How do you administer this medicine?
What is Linezolid Amneal?
Linezolid Amneal (Linezolid Amneal) is an antibiotic that fights bacteria in the body. Linezolid Amneal is also an MAO (monoamine oxidase) inhibitor.
Linezolid Amneal is used to treat different types of bacterial infections, such as pneumonia, skin infections, and infections that are resistant to other antibiotics.
Linezolid Amneal may also be used for purposes not listed in this medication guide.
Linezolid Amneal indications
Linezolid Amneal Tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid Amneal Tablets are not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected.
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae.
Community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only).
1.2 Skin and Skin Structure Infections
Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae. Linezolid Amneal Tablets have not been studied in the treatment of decubitus ulcers.
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.
Vancomycin-resistant Enterococcus faecium Infections
Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezolid Amneal Tablets and other antibacterial drugs, Linezolid Amneal Tablets should be used only to treat or prevent 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.
The safety and efficacy of Linezolid Amneal Tablets given for longer than 28 days have not been evaluated in controlled clinical trials.
How should I use Linezolid Amneal?
Use Linezolid Amneal suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Linezolid Amneal suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Gently mix before each dose by turning the bottle upside-down 3 to 5 times. Do not shake Linezolid Amneal suspension.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- To clear up your infection completely, take Linezolid Amneal suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Linezolid Amneal suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Linezolid Amneal suspension.
Uses of Linezolid Amneal in details
Linezolid Amneal is used to treat bacterial infections such as pneumonia (community acquired pneumonia and nosocomial pneumonia), skin infections and infections that are resistant to other antibiotics.
Linezolid Amneal description
Linezolid Amneal I.V. Injection, Linezolid Amneal Tablets, and Linezolid Amneal for
Oral Suspension contain Linezolid Amneal, which is a synthetic antibacterial agent of the oxazolidinone class.
Linezolid Amneal Tablet for oral administration contains 600 mg Linezolid Amneal as a film-coated compressed tablet. The sodium (Na+) content is 2.92 mg per 600-mg tablet (0.1 mEq/tablet).
Linezolid Amneal for
Oral Suspension is supplied as an orange-flavored granule/powder for constitution into a suspension for oral administration. Following constitution, each 5 mL contains 100 mg of Linezolid Amneal. The sodium (Na+) content is 8.52 mg/5 mL (0.4 mEq/5 mL).
Linezolid Amneal I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of Linezolid Amneal. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300-mL bag; 3.3 mEq/200-mL bag; and 1.7 mEq/100-mL bag).
The chemical name for Linezolid Amneal is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide.
The empirical formula is C16H20FN3O4. Its molecular weight is 337.35.
Excipients/Inactive Ingredients: Film-Coated Tablet: Corn starch, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, and carnauba wax. Powd for
Oral Suspension: Sucrose, citric acid, sodium citrate, microcrystalline cellulose and carboxymethylcellulose sodium, aspartame, xanthan gum, mannitol, sodium benzoate, colloidal silicon dioxide, sodium chloride, and flavors. Infusion: Sodium citrate, citric acid, and dextrose in an aqueous vehicle for intravenous administration.
Linezolid Amneal dosage
Patients whose therapy is started with Linezolid Amneal injection may be switched to Linezolid Amneal tablets or Linezolid Amneal for oral suspension, with no dosage adjustment.
Duration of treatment is variable, depending on the pathogen isolated, site of infection and its severity. To date, the maximum duration of treatment has been 28 days.
Pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic Linezolid Amneal clearance values and larger AUC values than many full-term neonates and older infants. By day 7 of age, Linezolid Amneal clearance and AUC values are similar to those of full-term neonates and older infants.
Elderly patients: No dose adjustment is required.
Patients with Renal Insufficiency: No dose adjustment is required. Patients with severe renal insufficiency (ie, creatinine clearance <30 mL/min): No dose adjustment is required. Due to the unknown clinical significance of higher exposure (up to 10-fold) to the 2 primary metabolites of Linezolid Amneal in patients with severe renal insufficiency, Linezolid Amneal should be used with special caution in these patients and only when the anticipated benefit is considered to outweigh the theoretical risk.
