Servalin Injection

Clear, colorless to yellow solution contained in a plastic bag.
Each mL contains: Linezolid 2mg.
Excipients/Inactive Ingredients: Sodium citrate dehydrate 1.64 mg, Anhydrous citric acid 0.85 mg, Dextrose 50.24 mg, Sodium hydroxide q.s., Hydrochloric acid q.s., Water for injection q.s.

Pharmacology: Toxicology: Fertility and reproductive toxicity study: 50 mg/kg was given to rats, mating rate, fertility rate as well as the average performance of sperm were reversibly decreased in adult male rats. After the implementation, a loss of embryo and decreased number of survived fetus in females were found. A delay of development such as decrease of the average weight, auditory reflex, late auricle detachments, etc., was found in neonates.
In embryo-fetal development study, when rats were given more than 15 mg/kg, weight loss and frameshift mutation (Differentiation of infant sternebra) were found. And when a dose of 450 mg/kg/day was given to mice, an increase of post implantational embryo death, including total litter loss, decrease of fetal body weights, and an increased incidence of costal cartilage fusion were observed.
In sexually mature male rats exposed to drugs as juveniles, mildly decreased fertility was observed following treatment with linezolid through most of their period of sexual development (50 mg/kg/day from days 7 to 36 of age, and 100 mg/kg/day from days 37 to 55 of age), with exposures up to 1.7 -fold greater than mean AUCs observed in pediatric patients aged 3 months to 11 years. Decreased fertility was not observed with shorter treatment periods, corresponding to exposure in utero through the early neonatal period (gestation day 6 through postnatal day 5), neonatal exposure (postnatal days 5 to 21), or to juvenile exposure (postnatal days 22 to 35). Reversible reductions in sperm motility and altered sperm morphology were observed in rats treated from postnatal day 22 to 35.

Susceptible Microorganism: Linezolid has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections, as described in this section.
Aerobic and facultative Gram-positive microorganisms: Enterococcus faecium (vancomycin-resistant strains only), Staphylococcus aureus (including methicillin-resistant strains), Streptococcus agalactiae, Streptococcus pneumoniae (Penicillin-susceptible strains only), Streptococcus pyogenes.
The following in vitro data are available, but their clinical significance is unknown. At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for linezolid. However, the safety and effectiveness of linezolid in treating clinical infections due to these microorganisms have not been established in adequate and well-tolerated clinical trials.
Aerobic and facultative Gram-positive microorganisms: Enterococcus faecalis (including vancomycin-resistant strains) Enterococcus faecium (vancomycin-resistant strains), Staphylococcus epidermidis (including methicillin-resistant strains), Staphylococcus haemolyticus, Streptococcus pneumoniae (penicillin-resistant strains), Viridans group streptococci.
Aerobic and facultative Gram-negative microorganisms: Pasteurella multocida.
Linezolid has no clinical activity against Gram-negative against pathogens and is 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.
Infectious Diseases: LINEZOLID is used for treatment of patients with the following infections: Nosocomial pneumonia; Community-acquired pneumonia (including concurrent bacteremia); Complicated skin and skin structure infections (including diabetic foot infections, without concomitant osteomyelitis); Uncomplicated skin and skin structure infections; Vancomycin-resistant Enterococcus faecium infections (including concurrent bacteremia).

See table.

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Neonates <7 days: Most pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic linezolid clearance values and larger AUC values that many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg q12h. Consideration may be given to the use of 10 mg/kg q8h regimen in neonates with a sub-optimal clinical response. All neonatal patient should receive 10 mg/kg q8h by 7 days of life.
Adult patients with infection due to MRSA should be treated with LINEZOLID 600 mg q12h.
LINEZOLID should be administered by intravenous infusion over a period of 30 to 120 minutes.
No dose adjustment is necessary when switching from intravenous to oral administration. Patients whose therapy started with LINEZOLID I.V. Injection may be switched to either Linezolid Tablets or Oral Suspension at the discretion of the physician, when clinically indicated.

In the event of overdosage, supportive care is advised, with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination. In a Phase 1 clinical trial, approximately 30% of a dose of linezolid was removed during a 3-hour hemodialysis session beginning 3 hours after the dose of linezolid was administered. Data are not available for removal of linezolid 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.

