Sivextro: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

SIVEXTRO is a medicine which is used to treat infections of the skin caused by certain bacteria, in adults 18 years of age and over.

What it does:

SIVEXTRO belongs to a class of medicines called antibiotics and it works by stopping protein synthesis in certain bacteria, reducing bacterial growth and the number of bacteria, thereby reducing the skin infection.

When it should not be used:

• If you are allergic to the active substance in SIVEXTRO or any of the other ingredients in this medicine (see What the important non-medicinal ingredients are)

What the medicinal ingredient is:

Tedizolid phosphate

What the important nonmedicinal ingredients are:

SIVEXTRO tablets contain: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, povidone, talc, titanium dioxide, and yellow iron oxide.

SIVEXTRO for injection contains: mannitol and sodium hydroxide. May contain hydrochloric acid in minimal quantity for pH adjustment.

What dosage forms it comes in:

200 mg tedizolid phosphate tablets

Vial containing 200 mg tedizolid phosphate for injection, provided as a powder that will be dissolved in sterile water and diluted with salt water so that it can be injected.

WARNINGS AND PRECAUTIONS

Antibacterial drugs including SIVEXTRO should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

Do not drive or use machines if you feel dizzy, sleepy, or tired after taking SIVEXTRO.

BEFORE you use SIVEXTRO talk to your doctor or pharmacist if:

• You are allergic to this drug or any of the ingredients in

  SIVEXTRO or components of the container

• You have neutropenia (low white blood cells)

• You are pregnant or plan to become pregnant. If you are of child-bearing potential, you should use reliable contraception during SIVEXTRO use.

• You are breastfeeding or plan to breastfeed. You should not breastfeed while taking SIVEXTRO.

INTERACTIONS WITH THIS MEDICATION

Clinical drug interaction studies have not been done with SIVEXTRO.

Tell your doctor if you are using any of the following drugs as they may interact with SIVEXTRO:

• anticancer drugs (e.g., imatinib, lapatinib)
• anticoagulants (e.g., warfarin)
• antipsychotic drugs (e.g., midazolam, triazolam, pimozide)
• cholesterol lowering drugs (e.g., atorvastatin, fluvastatin, lovastatin, rosuvastatin)
• heart drugs (e.g., quinidine, digoxin)
• high blood pressure medications (e.g., olmesartan, valsartan)
• immune suppressants (e.g., cyclosporine, tacrolimus, sirolimus)
• medications to control blood sugar (e.g., glyburide, repaglinide)
• oral contraceptives
• opioid analgesics (e.g., alfentanil, fentanyl)
• selective serotinin re-uptake inhibitors (SSRI’s)
• serotonin norepinephrine re-uptake inhibitors (SNRI’s)

PROPER USE OF THIS MEDICATION

Usual adult dose:

200 mg taken once a day as a tablet or as an intravenous infusion over 1 hour, as decided by your doctor.

Treatment usually lasts for 6 days.

SIVEXTRO may be taken with or without food.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of SIVEXTRO, you should take the dose as soon as possible, anytime up to 8 hours before the next scheduled dose. This will help keep a constant amount of medication in your blood. If less than 8 hours remains before the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take double doses.

You should always take the full number of doses prescribed by your doctor because not completing the full course of therapy may decrease the effectiveness of treatment.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, SIVEXTRO can cause side effects although not everyone experiences them. Most of side effects are mild and do not mean that you have to stop taking the medicine.

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking SIVEXTRO and contact your healthcare professional immediately.

Common side effects (affecting 1-10 users in 100):

• Nausea
• Headache
• Diarrhea
• Vomiting
• General itching
• Dizziness
• Tiredness

If any of these side effects bother you or become serious, please tell your doctor.

This is not a complete list of side effects. For any unexpected effects while taking SIVEXTRO, contact your doctor or pharmacist.

HOW TO STORE IT

Keep out of the reach and sight of children.

SIVEXTRO Tablets:

Store at room temperature (15°C - 30°C). Do not use this medication after the expiration date printed on the label.

SIVEXTRO for Injection:

The healthcare professional will store the product at room temperature (15°C - 30°C). Storage time of the reconstituted solution in the vial should not exceed 24 hours at either room temperature (15°C - 30°C) or under refrigeration at 2 to 8°C. The total time from reconstitution to administration of the diluted solution for infusion should not exceed 24 hour at room temperature or under refrigeration.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect • Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701D Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about SIVEXTRO:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or Merck Canada web site www.merck.ca or by calling Merck Canada at 1-800-567-2594.

To report an adverse event related to SIVEXTRO, please contact 1-800-567-2594.

Inc. Last revised: September 29, 2015

™ Trius Therapeutics, Inc. Used under license.

© 2015 Merck Canada Inc. All rights reserved.