V. injection vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of MERREM I. V. ) may be stored for up to 2 hours at controlled room temperature 15-25°C (59-77°F) or for up to 12 hours at 4°C (39°F). Intravenous Infusion Administration.

Stability in Infusion Vials: MERREM I. V. infusion vials constituted with Sodium Chloride Injection 0. 9% (MERREM I. V. concentrations ranging from 2. 5 to 50 mg/mL) are stable for up to 2 hours at controlled room temperature 15-25°C (59-77°F) or for up to 18 hours at 4°C (39°F). Infusion vials of MERREM I. V. constituted with Dextrose Injection 5% (MERREM I. V. concentrations ranging from 2. 5 to 50 mg/mL) are stable for up to 1 hour at controlled room temperature 15-25°C (59-77°F) or for up to 8 hours at 4°C (39°F). Stability in Plastic I. V.

Bags: Solutions prepared for infusion (MERREM I.V. concentrations ranging from 1 to 20 mg/mL) may be stored in plastic intravenous bags with diluents as shown below: Number of Hours Stable at Number of Controlled Room Temperature Hours Stable 15-25°C (59-77°F) at 4°C (39°F) Sodium Chloride Injection 0. 9% 4 24 Dextrose Injection 5. 0% 1 4 Dextrose Injection 10. 0% 1 2 Dextrose and Sodium Chloride Injection 1 2 5. 0%/0. 9% Dextrose and Sodium Chloride Injection 1 4 5. 0%/0. 2% Potassium Chloride in Dextrose Injection 1 6 0. 15%/5. 0% Sodium Bicarbonate in Dextrose Injection 1 6 0. 02%/5. 0% Dextrose Injection 5.

0% in Normosol®-M† 1 8 Dextrose Injection 5. 0% in Ringers Lactate 1 4 Injection Dextrose and Sodium Chloride Injection 3 12 2. 5%/0. 45% Mannitol Injection 2. 5% 2 16 Ringers Injection 4 24 Ringers Lactate Injection 4 12 Sodium Lactate Injection 1/6 N 2 24 Sodium Bicarbonate Injection 5. 0% 1 4 † NORMOSOL is a registered trademark of Hospira Inc. MERREM® I. V. (meropenem for Injection) Stability in Baxter Minibag Plus: Solutions of MERREM I. V. (MERREM I. V. concentrations ranging from 2. 5 to 20 mg/mL) in Baxter Minibag Plus bags with Sodium Chloride Injection 0.

9% may be stored for up to 4 hours at controlled room temperatures 15-25°C (59-77°F) or for up to 24 hours at 4°C (39°F). Solutions of MERREM I. V. (MERREM I. V. concentrations ranging from 2. 5 to 20 mg/mL) in Baxter Minibag Plus bags with Dextrose Injection 5. 0% may be stored up to 1 hour at controlled room temperatures 15-25°C (59-77°F) or for up to 6 hours at 4°C (39°F). Stability in Plastic Syringes, Tubing and Intravenous Infusion Sets: Solutions of MERREM I. V. (MERREM I. V. concentrations ranging from 1 to 20 mg/mL) in Water for Injection or Sodium Chloride Injection 0. 9% (for up to 4 hours) or in Dextrose Injection 5.

0% (for up to 2 hours) at controlled room temperatures 15-25°C (59-77°F) are stable in plastic tubing and volume control devices of common intravenous infusion sets. Solutions of MERREM I. V. (MERREM I. V. concentrations ranging from 1 to 20 mg/mL) in Water for Injection or Sodium Chloride Injection 0. 9% (for up to 48 hours) or in Dextrose Injection 5% (for up to 6 hours) are stable at 4°C (39°F) in plastic syringes. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 3.

DOSAGE FORMS AND STRENGTHS Single use clear glass vials containing 500 mg or 1 g (as the trihydrate blend with anhydrous sodium carbonate for constitution) of sterile meropenem powder. 4 CONTRAINDICATIONS MERREM I. V. is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to ? -lactams.

5 WARNINGS AND PRECAUTIONS 5. 1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with ?-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.

There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another ? -lactam. Before initiating therapy with MERREM I. V. , careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other ? -lactams, and other allergens. If an allergic reaction to MERREM I. V. occurs, discontinue the drug immediately.

Serious anaphylactic reactions require immediate emergency treatment with epinephrine, oxygen, intravenous steroids, and airway management, including intubation. Other therapy may also be administered as indicated. 5. 2 Seizure Potential Seizures and other adverse CNS experiences have been reported during treatment with MERREM I. V. These experiences have occurred most commonly in patients with CNS disorders (e. g. , brain lesions or history of seizures) or with bacterial meningitis and/or compromised renal function [see Adverse Reactions (6.1) and Drug Interactions (7. 2)].

During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with the overall seizure rate being 0. 7% (based on 20 patients with this adverse event). All meropenem-treated patients with seizures had pre-existing contributing factors. Among these are included prior history of seizures or CNS abnormality and concomitant medications with seizure potential. Dosage adjustment is recommended in patients with advanced age and/or reduced renal function [see Dosage and Administration (2.2)].

Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity. Anti-convulsant therapy should be continued in patients with known seizure disorders. If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically, placed on anti-convulsant therapy if not already instituted, and the dosage of MERREM I. V. re-examined to determine whether it should be decreased or the antibiotic discontinued. 5. 3 Interaction with Valproic Acid.

Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended.

Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of MERREM I. V. is necessary, supplemental anti-convulsant therapy should be considered [see Drug Interactions (7. 2)]. 5. 4 Clostridium difficile–Associated Diarrhea Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MERREM I. V. , 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 isolates 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 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 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. 3 5. 5 Development of Drug-Resistant Bacteria Prescribing MERREM I. V. 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.