LINEZOLID formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components.
Monoamine oxidase inhibitors: Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g., phenelzine, isocarboxazid, selegiline, moclobemide) or within two weeks of taking any such medicinal product.
Unless patients are monitored for potential increases in blood pressure, since potential interactions producing elevation of blood pressure, linezolid should not be administered to the following patients: Patients with uncontrolled hypertension; Patients with pheochromocytoma; Patients with thyrotoxicosis; Patients with bipolar disorder; Patients with schizoaffective disorder; Patients with acute confusional state; Patients taking any of the following types of medications: directly and indirectly acting sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), dopaminergic agents (e.g., dopamine, dobutamine).
Unless clinically appropriate and patients are clinically observed for signs and symptoms of serotonin syndrome or neuroleptic malignant syndrome like (NMS-like) reactions, linezolid should not be administered to patients with: Patients with carcinoid syndrome; Patients taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5HT1 receptor agonists (triptans), meperidine, bupropion, or buspirone.

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with an increase hemorrhagic risk, those with pre-existing myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, those receiving concomitant drugs that a tendency to decrease hemoglobin, decrease platelet count or function, or those with a chronic infection who have received previous or concomitant antibiotic therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression. Myelosuppression, decreased extra medullary hematopoiesis in spleen and liver, lymphoid depletion occurred in thymus, lymph nodes, and spleen have been seen in juvenile and adult rats and dogs.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including LINEZOLID, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use.
According to a study, C. difficile produces toxins which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Linezolid has no clinical activity against Gram-negative pathogens and is 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. An imbalance in mortality was seen in patients treated with linezolid relative to vancomycin/dicloxacillin/oxacillin in an open-label study in seriously ill patients with intravascular catheter-related infections [78/363 (21.5%) vs. 58/363 (16.0%); odds ratio 1.426, 95 % Cl 0.970, 2.098]. While causality has not been established, this observed imbalance occurred primarily in linezolid-treated patients in whom either Gram-negative pathogens, mixed Gram-negative and Gram-positive pathogens, or no pathogen were identified at baseline, but was not seen in patients with Gram-positive infections only.
Linezolid is not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections.
Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents when treated with linezolid, a reversible, nonselective MAO inhibitor. Some MAO inhibitors have been associated with hypoglycemic episodes in diabetic patients receiving insulin of hypoglycemic agents. While a causal relationship between linezolid and hypoglycemia has not been established, diabetic patients should be cautioned of potential hypoglycemic reactions when treated with linezolid. If hypoglycemia occurs, a decrease in the dose of insulin or oral hypoglycemic agent, or discontinuation of oral hypoglycemic agent, insulin, or linezolid may be required.

