Xywav
Generic name: Calcium Oxybate, Magnesium Oxybate, Potassium Oxybate, And Sodium Oxybate
Dosage form: oral solution(0.5 g per mL)
Drug class:
Miscellaneous anxiolytics , Antineoplastic Agents
Usage of Xywav
Xywav is used to treat cataplexy (sudden loss of muscle strength) or to reduce excessive daytime sleepiness caused by narcolepsy. Xywav is also used in adults to treat idiopathic hypersomnia (IH) which is an uncommon chronic sleep disorder that causes daytime sleepiness even after a good night's sleep.
Xywav is a central nervous system depressant. Xywav is an oral solution containing a combination of calcium oxybate, potassium oxybate, magnesium oxybate and sodium oxybate. Xywav is a low-sodium alternative to Xyrem.
Xywav contains an ingredient also known as GHB, a known street drug of abuse. Because of the potential for abuse and serious side effects, Xywav is available only from a certified pharmacy under a special program (XYREM REMS). You must be registered in the program and understand the risks and benefits of this medicine.
Xywav side effects
Get emergency medical help if you have signs of an allergic reaction to Xywav: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common Xywav side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking Xywav
Do not drink alcohol or take other sleep medicines together with Xywav. Dangerous side effects or death could occur.
Do not give Xywav to anyone with a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency (which can cause mental or physical impairment).
To make sure you can safely take Xywav, tell your doctor if you have ever had:
Not approved for use by anyone younger than 7 years old with narcolepsy. Not approved for use by anyone younger than 18 years old with idiopathic hypersomnia.
Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Xywav can harm your unborn baby.
Breastfeeding
Tell your healthcare professional if are breastfeeding or plan to breastfeed. Xywav passes into breast milk. You and your doctor should decide if you or your child will take Xywav or breastfeed.
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How to use Xywav
Usual Adult Dose of Xywav for Narcolepsy
Initial dose: 4.5 g orally per day, divided and given as 2 equal doses of up to 2.25 g/dose
Maintenance dose: The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals up to 6 to 9 g/day.
Maximum dose: 9 g/day
Comments:
Use: Treatment of cataplexy (excessive daytime sleepiness) in patients with narcolepsy
Usual Adult Dose of Xywav for Idiopathic Hypersomnia
Two times a night regimen:
Initial dose: 4.5 g orally per day, divided and given as 2 equal doses
The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals
Maintenance dose: 6 to 9 g/day
Maximum dose: 9 g/day
Once a night regimen:
Initial dose: 3 g orally per day, divided and given as 2 equal doses
The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals
Maintenance dose: 3 to 6 g/day
Maximum dose: 6 g/day
Comments:
Use: Treatment of idiopathic hypersomnia
Usual Pediatric Dose for Narcolepsy (7 years and older)
Less than 20 kg:
Specific dosing recommendations are not available.
20 to less than 30 kg:
Initial dose: Up to 2 g orally per day, divided and given as 2 equal doses of up to 1 g/dose
Maintenance dose: The dose may be increased by 1 g (OR 0.5 g/dose) orally per night at 1 to 2-week intervals up to 6 g/day.
Maximum dose: 6 g/day
30 to less than 45 kg:
Initial dose: Up to 3 g orally per day, divided and given as 2 equal doses of up to 1.5 g/dose
Maintenance dose: The dose may be increased by 1 g (OR 0.5 g/dose) orally per night at 1 to 2-week intervals up to 7.5 g/day.
Maximum dose: 7.5 g/day
45 kg and greater:
Initial dose: Up to 4.5 g orally per day, divided and given as 2 equal doses of up to 2.25 g/dose
Maintenance dose: The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night at 1 to 2-week intervals up to 9 g/day.
Maximum dose: 9 g/day
Comments:
Use: Treatment of cataplexy (excessive daytime sleepiness) in patients with narcolepsy.
Warnings
Xywav can cause severe drowsiness and can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines. You should not do anything that requires you to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking Xywav. Those activities should not be done until you know how Xywav affects you or your child.
Fatal side effects can occur if you take Xywav with: alcohol, other sleep medicines, or other drugs that cause drowsiness or slow your breathing.
Misuse of Xywav can cause breathing problems, seizure, loss of consciousness, or death. Keep the medication in a place where others cannot get to it.
Xywav may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it.
What other drugs will affect Xywav
Fatal side effects can occur if you take Xywav with other drugs that cause drowsiness or slow your breathing. Ask your doctor before taking cold or allergy medicine, opioid medication, sedatives, muscle relaxers, seizure medicine, or medicine for depression, anxiety, or mental illness.
If you start or stop taking divalproex (Depakote), your doctor may need to adjust your Xywav dose.
Other drugs may interact with Calcium, magnesium, potassium, and sodium oxybates, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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