Patient Medication Information: uses, side effects, how to take - Cystadane
ABOUT THIS MEDICATION
What the medication is used for:
CYSTADANE is used in the treatment of homocystinuria. Homocystinuria is a rare disease in which abnormal levels of a naturally occurring amino acid, homocysteine, is found in blood and urine. Homocystinuria is caused by a lack of enzymes, cystathionine beta-synthase (CBS) or methlenetetrahydrofolate reductase (MTHFR), or a defect in the cobalamin cofactor metabolism (cbl).
What it does:
CYSTADANE reduces the extra homocysteine from the body by aiding in the conversion of homocysteine to methionine.
When it should not be used:
Do not use if you (or your child) are allergic to betaine
(bay-ta-een).
What the medicinal ingredient is:
CYSTADANE contains the medicinal ingredient betaine (bay-
ta-een).
What the important nonmedicinal ingredients are:
There are no nonmedicinal ingredients in CYSTADANE.
What dosage forms it comes in:
CYSTADANE is available in a powder form for oral solution.
CYSTADANE is available in plastic bottles of 180 g. Each bottle contains a measuring scoop. One level scoop (1.7 cc) equals 1 gram of betaine anhydrous powder.
WARNINGS AND PRECAUTIONS
BEFORE you use CYSTADANE talk to your doctor or pharmacist:
- About your past and present health problems and medical condition.
If you are pregnant, plan to become pregnant, or are breast-feeding.
CYSTADANE may cause hypermethioninemia resulting in cerebral edema. Methionine blood levels should be monitored while taking CYSTADANE.
INTERACTIONS WITH THIS MEDICATION
Before you (your child) use CYSTADANE tell your (your child’s) doctor or pharmacist if you (your child) take or plan to take any other medication including prescription and non- prescription medication, vitamin supplements, and natural health products. CYSTADANE has been used with vitamin B6 (pyridoxine), B12 (cobalamin), and folate.
PROPER USE OF THIS MEDICATION
The prescribed dose of CYSTADANE should be measured with the measuring scoop provided. One level 1.7 cc scoop is equal to 1 gram of betaine anhydrous powder. Mix the measured dose with 120 to 180 mL (4 to 6 ounces) of water, juice, milk, or infant formula until completely dissolved, or mix with food. Take immediately after preparing dose.
Adult dose:
Take as prescribed by your doctor. The usual dose is 6 grams per day taken orally in divided doses of 3 grams two times per day. Your doctor may adjust your dose as needed.
Children dose:
In children, the dose is based on body weight. Your doctor may prescribe an initial dose of 100 mg/kg body weight per day and then may increase the dose by 50 mg/kg body weight after 4 to 6 weeks to a maximum of 150 mg/kg/day. The maximum dose must not exceed 6 grams per day.
Overdose:
If you think you or someone else has taken an overdose of CYSTADANE, tell your doctor or go to the emergency room at the nearest hospital.
Missed Dose:
Take the missed dose of CYSTADANE as soon as you remember.
If it is almost time for your next dose, skip the one you missed and go back to your regular dosing schedule.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include: nausea, diarrhea, body odour, stomach and intestinal problems. Consult your doctor or pharmacist if any side effects continue or are bothersome.
| 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 | ||
Cerebral edema (abnormal pooling of fluid in the brain with associated symptoms of severe headache, nausea, vomiting, loss of eyesight, confusion and coma) | √ | ||
| Allergic reaction (rash, swelling of the lips, face or neck, difficulty breathing or speaking) | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking CYSTADANE, contact your doctor or pharmacist.
HOW TO STORE IT
Store CYSTADANE at room temperature (15°-30°C). Replace cap tightly after using. Protect from moisture.
Keep all medicines away from children.
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. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the Canadian distributor, Recordati Rare Diseases Canada Inc., at:
905-827-1300
Last revised: April 10, 2018.
Part No. Orphan Europe: OEP1002