The drug is administered cautiously in the following patients: Patients with preexisting myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia), those receiving concomitant drugs that produce bone marrow suppression, or those with chronic infection who have received previous or concomitant antibiotic therapy, and who receive linezolid for longer than two weeks; Patients with severe renal insufficiency; Patients who weigh less than 40 kg (no clinical experience).
General precautions: Lactic acidosis has been reported with the use of LINEZOLID. 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 should receive immediate medical evaluation.
Thrombocytopenia has been reported with the use of LINEZOLID. The platelet counts should be monitored in patients who received Linezolid particularly in those who receive Linezolid for longer than two weeks or those with an increase hemorrhagic risk, thrombocytopenia, or receiving concomitant drugs that decrease platelet count or function.
The use of antibiotics may promote the overgrowth of nonsusceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken.
LINEZOLID has not been studied in patients with uncontrolled hypertension, pheochromocytoma, carcinoid syndrome, or untreated hyperthyroidism.
The safety and efficacy of LINEZOLID formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
Peripheral and optic neuropathy have been reported in patients treated with LINEZOLID, 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 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.
If peripheral or optic neuropathy occurs, the continued use of LINEZOLID in these patients should be weighed against potential risks.
Patients should inform their physician if taking medications containing pseudoephedrine or phenylpropanolamine, such as cold remedies and decongestants, if taking serotonin re-uptake inhibitors or other antidepressants or if they have a history of hypertension.
Prescribing LINEZOLID 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.
Convulsions have been reported in patients when treated with linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported. Patients should inform their physician if they have a history of seizures.
Renal Impairment: The pharmacokinetics of the parent drug, linezolid, are not altered in patients with any degree of renal insufficiency; however, the two primary metabolites of linezolid may accumulate in patients with renal insufficiency, with the amount of accumulation increasing with the severity of renal dysfunction. The clinical significance of accumulation of these two metabolites has not been determined in patients with severe renal insufficiency.
Because similar plasma concentrations of linezolid are achieved regardless of renal function, no dose adjustment is recommended for patients with renal insufficiency. However, given the absence of information on the clinical significance of accumulation of the primary metabolites, use of linezolid in patients with renal insufficiency should be weighed against the potential risks of accumulation of these metabolites.
Both linezolid and the two metabolites are eliminated by dialysis. No information is available on the effect of peritoneal dialysis on the pharmacokinetics of linezolid. Approximately 30% of a dose was eliminated in a 3-hour dialysis session beginning 3 hours after the dose of linezolid was administered; therefore, linezolid should be given after hemodialysis.
Hepatic Impairment: The pharmacokinetics of linezolid are not altered in patients with mild-to-moderate hepatic insufficiency. On the basis of the available information, no dose adjustment is recommended for patients with mild-to-moderate hepatic insufficiency. The pharmacokinetics of linezolid in patients with severe hepatic insufficiency have not been evaluated.
Use in Children: The C_max and the volume of distribution (V_ss) of linezolid are similar regardless of age in pediatric patients. However, linezolid clearance is a function of age. Excluding neonates less than a week of age, clearance is most rapid in the youngest age groups ranging from >1 week old to 11 years, resulting in lower single-dose systemic exposure (AUC) and shorter half-life as compared with adults. As age of pediatric patients increases, the clearance of linezolid gradually decreases, and by adolescence, means clearance values approach those observed for the adult population. There is wider inter-subject variability in linezolid clearance and in systemic drug exposure (AUC) across all pediatric age groups as compared with adults.
Similar mean daily AUC values were observed in pediatric patients from birth to 11 years of age dosed q8h relative to adolescents or adults dose q12h. Therefore, the dosage for pediatric patients up to 11 years of age should be 10 mg/kg q8h. Pediatric patients 12 years and older should receive 600 mg q12h.
Use in the Elderly: Of the 2046 patients treated with LINEZOLID in Phase 3 comparator-controlled clinical trials, 589 (29%) were 65 years or older and 253 (12%) were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. LINEZOLID should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Linezolid and its metabolites are excreted in the milk of lactating animals. It should be discontinued previous or during breast-feeding.

