Patient Medication Information: uses, side effects, how to take - Ultresa
ABOUT THIS MEDICATION
What the medication is used for:
ULTRESA is a medication used to treat people who cannot digest food normally because their pancreas does not produce enough enzymes due to various medical conditions such as:
- Cystic fibrosis (rare inherited disorder).
- Chronic pancreatitis (inflammation of the pancreas).
- Pancreatic surgery (pancreatectomy).
- Gastrointestinal bypass surgery (e.g., Billroth II gastroenterostomy) (surgical opening between the stomach wall and intestine).
- Ductal obstruction of the pancreas or the common bile duct (e.g., from tumor).
What it does:
ULTRESA is intended as a replacement therapy when your pancreas, which produces enzymes necessary to digest fat, protein and sugars, has stopped functioning or is not functioning as it should be. The medical term for this condition is exocrine pancreatic insufficiency. Symptoms of exocrine pancreatic insufficiency include steatorrhea (excess of fat in stools).
ULTRESA contains an enzyme mixture (lipases, proteases, amylases) that helps you digest food. The enzymes are taken from pig pancreas glands.
The enzymes in ULTRESA work by digesting food as it passes through the gut. You should take ULTRESA before or with a meal or snack. This will allow the enzymes to mix thoroughly with the food.
When it should not be used:
ULTRESA should not be used:
- if you have a known hypersensitivity to porcine protein, pancreatic enzymes or any excipients.
during acute pancreatitis or the acute
- exacerbation of chronic pancreatits.
What the medicinal ingredient is:
Pancrelipase (lipase, protease and amylase).
What the important nonmedicinal ingredients are:
Colloidal silicon dioxide, croscarmellose sodium, gelatin, hydrogenated castor oil, hydroxypropyl methylcellulose phthalate (HP 55) (as dry substance), iron oxides, magnesium stearate, microcrystalline cellulose, talc, triethyl citrate and titanium dioxide.
What dosage forms it comes in:
Ultresa is available in 3 strengths as orally administered delayed-release capsules containing microtablets of the porcine pancreatic enzyme concentrate.
ULTRESA (13,800 USP units lipase): containing 13,800 USP units of lipase, 58,800 USP units of amylase, and 53,400 USP units of protease.
ULTRESA (20,700 USP units lipase): containing 20,700 USP units of lipase, 88,200 USP units of amylase, and 80,000 USP units of protease.
ULTRESA (23, 000 USP units lipase): containing 23,000 USP units of lipase, 98,000 USP units of amylase, and 88,900 USP units of protease.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
A rare bowel condition called “fibrosing colonopathy”, where your gut is narrowed, has been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes. As a precaution, consult your doctor if you experience any unusual abdominal symptoms or any change in abdominal symptoms, especially if you are taking more than 10,000 units of lipase/kg body weight/day or more than 4,000 units of lipase/gram fat intake.
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or are breast-feeding. Your doctor will decide if you should take ULTRESA and at which dose.
Potential Viral Exposure from the Product Source:
The pancreas glands used to make ULTRESA and other pancreatic enzyme products come from pigs used for food.
These pigs may carry viruses. When ULTRESA is made, several steps are taken to reduce the risk of viruses being spread, including destruction of viruses and testing for specific viruses. The risk of infections caused by these or other unknown or novel viruses cannot be totally ruled out. However, there have not been any cases reported where infection of patients has occurred.
BEFORE you use ULTRESA talk to your doctor or pharmacist if you:
- are allergic to pork (pig) products.
- have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy).
- have gout, kidney disease, or a condition called high blood uric acid (hyperuricemia).
- have any other medical condition.
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed.
- have trouble swallowing capsules.
INTERACTIONS WITH THIS MEDICATION
There are no known drug interactions with ULTRESA.
Tell your doctor or pharmacist if you are taking or have recently taken any other prescription or over-the-counter medicines, vitamins or natural health products during your treatment with ULTRESA.
PROPER USE OF THIS MEDICATION
Take ULTRESA exactly as your doctor tells you.
Do not switch ULTRESA with any other pancreatic enzyme product without first talking to your doctor.
Always take ULTRESA with a meal or snack and enough liquid to swallow.
Swallow ULTRESA capsules whole. Do not crush or chew the ULTRESA capsules or their contents, and do not hold the capsule or capsule contents in your mouth. Crushing, chewing or holding the ULTRESA capsules in your mouth may cause irritation in your mouth or change the way ULTRESA works in your body. Do not divide the capsule contents into small amounts to give small doses of ULTRESA.
If you have difficulty swallowing capsules, open the capsule and sprinkle the contents on a small amount of soft acidic food including applesauce or yogurt. Swallow it right after you mix it and drink plenty of water or juice to make sure the medicine is swallowed completely. Do not store ULTRESA that is mixed with food. Throw away any unused portion of capsule contents. Ask your doctor about other foods you can mix with ULTRESA.
Usual dose:
Your dose is measured in ‘lipase units’. Lipase is one of the enzymes in ULTRESA.
Different strengths of pancreatic enzymes may contain different amounts of lipase.
Your doctor will adjust your dose to suit you. It will depend on:
- your illness
- your weight
- your diet
- how much fat is in your stools.
If you still have fatty stools or other stomach or gut problems (gastrointestinal symptoms), talk to your doctor as your dose may need to be adjusted.
The usual starting dose for children under 4 years of age is 1,000 lipase units per kilogram body weight per meal.
- The usual starting dose for children 4 years of age and over, adolescents and adults is 500 lipase units per kilogram body weight per meal.
- Usually, half the standard dose is given with snacks.
- The maximum dose is 2,500 lipase units per kilogram body weight per meal.
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. |
If you know or suspect that you have taken more of this product than you normally do, or notice any unusual symptoms, contact your doctor or nearest hospital emergency department immediately. Ensure that you are adequately hydrated during this time by drinking plenty of fluids.
Extremely high doses of pancreatic enzymes have sometimes causes too much uric acid in the urine (hyperuricosuria) and in the blood (hyperuricaemia).
Missed Dose:
If a dose of ULTRESA has been missed, take your next dose at the usual time, with your next meal. Do not try to make up for the dose that you have missed.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with all medicines, patients taking ULTRESA may experience side effects, although not everybody gets them.
The most common side effects of ULTRESA include abdominal discomfort and abdominal pain.
Other reactions are less common such as abnormal stools and diarrhea. Cases of allergic reactions have also been reported.
| 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 | |||
| Common | Abdominal pain | √ | ||
| Vomiting | √ | |||
| Unknown | Allergic reactions: skin rash, itching or hives. | √ | √ | |
This is not a complete list of side effects. For any unexpected effects while taking ULTRESA, contact your doctor or pharmacist.
Tell your doctor or pharmacist if you have any side effect that bothers you or that does not go away.
HOW TO STORE IT
Store ULTRESA capsules at room temperature (20°C to 25°C). Protect from heat and moisture.
Store ULTRESA® capsules in a dry place and in the original container. After opening the bottle, keep it closed tightly between uses to protect from moisture. The ULTRESA bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not eat or throw away the desiccant packet.
Keep ULTRESA out of reach of children.
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: -------------------------------------------------------------------------
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.actavis.com by contacting the sponsor, Aptalis Pharma Canada Inc., at:
1-855-892-8766
ULTRESA® is a registered trademark of Actavis Specialty Pharmaceuticals Co. or its affiliates and is used under license.