Calcium-Magnesium-Potassium-Sodium-Oxybates

Calcium, Magnesium, Potassium, and Sodium Oxybates is a combination prescription medication used to treat cataplexy (sudden loss of muscle strength) or to reduce daytime sleepiness caused by narcolepsy. 

• Calcium, Magnesium, Potassium, and Sodium Oxybates is available under various brand names: Xywav

Common side effects of Calcium, Magnesium, Potassium, and Sodium Oxybates include:

• falling asleep quickly even while standing or getting up from bed.
• sleepwalking.
• drowsiness, dizziness, headache.
• bedwetting (in children).
• sweating, anxiety; or
• nausea, vomiting, diarrhea, loss of appetite, weight loss.

Serious side effects of Calcium, Magnesium, Potassium, and Sodium Oxybates include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• weak or shallow breathing, breathing that stops for short periods.
• severe drowsiness, feeling light-headed.
• sleepwalking (may result in an injury), waking, and confused behavior at night.
• a seizure.
• depression, anxiety, unusual or unpleasant thoughts.
• feelings of low self-worth, loss of interest in things you once enjoyed.
• confusion, paranoia, hallucinations (seeing or hearing things).
• increased tiredness, trouble concentrating; or
• suicidal thoughts or actions.

Rare side effects of Nitrofurantoin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, Lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Oral solution, Schedule III

• 500 mg/mL (ie, calcium oxybate 234 mg/mL, magnesium oxybate96 mg/mL, potassium oxybate 13 mg/mL, and sodium oxybate 4 mg/mL)
• Contents equivalent to 413 mg/mL of oxybate

Hypersomnia (idiopathic):

Adult dosage

Once-nightly dosing: 

• Initial: Oral: below 3 g at bedtime after the patient is in bed. May increase the nightly dose by below 1.5 g at weekly intervals based on efficacy and tolerability. 
• maximum dose: 6 g/night.

Twice-nightly dosing: 

• Initial: Oral: below 2.25 g at bedtime after the patient is in bed and below 2.25 g taken 2.5 to 4 hours later (below 4.5 g/night). 
• May increase the nightly dose by below 1.5 g (below 0.75 g at bedtime and below 0.75 g 2.5 to 4 hours later) at weekly intervals based on efficacy and tolerability; maximum dose: 9 g/night.

Narcolepsy

Adult dosage

• Oral: Initial: 2.25 g at bedtime after the patient is in bed, and 2.25 g taken 2.5 to 4 hours later (4.5 g/night). 
• May increase the nightly dose by 1.5 g (0.75 g at bedtime and 0.75 g 2.5 to 4 hours later) at weekly intervals based on efficacy and tolerability; usual effective dosage range: 6 to 9 g/night.
• Maximum dose: 9 g/night.

Pediatric dosage

• Children above 7 years and Adolescents:
• Children Below 20 kg: 
  • Oral: There are no specific dosage recommendations in the manufacturer's labeling due to insufficient data; however, a lower initial starting dose and lower maximum dosages are recommended.
• Children 20 to below 30 kg: 
  • Oral: Initial: below 1 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer a second dose of below 1 g. After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase the dose in below 0.5 g/dose (below 1 g/night) increments per week; maximum single dose: 3 g/dose; maximum daily dose: 6 g/night.
• Children 30 to below 45 kg: 
  • Oral: Initial: below 1.5 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer a second dose of below 1.5 g. 
  • After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase the dose in below 0.5 g/dose (below 1 g/night) increments per week; maximum single dose: 3.75 g/dose; maximum daily dose: 7.5 g/ night.
• Children Above 45 kg: 
  • Oral: Initial: below 2.25 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer a second dose of below 2.25 g. 
  • After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase the dose in below 0.75 g/dose (below 1.5 g/night) increments per week; maximum single dose: 4.5 g/dose; maximum daily dose: 9 g/night.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Calcium, Magnesium, Potassium, and Sodium Oxybates has severe interactions with the following drugs:
  • amobarbital
  • azelastine
  • butabarbital
  • chloral hydrate
  • estazolam
  • eszopiclone
  • ethanol
  • flurazepam
  • mephobarbital
  • phenobarbital
  • quazepam
  • ramelteon
  • sufentanil SL
  • temazepam
  • zaleplon
  • zolpidem
• Calcium, Magnesium, Potassium, and Sodium Oxybates has serious interactions with at least 137 other drugs.
• Calcium, Magnesium, Potassium, and Sodium Oxybates has moderate interactions with the following drugs:
  • brexanolone
  • carbamatete
  • esketamine intranasal
  • food
  • ganaxolone
  • lasmiditan
  • midazolam intranasal
  • remimazolam
• Calcium, Magnesium, Potassium, and Sodium Oxybates has minor interactions with the following drugs:
  • eucalyptus
  • ketotifen, ophthalmic
  • sage

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• 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 who has a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency (which can cause mental or physical impairment).

Effects of drug abuse

• Breathing problems
• Seizure
• Loss of conciousness
• Death

Short-Term Effects

• See “What Are Side Effects Associated with Using Calcium, Magnesium, Potassium, and Sodium Oxybates?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Calcium, Magnesium, Potassium, and Sodium Oxybates?”

Cautions

• This medicine can cause severe drowsiness and can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines.
• 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 this medicine can cause breathing problems, seizures, loss of consciousness, or death. Keep the medication in a place where others cannot get to it.
• Xywav will cause drowsiness and can impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Wait at least 6 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
• Do not take other sleep medicines together with Xywav.

Pregnancy and Lactation

• Tell your doctor if you are pregnant.
• No adequate data available on the developmental risk associated with use in pregnant females
• Clinical considerations
• Not studied in labor or delivery
• In obstetric anesthesia using an injectable formulation of sodium oxybate, newborns had stable but were very sleepy, causing a slight decrease in Apgar scores
• There was a fall in the rate of uterine contractions 20 minutes after injection
• Placental transfer is rapid, and GHB has been detected in newborns at delivery after intravenous administration of GHB to mothers
• Subsequent effects of sodium oxybate on later growth, development, and maturation in humans are unknown
• Lactation
  • Tell your doctor if you are breastfeeding.
  • GHB is excreted in human milk after oral administration of sodium oxybate
  • There is insufficient information on the risks to a breastfed infant, and on milk production in nursing mothers