What happens if I overdose Linezolid Actavis?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Linezolid Actavis suspension:
Store Linezolid Actavis suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep the bottle tightly closed. Discard any unused medicine 21 days after mixing. Keep Linezolid Actavis suspension out of the reach of children and away from pets.
Overdose of Linezolid Actavis in details
In the event of overdosage, supportive care is advised, with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of Linezolid Actavis. In a Phase 1 clinical trial, approximately 30% of a dose of Linezolid Actavis was removed during a 3-hour hemodialysis session beginning 3 hours after the dose of Linezolid Actavis was administered. Data are not available for removal of Linezolid Actavis with peritoneal dialysis or hemoperfusion. Clinical signs of acute toxicity in animals were decreased activity and ataxia in rats and vomiting and tremors in dogs treated with 3000 mg/kg/day and 2000 mg/kg/day, respectively.
What should I avoid while taking Linezolid Actavis?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Linezolid Actavis and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Eating tyramine while you are using Linezolid Actavis can raise your blood pressure to dangerous levels. Avoid foods that have a high level of tyramine, such as:
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aged cheeses or meats;
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pickled or fermented meats, smoked or air-dried meats;
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sauerkraut;
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soy sauce;
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tap beer (alcoholic and nonalcoholic);
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red wine; or
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any meat, cheese, or other protein-based food that has been improperly stored.
You should become very familiar with the list of foods you must avoid while you are using Linezolid Actavis.
Linezolid Actavis warnings
General
Lactic Acidosis
Lactic acidosis has been reported with the use of Linezolid Actavis. In reported cases, patients
experienced repeated episodes of nausea and vomiting. Patients who develop
recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level while
receiving Linezolid Actavis should receive immediate medical evaluation.
Serotonin Syndrome
Spontaneous reports of serotonin syndrome associated with the co-administration of
Linezolid Actavis and serotonergic agents, including antidepressants such as selective serotonin
reuptake inhibitors (SSRIs), have been reported ).
Where administration of Linezolid Actavis and concomitant serotonergic agents is clinically
appropriate, patients should be closely observed for signs and symptoms of serotonin
syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia and
incoordination. If signs or symptoms occur physicians should consider discontinuation
of either one or both agents. If the concomitant serotonergic agent is withdrawn,
discontinuation symptoms can be observed )
for a description of the associated discontinuation symptoms).
Peripheral and Optic Neuropathy
Peripheral and optic neuropathy have been reported in patients treated with Linezolid Actavis,
primarily those patients treated for longer than the maximum recommended duration of 28
days. In cases of optic neuropathy that progressed to loss of vision, patients were treated for
extended periods beyond the maximum recommended duration. Visual blurring has been
reported in some patients treated with Linezolid Actavis for less than 28 days.
If patients experience symptoms of visual impairment, such as changes in visual acuity,
changes in color vision, blurred vision, or visual field defect, prompt ophthalmic evaluation
is recommended. Visual function should be monitored in all patients taking Linezolid Actavis
for extended periods (? 3 months) and in all patients reporting new visual symptoms
regardless of length of therapy with Linezolid Actavis. If peripheral or optic neuropathy occurs,
the continued use of Linezolid Actavis in these patients should be weighed against the potential risks.
Convulsions have been reported in patients when treated with Linezolid Actavis. In some of these
cases, a history of seizures or risk factors for seizures was reported.
The use of antibiotics may promote the overgrowth of nonsusceptible organisms. Should
superinfection occur during therapy, appropriate measures should be taken.
Linezolid Actavis has not been studied in patients with uncontrolled hypertension,
pheochromocytoma, carcinoid syndrome, or untreated hyperthyroidism.
The safety and efficacy of Linezolid Actavis formulations given for longer than 28 days have not
been evaluated in controlled clinical trials.
Prescribing Linezolid Actavis in the absence of a proven or strongly suspected bacterial infection or
a prophylactic indication is unlikely to provide benefit to the patient and increases the risk
of the development of drug-resistant bacteria.
What should I discuss with my healthcare provider before taking Linezolid Actavis?
You should not use Linezolid Actavis if you are allergic to Linezolid Actavis.
Do not use Linezolid Actavis if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.
Some medicines can interact with Linezolid Actavis and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:
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buspirone, clozapine, cyclobenzaprine, epinephrine (Epi-Pen), meperidine, procarbazine, St. John's wort, tramadol;
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ADHD medication--Adderall, Ritalin, and others; a diet pill or other stimulant; cold medicine that contains a decongestant; medicine that can raise blood pressure such as dobutamine, dopamine, norephinephrine;
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an antidepressant--bupropion, citalopram, fluoxetine, imipramine, milnacipran, nefazodone, paroxetine, sertraline, trazodone, venlafaxine, and others; migraine or cluster headache medications-- ("triptans") such as Amerge, Imitrex or Maxalt, Zomig and others;
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medication to treat Parkinson's disease or restless leg syndrome; glaucoma medicine used in the eyes--apraclonidine, brimonidine.
