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Servalin Tablet

Servalin Tablet

linezolid

Manufacturer:

Hetero Labs

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Linezolid
Indications/Uses
Adults w/ nosocomial pneumonia, community acquired pneumonia, or complicated skin & soft tissue infections that is known or suspected to be caused by susceptible gm +ve bacteria.
Dosage/Direction for Use
Max treatment duration: 28 days. Adult Nosocomial pneumonia & community acquired pneumonia 600 mg bid for 10-14 consecutive days. Complicated skin & soft tissue infections 600 mg bid.
Administration
May be taken with or without food.
Contraindications
Uncontrolled HTN, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute confusional states. Concomitant use w/ medicinal products which inhibit MAO-A or B (eg, phenelzine, isocarboxazid, selegiline, moclobemide) or taking any medicinal products w/in 2 wk; SSRIs, TCAs, serotonin 5-HT1 receptor agonists (triptans), directly & indirectly acting sympathomimetic agents (including adrenergic bronchodilators, pseudoephedrine & phenylpropanolamine), vasopressive agents (eg, epinephrine, norepinephrine), dopaminergic agents (eg, dopamine, dobutamine), pethidine or buspirone. Lactation.
Special Precautions
Reports of myelosuppression including anaemia, leucopenia, pancytopenia & thrombocytopenia; lactic acidosis; serotonin syndrome; peripheral & optic neuropathy & optic neuritis progressing to loss of vision; convulsions. Closely monitor blood counts in patients w/ preexisting anaemia, granulocytopenia or thrombocytopenia, severe renal insufficiency; those receiving concomitant medications that may decrease Hb levels, depress blood counts or adversely affect platelet count or function. Monitor CBC wkly regardless of baseline blood count. Use only in patients w/ known or possible co-infection w/ gm -ve organisms if there are no alternative treatment options available in complicated skin & soft tissue infections. Consider antibiotic-associated diarrhoea & colitis, including pseudomembranous colitis & Clostridium difficile-associated diarrhoea in patients who develop serious diarrhoea during or after use. Discontinue ongoing treatment & initiate adequate therapeutic measures immediately if antibiotic-associated diarrhoea or colitis is suspected or confirmed; drugs inhibiting peristalsis are contraindicated in this situation. Inhibits mitochondrial protein synthesis. Patients w/ history of seizures. Limited data when administered to patients w/ underlying conditions &/or on concomitant medications which might put them at risk from MAO inhibition; experience in patients w/ diabetic foot lesions, decubitus or ischaemic lesions, severe burns or gangrene. Take appropriate measures should superinfection occur during therapy. Safety & effectiveness when administered for periods >28 days have not been established. Warn patients about the potential for dizziness or symptoms of visual impairment while on treatment & advise not to drive or operate machinery if these symptoms occur. Use in patients w/ severe renal & hepatic insufficiency only when the anticipated benefit is considered to outweigh the theoretical risk. No experience in patients undergoing continuous ambulatory peritoneal dialysis or alternative treatments for renal failure. Not to be used during pregnancy unless clearly necessary. Discontinue breastfeeding prior to & throughout administration. Safety & efficacy has not been established in childn <18 yr. Greater risk of experiencing blood dyscrasias in elderly.
Adverse Reactions
Candidiasis, oral & vag candidiasis, fungal infections; anaemia; insomnia; headache, taste perversion (metallic taste), dizziness; HTN; diarrhoea, nausea, vomiting, localised or general abdominal pain, constipation, dyspepsia; abnormal LFT, increased AST, ALT or alkaline phosphatase; pruritus, rash; increased BUN; fever, localised pain; increased LDH, creatinine kinase, lipase, amylase or non-fasting glucose; decreased total protein, albumin, Na or Ca; increased/decreased K or bicarbonate; increased neutrophils or eosinophils; decreased Hb, haematocrit or RBC count; increased/decreased platelet or WBC counts. Lactic acidosis, anaemia & neuropathy (optic & peripheral) may occur when used >28 days.
Drug Interactions
Not recommended w/ MAOIs. Potential interactions producing elevation of BP caused by pseudoephedrine & phenylpropanolamine HCl. Potential serotonergic interactions w/ dextromethorphan; serotonergic agents including antidepressants eg, SSRIs. Avoid ingesting excessive amounts of food & beverages w/ high tyramine content (eg, mature cheese, yeast extr, undistilled alcoholic beverages, & fermented soya bean products eg, soy sauce). Decreased Cmax & AUC w/ rifampicin. Reduced mean max INR w/ warfarin. Increased risk of neuropathies when concomitantly used w/ antimycobacterial medications for treatment of TB.
MIMS Class
Other Antibiotics
ATC Classification
J01XX08 - linezolid ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Form
Servalin Tablet FC tab 600 mg
Packing/Price
10's
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