Adults: The safety of LINEZOLID formulations was evaluated in 2046 adult 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 mode rate in intensity. The most common adverse events in patients treated with LINEZOLID were diarrhea (2.8% to 11.0%), headache (0.5% to 11.3%) and nausea (3.4% to 9.6%).
Body as a whole: Headache, Moniliasis, Fungal infection, Fever.
Nervous system: Dizziness, Insomnia.
Special senses other: Taste alteration.
Gastrointestinal: Diarrhea, Nausea, Vomiting, Abdominal pain, Constipation, Dyspepsia, Tongue discoloration.
Cardiovascular: Hypertension.
Hemolymph system: Thrombocytopenia, Hemoglobin disease, Leukopenia, Neutropenia.
Genitourinary system: Vaginal moniliasis.
Skin: Rash, Pruritus.
Abnormal liver function tests.
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). In these studies, 83% and 99%, respectively, of the adverse events reported with Linezolid were described as mild to mode rate in intensity. In the study of hospitalized pediatric patients (birth through 11 years) with Gram positive infections, mortality was 6.0% (131215) in the linezolid arm and 3.0% (31101) in the control arm. However, given the severe underlying illness in the population, no causality could be established. The meaning of common adverse events are more than 5%, uncommon adverse events are 0.1-5%.
Uncomplicated Skin and Skin Structure Infections: Adverse reacts in the clinical study of pediatric patients aged from 5 through 17 years are shown as follows.
Body as a whole: Common: Headache; Uncommon: Fever, Trauma, Localized pain.
Nervous system: Uncommon: Dizziness.
Gastrointestinal: Common: Diarrhea; Uncommon: Nausea, Vomiting, Abdominal pain, Loose stools.
Skin: Uncommon: Rash, Skin disorder, Pruritus at non-application site.
Hemolymph system: Uncommon: Eosinophilia.
Respiratory system: Uncommon: Upper respiratory infection, Pharyngitis, Cough.
Other Indications: In a study of hospitalized pediatric patients ranging in age from birth through 11 years was shown as follows.
Body as a whole: Common: Fever, Sepsis; Uncommon: Headache, Trauma, Edema, Localized pain, Site of injection or vascular catheter-related reaction, Anaphylaxis.
Nervous system: Uncommon: Convulsion.
Gastrointestinal: Common: Diarrhea, Nausea; Uncommon: Vomiting, Abdominal pain, Gastrointestinal bleeding, Loose stools, Oral moniliasis.
Skin: Common: Rash; Uncommon: Skin disorder.
Hemolymph system: Common: Anemia; Uncommon: Thrombocytopenia, Thrombocythemia, Eosinophilia.
Respiratory system: Uncommon: Upper respiratory infection, Pharyngitis, Pneumonia, Cough, Apnea.
Metabolism and Nutrition: Uncommon: Hypokalemia.
Postmarketing Experience: Myelosuppression (including anemia, leukopenia, pancytopenia and thrombocytopenia) has been reported during postmarketing use of LINEZOLID. Peripheral neuropathy, and optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with Linezolid. Although these reports have primarily been in patients treated for longer than the maximum recommended duration of 28 days. Lactic acidosis, angioedema, anaphylaxis have been reported with the use of LINEZOLID. Very rarely 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, 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.
Local Postmarketing Findings: Over 6 years, a local postmarketing of LINEZOLID was conducted on 702 patients. Regardless of the relation of the drug, 44.02% (309/702, total: 569 cases) were reported, those reported cases are summarized per physiological system as follows: Body as a whole: Septic shock, Sepsis, Superinfection, Multiple organ failure, Fever, Fungal infection, Headache, Infection, Bacteremia, Moniliasis, Herpes zoster, Edema, Death, Fungaemia, Therapeutic response decreased, candidemia, Skin cellulitis.
Hemolymph system: Thrombocytopenia, Hemoglobin decreased, Leukopenia, Neutropenia, Leukocytosis, Thrombocythemia, Disseminated intravascular coagulation, INR increase, aPTT increase, Normoskeocytosis, Pancytopenia, Hemoperitoneum, Eosinophilia, Metamyelocyte increase, Exacerbation of acute Myeloid leukaemia, Exacerbation of leukemia, lymphocytic, Exacerbation of acute myeloid, Malignant lymphoma progress.
Gastrointestinal: Nausea, Vomiting, Diarrhea, Abdominal pain, Gastrointestinal bleeding, Dyspepsia, Meteorism, Constipation, Exacerbation of colitis pseudomembranous, Ulceration, Tongue discoloration, Bloody stool, Recurrence of esophageal, Cancer, Gastric cancer.
Respiratory system: Respiratory failure, Pneumonia, Pulmonary Hemorrhage, Hemoptysis, Acute respiratory distress syndrome, Pulmonary edema, Pneumothorax, Acute interstitial pneumonitis, Acute respiratory failure, Emphysema exacerbation, Apnea, Hypoxia exacerbation, Pulmonary infection, Stridor, Dyspnea.
Urinary system: Non protein nitrogen increase, Acute renal failure, Urinary tract infection, Blood urea nitrogen increase, Renal failure, Pyuria, Haematuria.
Hepatic system: Liver function test abnormal, Hepatic Failure, Bilirubinaemia, Blood bilirubin increase, Advancement of hepatic coma, Exacerbation of hepatic neoplasm, Hepatorenal syndrome, Advancement of cholangioma, Exacerbation of cholangitis, Cholecystitis, Exacerbation of empyema of gall bladder, Cholangitis, Exacerbation of colorectal cancer hepatic metastasis, Jaundice.
Cardiovascular: Ventricular tachycardia, Tachycardia, Auricular fibrillation. Myocardial infarction, Exacerbation of cardiac failure, Cardiac arrest, Acute cardio-respiratory failure, Arrhythmia, Recurrence of myocardial infarction, Hypotension.
Metabolism and nutrition: Hyponatremia, Hyperkalemia, Hypokalemia, Electrolyte disorders, Exacerbation of hypocalcemia.
Skin: Rash, Pruritus.
Nervous system: Convulsion, Insomnia, Hyperesthesia, Anxiety, Depression.
Central nervous system: Meningitis.
Blood vessel: Advancement and exacerbation of subdural hemorrhage, Intraventricular hemorrhage, Intraventricular hemorrhage disorder, Variceal hemorrhage, Exacerbation of thrombotic microangiopathy.
Musculoskeletal system: Foot drop, Advancement of septic arthritis.
Endocrine system: Hyperthyroidism.
Others: Exacerbation of graft versus host reaction.

