LINEZOLID DENK solution for infusion
Linezolid
2mg/ml
DENK PHARMA GmbH & Co. KG
| Pack size | 10 LDPE Bags (300 ml) |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | AL ITTIHAD DRUG STORE |
| Retail Price | 1932.00 AED |
Indications
LINEZOLID DENK solution for infusion is used for:
Community-acquired pneumonia, Skin and skin structure infections, Nosocomial pneumonia
Adult Dose
Oral
Uncomplicated skin and skin structure infections
Adult: 400 mg 12 hrly for 10-14 days.
Vancomycin-resistant Enterococcus faecium
Adult: 600 mg 12 hrly for 14-28 days.
Methicillin-resistant Staphylococcus aureus infections
Adult: 600 mg bid for 7-21 days.
Community-acquired pneumonia; Nosocomial pneumonia; Complicated skin and skin structure infections
Adult: 600 mg 12 hrly for 10-14 days.
Elderly: No dosage adjustment needed.
Hepatic impairment: Mild to moderate: No dosage adjustment needed.
Child Dose
Oral
For Pediatric Patients
Pneumonia, complicated skin infections, vancomycin resistant enterococci:
Birth–11 y: 30 mg/kg/day q8h
>11 y: 1,200 mg/day q12h
Uncomplicated skin infections:
Birth–5 y: 30 mg/kg/day q8h
5–11 y: 20 mg/kg/day q12h
>11–18 y: 1,200 mg/day q12h
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
May be taken with or without food.
Contra Indications
Linzolid formulations are contraindicated for use in patients who have known hypersensitivity to Linzolid or any of the other product components. Linzolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product. Linzolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome and/or patients taking directly and indirectly acting sympathomimetic agents (e.g. pseudoephedrine), vasopressive agents (e.g. epinephrine, norepinephrine), dopaminergic agents (e.g. dopamine, dobutamine), serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone.
Precautions
Preexisting myelosuppression, renal impairment (CrCl < 30ml/min), uncontrolled hypertension, phaeochromocytoma, carcinoid syndrome, untreated hyperthyroidism, chronic infection, history of seizures, bipolar depression, schizophrenia or acute confusional states. Pregnancy and lactation. Monitor complete blood counts weekly. Give after haemodialysis. Not known if linezolid or metabolites removed during peritoneal dialysis.
Lactation: Unknown; use caution
Pregnancy-Lactation
Pregnancy category: C
Lactation: Unknown; use caution
Interactions
May reduce serum levels w/ rifampicin and phenytoin. May cause hypoglycaemia w/ insulin or oral antidiabetics. May increase risk of seizures w/ tramadol.
Potentially Fatal: Increased risk of serotonin syndrome w/ MAOIs, TCAs, SNRIs, or other serotonergic drugs (e.g. bupropion, vilazodone, mirtazapine, amoxapine, buspirone, maprotiline, meperidine, trazodone, nefazodone). Significant increase in BP w/ vasopressive agents (e.g. epinephrine, norepinephrine), sympathomimetic agents (e.g. pseudoephedrine) and dopaminergic agents (e.g. dopamine, dobutamine).
Adverse Effects
Side effects of Linezolid :
>10%
Pediatrics
Diarrhea (7.8-10.8%)
1-10%
Headache (5.7-8.8%).Diarrhea (8.2-8.3%), Nausea (5.1-6.6%), Vomiting (2-4.3%), Dizziness (1.8-2.6%), Rash (1.1-2.3%), Vaginal moniliasis (1.1-1.8%), Taste alteration (1-1.8%), Oral moniliasis (0.5-1.7%), Abnormal LFTs (0.4-1.6%), Fungal infection (0.3-1.5%), Localized abdominal pain (1.2-1.3%), Tongue discoloration (0.3-1.3%), Generalized abdominal pain (0.9-1.2%)
Pediatrics
Vomiting (2.9-9.4%), Headache (0.9-6.5%), Anemia (5.6%), Thrombocytopenia (4.7%), Nausea (1.9-3.7%), Generalized abdominal pain (0.9-2.4%), Localized abdominal pain (0.5-2.4%), Loose stools (1.6-2.3%), Eosinophilia (0.4-1.9%), Pruritus, other than application site (0.8-1.4%), Vertigo (1.2%)
<1%
Lactic acidosis, Myelosuppression, Peripheral neuropathy, Disorder of optic nerve, Serotonin syndrome
Potentially Fatal: Reversible myelosuppression including anaemia, leukopenia, pancytopenia and thrombocytopenia (particularly if using > 10-14 days), transient ischaemic attacks, renal failure, Stevens-Johnson syndrome.
Mechanism of Action
Linezolid is a bacteriostatic oxazolidinone which acts by inhibiting ribosomal protein synthesis. It is active against gm+ve bacteria including vancomycin-resistant enterococci and MRSA. It has limited in vitro activity against gm-ve bacteria.
Note
LINEZOLID DENK 2mg/ml solution for infusion manufactured by DENK PHARMA GmbH & Co. KG. Its generic name is Linezolid. LINEZOLID DENK is availble in United Arab Emirates.
Farmaco UAE drug index information on LINEZOLID DENK solution for infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.