To make sure Linezolid Actavis is safe for you, tell your doctor if you have:
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a history of high blood pressure;
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a thyroid disorder;
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a carcinoid tumor;
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bone marrow suppression or a weak immune system;
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kidney or liver disease;
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pheochromocytoma (adrenal gland tumor);
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diabetes;
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epilepsy or a history of seizures; or
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if you use a catheter.
FDA pregnancy category C. It is not known whether Linezolid Actavis will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether Linezolid Actavis passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
The liquid form of Linezolid Actavis may contain phenylalanine. Talk to your doctor before using this form of Linezolid Actavis if you have phenylketonuria (PKU).
Linezolid Actavis precautions
Reversible myelosuppression (anemia, thrombocytopenia, leukopenia, and pancytopenia) that may be dependent on duration of therapy has been reported in some patients receiving Linezolid Actavis. Monitoring of complete blood counts should be considered for patients who are at increased risk for bleeding, who have pre-existing myelosuppression, who receive concomitant medications that may decrease hemoglobin levels or platelet count or function, or who receive Linezolid Actavis for more than 2 weeks.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Linezolid Actavis, and may range in severity from mild to life-threatening.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Linezolid Actavis, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C.
Peripheral and optic neuropathy have been reported in patients treated with Linezolid Actavis, primarily those patients treated for longer than the maximum recommended duration of 28 days. In cases of optic neuropathy that progressed to loss of vision, patients were treated for extended periods beyond the maximum recommended duration.
If symptoms of visual impairment appear, such as changes in visual acuity, changes in color vision, blurred vision, or visual field defect, prompt ophthalmic evaluation is recommended. Visual function should be monitored in all patients taking Linezolid Actavis for extended periods (greater than or equal to 3 months) and in all patients reporting new visual symptoms regardless of length of therapy with Linezolid Actavis. If peripheral or optic neuropathy occurs, the continued use of Linezolid Actavis in these patients should be weighed against the potential risks.
Lactic acidosis has been reported with the use of Linezolid Actavis. Patients who develop recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level while receiving Linezolid Actavis should receive immediate medical attention.
Convulsions have been reported to occur rarely in patients when treated with Linezolid Actavis. In most of these cases, a history of seizures or risk factors for seizures were reported.
Spontaneous reports of serotonin syndrome associated with the co-administration of Linezolid Actavis and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs) have been reported.
Where administration of Linezolid Actavis and concomitant serotonergic agents is clinically appropriate, patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia and incoordination. If signs or symptoms occur physicians should consider discontinuation of either one or both agents. If the concomitant serotonergic agent is withdrawn, discontinuation symptoms can be observed.
In healthy volunteers, coadministration of rifampin with Linezolid Actavis resulted in a 21% decrease in Linezolid Actavis Cmax and a 32% decrease in Linezolid Actavis AUC. The clinical significance of this interaction is unknown.
Linezolid Actavis has no clinical activity against Gram-negative pathogens and is not indicated for the treatment of gram-negative infections. Specific Gram-negative therapy is required if a concomitant Gram-negative pathogen is documented or suspected. Linezolid Actavis should be used with special caution in patients at high risk for life threatening systemic infections, such as those with infections related to central venous catheters in intensive care units. Linezolid Actavis is not approved for the treatment of patients with catheter related bloodstream infections.
Clinical Trial in Catheter-Related Gram-Positive Bloodstream Infections: An open-label, randomized clinical trial was conducted in adult patients with catheter related gram-positive bloodstream infections comparing Linezolid Actavis (600 mg q12h IV/PO) to vancomycin 1 g IV q12h or oxacillin 2 g IV q6h/dicloxacillin 500 mg PO q6h with a treatment duration of 7 to 28 days. The mortality rates in this study were 78/363 (21.5%) and 58/363 (16.0%) on Linezolid Actavis and the comparator, respectively. Based on results from a logistic regression, the estimated odds ratio is 1.426 (95% CI 0.970, 2.098). While causality has not been established, this observed imbalance occurred primarily in Linezolid Actavis-treated patients in whom either Gram-negative pathogens, mixed Gram-negative and Gram-positive pathogens, or no pathogen were identified at baseline. Patients randomized to Linezolid Actavis who had only a Gram-positive infection at baseline, including the subgroup of patients with Gram-positive bacteremia experienced a survival rate similar to the comparator.
Effects on Ability to Drive and Use Machines: The effect of Linezolid Actavis on the ability to drive or operate machinery has not been systematically evaluated.
What happens if I miss a dose of Linezolid Actavis?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
References
- 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).
- DrugBank. "linezolid". http://www.drugbank.ca/drugs/DB00601 (accessed September 17, 2018).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