Monoamine Oxidase Inhibition: Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, linezolid has the potential for interaction with adrenergic and serotonergic agents.
Adrenergic Agents: Some individuals receiving LINEZOLID 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. A significant presser response has been observed in normal adult subjects receiving linezolid and tyramine doses of more than 100 mg. Therefore, patients receiving linezolid need to avoid consuming large amounts of foods or beverages with high tyramine content.
Serotonergic Agents: Co-administration of linezolid and serotonergic agents was not associated with serotonin syndrome in clinical studies. Spontaneous reports of serotonin syndrome associated with co-administration of LINEZOLID and serotonergic agents, including antidepressants such as selective serotonin inhibitors (SSRIs), have been reported. Where administration of LINEZOLID 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.
Drugs Metabolized by Cytochrome P450: Linezolid is not an inducer of cytochrome P450 (CYP) in rats. It is not detectably metabolized by human cytochrome P450 and it does not inhibit the activities of clinically significant human CYP isoforms (1A2, 2C9, 2C19, 206, 3A4). Therefore, no CYP450-induced drug interactions are expected with linezolid. Concurrent administration of linezolid does not substantially alter the pharmacokinetic characteristics of (S) warfarin, which is extensively metabolized by CYP2C9. Drugs such as warfarin and phenytoin, which are CYP2C9 substrates, may be given with linezolid without changes in dosage regimen.
Antibiotics: The pharmacokinetics of linezolid, gentamicin, or aztreonam are not altered when administered together.

Precautions in Storage and Handling: Do not transfer the drug from the original package to other one. It may result in accidents and/or deteriorate the quality of drug.
Intravenous Administration: LINEZOLID is supplied in single-use, ready-to-use infusion bags. Parenteral drug products should be inspected visually for particulate matter prior to administration. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired.
LINEZOLID should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous infusion bag in series connections. Additives should not be introduced into this solution. If LINEZOLID I.V. 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. In particular, physical incompatibilities resulted when LINEZOLID I.V. Injection was combined with the following drugs during simulated Y-site administration: amphotericin-B, chlorpromazine HCl, diazepam, pentamidine isethionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when LINEZOLID I.V. injection was combined with ceftriaxone sodium.
If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of LINEZOLID I.V. Injection with an infusion solution compatible with LINEZOLID I.V. Injection and with other drug(s) administered via this common line (see Compatible Intravenous Solutions as follows).
Compatible Intravenous Solutions: 5% Dextrose Injection, 0.9% Sodium Chloride Injection, Lactated Ringer's Injection.
Keep the infusion bags in the overwrap until ready to use. Store at room temperature. Protect from freezing. LINEZOLID I.V. Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.
How to Use Safe-Flex container: 1. By placing the bag upside down, hold the upper part of the safe-flex bag with your hand, and then hold the opening with the other hand and gently pull the over-wrap downward (horizontal direction from body) while you remove the over-wrap.
2. After checking the product's condition, if medication needs to be added to the bag, you can insert the 19-22 gauge needle into the medication port of your bag which is closed with a yellow rubber cap. Additional medication can be inserted about 5 to 6 times.
3. Rotate the blue protection cap and remove it.
4. Insert the spike of infusion set by turning to the right.
5. When you check the scale while the infusion, scale can be read at the front The error range is less than ±5%.
6. After the administration, collect the empty bag and dispose off property.

Store at temperatures not exceeding 30°C.
It is recommended that the infusion bags be kept in the overwrap until ready to use.
Protect infusion bags from freezing and heating.

Other Antibiotics

J01XX08 - linezolid ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.

Rx