Product image of sodium oxybate .5 g/mL (Sodium Oxybate) .5 g/mL SOLUTION supplied by GNH India

sodium oxybate .5 g/mL

Active Ingredient:
Sodium Oxybate
Form:
SOLUTION
Brand:
sodium oxybate
Origin:
USA

sodium oxybate .5 g/mL (Sodium Oxybate SOLUTION) .5 g/mL

Sodium oxybate, the active ingredient in sodium oxybate, is a gamma-hydroxybutyrate (GHB) central nervous system (CNS) depressant presented as a 0.5 g/mL solution for oral use. It is primarily used to treat narcolepsy with cataplexy in patients 7 years of age and older.

GNH India supplies sodium oxybate as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

Strength

.5 g/mL

Pack Size

180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)

Manufacturer / TM Owner

Hikma Pharmaceuticals USA Inc.

1
Pack/s
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Indications & Clinical Uses

Sodium oxybate is a central nervous system depressant used to manage specific sleep disorders.

  • Narcolepsy with cataplexy: Reduces the frequency of sudden muscle weakness episodes and excessive daytime sleepiness.
  • Idiopathic hypersomnia: Treats excessive daytime sleepiness in adults, though this is an off-label use.
  • Narcolepsy without cataplexy: May be prescribed to manage excessive daytime sleepiness in some cases.

How It Works

  • Sodium oxybate acts as an agonist at GHB receptors and GABA_B receptors, modulating sleep architecture and reducing nocturnal awakenings. It promotes deeper, more restorative sleep by influencing the brain's sleep-wake cycles, thereby improving sleep quality and reducing symptoms of narcolepsy.

Side Effects

Sodium oxybate can cause various side effects, ranging from mild to severe.

Common Side Effects

  • Dizziness: Feeling lightheaded or unsteady.
  • Nausea: A feeling of sickness in the stomach.
  • Headache: Pain or discomfort in the head.
  • Confusion: Difficulty thinking clearly or disorientation.
  • Sweating: Excessive perspiration.
  • Agitation: A state of nervous excitement or restlessness.

Serious or Rare Side Effects

  • Respiratory depression: Slowed or shallow breathing.
  • Loss of consciousness: Fainting or passing out.
  • Depression: Persistent feelings of sadness or hopelessness.
  • Anxiety: Excessive worry or fear.
  • Seizures: Sudden, uncontrolled electrical disturbances in the brain.
  • Hallucinations: Seeing or hearing things that are not real.

Precautions & Warnings

Sodium oxybate requires careful handling and monitoring to ensure safe use.

  • Prescription use: Only take sodium oxybate as prescribed by a healthcare professional.
  • Bedtime administration: Take the medication only when you are ready to go to bed and can stay in bed for at least 4 hours.
  • Alcohol avoidance: Do not consume alcohol while taking sodium oxybate.
  • Driving and machinery: Avoid activities that require alertness until the effects of the medication are known.
  • Gradual discontinuation: Do not stop taking sodium oxybate suddenly; consult your doctor for a gradual reduction.
  • Storage: Store at room temperature: keep in the original container, tightly closed, and out of reach of children and pets.

Avoid Interactions

Sodium oxybate can interact with other medications, potentially altering its effects or increasing the risk of side effects.

Major Interactions (Avoid)

  • Alcohol: Increases the risk of severe sedation and respiratory depression.
  • CNS depressants: Such as benzodiazepines and opioids, which can enhance the sedative effects.
  • Other sleep aids: May exacerbate excessive sedation.

Moderate Interactions (Monitor Closely)

  • Antidepressants: May alter the effectiveness of sodium oxybate.
  • Antipsychotics: Can increase the risk of side effects like dizziness and confusion.
  • Antihistamines: May enhance sedative effects.

Frequently Asked Questions

Sodium oxybate is primarily used to treat narcolepsy with cataplexy, a sleep disorder characterized by sudden muscle weakness and excessive daytime sleepiness. It is also used off-label to treat idiopathic hypersomnia, a condition causing excessive daytime sleepiness without an identifiable cause.

Sodium oxybate acts as an agonist at GHB receptors and GABA_B receptors, modulating sleep architecture and reducing nocturnal awakenings. It promotes deeper, more restorative sleep by influencing the brain's sleep-wake cycles, thereby improving sleep quality and reducing symptoms of narcolepsy.

The dosage of sodium oxybate is determined by a healthcare professional based on individual patient needs. It is typically taken twice at night, with the first dose at bedtime and the second dose 2.5 to 4 hours later. The exact dosage and schedule should be followed as prescribed.

Sodium oxybate is classified as a Category C drug, meaning it should be used during pregnancy only if the potential benefits outweigh the risks. It is not recommended for use during breastfeeding. Always consult a healthcare provider for personalized advice.

To order sodium oxybate from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will then reply with pricing, availability, shipping, and the import paperwork.

Sodium oxybate is unique in its mechanism of action and is specifically indicated for narcolepsy with cataplexy. It is more effective than some other treatments in reducing symptoms of cataplexy and excessive daytime sleepiness. However, the choice of treatment depends on individual patient needs and should be discussed with a healthcare provider.

Sodium oxybate should be stored at room temperature, in the original container, tightly closed, and out of reach of children and pets. Any remaining medication should be disposed of properly if it is more than 24 hours after preparation. Always follow the storage instructions provided with the medication.

Sodium oxybate is taken orally as a solution mixed with water. It is usually taken twice at night, with the first dose at bedtime and the second dose 2.5 to 4 hours later. The medication should be taken on an empty stomach, at least 2 hours after eating.

The most serious risks associated with sodium oxybate include respiratory depression, loss of consciousness, depression, anxiety, seizures, and hallucinations. Patients should be monitored for these side effects, and any concerning symptoms should be reported to a healthcare provider immediately.

Sodium oxybate should not be used by individuals with a history of severe allergic reactions to the medication, those with untreated sleep apnea, or those who are unable to stay in bed for at least 4 hours after taking the medication. It should also be avoided by individuals with a history of substance abuse or those taking other CNS depressants.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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