As approximately 30% of a Linezolid Amneal dose is removed during 3 hrs of hemodialysis, Linezolid Amneal should be given after dialysis in patients receiving such treatment. The primary metabolites of Linezolid Amneal are removed to some extent by hemodialysis, but the concentrations of these metabolites are still very considerably higher following dialysis than those observed in patients with normal renal function or mild to moderate renal insufficiency.
Therefore, Linezolid Amneal should be used with special caution in patients with severe renal insufficiency who are undergoing dialysis and only when the anticipated benefit is considered to outweigh the theoretical risk.
To date, there is no experience of Linezolid Amneal administration to patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal failure (other than haemodialysis).
Patients with Hepatic Insufficiency: No dose adjustment is required. However, there are limited clinical data and it is recommended that Linezolid Amneal should be used in such patients only when anticipated benefit is considered to outweigh the theoretical risk.
Children: Recommended dosages for pediatric patients, see Table 2.
Linezolid Amneal Injection: Administer Linezolid Amneal injection by IV infusion over a period of 30-120 min. Do not use the IV infusion bag in series connections. Do not introduce additives into the IV solution. If Linezolid Amneal 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.
Linezolid Amneal interactions
Drugs Metabolized by Cytochrome P-450: Linezolid Amneal 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 Amneal. Drugs eg, warfarin and phenytoin, which are CYP2C9 substrates, may be given with Linezolid Amneal without changes in dosage regimen.
Antibiotics: The pharmacokinetics of Linezolid Amneal were not altered when administered together with either aztreonam or gentamicin. The effect of rifampin on the pharmacokinetics of Linezolid Amneal was studied in 16 healthy adult male volunteers administered Linezolid Amneal 600 mg twice daily for 2.5 days with and without rifampin 600 mg once daily for 8 days. Rifampin decreased the Linezolid Amneal 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 Amneal is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, Linezolid Amneal 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 Amneal and tyramine doses of >100 mg. Therefore, patients receiving Linezolid Amneal 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 Amneal 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 Amneal alone, and the combination of steady-state Linezolid Amneal (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 Amneal alone=120 (107-135); PPA alone=125 (106-139); PPA with Linezolid Amneal=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 Amneal 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 Amneal. No serotonin syndrome effects (confusion, delirium, restlessness, tremors, blushing, diaphoresis, hyperpyrexia) have been observed in normal subjects receiving Linezolid Amneal 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 Amneal and serotonergic agents have been reported.
Incompatibilities: Injection: Additives should not be introduced into this solution. If Linezolid Amneal 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 Amneal administration with a compatible infusion solution.
Linezolid Amneal 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).
Linezolid Amneal side effects
Adult Patients: The safety of Linezolid Amneal formulations was evaluated in 2046 adult patients enrolled in 7 phase III comparator-controlled clinical trials who were treated for up to 28 days. In these studies, 85% of the adverse events reported with Linezolid Amneal were described as mild to moderate in intensity. Table 14 shows the incidence of adverse events reported in at least 2% of patients in these trials. The most common adverse events in patients treated with Linezolid Amneal were diarrhea (incidence across studies: 2.8-11%), headache (incidence across studies: 0.5-11.3%) and nausea (incidence across studies: 3.4-9.6%).
Other adverse events reported in phase II and phase III studies included oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus and tongue discoloration.
Table 15 shows the incidence of drug-related adverse events reported in at least 1% of adult patients in these trials by dose of Linezolid Amneal.
