Linezolid Hetero

Linezolid Hetero Adverse Reactions

linezolid

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Full Prescribing Info
Adverse Reactions
Adverse events: Clinical Trials: Adverse events considered drug-related in controlled clinical trials with an incidence of at least 1% were: abdominal pain/cramp/distension, abnormal hematology tests, abnormal liver function tests, diarrhea, headache, moniliasis, nausea, taste alteration, and vomiting.
Adult Patients: The safety of linezolid formulations was evaluated in 2046 patients enrolled in seven phase 3 comparator-controlled clinical trials, who were treated for up to 28 days. In these studies, 85% of the adverse events reported with LINEZOLID were described as mild to moderate in intensity. Table 3 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 were diarrhea (incidence across studies: 2.8% to 11.0%), headache (incidence across studies: 0.5% to 11.3%), and nausea (incidence across studies: 3.4% to 9.6%). (See Tables 3 and 4.)

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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 these studies, 83% and 99%, respectively, of the adverse events reported with LINEZOLID 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 to 1 (linezolid: vancomycin), mortality was 6.0% (13/215) in the linezolid arm and 3.0% (3/101) in the vancomycin arm. However, given the severe underlying illness in the patient population, no causality could be established. Table 5 shows the incidence of adverse events reported in at least 2% of pediatric patients treated with LINEZOLID in these trials. Table 6 shows the incidence of drug-related adverse events reported in more than 1% of pediatric patients (and more than 1 patient) in either treatment group in the comparator-controlled phase 3 trials. (See Tables 5 and 6.)

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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 10.0%) with Linezolid and 1.5% (range among studies: 0.4 to 7.0%) 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 Precautions).
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 haematologic or serum chemistry value is presented in Tables 7, 8, 9 & 10. (See Tables 7, 8, 9 and 10.)

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Post marketing: Blood and Lymphatic System Disorders: Reversible anemia, thrombocytopenia, leucopenia, pancytopenia and sideroblastic anemia.
Nervous System Disorders: Peripheral neuropathy, convulsions (see Precautions).
Eye Disorders: Optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with linezolid. These reports have primarily been in patients treated for longer than the maximum recommended duration of 28 days (see Precautions).
Immune System Disorders: Anaphylaxis.
Metabolism and Nutrition Disorders: Lactic acidosis (see Precautions).
Skin and Subcutaneous Tissue Disorders: Rash, angioedema, bullous skin disorders including severe cutaneous adverse reactions (SCAR) such as toxic epidermal necrolysis and Stevens Johnson syndrome.
Gastrointestinal Disorders: Tongue discoloration. Superficial tooth discoloration has been reported very rarely with the use of linezolid. The discoloration was removable with professional dental cleaning (manual descaling) in cases with known outcome.
Serotonin syndrome has been reported in patients receiving concomitant serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and LINEZOLID.
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