Linezolid

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Dosage, Route, and Frequency of Administration Infection Pediatric Patients (Birth through 11 years of Age)
• Adults and Adolescents (12 years and Older) Duration (days) Nosocomial pneumonia 10 mg/kg intravenous or oral every 8 hours 600 mg intravenous 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 intravenous or oral every 8 hours 600mg intravenous 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 to 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
• 2.1 General Dosage and Administration The recommended dosage for linezolid for oral suspension formulations for the treatment of infections is described in Table 1.
• Table 1.
• Dosage Guidelines for Linezolid for Oral Suspension Infection Due to the designated pathogens [see Indications and Usage (1)] Dosage, Route and Frequency of Administration Recommended Duration of Treatment (consecutive days) Pediatric Patients 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 sub-optimal 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)].
• (Birth through 11 Years of Age)
• Adults and Adolescents (12 Years and Older) Nosocomial pneumonia 10 mg/kg intravenously or oral Oral dosing using either linezolid Tablets or linezolid for Oral Suspension [see How Supplied/Storage and Handling (16)]. 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 No dose adjustment is necessary when switching from intravenous to oral administration.
• 2.5 Constitution of Oral Suspension Linezolid 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.
• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of linezolid for the treatment of pediatric patients with the following infections are supported by evidence from adequate and well-controlled studies in
• adults, pharmacokinetic data in pediatric patients, and additional data from a comparator-controlled study of Gram-positive infections in pediatric patients ranging in age from birth through 11 years [see Indications and Usage (1) , Clinical Pharmacology (12.3) and Clinical Studies (14) ]:
• nosocomial pneumonia complicated skin and skin structure infections community-acquired pneumonia (also supported by evidence from an uncontrolled study in patients ranging in age from 8 months through 12 years) vancomycin-resistant Enterococcus faecium infections The safety and effectiveness of linezolid for the treatment of pediatric patients with the following infection have been established in a comparator-controlled study in pediatric patients ranging in age from 5 through 17 years [see Clinical Studies (14) ]:
• uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes Pharmacokinetic information generated in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) linezolid concentrations following single and multiple dosing of linezolid; therapeutic concentrations were not consistently achieved or maintained in the CSF.
• Therefore, the use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended.
• The pharmacokinetics of linezolid have been evaluated in pediatric patients from birth to 17 years of age.
• In general, weight-based clearance of linezolid gradually decreases with increasing age of pediatric patients.
• However, in preterm (gestational age < 34 weeks) neonates < 7 days of age, linezolid clearance is often lower than in full-term neonates < 7 days of age.
• Consequently, preterm neonates < 7 days of age may need an alternative linezolid dosing regimen of 10 mg/kg every 12 hours [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ].
• In limited clinical experience, 5 out of 6 (83%) pediatric patients with infections due to Gram-positive pathogens with minimum inhibitory concentrations (MICs) of 4 mcg/mL treated with linezolid had clinical cures.
• However, pediatric patients exhibit wider variability in linezolid clearance and systemic exposure (AUC) compared with
• adults.
• In pediatric patients with a sub-optimal clinical response, particularly those with pathogens with MIC of 4 mcg/mL, lower systemic exposure, site and severity of infection, and the underlying medical condition should be considered when assessing clinical response [see Clinical Pharmacology (12.3) and Dosage and Administration (2) ].

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the 2,046 patients treated with linezolid in Phase 3 comparator-controlled clinical trials, 589 (29%) were 65 years or older and 253 (12%) were 75 years or older.
• No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

