tedizolid phosphate200 mg film-coated tablets
tedizolid phosphate
What Sivextro is and what it is used for
Sivextro is an antibiotic that contains the active substance tedizolid phosphate. It belongs to a group of medicines called “oxazolidinones”.
It is used to treat adults and adolescents from 12 years of age with infection in the skin and tissues under the skin.
It works by stopping the growth of certain bacteria that can cause serious infections.
What you need to know before taking Sivextro
Do not take Sivextro
- if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Your doctor has decided that Sivextro is suitable for treating your infection.
Talk to your doctor or nurse before taking Sivextro if any of the following apply to you:
- if you have diarrhea, or have had diarrhea while (or up to 2 months after) you have taken antibiotics in the past.
- if you are allergic to other medicines that belong to the “oxazolidinones” group, e.g. linezolid, cycloserine).
- if you have a history of bleeding or easy bruising (which may be a sign of a low number of platelets, the small cells that help the blood to clot).
- if you have kidney problems.
- if you are taking certain medicines to treat depression called tricyclics, SSRIs (selective serotonin reuptake inhibitors), or MAOIs (monoamine oxidase inhibitors). See Other medicines and Sivextro for examples.
- if you take certain medicines to treat migraines called ‘triptans’. See Other medicines and Sivextro for examples.
Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.
Diarrhea
Contact your doctor immediately if you develop diarrhea during or after treatment. Do not take any medicine to treat diarrhea without first consulting your doctor.
Resistance to antibiotics
Bacteria can become resistant to antibiotic treatment over time. This means that antibiotics cannot stop the growth of bacteria and treat your infection. Your doctor will decide whether you should receive Sivextro to treat your infection.
Possible side effects are
Some side effects have been seen with Sivextro or another member of the oxazolidinone class when administered for a period longer than that recommended for Sivextro. Tell your doctor immediately if you experience any of the following while taking Sivextro:
- a low white blood cell count
- anemia (low red blood cell count )
- bleeds or bruises easily
- loss of sensation in the hands and feet (for example, numbness, tingling/tingling, or severe pain)
- vision problems, e.g. blurred vision, altered color vision, difficulty seeing details, or if the field of vision becomes restricted.
Children
This medicine should not be used in children under 12 years of age as it has not been sufficiently studied in this patient group.
Other medicines and Sivextro
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines. You must tell your doctor if you are also taking:
- amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline, and sertraline (used to treat depression)
- sumatriptan, zolmitriptan (used to treat migraine )
- imatinib, lapatinib (used to treat cancer)
- methotrexate (used to treat cancer, rheumatoid arthritis, or psoriasis )
- sulfasalazine (used to treat inflammatory bowel disease)
- topotecan (used to treat cancer)
- statins such as pitavastatin, and rosuvastatin (used to lower blood cholesterol levels)
Sivextro can interfere with the effects of these medicines. Your doctor can explain in more detail.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is unknown if Sivextro is excreted in breast milk. Consult your doctor before breastfeeding your baby.
Driving ability and use of machinery
Avoid driving or using machines if you feel dizzy or tired after taking this medicine.
How to take Sivextro
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one 200 mg tablet once daily for 6 days. The tablets must be swallowed whole and can be taken with or without food or drink.
Talk to your doctor if you do not feel better or if you feel worse after 6 days.
If you have taken too much Sivextro
Contact a doctor, pharmacist, or the nearest emergency department as soon as possible if you have taken more tablets than you should, and take the medicine with you.
If you forget to take Sivextro
If you forget to take your medicine, take a dose as soon as possible up to 8 hours before the next scheduled dose. If it is less than 8 hours until the next dose, wait until it is time for the next scheduled dose. Do not take a double dose to make up for a missed dose. If you are unsure, consult a pharmacist.
You must take all 6 tablets to complete the treatment course, even if you have missed a dose.
If you stop taking Sivextro
If you stop taking Sivextro without first consulting your doctor, your symptoms may worsen. Talk to your doctor or pharmacist before you stop taking the medicine.
If you have any further questions about this medicine, ask your doctor or pharmacist
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you develop diarrhea during or after treatment.
Other side effects can be:
Common side effects (may affect up to 1 in 10 users)
- Nausea
- Vomiting
- Headache
- Itching all over the body
- Fatigue
- Dizziness
Uncommon side effects (may affect up to 1 in 100 users)
- Fungal infections of the skin, mouth, and vagina (oral/vaginal thrush)
- Itching (including itching due to an allergic reaction ), hair loss, acne, red and/or itchy rash or hives, profuse sweating
- Decreased or lost sensitivity in the skin, tingling/stinging sensation in the skin
- Flushing or redness of the face, neck, or upper chest
- An abscess (swollen, fluid-filled lump)
- Infection, inflammation, or itching in the vagina
- Restlessness, irritability, shaking, or tremors
- Respiratory tract infection (sinuses, pharynx, and chest)
- Dryness of the nose, congestion in the chest, cough
- Drowsiness, abnormal sleep patterns, difficulty sleeping, nightmares (unpleasant/disturbing dreams)
- Dry mouth, constipation, indigestion, stomach (abdominal) pain/discomfort, retching, belching, bright red blood in the stool
- Reflux disease (heartburn, pain, or difficulty swallowing), gas in the stomach
- Joint pain, muscle cramps, back pain, neck pain, pain/discomfort in arms and legs, decreased grip strength
- Blurry vision, “spots” (small dots that float around in the field of vision, etc.)
- Swollen or enlarged lymph nodes
- Allergic reaction
- Dehydration
- Poor control of diabetes
- Abnormal taste experience
- Slow heartbeat
- Fever
- Swollen ankles and/or feet
- Urine smells abnormal, and abnormal blood tests
Frequency not known (cannot be estimated from available data)
- Bleeding and bruising more easily (due to a low number of platelets, the small cells that help the blood clot)
How Sivextro should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton or blister label after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tedizolid phosphate. One film-coated tablet contains 200 mg of tedizolid phosphate.
- Other ingredients are microcrystalline cellulose, mannitol, povidone, crospovidone, and magnesium stearate inside the tablet core. The film coating of the tablet contains polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and yellow iron oxide (E172).
Appearance and package sizes of the medicine
Sivextro is an oval, yellow, film-coated tablet marked with ‘TZD’ on one side and ‘200’ on the other side.
It is supplied as 6 × 1 tablets in perforated unit dose blisters.
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
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