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Tedizolid phosphate oral

Updated 2 Feb 2023 | Oxazolidinones

Presentation

Oral formulations containing tedizolid phosphate.

Drugs List

  • SIVEXTRO 200mg tablets
  • tedizolid phosphate 200mg tablets
  • Therapeutic Indications

    Uses

    Treatment of skin and skin structure infections

    Dosage

    Adults

    200mg once daily for 6 days.

    Elderly

    200mg once daily for 6 days.

    Additional Dosage Information

    If a fast antibiotic effect is needed, parenteral tedizolid phosphate should be considered. See Monograph for parenteral tedizolid phosphate for further information.

    Missed dose
    If a dose is missed it should be given to the patient any time up to 8 hours prior to the next scheduled dose. If there are less than 8 hours before the next scheduled dose, wait to administer the next scheduled dose. Avoid double dosing.

    Contraindications

    Children under 18 years
    Breastfeeding
    Pregnancy

    Precautions and Warnings

    Severe immunosuppression
    Neutropenia

    Advise patient dizziness may affect ability to drive or operate machinery
    Consult national/regional policy on the use of anti-infectives
    Diabetic control may need adjustment
    Perform blood counts on prolonged use of this treatment
    Perform eye tests in any patient with vision change/ophthalmologic symptoms
    Advise patient to report any blurred vision or any other eye symptoms
    Consider C. difficile if diarrhoea occurs within 2 months of treatment
    Discontinue therapy if marked diarrhoea occurs
    Duration of treatment should not exceed 6 days

    The manufacturer suggests alternative therapies should be considered when treating patients with neutropenia. The safety and efficacy of tedizolid phosphate in patients with neutrophil counts of less than 1000 cells per cubic millimetre have not been investigated. In an animal model of infection, the antibacterial activity of tedizolid phosphate was reduced in the absence of granulocytes. The clinical relevance of this finding is unknown.

    Cases of thrombocytopenia have been observed when treatment lasted longer than the recommended duration. There may be an association with thrombocytopenia in patients with renal insufficiency.

    Pregnancy and Lactation

    Pregnancy

    Tedizolid phosphate is contraindicated during pregnancy.

    The manufacturer recommends tedizolid phosphate should be avoided during pregnancy.

    At the time of writing, there are no data from the use of tedizolid phosphate in pregnant women. Studies in mice and rats showed developmental effects.

    Lactation

    Tedizolid phosphate is contraindicated during breastfeeding.

    The manufacturer suggests a risk to the breastfeeding infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or tedizolid phosphate taking into consideration the benefit of breastfeeding for the child and the benefit of therapy for the patient. The Drugs and Lactation Database (LactMed) suggests that if required, tedizolid phosphate is not a reason to discontinue breastfeeding. However, the infant should be monitored for possible gastrointestinal tract effects. Alternate therapy may be prefered because of the lack of published data.

    At the time of writing, it is unknown whether tedizolid phosphate is excreted in human milk. Tedizolid phosphate is excreted in the milk of rats.

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Abscess
    Acne
    Alopecia
    Antibiotic-associated colitis
    Anxiety
    Arthralgia
    Back pain
    Blurred vision
    Bradycardia
    Candidiasis (mouth or throat)
    Chills
    Constipation
    Cough
    Decreased glycaemic control in diabetes
    Dehydration
    Diarrhoea
    Discomfort in limb
    Dizziness
    Dry mouth
    Dysgeusia
    Dyspepsia
    Erythematous rash
    Flatulence
    Floaters
    Flushing
    Fungal infection
    Gastroesophageal reflux disease
    Haematochezia
    Haemoglobin decrease
    Headache
    Hot flushes
    Hyperhidrosis
    Hyperkalaemia
    Hypersensitivity reactions
    Hypoaesthesia
    Increase in serum transaminases
    Insomnia
    Irritability
    Lymphadenopathy
    Maculopapular rash
    Muscle spasm
    Nasal dryness
    Nausea
    Neck pain
    Nightmares
    Paraesthesia
    Peripheral oedema
    Pruritic rash
    Pruritus
    Pulmonary congestion
    Pyrexia
    Rash
    Reduced neutrophil count
    Reduced platelet count
    Respiratory tract infection
    Retching
    Sleep disturbances
    Somnolence
    Thrombocytopenia
    Tremor
    Urine abnormality
    Urticaria
    Vomiting
    Vulvovaginal infections
    Vulvovaginal irritation
    Weakness of the hands
    White blood cell count decreased

    Further Information

    Last Full Review Date: October 2019

    Reference Sources

    Summary of Product Characteristics: Sivextro 200 mg film-coated tablets. Merck Sharp and Dohme. January 2021.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Tedizolid. Last revised: 04 September 2014.
    Last accessed: 21 August 2017.

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