• Most common adverse reactions (>5% of adult and/or pediatric patients treated with linezolid for oral suspension) include:
• diarrhea, vomiting, headache, nausea, and anemia.
• (6) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-886-495-1995 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 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.
• Adults The safety of linezolid formulations was evaluated in 2,046 adult patients enrolled in seven Phase 3 comparator-controlled clinical trials, who were treated for up to 28 days.
• Of the patients treated for uncomplicated skin and skin structure infections (uSSSIs), 25.4% of linezolid -treated and 19.6% of comparator-treated patients experienced at least one drug-related adverse event.
• For all other indications, 20.4% of linezolid -treated and 14.3% of comparator-treated patients experienced at least one drug-related adverse event.
• Table 2 shows the incidence of all-causality, treatment-emergent adverse reactions reported in at least 1% of adult patients in these trials by dose of linezolid.
• Table 2.
• Incidence (%) of Treatment–Emergent Adverse Reactions Occurring in >1% of Adult Patients Treated with Linezolid in Comparator-Controlled Clinical Trials ADVERSE REACTIONS Uncomplicated Skin and Skin Structure Infections All Other Indications Linezolid 400 mg by mouth every 12 hours (n=548) Clarithromycin 250 mg by mouth every 12 hours (n=537) Linezolid 600 mg every 12 hours (n=1498) All Other Comparators Comparators included cefpodoxime proxetil 200 mg by mouth every 12 hours; ceftriaxone 1 g intravenously every 12 hours; dicloxacillin 500 mg by mouth every 6 hours; oxacillin 2 g intravenously every 6 hours; vancomycin 1 g intravenously every 12 hours.
• (n=1464) Headache 8.8 8.4 5.7
• 4.4 Diarrhea 8.2 6.1 8.3
• 6.4 Nausea 5.1 4.5 6.6
• 4.6 Vomiting 2 1.5 4.3
• 2.3 Dizziness 2.6 3 1.8
• 1.5 Rash 1.1 1.1 2.3
• 2.6 Anemia 0.4 0 2.1
• 1.4 Taste alteration 1.8 2 1
• 0.3 Vaginal moniliasis 1.8 1.3 1.1
• 0.5 Oral moniliasis 0.5 0 1.7 1 Abnormal liver function tests 0.4 0.2 1.6
• 0.8 Fungal infection 1.5 0.2 0.3
• 0.2 Tongue discoloration 1.3 0 0.3 0 Localized abdominal pain 1.3 0.6 1.2
• 0.8 Generalized abdominal pain 0.9 0.4 1.2 1 Of the patients treated for uSSSIs, 3.5% of linezolid -treated and 2.4% of comparator-treated patients discontinued treatment due to drug-related adverse events.
• For all other indications, discontinuations due to drug-related adverse events occurred in 2.1% of linezolid -treated and 1.7% of comparator-treated patients.
• The most common reported drug-related adverse events leading to discontinuation of treatment were nausea, headache, diarrhea, and vomiting.
• Pediatric Patients The safety of linezolid formulations was evaluated in 215 pediatric patients ranging in age from birth through 11 years, and in 248 pediatric patients aged 5 through 17 years (146 of these 248 were age 5 through 11 and 102 were age 12 to 17).
• These patients were enrolled in two Phase 3 comparator-controlled clinical trials and were treated for up to 28 days.
• In the study of hospitalized pediatric patients (birth through 11 years) with Gram-positive infections, who were randomized 2 to 1 (linezolid:
• vancomycin), mortality was 6.0% (13/215) in the linezolid arm and 3 % (3/101) in the vancomycin arm.
• However, given the severe underlying illness in the patient population, no causality could be established.
• Of the pediatric patients treated for uSSSIs, 19.2% of linezolid-treated and 14.1% of comparator-treated patients experienced at least one drug-related adverse event.
• For all other indications, 18.8% of linezolid -treated and 34.3% of comparator-treated patients experienced at least one drug-related adverse event.
• Table 3 shows the incidence of all-causality, treatment-emergent adverse reactions reported in more than 1% of pediatric patients (and more than 1 patient) in either treatment group in the comparator-controlled Phase 3 trials.
• Table 3.
• Incidence (%) of Treatment-Emergent Adverse Reactions Occurring in > 1% of Pediatric Patients (and >1 Patient) in Either Treatment Group in Comparator-Controlled Clinical Trials ADVERSE REACTIONS Uncomplicated Skin and Skin Structure Infections Patients 5 through 11 years of age received linezolid 10 mg/kg by mouth every 12 hours or cefadroxil 15 mg/kg by mouth every 12 hours.
• Patients 12 years or older received linezolid 600 mg by mouth every 12 hours or cefadroxil 500 mg by mouth every 12 hours.
• All Other Indications Patients from birth through 11 years of age received linezolid 10 mg/kg intravenously by mouth every 8 hours or vancomycin 10 to 15 mg/kg intravenously every 6-24 hours, depending on age and renal clearance.
• Linezolid (n=248) Cefadroxil (n=251) Linezolid (n=215) Vancomycin (n=101) Diarrhea 7.8 8 10.8
• 12.1 Vomiting 2.9 6.4 9.4
• 9.1 Headache 6.5 4 0.9 0 Anemia 0 0 5.6
• 7.1 Thrombocytopenia 0 0 4.7 2 Nausea 3.7 3.2 1.9 0 Generalized abdominal pain 2.4 2.8 0.9 2 Localized abdominal pain 2.4 2.8 0.5 1 Loose stools 1.6 0.8 2.3 3 Eosinophilia 0.4 0.8 1.9 1 Pruritus at non-application site 0.8 0.4 1.4 2 Vertigo 1.2 0.4 0 0 Of the pediatric patients treated for uSSSIs, 1.6% of linezolid-treated and 2.4% of comparator-treated patients discontinued treatment due to drug-related adverse events.
• For all other indications, discontinuations due to drug-related adverse events occurred in 0.9% of linezolid-treated and 6.1% of comparator-treated patients.
• Laboratory Abnormalities Linezolid has been associated with thrombocytopenia when used in doses up to and including 600 mg every 12 hours for up to 28 days.
• In Phase 3 comparator-controlled trials, the percentage of adult patients who developed a substantially low platelet count (defined as less than 75% of lower limit of normal and/or baseline) was 2.4% (range among studies:
• 0.3 to 10%) with linezolid and 1.5% (range among studies:
• 0.4 to 7%) with a comparator.
• In a study of hospitalized pediatric patients ranging in age from birth through 11 years, the percentage of patients who developed a substantially low platelet count (defined as less than 75% of lower limit of normal and/or baseline) was 12.9% with linezolid and 13.4% with vancomycin.
• In an outpatient study of pediatric patients aged from 5 through 17 years, the percentage of patients who developed a substantially low platelet count was 0% with linezolid and 0.4% with cefadroxil.
