Tezo 200 mg

INDICATIONS

Tedizolid Phosphate is an oxazolidinone-class antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible ... Read moreTedizolid Phosphate is an oxazolidinone-class antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis.

PHARMACOLOGY

Tedizolid Phosphate is a prodrug that is converted by phosphatases to Tedizolid, the microbiologically active moiety, following oral and intravenous administration. Following multiple once-daily oral or intravenous administration, steady-state concentrations are achieved within approximately three days with Tedizolid, accumulation of approximately 30% (Tedizolid half-life of approximately 12 hours). Peak plasma Tedizolid concentrations are achieved within approximately 3 hours following oral administration under fasting conditions. The absolute bioavailability is approximately 91% and no dosage adjustment is necessary between intravenous and oral administration. Protein binding of Tedizolid to human plasma proteins is approximately 70 to 90%. Other than Tedizolid Phosphate, which accounts for approximately 95% of the total radiocarbon AUC in plasma, there are no other significant circulating metabolites in humans. There was no degradation of Tedizolid in human liver microsomes indicating Tedizolid Phosphate is unlikely to be a substrate for hepatic CYP450 enzymes. Following single oral administration of 14C-labeled Tedizolid Phosphate under fasted conditions, the majority of elimination occurred via the liver, with 82% of the radioactive dose recovered in feces and 18% in urine.

DOSAGE & ADMINISTRATION

Tedizolid Phosphate is recommended in patients with 18 years of age or older. Tedizolid should be administered 200 mg once daily for six (6) days orally (with or without food). If patients miss a dose, they should take it as soon as possible at anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.Use in Children & Adolescents: Safety and effectiveness in paediatric patients below the age of 18 have not been established. No overall differences in pharmacokinetics were observed between elderly subjects and youngersubjects.

INTERACTION

No potential drug interactions with Tedizolid Phosphate were identified in vitro CYP inhibition or induction studies. No clinically significant inhibition of any transporter was observed at Tedizolid Phosphate circulating plasma concentrations. Tedizolid Phosphate is a reversible inhibitor of monoamine oxidase in vitro.

SIDE EFFECTS

The most common side effects in patients treated with Tedizolid Phosphate are nausea, headache, diarrhea, vomiting and dizziness. The following selected adverse reactions may be reported in Tedizolid Phosphate treated patients: anemia, palpitations, tachycardia, blurred vision, visual impairment, infusion-related reactions, drug hypersensitivity, insomnia, pruritus, urticaria, dérmatitis and hypertension etc.

PREGNANCY & LACTATION

Pregnancy category C. There are no adequate and well controlled studies of Tedizolid Phosphate in pregnant women. Tedizolid Phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Tedizolid Phosphate is excreted in human milk.

PRECAUTIONS & WARNINGS

Alternative therapies should be considered when treating patients with neutropenia and acute bacterial skin and skin structure infection, Clostridium difficile-associated diarrhea and the risk of the development of drug-resistant bacteria.Pharmaceutical precautions: Administer Tedizolid Phosphate infusion as an intravenous infusion only. The intravenous bag containing the reconstituted and diluted intravenous solution should be inspected visually for particulate matter prior to administration. After reconstitution and dilution, it is to be administered via intravenous infusion using a total time of 1 hour. The total time from reconstitution to administration should not exceed 24 hours at room temperature or under refrigeration at 2°C to 8°C.

THERAPEUTIC CLASS

Other antibiotic

STORAGE CONDITIONS

Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.