Linezlid Uses

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What is Linezlid?

Linezlid (Linezlid) is an antibiotic that fights bacteria in the body. Linezlid is also an MAO (monoamine oxidase) inhibitor.

Linezlid is used to treat different types of bacterial infections, such as pneumonia, skin infections, and infections that are resistant to other antibiotics.

Linezlid may also be used for purposes not listed in this medication guide.

Linezlid indications

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Linezlid Tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezlid 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.

Pneumonia

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. Linezlid 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.

1.4 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezlid Tablets and other antibacterial drugs, Linezlid 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 Linezlid Tablets given for longer than 28 days have not been evaluated in controlled clinical trials.

How should I use Linezlid?

Use Linezlid suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Linezlid suspension.

Uses of Linezlid in details

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Linezlid 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.

Linezlid description

Linezlid I.V. Injection, Linezlid Tablets, and Linezlid for

Oral Suspension contain Linezlid, which is a synthetic antibacterial agent of the oxazolidinone class.

Linezlid Tablet for oral administration contains 600 mg Linezlid as a film-coated compressed tablet. The sodium (Na+) content is 2.92 mg per 600-mg tablet (0.1 mEq/tablet).

Linezlid 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 Linezlid. The sodium (Na+) content is 8.52 mg/5 mL (0.4 mEq/5 mL).

Linezlid I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of Linezlid. 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 Linezlid 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.

Linezlid dosage

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Patients whose therapy is started with Linezlid injection may be switched to Linezlid tablets or Linezlid 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 Linezlid clearance values and larger AUC values than many full-term neonates and older infants. By day 7 of age, Linezlid 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 Linezlid in patients with severe renal insufficiency, Linezlid 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 Linezlid dose is removed during 3 hrs of hemodialysis, Linezlid should be given after dialysis in patients receiving such treatment. The primary metabolites of Linezlid 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, Linezlid 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 Linezlid 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 Linezlid 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.

Linezlid Injection: Administer Linezlid 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 Linezlid 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.

Linezlid interactions

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What other drugs will affect Linezlid?

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Monoamine Oxidase Inhibition: Linezlid is a reversible, nonselective inhibitor of

monoamine oxidase. Therefore, Linezlid has the potential for interaction with adrenergic

and serotonergic agents.

Adrenergic Agents: Some individuals receiving Linezlid may experience a reversible

enhancement of the pressor response to indirect-acting sympathomimetic agents,

vasopressor or dopaminergic agents. Commonly used drugs such as phenylpropanolamine

and pseudoephedrine have been specifically studied. Initial doses of adrenergic agents, such

as dopamine or epinephrine, should be reduced and titrated to achieve the desired response.

Serotonergic Agents: Co-administration of Linezlid and serotonergic agents was not

associated with serotonin syndrome in Phase 1, 2 or 3 studies. Spontaneous reports of

serotonin syndrome associated with co-administration of Linezlid and serotonergic agents,

including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been

reported. Patients who are treated with Linezlid and concomitant serotonergic agents

should be closely observed as described in the PRECAUTIONS, General Section.

Strong CYP450 Inducers: In a study in healthy volunteers, co-administration of rifampin

with oral Linezlid resulted in a 21% decrease in Linezlid Cmax and a 32% decrease in

Linezlid AUC0-12. The clinical significance of this interaction is unknown. Other strong

inducers of hepatic enzymes (e.g. carbamazepine, phenytoin, phenobarbital) could cause a

similar or smaller decrease in Linezlid exposure.

Linezlid side effects

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What are the possible side effects of Linezlid?

Adult Patients: The safety of Linezlid 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 Linezlid 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 Linezlid 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 Linezlid.

Pediatric Patients: The safety of Linezlid 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 Linezlid 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 (Linezlid:vancomycin), mortality was 6% (13/215) in the Linezlid 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 Linezlid 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: Linezlid 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 Linezlid 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 Linezlid 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 Linezlid and 0.4% with cefadroxil. Thrombocytopenia associated with the use of Linezlid 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 Linezlid; the role of Linezlid in these events cannot be determined.

Changes seen in other laboratory parameters, without regard to drug relationship, revealed no substantial differences between Linezlid 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 Linezlid. Peripheral neuropathy and optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with Linezlid. Lactic acidosis has been reported with the use of Linezlid. 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 Linezlid. Convulsions have been reported with the use of Linezlid. Superficial tooth discoloration and tongue discoloration have been reported with the use of Linezlid. 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 Linezlid 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.

Linezlid contraindications

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What is the most important information I should know about Linezlid?

Do not use Linezlid 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 Linezlid. Before using Linezlid, tell your doctor about all other medications you use. You may need to stop using certain medicines before using Linezlid (in some cases for up to 5 weeks before you start Linezlid). During your treatment with Linezlid, do not start or stop using any other medications unless your doctor tells you to.

You should not use Linezlid 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 Linezlid 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 Linezlid:

Linezolid


List of Linezlid substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Linezolid 600 mg
Zyvox 600 mg tablet$ 93.81
Zyvox 200 mg/100 ml iv soln$ 0.60
Linezolid tablet, film coated 600 mg/1 (Apotex Corp. (US))
Linezolid suspension 100 mg/5mL (Greenstone LLC (US))
Linezolid tablet 600 mg (Panda Pharmaceuticals Inc. (Canada))
Linezolid injection, solution 2 mg/mL (Hospira, Inc. (US))
Linezolid injection, solution 600 mg/300mL (Auro Medics Pharma Llc (US))
Linezolid injection, solution 200 mg/100mL (Sandoz Inc (US))
Linezolid tablet 600 mg/1 (Amneal Pharmaceuticals of New York, LLC (US))
LINEZOLID 600MG INFUSION 1 bottle / 300 ML infusion each (Jan Aushadhi)$ 1.15
LINEZOLID 600MG TABLET 1 strip / 10 tablets each (Jan Aushadhi)$ 2.12

References

  1. 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).
  2. PubChem. "linezolid". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "linezolid". http://www.drugbank.ca/drugs/DB00601 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Linezlid 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 Linezlid. 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.

User reports

1 consumer reported useful

Was the Linezlid drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Not useful1
100.0%


Consumer reported price estimates

No survey data has been collected yet


1 consumer reported time for results

To what extent do I have to use Linezlid before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 5 days and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Linezlid. To get the time effectiveness of using Linezlid drug by other patients, please click here.
Users%
5 days1
100.0%


Consumer reported age

No survey data has been collected yet


Consumer reviews


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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