• Thrombocytopenia associated with the use of linezolid appears to be dependent on duration of therapy (generally greater than 2 weeks of treatment).
• The platelet counts for most patients returned to the normal range/baseline during the follow-up period.
• No related clinical adverse events were identified in Phase 3 clinical trials in patients developing thrombocytopenia.
• Bleeding events were identified in thrombocytopenic patients in a compassionate use program for linezolid; the role of linezolid in these events cannot be determined [see Warnings and Precautions (5.1) ].
• Changes seen in other laboratory parameters, without regard to drug relationship, revealed no substantial differences between linezolid and the comparators.
• These changes were generally not clinically significant, did not lead to discontinuation of therapy, and were reversible.
• The incidence of adult and pediatric patients with at least one substantially abnormal hematologic or serum chemistry value is presented in Tables 4, 5, 6, and 7.
• Table 4.
• Percent of Adult Patients who Experienced at Least One Substantially Abnormal <75% (<50% for neutrophils) of Lower Limit of Normal (LLN) for values normal at baseline; <75% (<50% for neutrophils) of LLN and of baseline for values abnormal at baseline.
• Hematology Laboratory Value in Comparator-Controlled Clinical Trials with Linezolid Laboratory Assay Uncomplicated Skin and Skin Structure Infections All Other Indications Linezolid 400 mg every 12 hours Clarithromycin 250 mg every 12 hours Linezolid 600 mg every 12 hours All Other Comparators Comparators included cefpodoxime proxetil 200 mg by mouth every 12 hours; ceftriaxone 1 g intravenously every 12 hours; dicloxacillin 500 mg by mouth every 6 hours; oxacillin 2 g intravenously every 6 hours; vancomycin 1 g intravenously every 12 hours.
• Hemoglobin (g/dL) 0.9 0 7.1
• 6.6 Platelet count (x 10 3 /mm 3 ) 0.7 0.8 3
• 1.8 WBC (x 10 3 /mm 3 ) 0.2 0.6 2.2
• 1.3 Neutrophils (x 10 3 /mm 3 ) 0 0.2 1.1
• 1.2 Table 5.
• Percent of Adult Patients who Experienced at Least One Substantially Abnormal >2 x Upper Limit of Normal (ULN) for values normal at baseline; >2 x ULN and >2 x baseline for values abnormal at baseline.
• Serum Chemistry Laboratory Value in Comparator-Controlled Clinical Trials with Linezolid Laboratory Assay Uncomplicated Skin and Skin Structure Infections All Other Indications Linezolid 400 mg every 12 hours Clarithromycin 250 mg every 12 hours Linezolid 600 mg every 12 hours All Other Comparators Comparators included cefpodoxime proxetil 200 mg by mouth every 12 hours; ceftriaxone 1 g intravenously every 12 hours; dicloxacillin 500 mg by mouth every 6 hours; oxacillin 2 g intravenously every 6 hours; vancomycin 1 g intravenously every 12 hours.
• AST (U/L) 1.7 1.3 5
• 6.8 ALT (U/L) 1.7 1.7 9.6
• 9.3 LDH (U/L) 0.2 0.2 1.8
• 1.5 Alkaline phosphatase (U/L) 0.2 0.2 3.5
• 3.1 Lipase (U/L) 2.8 2.6 4.3
• 4.2 Amylase (U/L) 0.2 0.2 2.4 2 Total bilirubin (mg/dL) 0.2 0 0.9
• 1.1 BUN (mg/dL) 0.2 0 2.1
• 1.5 Creatinine (mg/dL) 0.2 0 0.2
• 0.6 Table 6.
• Percent of Pediatric Patients who Experienced at Least One Substantially Abnormal <75% (<50% for neutrophils) of Lower Limit of Normal (LLN) for values normal at baseline; <75% (<50% for neutrophils) of LLN and <75% (<50% for neutrophils, <90% for hemoglobin if baseline <LLN) of baseline for values abnormal at baseline.
• Hematology Laboratory Value in Comparator-Controlled Clinical Trials with Linezolid Laboratory Assay Uncomplicated Skin and Skin Structure Infections Patients 5 through 11 years of age received linezolid 10 mg/kg by mouth every 12 hours or cefadroxil 15 mg/kg by mouth every 12 hours.
• Patients 12 years or older received linezolid 600 mg by mouth every 12 hours or cefadroxil 500 mg by mouth every 12 hours.
• All Other Indications Patients from birth through 11 years of age received linezolid 10 mg/kg intravenously by mouth every 8 hours or vancomycin 10 to 15 mg/kg intravenously every 6 to 24 hours, depending on age and renal clearance.
• Linezolid Cefadroxil Linezolid Vancomycin Hemoglobin (g/dL) 0 0 15.7
• 12.4 Platelet count (x 10 3 /mm 3 ) 0 0.4 12.9
• 13.4 WBC (x 10 3 /mm 3 ) 0.8 0.8 12.4
• 10.3 Neutrophils (x 10 3 /mm 3 ) 1.2 0.8 5.9
• 4.3 Table 7.
• Percent of Pediatric Patients who Experienced at Least One Substantially Abnormal 11 Serum Chemistry Laboratory Value in Comparator-Controlled Clinical Trials with Linezolid Laboratory Assay Uncomplicated Skin and Skin Structure Infections Patients 5 through 11 years of age received linezolid 10 mg/kg by mouth every 12 hours or cefadroxil 15 mg/kg by mouth every 12 hours.
• Patients 12 years or older received linezolid 600 mg mouth every 12 hours or cefadroxil 500 mg by mouth every 12 hours.
• All Other Indications 13 Linezolid Cefadroxil Linezolid Vancomycin ALT (U/L) 0 0 10.1
• 12.5 Lipase (U/L) 0.4 1.2 --- --- Amylase (U/L) --- --- 0.6
• 1.3 Total bilirubin (mg/dL) --- --- 6.3
• 5.2 Creatinine (mg/dL) 0.4 0 2.4 1
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of linezolid.
• 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:
• Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) [see Warnings and Precautions (5.1) ]; sideroblastic anemia.
• Peripheral neuropathy, and optic neuropathy sometimes progressing to loss of vision [see Warnings and Precautions (5.2) ].
• Lactic acidosis [see Warnings and Precautions (5.7) ].
• Although these reports have primarily been in patients treated for longer than the maximum recommended duration of 28 days, these events have also been reported in patients receiving shorter courses of therapy.
• Serotonin syndrome has been reported in patients receiving concomitant serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and opioids, and linezolid [see Warnings and Precautions (5.3) ].
• Convulsions [see Warnings and Precautions (5.8) ].
• Anaphylaxis, angioedema, bullous skin disorders including severe cutaneous adverse reactions (SCAR) such as toxic epidermal necrolysis and Stevens-Johnson syndrome, and hypersensitivity vasculitis.
• Superficial tooth discoloration and tongue discoloration have been reported with the use of linezolid.
• The tooth discoloration was removable with professional dental cleaning (manual descaling) in cases with known outcome.
• Hypoglycemia, including symptomatic episodes [see Warnings and Precautions (5.9) ].
• Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) [see Warnings and Precautions (5.10) ].

