Xyrem success program canada

Eligibility is assessed as part of the standard benefit investigation process performed by the pharmacy Reimbursement Specialist. If you meet certain financial criteria, such as having a low income level, are uninsured or underinsured, you may be eligible to receive XYREM at no cost.

WARNING: Taking XYREM with other Central Nervous System CNS depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing respiratory depression , low blood pressure hypotension , changes in alertness drowsiness , fainting syncope , and death.

Abuse or misuse of illegal GHB alone or with other CNS depressants drugs that cause changes in alertness or consciousness have caused serious side effects. These effects include seizures, trouble breathing respiratory depression , changes in alertness drowsiness , coma, and death. It is also known as gamma hydroxybutyrate GHB. Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using sodium oxybate and each time you get a refill.

If you have any questions, ask your doctor or pharmacist. Take this medication by mouth at least 2 hours after eating in 2 separate doses as directed by your doctor. Prepare your 2 doses as directed.

The doses must each be mixed with 2 ounces 60 milliliters of water. Take the first dose at bedtime while in bed. Set an alarm clock to awaken you for the second dose in 2-and-a-half hours to 4 hours.

Take the second dose while sitting in bed, and turn off the alarm. If you have children or pets in the house, be sure to use the child-resistant caps that come with the medication cups. The dosage is based on your medical condition, weight for children , response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use including prescription drugs, nonprescription drugs, and herbal products.

Your doctor will gradually increase your dose over 1 to 2 weeks to lessen the risk of side effects. This process will continue until your doctor has found the right dose for you. Follow your doctor's directions carefully. Do not increase your dose, take it more frequently, or use it for longer than prescribed. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each night. If you suddenly stop using this medication, you may have withdrawal symptoms such as anxiety, psychosis, fast heartbeat, trouble sleeping.

To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used sodium oxybate solution for a long time or in high doses.

Tell your doctor or pharmacist right away if you have withdrawal. Drowsiness, dizziness, nausea, vomiting, stomach pain, diarrhea, increased sweating, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects.

You may report side effects to Health Canada at Before taking sodium oxybate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of:.

Sleep disorders may decrease your ability to react quickly. Though sodium oxybate helps keep you awake during the day, you still may not be able to safely perform tasks that require alertness such as driving, flying. This drug may also make you dizzy. Legal efforts to control the sale and distribution of GHB and its analogues nearly prevented the clinical development of sodium oxybate for narcolepsy in the US. However, following extensive discussions with a variety of interested parties, a satisfactory solution was devised, including legislative action and the development of the Xyrem Risk Management Program.

To promote the safe use of sodium oxybate, as well as alleviate concerns over possible diversion and abuse following product approval, a proprietary restricted drug distribution system was created, called the Xyrem Success Program. Components of the programme include a centralised distribution and dispensing system, a physician and patient registry, compulsory educational materials for patients and physicians, a specially trained pharmacy staff, a method for tracking prescription shipments, and an initial post-marketing surveillance programme.