Patient Medication Information: uses, side effects, how to take - Tigecycline
Serious Warnings and Precautions
- TIGECYCLINE is associated with an increased risk of death.
- TIGECYCLINE should only be used in situations where alternative treatments are not suitable.
What is TIGECYCLINE used for?
TIGECYCLINE is an antibiotic medicine. It is used to treat the following serious bacterial infections in adults:
- skin infections
- abdomen infections
- community acquired pneumonia (lung infections caught outside of hospitals or other health care facilities)
Antibacterial drugs like TIGECYCLINE treat only bacterial infections. They do not treat viral infections.
How does TIGECYCLINE work?
TIGECYCLINE belongs to the class of medicines called tetracycline antibiotics. It works by helping to stop the growth of bacteria responsible for your infection.
What are the ingredients in TIGECYCLINE?
Medicinal ingredients: Tigecycline
Non-medicinal ingredients: Hydrochloric acid, lactose monohydrate, sodium hydroxide
TIGECYCLINE comes in the following dosage forms:
TIGECYCLINE comes as a powder to be mixed with a specific liquid and injected slowly into a vein.
TIGECYCLINE is supplied as a single-dose 5 mL glass vial.
Each TIGECYCLINE vial contains 50 mg of tigecycline powder.
Do not use TIGECYCLINE if:
- you are allergic to tigecycline,
- you are allergic to any other ingredients of TIGECYCLINE (see What are the ingredients in TIGECYCLINE?),
- you are allergic to other tetracycline antibiotics such as doxycycline, minocycline, and tetracycline.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TIGECYCLINE. Talk about any health conditions or problems you may have, including if you:
- have other infections.
- have liver problems.
- have any heart conditions.
are pregnant or planning to become pregnant. TIGECYCLINE may cause fetal harm.
- are breastfeeding or planning to breastfeed. It is not known if TIGECYCLINE passes into breast milk. There is a possibility of permanent staining of the teeth of the child.
Other warnings you should know about:
Children
TIGECYCLINE is for use in adults aged 18 and over. There is no experience with the use of TIGECYCLINE in children under 18 years of age. TIGECYCLINE may cause enamel loss and staining in developing teeth.
While taking TIGECYCLINE
Do not drive or operate machinery. TIGECYCLINE may cause side effects such as dizziness.
TIGECYCLINE may make your skin more sensitive to sunlight than it is normally. To protect your skin from sunburn, you should:
- Wear protective clothing and sunglasses
- Limit your time in the sun especially between 11 a.m. and 4 p.m.
- Use sunscreen
- Avoid using tanning beds
- If you develop severe diarrhea during your treatment with TIGECYCLINE or over 2 months after your treatment is finished, call your healthcare professional immediately (see What are possible side effects from using TIGECYCLINE? Section below).
- Do not use any medicine to treat your diarrhea without first checking with your doctor.
- Your healthcare professional may order some blood tests for you before and while you are on treatment with TIGECYCLINE.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TIGECYCLINE:
- anticoagulants (blood thinners) such as warfarin
- contraceptive pill (birth control pill). Talk to your doctor about the need for an additional method of contraception while receiving TIGECYCLINE.
- drugs that weaken the immune system such as tacrolimus or cyclosporine. Taking TIGECYCLINE may lead to increased levels of these drugs in your body. Tell your healthcare professional if you are taking tacrolimus or cyclosporine so that blood levels can be checked before, during and after taking TIGECYCLINE. The dose of tacrolimus or cyclosporine may be adjusted while you are taking TIGECYCLINE.
How to take TIGECYCLINE:
- Your healthcare professional will give TIGECYCLINE by intravenous infusion (slow drip through a needle into a large vein) over a period of 30 to 60 minutes.
- Although you may feel better early in treatment, TIGECYCLINE should be used exactly as directed.
- Misuse or overuse of TIGECYCLINE could lead to the growth of bacteria that will not be killed by TIGECYCLINE (resistance). This means that TIGECYCLINE may not work for you in the future.
- Do not share your medicine.
- If your condition does not improve in a few days or if it gets worse, contact your healthcare professional.
Usual dose:
The usual adult dose of TIGECYCLINE is 100 mg for the first dose, followed by 50 mg every 12 hours.
The length of your treatment depends on the type of infection you have and how your body responds to TIGECYCLINE.
Overdose:
If you think you, or a person you are caring for, have taken too much TIGECYCLINE, contact a 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.
What are possible side effects from using TIGECYCLINE?
These are not all the possible side effects you may have when taking TIGECYCLINE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Dizziness
- Skin rash
- Itching
- Headache
- Abdominal discomfort
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 TIGECYCLINE and contact your healthcare professional immediately.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Injection site reaction (pain, redness, inflammation) | √ | ||
| Vein irritations from the injection (including pain, inflammation, swelling and clotting) | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Fever | √ | ||
| Cardiovascular issues: racing heartbeat (palpitations) or fainting | √ | ||
| Chills | √ | ||
| Chest pain | √ | ||
Decreased platelets (cells in the blood that help the blood clot):
| √ | ||
| Jaundice: dark urine, yellowness of skin or eye | √ | ||
| Pancreatitis (Inflammation of the pancreas): severe upper stomach pain, often with nausea and vomiting | √ | ||
| Pseudotumor cerebri (pressure inside the skull is increased): severe headache, buzzing sound in the ears (tinnitus), severe dizziness, vision changes, severe nausea | √ | ||
| Serious Skin Reactions (Stevens Johnson syndrome): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | √ | ||
| Allergic reactions: rash, difficulty breathing, tightening of chest, swelling of lips, tongue or throat | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
The healthcare professional will store the product under appropriate conditions.
Keep out of reach and sight of children.
TIGECYCLINE will be given to you only within the “use-by” date of the product.
If you want more information about TIGECYCLINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.