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Dosage of Linezolid HCS 600 mg in details
General Dosage And Administration
The recommended dosage for Linezolid HCS 600 mg formulations for the treatment of infections is described in Table 1.
Table 1:Dosage Guidelines for Linezolid HCS 600 mg
|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 or oral‡ every 8 hours||600 mg intravenously or oral‡ 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 or oral‡ every 8 hours||600 mg intravenously or oral‡ every 12 hours||14 to 28|
|Uncomplicated skin and skin structure infections||less than 5 yrs: 10 mg/kg oral‡ every 8 hours 5-11 yrs: 10 mg/kg oral‡ every 12 hours||Adults: 400 mg oral‡ every 12 hours Adolescents: 600 mg oral‡ every 12 hours||10 to 14|
|*Due to the designated pathogens |
† 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 HCS 600 mg 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 sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life.
Oral dosing using either Linezolid HCS 600 mg Tablets or Linezolid HCS 600 mg for
No dose adjustment is necessary when switching from intravenous to oral administration.
Linezolid HCS 600 mg I.V. Injection is supplied in single-use, ready-to-use infusion bags.
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 infusion bags in the overwrap until ready to use. Store at room temperature. Protect from freezing. Linezolid HCS 600 mg I.V. Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.
Linezolid HCS 600 mg I.V. Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous infusion bag in series connections. Additives should not be introduced into this solution. If Linezolid HCS 600 mg I.V. 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 HCS 600 mg I.V. Injection with an infusion solution compatible with Linezolid HCS 600 mg I.V. Injection and with any other drug(s) administered via this common line.
Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer's Injection, USP.
Physical incompatibilities resulted when Linezolid HCS 600 mg I.V. 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 HCS 600 mg I.V. Injection was combined with ceftriaxone sodium.
Linezolid HCS 600 mg for
Oral Suspension is supplied as a powder/granule for constitution. Gently tap bottle to loosen powder. Add a total of 123 mL distilled water in two portions. After adding the first half, shake vigorously to wet all of the powder. Then add the second half of the water and shake vigorously to obtain a uniform suspension. After constitution, each 5 mL of the suspension contains 100 mg of Linezolid HCS 600 mg. Before using, gently mix by inverting the bottle 3 to 5 times. Do not shake. Store constituted suspension at room temperature. Use within 21 days after constitution.
Dosage Forms And Strengths
Linezolid HCS 600 mg I.V. Injection: 100-mL (200 mg Linezolid HCS 600 mg), 200-mL (400 mg Linezolid HCS 600 mg) and 300-mL (600 mg Linezolid HCS 600 mg) single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free.
Linezolid HCS 600 mg 600 mg Tablet:
white, capsule-shaped, film-coated tablet printed with “Linezolid HCS 600 mg 600 mg”
white, capsule-shaped, film-coated tablet debossed with “ZYV” on one side and “600” on the other
Linezolid HCS 600 mg for
Oral Suspension: dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of Linezolid HCS 600 mg per each 5 mL.
Storage And Handling
Linezolid HCS 600 mg I.V. Injection is available in single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free. The infusion bags are available in the following package sizes:
100 mL bag (200 mg Linezolid HCS 600 mg) NDC 0009-5137-01
100 mL bag (200 mg Linezolid HCS 600 mg) x 10 NDC 0009-5137-04
200 mL bag (400 mg Linezolid HCS 600 mg) NDC 0009-5139-01
300 mL bag (600 mg Linezolid HCS 600 mg) NDC 0009-5140-01
300 mL bag (600 mg Linezolid HCS 600 mg) 10 NDC 0009-5140-04
Linezolid HCS 600 mg Tablets are available as follows:
600 mg (white, capsule-shaped, film-coated tablets printed with “Linezolid HCS 600 mg 600 mg”)
100 tablets in HDPE bottle NDC 0009-5135-01
20 tablets in HDPE bottle NDC 0009-5135-02
Unit dose packages of 30 tablets NDC 0009-5135-03
600 mg (white, capsule-shaped, film-coated tablets debossed with “ZYV” on one side and “600” on the other)
20 tablets in HDPE bottle NDC 0009-5138-02
Unit dose packages of 30 tablets NDC 0009-5138-03
Linezolid HCS 600 mg for
Oral Suspensionis available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of Linezolid HCS 600 mg per each 5 mL. Linezolid HCS 600 mg for
Oral Suspension is supplied as follows:
100 mg/5 mL in 240-mL glass bottles NDC 0009-5136-01
Store at 25°C (77°F). Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.
Distributed by: Pharmacia & Upjohn Co., Division of Pfizer Inc., NY, NY 10017. Revised: Jul 2015
What other drugs will affect Linezolid HCS 600 mg?
During your treatment with Linezolid HCS 600 mg, do not start or stop using any other medications unless your doctor tells you to.
If you take an antidepressant or psychiatric medication, call your doctor right away if you have signs of a serious drug interaction, including: confusion, memory problems, feeling hyperactive (mentally or physically), loss of coordination, muscle twitching, shivering, sweating, diarrhea, and/or fever.
