Linezolid

Linezolid Manufacturers

• Hospira, Inc.
  

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  Linezolid | Hospira, Inc.

  

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  2.1 General Dosage and Administration

  The recommended dosage for linezolid formulations for the treatment of infections is described in Table 1.

  Table 1. Dosage Guidelines for Linezolid Injection * Due to the designated pathogens [ see Indications and Usage (1)] † Neonates less than 7 days: Most pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a suboptimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life [ see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].

  Infection*

  Dosage and Route of Administration

  Recommended
  Duration of
  Treatment

  (consecutive days)

  Pediatric Patients†
  (Birth through
  11 Years of Age)

  Adults and
  Adolescents (12 Years and Older)

  Nosocomial pneumonia

  10 mg/kg intravenously every 8 hours

  600 mg intravenously every 12 hours

  10 to 14

  Community-acquired pneumonia, including concurrent bacteremia

  Complicated skin and skin structure infections

  Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia

  10 mg/kg intravenously every 8 hours

  600 mg intravenously every 12 hours

  14 to 28

  No dose adjustment is necessary when switching from intravenous to oral administration.

  2.2 Intravenous Administration

  Linezolid Injection is supplied in single-use, ready-to-use container (VisIV™ Container). Parenteral drug products should be inspected visually for particulate matter prior to administration. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired. Keep the containers in the overwrap until ready to use. Store at room temperature. Protect from freezing. Linezolid Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

  Linezolid Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous container in series connections. Additives should not be introduced into this solution. If Linezolid Injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each product.

  If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Linezolid Injection with an infusion solution compatible with Linezolid Injection and with any other drug(s) administered via this common line.

  2.3 Compatibilities

  Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer’s Injection, USP.

  2.4 Incompatibilities

  Physical incompatibilities resulted when Linezolid Injection was combined with the following drugs during simulated Y-site administration: amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when Linezolid Injection was combined with ceftriaxone sodium.

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• Teva Pharmaceuticals Usa Inc
  

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  Linezolid | Taro Pharmaceuticals Laboratories, Inc.

  

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  Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with etodolac capsules and tablets, USP, the dose and frequency should be adjusted to suit an individual patient's needs.

  Dosage adjustment of etodolac capsules and tablets, USP is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function (see WARNINGS, Renal Effects).

  Analgesia

  The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled trials.

  Osteoarthritis and Rheumatoid Arthritis

  The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

  In chronic conditions, a therapeutic response to therapy with etodolac is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

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• Apotex Corp.
  

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  Linezolid | Taro Pharmaceuticals U.s.a., Inc.

  

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  Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with etodolac extended-release tablets, the dose and frequency should be adjusted to suit an individual patient's needs.

  Juvenile Rheumatoid Arthritis

  For relief of signs and symptoms of juvenile rheumatoid arthritis in patients 6 to 16 years of age, the recommended dose given orally once per day should be based on body weight, according to the following table:

  Table 4. Body Weight Range (kg) Dose 20 to 30 400 mg Tablet × 1 31 to 45 600 mg Tablet × 1 46 to 60 400 mg Tablet × 2 >60 500 mg Tablet × 2 Rheumatoid Arthritis and Osteoarthritis

  For relief of the signs and symptoms of osteoarthritis or rheumatoid arthritis, the recommended starting dose of etodolac extended-release is 400 to 1000 mg, given once daily. As with other NSAIDs, the lowest effective dose should be sought for each patient. In chronic conditions, a therapeutic response to therapy with etodolac extended-release tablets is sometimes seen within one week of therapy, but most often is observed by two weeks.

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• Hospira, Inc.
  

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  Linezolid | Hospira, Inc.

  

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  2.1 General Dosage and Administration

  The recommended dosage for linezolid injection for the treatment of infections is described in Table 1. No dose adjustment is necessary when switching from intravenous to oral administration.