Pediatric Patients: The safety of Linezolid Amneal formulations was evaluated in 215 pediatric patients ranging in age from birth through 11 years and in 248 pediatric patients 5-17 years (146 of these 248 were 5-11 years and 102 were 12-17 years). These patients were enrolled in 2 phase III comparator-controlled clinical trials and were treated for up to 28 days. In these studies, 83% and 99%, respectively, of the adverse events reported with Linezolid Amneal were described as mild to moderate in intensity. In the study of hospitalized pediatric patients (birth through 11 years) with gram-positive infections who were randomized 2:1 (Linezolid Amneal:vancomycin), mortality was 6% (13/215) in the Linezolid Amneal arm and 3% (3/101) in the vancomycin arm. However, given the severe underlying illness in the patient population, no causality could be established. Table 16 shows the incidence of adverse events reported in at least 2% of pediatric patients treated with Linezolid Amneal in these trials.
Table 17 shows the incidence of drug-related adverse events reported in >1% of pediatric patients (and >1 patient) in either treatment group in the comparator-controlled phase III trials.
Laboratory Changes: Linezolid Amneal has been associated with thrombocytopenia when used in doses up to and including 600 mg every 12 hrs for up to 28 days. In phase III comparator-controlled trials, the percentage of adult patients who developed a substantially low platelet count (defined as <75% of lower limit of normal and/or baseline) was 2.4% (range among studies: 0.3-10%) with Linezolid Amneal and 1.5% (range among studies: 0.4-7%) 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 <75% of lower limit of normal and/or baseline) was 12.9% with Linezolid Amneal and 13.4% with vancomycin. In an outpatient study of pediatric patients from 5-17 years, the percentage of patients who developed a substantially low platelet count was 0% with Linezolid Amneal and 0.4% with cefadroxil. Thrombocytopenia associated with the use of Linezolid Amneal appears to be dependent on duration of therapy (generally >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 III clinical trials in patients developing thrombocytopenia. Bleeding events were identified in thrombocytopenic patients in a compassionate use program for Linezolid Amneal; the role of Linezolid Amneal in these events cannot be determined.
Changes seen in other laboratory parameters, without regard to drug relationship, revealed no substantial differences between Linezolid Amneal and the comparators. These changes were generally not clinically significant, did not lead to discontinuation of therapy and were reversible. The incidence of adults and pediatric patients with at least 1 substantially abnormal hematologic or serum chemistry value is presented in Tables 18, 19, 20 and 21.
Post-Marketing Experience: Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported during post-marketing use of Linezolid Amneal. Peripheral neuropathy and optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with Linezolid Amneal. Lactic acidosis has been reported with the use of Linezolid Amneal. 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 eg, selective serotonin reuptake inhibitors (SSRIs) and Linezolid Amneal. Convulsions have been reported with the use of Linezolid Amneal. Superficial tooth discoloration and tongue discoloration have been reported with the use of Linezolid Amneal. The tooth discoloration was removable with professional dental cleaning (manual descaling) in case with known outcome. Anaphylaxis, angioedema and bullous skin disorders such as those described as Stevens-Johnson syndrome have been reported. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Linezolid Amneal or a combination of these factors. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made and causal relationship cannot be precisely established.
Linezolid Amneal contraindications
Do not use Linezolid Amneal if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Many drugs can interact with Linezolid Amneal. Before using Linezolid Amneal, tell your doctor about all other medications you use. You may need to stop using certain medicines before using Linezolid Amneal (in some cases for up to 5 weeks before you start Linezolid Amneal). During your treatment with Linezolid Amneal, do not start or stop using any other medications unless your doctor tells you to.
You should not use Linezolid Amneal if you have untreated or uncontrolled high blood pressure, a carcinoid tumor, adrenal gland tumor, or a severely overactive thyroid.
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.
Eating tyramine while you are using Linezolid Amneal can raise your blood pressure to dangerous levels. Avoid foods that have a high level of tyramine, such as aged cheeses or meats, pickled or fermented meats, smoked or air-dried meats, sauerkraut, soy sauce, tap beer, red wine, or any meat, cheese, or other protein-based food that has been improperly stored.
Active ingredient matches for Linezolid Amneal:
Linezolid in Netherlands.
