What Tygacil is used for and how to use it
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Tygacil - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Intraabdominal Infection, Pneumonia, Skin and Structure Infection, Skin or Soft Tissue Infection
Class: Antibiotics/antineoplastics, Glycylcyclines
Form: Intravenous (IV), Powder
Ingredients: tigecycline, lactose

(tigecycline)

About this Medication

What the Medication is Used For

The name of the medicine you have been given is TYGACIL. Your doctor prescribed TYGACIL because you have one of the following types of serious infections:

   Complicated bacterial infection of the skin

   Complicated bacterial infection in the abdomen

   Mild to moderate community acquired pneumonia (lung infection caught outside of a hospital)

TYGACIL is for use in patients 18 years of age and over.

What it Does

TYGACIL is an antibiotic that works by helping to stop the growth of bacteria that cause infections.

When it Should not be Used

Do not use TYGACIL if you are allergic to tigecycline or tetracycline antibiotics.

What the Medicinal Ingredient Is

Tigecycline.

What the Important Nonmedicinal Ingredients Are

Lactose.

What Dosage Forms it Comes In

TYGACIL (tigecycline) for Injection is supplied in a single-dose 5 mL glass vial containing lyophilized powder for reconstitution, and is an orange cake or powder.

Warnings and Precautions

If you develop any allergic reaction, (e.g. rash, difficulty in breathing, tightening of chest, swelling of lips, tongue or throat, etc.), tell your doctor or nurse immediately.

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 TYGACIL and contact your healthcare professional immediately.

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

  • You have other infections

    While antibiotics including TYGACIL fight certain bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you for any potential infections and treat you if necessary.

  • You are pregnant

    TYGACIL may cause fetal harm. If you are pregnant, or are planning to become pregnant, talk to your doctor before receiving TYGACIL.

  • You are breast-feeding or planning to breast-feed

    It is not known if TYGACIL passes into breast milk. Since many drugs pass into breast milk and there is a possibility of permanent staining of the teeth of the child, ask your doctor for advice before breastfeeding your baby.

  • You have liver problems

    You should inform your doctor if you have or had liver disease. Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects.

  • You are driving or using machines

    TYGACIL may cause side effects such as dizziness. Do not drive or operate machinery until these side effects pass.

  • Children

    TYGACIL should not be used in children under 8 years of age due to the effects of enamel loss and tooth staining in developing teeth and is not recommended in children over 8 years of age due to lack of experience of use in children.

While Taking TYGACIL:

  • If you develop a racing heartbeat (palpitations) or faint while using TYGACIL, contact your doctor immediately.

Interactions With This Medication

Drugs that may interact with TYGACIL include:

Always tell your doctor if you are taking warfarin or any other medicines, including medicines you buy without a prescription.

TYGACIL may interfere with the contraceptive pill (birth control pill). Talk to your doctor about the need for an additional method of contraception while receiving TYGACIL.

Proper Use of This Medication

Usual Adult Dose

TYGACIL is given intravenously (into a vein) and administered to you by your doctor or nurse.

The recommended dose is 100 mg given initially, followed by 50mg every 12 hours, given by intravenous infusion over a period of 30-60 minutes.

It is very important that you continue to receive TYGACIL for as long as your doctor prescribes it. Your doctor will decide how many days of treatment you need.

Overdose

If you think you have taken too much TYGACIL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre Immediately, even if there are no symptoms.

Missed Dose

If you are concerned that you may have missed a dose, talk to your doctor or nurse immediately.

Side Effects and What to do About Them

Like all medicines, TYGACIL may have side effects.

The Most Common Side Effects Are

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Dizziness
  • Skin rash
  • Itching
  • Headache
  • Abdominal discomfort

Less Common Side Effects Are

  • Injection site reaction (pain, redness, inflammation)
  • Vein irritations from the injection including pain,
  • inflammation, swelling and clotting. Fever
  • Chills
  • Chest pain
  • Jaundice (yellowness of skin or eye)
  • Allergic reaction (e.g. rash, difficulty in breathing, tightening of chest, swelling of lips, tongue or throat, etc.)

If these become bothersome, contact your doctor.

Serious Side Effects, how Often They Happen and What to do About Them

Symptom/effectTalk with your doctor or pharmacistStop taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
Common
Uncommon- Injection site reaction
- Vein irritations
- Difficulty breathing
- Fever
- Chills
- Chest pain
- Jaundice
- Allergic reaction








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

How to Store It

TYGACIL will be stored in the hospital in the appropriate conditions. TYGACIL must be kept out of the reach and sight of children. TYGACIL will be given to you only within the “use-by” date of the product.

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:

  • 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

This document plus the full Product Monograph, prepared for health professionals, can be found at www.pfizer.ca or can be obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001 (Medical Information).