Details for: ZAXINE
Company: SALIX PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02410702 | ZAXINE | RIFAXIMIN | 550 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ZAXINE is an antibiotic that acts on the bacteria in the gut.
Hepatic Encephalopathy
ZAXINE is used to help prevent recurring episodes of a condition
called hepatic encephalopathy (HE). It may be used in
conjunction with lactulose, as directed by your doctor. HE occurs
when the liver is not working properly and cannot remove toxins
from the blood which affect brain function.
ZAXINE is intended to be used for preventing HE only in those
adult patients where HE is likely to occur again.
Antibacterial drugs like ZAXINE treat only bacterial infections.
They do not treat viral infections.
Irritable Bowel Syndrome with Diarrhea
ZAXINE is used to treat irritable bowel syndrome with diarrhea
(IBS-D) in adults.
What it does
Hepatic Encephalopathy
ZAXINE is thought to work by reducing the production of toxins
released into the blood by bacteria in the gut.
Irritable Bowel Syndrome with Diarrhea
ZAXINE is thought to work by reducing the amount of bacteria
and bacterial products in the gut. This can help with the most
common symptoms of IBS-D which include bloating, abdominal
pain and diarrhea.
When it should not be used
If you are allergic (hypersensitive) to the active substance rifaximin, rifamycin antibacterial agents, or any of the other ingredients of ZAXINE (see What the nonmedicinal ingredients are).
What the medicinal ingredient is
The active substance is rifaximin.
What the non-medicinal ingredients are
colloidal silicon dioxide, glyceryl distearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, gluten-free sodium starch glycolate, talc, and titanium dioxide.
What dosage form it comes in
Tablets: 550 mg
Warnings and precautions
BEFORE you use ZAXINE talk to your doctor or pharmacist if:
- You have severe liver problems – there is an increase in systemic (blood) exposure to rifaximin in subjects with severe liver disease.
- You have any allergies to this drug or its ingredients.
- You are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor can discuss with you the risks and benefits involved.
- You are breastfeeding ask your doctor or pharmacist for advice before taking this medicine. It is not known whether rifaximin passes into breast milk.
- ZAXINE should not be used in children or adolescents less than 18 years of age, as there is no information on the use in that population.
Interactions with this medication
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including nonprescription or herbal medicines. Tell your doctor if you are taking warfarin or oral contraceptives.
Proper use of this medication
ZAXINE can be taken with or without food.
ZAXINE tablets should be swallowed whole with plenty of water.
Do not crush tablets.
Although you may feel better early in treatment, ZAXINE should
be used exactly as directed.
Do not misuse or overuse ZAXINE.
Do not share your medicine.
Usual Dose
Hepatic Encephalopathy
The recommended dosage is one tablet twice daily.
Irritable Bowel Syndrome with Diarrhea
The recommended dosage is one tablet three times a day for
14 days. If your symptoms come back, your doctor may consider
retreatment when needed.
Overdose
Missed Dose
If you forget to take a dose, it should be taken as soon as possible.
However, if it is almost time for the next dose, no additional dose
should be taken and the regular dosing schedule should be
resumed.
If you are taking ZAXINE for Hepatic Encephalopathy:
No more than two doses of ZAXINE (1 tablet twice a day) should
be taken in a 24-hour period.
If you are taking ZAXINE for Irritable Bowel Syndrome with
Diarrhea:
No more than three doses of ZAXINE (1 tablet three times a day)
should be taken in a 24-hour period.
If you have trouble remembering to take your medicine, ask your
pharmacist for some hints.
Side effects and what to do about them
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects reported with ZAXINE are:
- Diarrhea
- Nausea
- Vomiting
- Abdominal pain or bloating
- Muscle spasms
- Dizziness or unsteadiness
- Headache
- Itchiness
ZAXINE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Unknown | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Rare | |||
| Clostridium difficile colitis (gut inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ZAXINE, contact your doctor or pharmacist.
How to store
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the bottle, after “EXP:”. The expiry date refers to the last day of
that month.
ZAXINE should be stored at room temperature (15°C to 30°C) in
a tightly closed container away from heat and direct light.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.
Reporting 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 three 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 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 the Health Canada website
www.canada.ca/en/health-canada.html; the manufacturer’s website
www.bauschhealth.com, the importer website
www.lupinpharma.ca or by calling 1-844-587-4623.
This leaflet was prepared by Salix Pharmaceuticals, Inc., a division
of Valeant Pharmaceuticals North America LLC.
Licensed from: Alfasigma S.p.A.
Distributed by:
Lupin Pharma Canada Limited
Montreal, QC, H2L 4P9
Manufactured for:
Salix Pharmaceuticals, Inc.
Bridgewater, NJ 08807 USA
Last revised: February 11, 2019