Linestad 600

Rx

Indications:

• Treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram positive bacteria.
• Treatment of complicated skin and soft tissue infections only when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria.

Dosage:

Adult and children ≥ 12 years: 600 mg every 12 hours usually for 10 – 14 days (max. duration of treatment 28 days).

Usage:

Linestad 600 is administered orally with or without food.

Hypersensitivity to linezolid or any of the excipients.

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.

Patients with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute confusional states (unless there are facilities available for close observation and monitoring of blood pressure).

Patients taking any of the following medications(unless there are facilities available for close observation and monitoring of blood pressure): Serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), directly and indirectly acting sympathomimetic agents (including the adrenergic bronchodilators, pseudoephedrine and phenylpropanolamine), vasopressive agents (e.g. epinephrine, norepinephrine), dopaminergic agents (e.g. dopamine, dobutamine), pethidine or buspirone.

Common: Candidiasis, oral candidiasis, vaginal candidiasis, fungal infections; headache, taste perversion (metallic taste), dizziness; diarrhoea, nausea, vomiting, localised or general abdominal pain, constipation, dyspepsia; abnormal liver function test; increased AST, ALT or alkaline phosphatase; increased BUN; insomnia; anaemia; hypertension; pruritus, rash; fever.

Myelosuppression (e.g., anemia, leukopenia, pancytopenia, thrombocytopenia) has been reported. Discontinuance of Linestad 600 should be considered if myelosuppression develops or worsens.

Lactic acidosis, characterized by recurrent nausea and vomiting, has been reported. Patients who develop recurrent nausea and vomiting, unexplained acidosis, or a low bicarbonate concentration while receiving linezolid should undergo immediate medical evaluation.

Peripheral and optic neuropathy, sometimes progressing to loss of vision, has been reported. If a patient experiences symptoms of visual impairment (e.g., changes in visual acuity or color vision, blurred vision, or visual field defect), an ophthalmic evaluation should be promptly performed. All patients receiving linezolid for extended periods of time (i.e., 3 months or longer) should have their visual function monitored.

Carefully medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued. If CDAD is suspected or confirmed, discontinuance of antiinfectives not directed against difficile may be needed.

A history of seizures or risk factors for seizures noted in some of these cases.

Linestad 600 should not be used during pregnancy unless clearly necessary. Breastfeeding should be discontinued prior to and throughout administration.

Patients should be warned about the potential for dizziness or symptoms of visual impairment whilst receiving Linestad 600 and should be advised not to drive or operate machinery if any of these symptoms occurs.