Linezolid Glenmark Side effects

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What are the possible side effects of Linezolid Glenmark?

Get emergency medical help if you have any of these signs of an allergic reaction to Linezolid Glenmark: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Common Linezolid Glenmark side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Linezolid Glenmark in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Adult Patients: The safety of Linezolid Glenmark 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 Glenmark 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 Glenmark 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 Glenmark.

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

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

What is the most important information I should know about Linezolid Glenmark?

Linezolid Glenmark contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Do not use Linezolid Glenmark 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 Glenmark. Before using Linezolid Glenmark, tell your doctor about all other medications you use. You may need to stop using certain medicines before using Linezolid Glenmark (in some cases for up to 5 weeks before you start Linezolid Glenmark). During your treatment with Linezolid Glenmark, do not start or stop using any other medications unless your doctor tells you to.

You should not use Linezolid Glenmark 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 Glenmark 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.


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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. European Chemicals Agency - ECHA. "(S)-N-((3-(3-Fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl)methyl)acetamide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  3. HSDB. "LINEZOLID". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Linezolid Glenmark 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 Glenmark. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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