Tezolid Injection
Tedizolid Phosphate
200 mg/vial
Incepta Pharmaceuticals Ltd.
| Pack size | 1's Pack |
|---|---|
| Unite Price | 800.00 BDT |
Indications
Tezolid Injection is used for:
Acute bacterial skin and skin structure infections (ABSSSI)
Adult Dose
Adult: 200 mg PO/IV once daily for 6 days
Hepatic impairment: No dosage adjustment required
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment or hemodialysis: No dosage adjustment required
Administration
Oral Administration
May take with or without food
IV Administration
Administer as IV infusion over 1 hr
Do NOT give as IV push or bolus
Not for intra-arterial, IM, IT, intraperitoneal, or SC administration
Contra Indications
Contraindicated for patients with hypersensitivity to Tedizolid and ingredients
Precautions
Patients w/ neutropenia (neutrophil counts <1,000 cells/mm3). Discontinue if C. difficile-associated diarrhoea (CDAD) is suspected or confirmed. Patients w/ concomitant complicated skin & soft tissue infection & secondary bacteremia & in treatment of ABSSSI w/ severe sepsis or septic shock; diabetic foot infections, decubitus or ischaemic ulcers, bone or joint infections, severe burns, necrotizing infections or gangrene. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <18 yr. Elderly ≥75 yr.
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women
Only use during pregnancy only if the potential benefit justifies the potential risk to the fetus
Animal data
In embryo-fetal studies in mice and rats, drug was shown to produce fetal developmental toxicities in mice and maternal toxicity and fetal developmental toxicities in rats
Drug administered orally during organogenesis to pregnant animals was associated with reduced fetal weights and an increased incidence of costal cartilage anomalies in the absence of maternal toxicity in mice; and maternal toxicity, decreased fetal weights, and increased skeletal variations in rats at plasma exposures approximately 4- and 6-times respectively, the human plasma exposure at the maximum recommended human dose (MRHD) of 200 mg/day
In female rats, drug administered during organogenesis through lactation, did not show evidence of fetal toxicity, developmental delays, or impaired reproduction in offspring at plasma exposures approximately equivalent to the human plasma exposure at the MRHD
Lactation
Tedizolid is excreted in the breast milk of rats; when drug is present in animal milk, it is likely that the drug will be present in human milk
Unknown whether tedizolid is excreted in human milk
Exercise caution when administering to a nursing woman; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
Increased AUC & Cmax of rosuvastatin. Inhibition of BCRP at the intestinal level, increased plasma conc of BCRP substrates, & the potential for adverse reactions especially for BCRP substrates w/ narrow therapeutic index (eg, methotrexate or topotecan), or rosuvastatin.
Side Effects
Side effects of Tedizolid Phosphate :
2-10%
Nausea (8%)
Headache (6%)
Diarrhea (4%)
Hemoglobin <10.1 g/dL (3.1%)
Vomiting (3%)
Platelets <112 x 10³/mm³ (2.3%)
Dizziness (2%)
<2%
Blood and lymphatic system disorders: Anemia
Cardiovascular: Palpitations, tachycardia
Eye disorders: Asthenopia, vision blurred, visual impairment, vitreous floaters
General disorders and administration site conditions: Infusion-related reactions
Immune system disorders: Drug hypersensitivity
Infections and infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection
Investigations: Hepatic transaminases increased, decreased WBCs
Nervous system disorders: Hypoesthesia, paresthesia, seventh nerve paralysis
Psychiatric disorders: Insomnia
Skin and subcutaneous tissue disorders: Pruritus, urticaria, dermatitis
Vascular disorders: Flushing, hypertension
Mode of Action
Inhibits protein synthesis by binding with 50S ribosomal sub-unit in bacteria
Note
Tezolid 200 mg/vial Injection generic name is Tedizolid Phosphate. Tezolid 200 mg/vial Injection is manufactured by Incepta Pharmaceuticals Ltd.Tezolid is availble in all over Bangladesh.
Mes BD drug index information on Tezolid Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.