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Important Administration Instructions Advise patients that linezolid for oral suspension may be taken with or without food.
• Peripheral and Optic Neuropathy Advise patients to inform their physician if they experience changes in vision while taking linezolid for oral suspension [see Warnings and Precautions (5.2) ].
• Serotonin Syndrome Advise patients to inform their physician if taking serotonergic agents, including serotonin re-uptake inhibitors or other antidepressants and opioids [see Warnings and Precautions (5.3) ].
• Potential Interactions Producing Elevation of Blood Pressure Advise patients to inform their physician if they have a history of hypertension.
• Advise patients to
• avoid large quantities of foods or beverages with high tyramine content while taking linezolid for oral suspension.
• Foods high in tyramine content include those that may have undergone protein changes by aging, fermentation, pickling, or smoking to improve flavor, such as aged cheeses, fermented or air-dried meats, sauerkraut, soy sauce, tap beers, and red wines.
• The tyramine content of any protein-rich food may be increased if stored for long periods or improperly refrigerated.
• Advise patients to inform their physician if taking medications containing pseudoephedrine HCl or phenylpropanolamine HCl, such as cold remedies and decongestants [see Warnings and Precautions (5.6) ].
• Lactic Acidosis Advise patients to inform their physician if they experience repeated episodes of nausea or vomiting while receiving linezolid for oral suspension [see Warnings and Precautions (5.7) ].
• Convulsions Advise patients to inform their physician if they have a history of seizures or convulsions [see Warnings and Precautions (5.8) ].
• Hypoglycemia Advise patients to inform their physician if they have diabetes mellitus.
• Hypoglycemic reactions, such as diaphoresis and tremulousness, along with low blood glucose measurements may occur when treated with linezolid.
• If such reactions occur, patients should contact a physician or other health professional for proper treatment [see Warnings and Precautions (5.9) ].
• Hyponatremia and/or SIADH Advise patients at risk for hyponatremia to inform their physician if they experience signs and symptoms of hyponatremia and/or SIADH, including confusion, somnolence, generalized weakness, and respiratory distress [see Warnings and Precautions (5.10) ].
• Phenylketonuria Advise patients with phenylketonuria (PKU) that each 5 mL of the 100 mg/5 mL linezolid for oral suspension contains 20 mg phenylalanine.
• The other linezolid for oral suspension formulations do not contain phenylalanine.
• Phenylalanine can be harmful to patients with phenylketonuria.
• Contact your physician or pharmacist when prescribed with linezolid for Oral Suspension [see Warnings and Precautions (5.11) ].
• Antibacterial Resistance Patients should be counseled that antibacterial drugs including linezolid for oral suspension should only be used to treat bacterial infections.
• They do not treat viral infections (e.g., the common cold).
• When linezolid for oral suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
• Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by linezolid for oral suspension or other antibacterial drugs in the future.
• Diarrhea Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterial drug is discontinued.
• Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug.
• If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.5) ].
• Infertility Advise male patients that linezolid for oral suspension may reversibly impair fertility [see Use in Specific Populations (8.3) ].
• Distributed by: American Health Packaging Columbus, OH 43217 Revised: 06/2023 2102455

