Drug Interaction:
Linezolid is a reversible , non-selective inhibitor of monoamine oxidase. When vasopressor or dopanergic agents are co-administered, the initial doses should be reduced and titrated to acheive the desired response and reduce the incidence of serotinin syndrome. Adrenogernic drugs such as dopamine ,epinephrine , phenylpropanolamine , pseudoephidrine may cause hypertension.
Monitor blood pressure and heart rate. Beverages and foods high in in tyramine content -increased blood pressure may occur when linezolid is used with diet high in tyramine.
Indication:
Nosocomial pneumonia,
Specticema, bacteremia,
Patients with severe enterococcocal infections,
Skin and structure infections,
Prophylaxis during surgical procedure.
LIST OF DRUGS DURING 2004
Sr.No- 206
Name of the Drug- Linezolid (600mg) Tablet
Pharmacological Classification- For Osteomyelitis in adults
Date of Approval- 30-05-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Lenezoid Anti-Bacterial 04-10-2001
2.Linezolid 600mg tablet 30-05-2004
For osteomylelitis in adults
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Linezolid 2mg + 01-04-2002
Dextrose 5% per ml injection
Complicated/uncomplicated skim & skin structure
infections/community acquired pneumonia
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Linezoid Antibiotics& Pharmacia 18-11-2014
Antifungals
Adverse Reaction:
Diarrhea, headache, nausea, Aabnormal liver function tests, Fever, vaginal oral monoliasis, skin rash, Thrombocytopenia, Vomiting, constipation, Dizziness, insomnia, anemia, Tongue discoloration, tast disturbances, lactic acidosis Mylosuppression, leukopenia and pancylopenia, Pseudomembraneous colitis.
Contra-Indications:
Linezolid is contraindicated in patients with a history of allergy to linezolid products.
Special Precautions:
Myelosuppression ( anemia leukopenia, pancytopenaia, thrombocytopenia) has been reported. Monitor blood counts weekly. Clostridium difficle-associated colitis is reported during therapy. Evaluate and monitor patients who develop diarrhea during therapy. MAOI precautions should be followed to avoid serious food-drug or drug-food interactions. Caution if used in nursing women. Children- safety and efficacy not established below 18 years
Dosages/ Overdosage Etc:
Indications:
Nosocomial pneumonia, Specticema, bacteremia, Patients with severe enterococcocal infections, Skin and structure infections, Prophylaxis during surgical procedure.
Dosage Oral or IV administaratin 600mg every 12 hours
Pharmacology/ Pharmacokinetics:
Pharmacology:
Oxazolidinones act via inhibition of the initiation pase of bacterial protein synthesis. The drug inhibits the formation of the initiation complex formed with 30S ribosomal subunit, mRNA, initial factors IF2 and IF3 .
Pharmacokinetics:
Rapidly and completely absorbed after oral adminisdtration with a mean absolute bioavailability of about 100%. Peak plasma concentration is acheived in 1- 2 hours. The elimination half-life is 4.5 - 5 hours at a steady state or after a single dose. About 80- 85% of the drug after a single 500mg oral dose is recovered in urine and 7-12 % in faeces over a seven day period following administration.
Interaction with Food:
Beverages and foods high in in tyramine content - increased blood pressure may occur when linezilid is used with diet high in tyramine.
Pregnancy and lactation:
Pregnancy Use with caution Lactation Caution if used in nursing women
Children- safety and efficacy not established below 18 years
Manufacturer Details