5. 6 Overgrowth of Nonsusceptible Organisms As with other broad-spectrum antibiotics, prolonged use of meropenem may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient is essential. If superinfection does occur during therapy, appropriate measures should be taken. 5. 7 Laboratory Tests While MERREM I. V. possesses the characteristic low toxicity of the beta-lactam group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy. 5.

8 Patients with Renal Impairment In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported [see Dosage and Administration (2. 2), Adverse Reactions (6. 1), Use In Specific Populations (8. 5) and (8. 6), and Clinical Pharmacology (12. 3)]. 5. 9 Dialysis There is inadequate information regarding the use of MERREM I. V. in patients on hemodialysis or peritoneal dialysis. 6 ADVERSE REACTIONS The following are discussed in greater detail in other sections of labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1)].

• Seizure Potential [see Warnings and Precautions (5. 2)] • Interaction with Valproic Acid [see Warnings and Precautions (5. 3)] • Clostridium difficile – Associated Diarrhea [see Warnings and Precautions (5. 4)] • Development of Drug-Resistant Bacteria [see Warnings and Precautions (5. 5)] • Overgrowth of Nonsusceptible Organisms [see Warnings and Precautions (5. 6)] • Laboratory Tests [see Warnings and Precautions (5. 7)] • Patients with Renal Impairment [see Warnings and Precautions (5. 8)] • Dialysis [see Warnings and Precautions (5. 9)] 6. 1 Adverse Reactions from Clinical Trials.

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the 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. Adult Patients: During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with MERREM I. V. (500 mg or 1000 mg every 8 hours). Deaths in 5 patients were assessed as possibly related to meropenem; 36 (1. 2%) patients had meropenem discontinued because of adverse events.

Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with MERREM I. V. The following adverse reaction frequencies were derived from the clinical trials in the 2904 patients treated with MERREM I. V. Local Adverse Reactions Local adverse reactions that were reported irrespective of the relationship to therapy with MERREM I. V. were as follows:

Inflammation at the injection site 2. 4% Injection site reaction 0. 9% Phlebitis/thrombophlebitis 0. 8% Pain at the injection site 0. 4% Edema at the injection site 0. 2% Systemic Adverse Reactions Systemic adverse reactions that were reported irrespective of the relationship to MERREM I. V. occurring in greater than 1. 0% of the patients were diarrhea (4. 8%), nausea/vomiting (3. 6%), headache (2. 3%), rash (1. 9%), sepsis (1. 6%), constipation (1. 4%), apnea (1. 3%), shock (1. 2%), and pruritus (1. 2%).

Additional systemic adverse reactions that were reported irrespective of relationship to therapy with MERREM I.V. and occurring in less than or equal to 1. 0% but greater than 0. 1% of the patients are listed below within each body system in order of decreasing frequency:

Bleeding events were seen as follows: gastrointestinal hemorrhage (0. 5%), melena (0. 3%), epistaxis (0. 2%), hemoperitoneum (0. 2%), summing to 1. 2%. Body as a Whole: pain, abdominal pain, chest pain, fever, back pain, abdominal enlargement, chills, pelvic pain Cardiovascular: heart failure, heart arrest, tachycardia, hypertension, myocardial infarction, pulmonary embolus, bradycardia, hypotension, syncope.

Digestive System: oral moniliasis, anorexia, cholestatic jaundice/jaundice, flatulence, ileus, hepatic failure, dyspepsia, intestinal obstruction Hemic/Lymphatic: anemia, hypochromic anemia, hypervolemia Metabolic/Nutritional: peripheral edema, hypoxia Nervous System: insomnia, agitation/delirium, confusion, dizziness, seizure, nervousness, paresthesia, hallucinations, somnolence, anxiety, depression, asthenia [see Warnings and Precautions (5. 2)] Respiratory: respiratory disorder, dyspnea, pleural effusion, asthma, cough increased, lung edema Skin and Appendages: urticaria, sweating, skin ulcer 4 MERREM® I.

V. (meropenem for Injection) Urogenital System: dysuria, kidney failure, vaginal moniliasis, urinary incontinence Adverse Laboratory Changes Adverse laboratory changes that were reported irrespective of relationship to MERREM I. V. and occurring in greater than 0. 2% of the patients were as follows: Hepatic: increased SGPT (ALT), SGOT (AST), alkaline phosphatase, LDH, and bilirubin Hematologic: increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased WBC, shortened prothrombin time and shortened partial thromboplastin time, leukocytosis, hypokalemia.

Renal: increased creatinine and increased BUN NOTE: For patients with varying degrees of renal impairment, the incidence of heart failure, kidney failure, seizure and shock reported irrespective of relationship to MERREM I. V. , increased in patients with moderately severe renal impairment (creatinine clearance >10 to 26 mL/min) [see Dosage and Administration (2. 2), Warnings and Precautions (5. 8), Use in Specific Populations (8. 5) and (8. 6) and Clinical Pharmacology (12. 3)]. Urinalysis: presence of red blood cells Complicated Skin and Skin Structure Infections.

In a study of complicated skin and skin structure infections, the adverse reactions were similar to those listed above. The most common adverse events occurring in >5% of the patients were: headache (7. 8%), nausea (7. 8%), constipation (7. 0%), diarrhea (7. 0%), anemia (5. 5%), and pain (5. 1%). Adverse events with an incidence of >1%, and not listed above, include: pharyngitis, accidental injury, gastrointestinal disorder, hypoglycemia, peripheral vascular disorder, and pneumonia.

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