List of Linezolid Amneal substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|Linezolida Teva (Portugal)|
|Linezonix 600mg TAB / 4 (Phoenix)||$ 3.30|
|LINEZONIX tab 600 mg x 4's (Phoenix)||$ 3.30|
|LINEZOX INFUSION 1 bottle / 300 ML infusion each (Claris Lifesciences Ltd)||$ 5.22|
|LINIBACT 600MG TABLET 1 strip / 4 tablets each (Goddres Pharmaceuticals Pvt Ltd)||$ 2.72|
|LINID Capsule/ Tablet / 600mg / 4 units (Zydus Cadila)||$ 6.15|
|600 mg x 300ml (Zydus Cadila)||$ 5.89|
|600 mg x 4's (Zydus Cadila)||$ 5.97|
|Linid 600 mg x 1 Box (Zydus Cadila)|
|Linid 600mg INF / 300ml (Zydus Cadila)||$ 5.89|
|Linid 600mg TAB / 4 (Zydus Cadila)||$ 5.97|
|LINID 600 MG TABLET 1 strip / 4 tablets each (Zydus Cadila)||$ 2.37|
|LINID 600 MG TABLET 1 strip / 10 tablets each (Zydus Cadila)||$ 5.11|
|LINID IV 600 MG INFUSION 1 bottle / 300 ML infusion each (Zydus Cadila)||$ 6.03|
|LINID OD TABLET 1 strip / 5 tablets each (Zydus Cadila)||$ 6.89|
|LINID infusion 600 mg x 300ml (Zydus Cadila)||$ 5.97|
|LINID tab 600 mg x 10's (Zydus Cadila)||$ 6.57|
|Linid 600mg INF / 300ml (Zydus Cadila)||$ 5.89|
|Linid 600mg TAB / 4 (Zydus Cadila)||$ 5.97|
|Linid 600mg Tablet (Zydus Cadila)||$ 0.53|
|Linid 600mg Infusion (Zydus Cadila)||$ 0.02|
|Linid 1200mg Tablet (Zydus Cadila)||$ 1.38|
|LINID INF Capsule/ Tablet / 600mg / 300ml units (Zydus Cadila)||$ 5.89|
|LINID-OD tab 1200 mg x 5's (Zydus Cadila)||$ 6.27|
|LINOBID tab 600 mg x 10's (Systemic)|
|LINOBID dry syr 100 mg x 30ml (Systemic)|
|LINOKEM 600 MG TABLET 1 strip / 10 tablets each (Alkem Laboratories Ltd)||$ 4.76|
|LINOKEM 600MG INFUSION 1 bottle / 300 ML infusion each (Alkem Laboratories Ltd)||$ 6.75|
|Linokem 600mg Infusion (Alkem Laboratories Ltd)||$ 0.02|
|Linokem 600mg Tablet (Alkem Laboratories Ltd)||$ 0.32|
|LINOLET tab 600 mg x 4's (Ikon)||$ 4.75|
|LINOLET infusion 600 mg x 300 mL x 300ml (Ikon)||$ 6.33|
|LINOMAX 200MG INFUSION 1 bottle / 300 ML infusion each (Venus Remedies Ltd)||$ 3.02|
|LINOPIK OD TABLET SR|
|LINOPIK OD TABLET SR 1 strip / 5 tablet srs each (Auxiliare Healthcare Pvt Ltd)||$ 6.27|
|200 mg x 100 mL x 300ml (AHPL)||$ 6.19|
|600 mg x 4's (AHPL)||$ 6.19|
|Linoplus 200mg x 100mL INF / 300ml (AHPL)||$ 6.19|
|Linoplus 600mg FC-TAB / 4 (AHPL)||$ 6.19|
|LINOPLUS 2MG INFUSION 1 bottle / 300 ML infusion each (AHPL)||$ 6.19|
|LINOPLUS 600MG TABLET 1 strip / 10 tablets each (AHPL)||$ 5.11|
- 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).
- PubChem. "linezolid". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "linezolid". http://www.drugbank.ca/drugs/DB00601 (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Linezolid Amneal are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Linezolid Amneal. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology