Sivextro 200 mg Tablets, Powder for solution for infusion
Clinical Summary
Quick overview from the medicine insert
Indication
Used to treat skin and soft tissue infections in adults.
Dosage (summary)
200 mg IV infusion over 1 hour once daily for 6 days.
Special Populations
- Children (< 18 years)
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding.
Key Drug Interactions
- Tricyclics
- SSRIs
- MAOIs
- Triptans
- Methotrexate
- Topotecan
- Rosuvastatin
Contraindications
- Allergy to tedizolid phosphate
- Pregnancy
- Breastfeeding
Common side effects
- Nausea
- Vomiting
- Headache
- Dizziness
- Infusion site pain
Counselling Points
- Do not drive if dizzy
- Report diarrhea immediately
- Consult before taking other medications
Serious warnings
- Risk of serious blood cell effects with prolonged use
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4. Possible side effects
SIVEXTRO can cause side effects, although not everybody gets them. Not all side-effects reported for SIVEXTRO are included in this leaflet. Should your general health worsen or if you experience any untoward effects, while taking SIVEXTRO, please consult your health care provider for advice.
Contact your doctor immediately if you suffer from diarrhoea during or after your treatment. Frequent medication-related undesirable effects in adults are nausea, vomiting, headache, itching all over the body, tiredness, dizziness and infusion site pain or swelling.
Less frequent reported medication-related undesirable effects in adults include:
- Fungal infections of skin, mouth and vagina (oral / vaginal thrush)
- Itching (including itching due to allergic reaction), hair loss, acne, red and/or itchy rash or hives, excessive sweating
- Decrease or loss of skin sensitivity, tingling/prickling skin sensation
- Hot flush or blushing/redness in the face, neck or upper chest
- Abscess (swollen, pus-filled lump)
- Vaginal infection, inflammation or itching
- Anxiety, irritability, Shaking or trembling
- Respiratory tract (sinuses, throat and chest) infection
- Dryness in the nose, congestion in the chest, cough
- Sleepiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing dreams)
- Dry mouth, constipation, indigestion, pain/discomfort in the belly (abdomen), retching, dry heaving, bright red blood in the stool
- Acid reflux disease (heartburn, pain or difficulty swallowing), flatulence/passing wind
- Joint pain, muscle spasms, back pain, neck pain, pain/discomfort in limbs, decrease of grip strength
- Blurred vision, u2018floatersu2019 (small shapes seen floating in the field of vision)
- Swollen or enlarged lymph nodes
- Allergic reaction
- Dehydration
- Poor control of diabetes
- Abnormal sense of taste
- Slow heartbeat
- Fever
- Swelling in ankles and/or feet
- Abnormal smelling urine, abnormal blood tests
- Infusion reactions (chills, shaking or shivering with fever, muscle pain, swelling of the face, weakness, fainting, shortness of breath, chest tightness and angina pectoris).
Other reported medication-related undesirable effects that have occurred at an unknown frequency in adults include:
- Bleeding or bruising easily
Certain side effects on blood cells have been observed with SIVEXTRO or another member of the oxazolidinone class when administered over a duration exceeding that recommended for SIVEXTRO. Tell your doctor immediately if you suffer from bleeding or bruising while taking SIVEXTRO. Other side effects may also occur rarely, and as with any prescription medicine, some side effects may be serious. Ask your doctor or pharmacist for more information. Both have a more complete list of side effects. Tell your doctor or pharmacist promptly about these or any other unusual symptoms. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SIVEXTRO.