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Linezolid for Oral Suspension:
• White or off white to brown granule/powder.
• When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL.
• For oral suspension: 100 mg of linezolid per each 5 mL.
• (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.3 Oral Suspension Linezolid for Oral Suspension is available as a dry, white or off-white to brown granule/powder.
• When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL.
• Linezolid for Oral Suspension is supplied as follows:
• 100 mg/5 mL in 250 mL glass bottles NDC 60687-754-05
• Storage and Handling
• Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature].
• Protect from light.
• Keep bottles tightly closed to protect from moisture.

Quoted from the official label, section “How Supplied”.

What is in it

• Linezolid for Oral Suspension contain linezolid USP, which is a synthetic antibacterial agent of the oxazolidinone class.
• The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4 morpholinyl) phenyl]-2-oxo- 5-oxazolidinyl] methyl]-acetamide.
• The empirical formula is C 16 H 20 FN 3 O 4 .
• Its molecular weight is 337.35, and its chemical structure is represented below:
• Linezolid for Oral Suspension is supplied as white or off white to brown granule/powder for constitution into a suspension for oral administration.
• Following constitution, each 5 mL contains 100 mg of linezolid.
• Inactive ingredients are anhydrous citric acid powder, aspartame, carboxymethylcellulose sodium, colloidal silicon dioxide, glycyrrhizinate ammonium, hypromellose, mannitol, microcrystalline cellulose, sodium benzoate, sodium chloride, sucrose, trisodium citrate dihydrate, xanthan gum, and flavors [see Patient Counseling Information (17) ].
• The sodium (Na + ) content is 8.18 mg/5 mL.
• Structural Formula

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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