Product Description

Indications:Tezo is an oxazolidinone-class antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive organisms, including Staphylococcus aureus (both methicillin-resistant and methicillin-susceptible strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group organisms, and Enterococcus faecalis.Pharmacology:Tedizolid Phosphate is a prodrug that is converted by phosphatases into the active antibacterial agent Tedizolid after oral or intravenous administration. Steady-state concentrations are generally achieved within three days of once-daily dosing, with approximately 30% accumulation due to its half-life of around 12 hours. Peak plasma concentrations occur about 3 hours after oral administration under fasting conditions. Oral bioavailability is approximately 91%, allowing interchangeable use between oral and intravenous formulations without dose adjustment. Protein binding ranges from 70% to 90%. Tedizolid Phosphate accounts for most of the circulating drug-related exposure, with no significant additional metabolites identified. It is not significantly metabolized by hepatic CYP450 enzymes. Elimination occurs mainly through the liver, with approximately 82% excreted in feces and 18% in urine.Dosage & Administration:Tezo is recommended for adults aged 18 years and older. The usual dose is 200 mg once daily for 6 days, administered orally with or without food.Missed Dose: If a dose is missed, it should be taken as soon as possible up to 8 hours before the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should be skipped and the regular schedule resumed.Use in Children & Adolescents: Safety and effectiveness in patients below 18 years of age have not been established. No significant pharmacokinetic differences have been observed between elderly and younger adults.Interaction:No clinically significant drug interactions have been identified through CYP inhibition or induction studies. Tedizolid does not significantly inhibit common drug transporters at therapeutic plasma concentrations. It is, however, a reversible monoamine oxidase (MAO) inhibitor in vitro.Contraindications:Tezo is contraindicated in patients with known hypersensitivity to Tedizolid Phosphate or any component of the formulation.Side Effects:Common adverse effects include nausea, headache, diarrhea, vomiting, and dizziness. Other reported reactions may include anemia, palpitations, tachycardia, blurred vision, visual disturbances, infusion-related reactions, hypersensitivity reactions, insomnia, pruritus, urticaria, dermatitis, and hypertension.Pregnancy & Lactation:Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tezo should only be used during pregnancy if the potential benefit justifies the possible risk to the fetus. It is not known whether Tedizolid is excreted into human breast milk.Precautions & Warnings:Alternative therapies should be considered in patients with neutropenia and acute bacterial skin infections. Caution is advised regarding the risk of Clostridium difficile-associated diarrhea and the potential development of drug-resistant bacteria.Pharmaceutical Precautions:Tezo infusion should be administered only as an intravenous infusion. The prepared solution should be visually inspected for particulate matter before use. Following reconstitution and dilution, the infusion must be administered over 1 hour. Total storage time after preparation should not exceed 24 hours at room temperature or under refrigeration (2°C to 8°C).Overdose Effects:In case of overdose, Tezo should be discontinued and supportive treatment should be provided.Therapeutic Class:Other AntibioticReconstitution:The vial should be reconstituted using aseptic technique. To minimize foaming, avoid vigorous shaking.Reconstitute the vial with 4 mL of normal saline using a syringe.Gently swirl and allow the powder to dissolve completely.Inspect the solution for particulate matter or undissolved powder.If necessary, gently invert the vial to dissolve remaining powder.Further dilute the reconstituted solution with the remaining normal saline.Gently invert the infusion bag to mix; do not shake.Administer via intravenous infusion over 1 hour.Compatible Infusion Fluid:0.9% Sodium Chloride Injection (Normal Saline)Storage Conditions:Store below 30°C in a cool, dry place away from light. Keep out of reach of children.