  Table 1. Dosage Guidelines for Linezolid Injection * Due to the designated pathogens [ see Indications and Usage (1)]

  Infection*

  Dosage, Route, and Frequency of Administration

  Recommended Duration of Treatment

  (consecutive days)

  Pediatric Patients less than 12 Years of Age

  Adults and Adolescents (12 Years and Older)

  Nosocomial pneumonia

  10 mg/kg intravenously every 8 hours

  600 mg intravenously every 12 hours

  10 to 14

  Community-acquired pneumonia, including concurrent bacteremia

  Complicated skin and skin structure infections

  Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia

  10 mg/kg intravenously every 8 hours

  600 mg intravenously every 12 hours

  14 to 28

  The maximum dose for pediatric patients should not exceed the recommended adult dose. The recommended dose is 10 mg per kg intravenously every 8 hours. Linezolid injection in a single use VisIV™ Container should be used only in pediatric patients who require the entire 600 mg dose and not any fraction thereof.

  2.2 Intravenous Administration

  Linezolid injection is supplied in single-use, ready-to-use container (VisIV™ Container) [see How Supplied/Storage and Handling (16)]. Parenteral drug products should be inspected visually for particulate matter prior to administration. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired. Keep the containers in the overwrap until ready to use. Store at room temperature. Protect from freezing. Linezolid injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

  Linezolid injection should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous container in series connections. Additives should not be introduced into this solution. If Linezolid injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each product.

  If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Linezolid injection with an infusion solution compatible with Linezolid injection and with any other drug(s) administered via this common line.

  2.3 Compatibilities

  Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer’s Injection, USP.

  2.4 Incompatibilities

  Physical incompatibilities resulted when Linezolid injection was combined with the following drugs during simulated Y-site administration: amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when Linezolid injection was combined with ceftriaxone sodium.

  2.1 General Dosage and Administration

  The recommended dosage for linezolid injection for the treatment of infections is described in Table 1. No dose adjustment is necessary when switching from intravenous to oral administration.

  Table 1. Dosage Guidelines for Linezolid Injection * Due to the designated pathogens [ see Indications and Usage (1)]

  Infection*

  Dosage, Route, and Frequency of Administration

  Recommended Duration of Treatment

  (consecutive days)

  Pediatric Patients less than 12 Years of Age

  Adults and Adolescents (12 Years and Older)

  Nosocomial pneumonia

  10 mg/kg intravenously every 8 hours

  600 mg intravenously every 12 hours

  10 to 14

  Community-acquired pneumonia, including concurrent bacteremia

  Complicated skin and skin structure infections

  Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia

  10 mg/kg intravenously every 8 hours

  600 mg intravenously every 12 hours

  14 to 28

  The maximum dose for pediatric patients should not exceed the recommended adult dose. The recommended dose is 10 mg per kg intravenously every 8 hours. Linezolid injection in a single use VisIV™ Container should be used only in pediatric patients who require the entire 600 mg dose and not any fraction thereof.

  2.2 Intravenous Administration

  Linezolid injection is supplied in single-use, ready-to-use container (VisIV™ Container) [see How Supplied/Storage and Handling (16)]. Parenteral drug products should be inspected visually for particulate matter prior to administration. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired. Keep the containers in the overwrap until ready to use. Store at room temperature. Protect from freezing. Linezolid injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

  Linezolid injection should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous container in series connections. Additives should not be introduced into this solution. If Linezolid injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each product.

  If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Linezolid injection with an infusion solution compatible with Linezolid injection and with any other drug(s) administered via this common line.

  2.3 Compatibilities

  Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer’s Injection, USP.

  2.4 Incompatibilities

  Physical incompatibilities resulted when Linezolid injection was combined with the following drugs during simulated Y-site administration: amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when Linezolid injection was combined with ceftriaxone sodium.

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• Teva Parenteral Medicines, Inc.
  

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  Linezolid | Xeransis Llc

  

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  Apply to underarms only. Apply 2-3 sprays to each underarm immediately before bedtime. Apply every other day for the first week of use and then 2-4 times weekly thereafter as needed. Shaving the application area may be necessary to ensure proper skin contact. Do not apply within 24 hours after shaving. Delay application after bathing by at least an hour.

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