Many other drugs can interact with Linezolid HCS 600 mg, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Linezolid HCS 600 mg interactions
Drugs Metabolized by Cytochrome P-450: Linezolid HCS 600 mg is not detectably metabolised by the cytochrome P-450 (CYP) enzyme system and it does not induce or inhibit the activities of clinically significant human CYP isoforms (1A2, 2C9, 2C19, 2D6, 2E1, 3A4). Therefore, no CYP450-induced drug interactions are expected with Linezolid HCS 600 mg. Drugs eg, warfarin and phenytoin, which are CYP2C9 substrates, may be given with Linezolid HCS 600 mg without changes in dosage regimen.
Antibiotics: The pharmacokinetics of Linezolid HCS 600 mg were not altered when administered together with either aztreonam or gentamicin. The effect of rifampin on the pharmacokinetics of Linezolid HCS 600 mg was studied in 16 healthy adult male volunteers administered Linezolid HCS 600 mg 600 mg twice daily for 2.5 days with and without rifampin 600 mg once daily for 8 days. Rifampin decreased the Linezolid HCS 600 mg Cmax and AUC by a mean 21% (90% CI, 15, 27) and a mean 32% (90% CI, 27, 37) respectively. The mechanism of this interaction and its clinical significance are unknown.
Monoamine Oxidase Inhibition: Linezolid HCS 600 mg is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, Linezolid HCS 600 mg has the potential for interaction with adrenergic and serotonergic agents.
Adrenergic Agents: A significant pressor response has been observed in normal adult subjects receiving Linezolid HCS 600 mg and tyramine doses of >100 mg. Therefore, patients receiving Linezolid HCS 600 mg need to avoid consuming large amounts of foods or beverages with high tyramine content (eg, mature cheese, yeast extracts, undistilled alcoholic beverages and fermented soya bean products eg, soy sauce).
A reversible enhancement of the pressor response of either pseudoephedrine HCl (PSE) or phenylpropanolamine HCl (PPA) is observed when Linezolid HCS 600 mg is administered to healthy normotensive subjects. A similar study has not been conducted in hypertensive patients. The interaction studies conducted in normotensive subjects evaluated the blood pressure and heart rate effects of placebo, PPA or PSE alone, Linezolid HCS 600 mg alone, and the combination of steady-state Linezolid HCS 600 mg (600 mg every 12 hrs for 3 days) with 2 doses of PPA (25 mg) or PSE (60 mg) given 4 hrs apart. Heart rate was not affected by any of the treatments.
Blood pressure was increased with both combination treatments. Maximum blood pressure levels were seen 2-3 hrs after the 2nd dose of PPA or PSE and returned to baseline 2-3 hrs after peak. The results of the PPA study follow, showing the mean (and range) maximum systolic blood pressure in mm Hg: Placebo=121 (103-158); Linezolid HCS 600 mg alone=120 (107-135); PPA alone=125 (106-139); PPA with Linezolid HCS 600 mg=147 (129-176). The results from the PSE study were similar to those in the PPA study. The mean maximum increase in systolic blood pressure over baseline was 32 mm Hg (range: 20-52 mm Hg) and 38 mm Hg (range: 18-79 mm Hg) during co-administration of Linezolid HCS 600 mg with pseudoephedrine or phenylpropanolamine, respectively. Initial doses of adrenergic agents eg, dopamine or dopamine agonists, should be reduced and titrated to achieve the desired response.
Serotonergic Agents: The potential drug-drug interaction with dextromethorphan was studied in healthy volunteers. Subjects were administered dextromethorphan (two 20-mg doses given 4 hrs apart) with or without Linezolid HCS 600 mg. No serotonin syndrome effects (confusion, delirium, restlessness, tremors, blushing, diaphoresis, hyperpyrexia) have been observed in normal subjects receiving Linezolid HCS 600 mg and dextromethorphan. The effects of other serotonin re-uptake inhibitors have not been studied. However, very rare spontaneous reports of serotonin syndrome with co-administration of Linezolid HCS 600 mg and serotonergic agents have been reported.
Incompatibilities: Injection: Additives should not be introduced into this solution. If Linezolid HCS 600 mg is to be given concomitantly with other drugs, each drug should be given separately in accordance with its own directions for use. Similarly, if the same IV line is to be used for sequential infusion of several drugs, the line should be flushed prior to and following Linezolid HCS 600 mg administration with a compatible infusion solution.
Linezolid HCS 600 mg solution for infusion is known to be physically incompatible with the following compounds: Amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium and sulfamethoxazole/trimethoprim. Additionally, it is chemically incompatible with ceftriaxone sodium.
Compatible Infusion Solutions: 5% dextrose injection; 0.9% sodium chloride injection; lactated ringer's injection (Hartmann's solution for injection).
- DailyMed. "LINEZOLID: 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/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "ISQ9I6J12J: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology