Patient Medication Information: uses, side effects, how to take - Ava-Domperidone
ABOUT THIS MEDICATION
What the medication is used for:
AVA-DOMPERIDONE is used to treat symptoms of slowed stomach emptying seen in people with some gastrointestinal disorders (e.g. gastritis- inflammation of the GI tract). AVA-DOMPERIDONE is also used to reduce symptoms such as nausea and vomiting caused by some drugs used to treat Parkinson’s disease.
What it does:
AVA-DOMPERIDONE increases the mild digestive contractions of the esophagus and stomach and helps to more effectively coordinate the emptying of food from the stomach into the intestine. It also helps to more effectively move digesting food material through the small intestine.
When it should not be used:
In should not be used in patients who are known to be allergic to it AVA-DOMPERIDONE or any of the nonmedicinal ingredients (See What the nonmedicinal ingredients are). It should not be used in patients who show signs of bleeding in the stomach or intestines, or who may have an obstruction or perforation of the stomach or intestines.
It should not be used in patients who have a tumour associated with the pituitary gland known as a prolactinoma.
What the medicinal ingredient is:
DOMPERIDONE Maleate
What the important nonmedicinal ingredients are:
Cornstarch, croscarmelose sodium, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium docusate 85%-sodium benzoate 15% and, titanium dioxide, triacetin.
What dosage forms it comes in:
AVA-DOMPERIDONE is available as 10 mg domperidone tablets
(as domperidone maleate).
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions AVA-DOMPERIDONE may be associated with an increased risk of heart rhythm disorder and sudden death (cardiac arrest). This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day. AVA-DOMPERIDONE should be used at the lowest effective dose in adults
BEFORE you use AVA-DOMPERIDONE talk to your doctor or pharmacist if:
$ you have, or have ever had breast cancer
$ you have an irregular heartbeat, or any other kind of heart disease
$ you have any kind of kidney disease
$ you are pregnant or plan to become pregnant $ you are breast feeding. AVA-DOMPERIDONE is excreted in breast milk. Discuss with your doctor. $ you experience any kind of unusual discharge of breast milk
$ you are a male and have any kind of irregular growth of the breasts
$ you are taking a drug called ketoconazole, or a drug called nefazodone
$ you are taking any other medications including those available without a prescription and natural health products.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with AVA-DOMPERIDONE include:
$ a drug called ketoconazole
$ any kind of drug known as:
$ an “anticholinergic” drug
$ an antifungal drug
$ an antibiotic drug
$ a drug to treat AIDS
$ a drug called nefazodone
PROPER USE OF THIS MEDICATION
Usual adult dose:
For disorders involving movement of food through the stomach and intestines: one 10 mg tablet taken 3 to 4 times per day, 15 to 30 minutes before meals, and at bedtime if required. As directed by your doctor, the dose may be increased to 20 mg 3 to 4 times per day.
For nausea and vomiting associated with drugs for Parkinsons
Ava‐Domperidone Page 2
disease: 20 mg taken 3 to 4 times per day.
In all cases, AVA-DOMPERIDONE should only be used at the lowest effective dose.
Overdose:
Symptoms of overdosage may include drowsiness, disorientation, difficulty with normal body movements, irregular heartbeat and lowered blood pressure.
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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Most side effects will gradually disappear with continuing administration of AVA-DOMPERIDONE and are easily tolerated. The more serious or troublesome side effects are dose related and gradually resolve after the dose is lowered or if administration of the drug is discontinued.
Common side effects include dry mouth, headache and migraine. Uncommon side effects include abdominal cramps, diarrhea, regurgitation (bring up stomach contents), nausea and rash. If these side effects become troublesome, talk to your doctor.
Contact your doctor if the more serious or troublesome side effects occur such as galactorrhea (excessive or spontaneous flow of breast milk), gynecomastia (excessive development of male mammary gland) or menstrual irregularities (spotting or delayed periods).
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Uncommon | palpitations irregular heart beat (arrhythmia) dizziness fainting | T | T T T | |
This is not a complete list of side effects. For any unexpected effects while takingAVA-DOMPERIDONE, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15-30°C. Protect from light. Unit dose strips should be stored between 15-25°C and protected from high humidity and light.
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 0701E
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 by contacting Avanstra Inc at: Avanstra Inc.
Suite 110
10761-25th street NE
Calgary, AB
T3N 0A4
Telephone: 1-855-708-3678
Facsimile: 1-855-227-5833
www.avanstra.com