Product image of Natriumoxybat Kalceks (Sodium Oxybate) supplied by GNH India

Natriumoxybat Kalceks

Active Ingredient:
Sodium Oxybate
Origin:
EU

Natriumoxybat Kalceks (Sodium Oxybate)

Sodium Oxybate, the active ingredient in Natriumoxybat Kalceks, is a gamma‑hydroxybutyrate (GHB) central nervous system depressant presented as an oral solution for oral administration. It is indicated for the management of narcolepsy with cataplexy and for reducing excessive daytime sleepiness in adult patients.

GNH India supplies Natriumoxybat Kalceks as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution channels aligned to EU regulatory standards. The product complies with European pharmacopeial specifications and is manufactured under strict quality‑assured processes.

Manufacturer / TM Owner

Kalceks

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Indications & Clinical Uses

Sodium Oxybate acts on the central nervous system to improve sleep architecture in narcolepsy.

  • Narcolepsy with cataplexy: reduces frequency and severity of cataplexy episodes.
  • Excessive daytime sleepiness in narcolepsy: improves wakefulness and reduces sleep attacks.
  • Disrupted nocturnal sleep in narcolepsy: enhances slow‑wave sleep and consolidates nighttime rest.

How It Works

  • Sodium Oxybate functions as an agonist at GHB receptors and modulates GABA_B receptors, leading to decreased neuronal firing in the thalamocortical network. This action promotes deep slow‑wave sleep and reduces the propensity for sudden sleep onset, thereby alleviating cataplexy and daytime sleepiness in narcoleptic patients. The combined receptor activity also influences neurotransmitter release of dopamine and serotonin, contributing to overall stabilization of sleep‑wake cycles.

Side Effects

Sodium Oxybate may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Dizziness: transient light‑headedness.
  • Headache: pressure or throbbing sensation.
  • Fatigue: increased tiredness after dosing.

Serious or Rare Side Effects

  • Respiratory depression: reduced breathing effort, potentially life‑threatening.
  • Seizures: rare occurrence of convulsive episodes.
  • Severe hypotension: marked drop in blood pressure.
  • Abuse potential: risk of dependence and misuse.

Precautions & Warnings

When prescribing Sodium Oxybate, clinicians should observe several safety considerations.

  • Contraindication: avoid use in patients with known hypersensitivity to sodium oxybate or GHB.
  • Monitoring: assess respiratory function and blood pressure regularly during therapy.
  • Pregnancy: limited data; use only if potential benefit justifies potential risk to fetus.
  • Breastfeeding: sodium oxybate is excreted in breast milk; advise against nursing while on treatment.
  • Driving: patients should be cautioned about impaired alertness and avoid operating machinery until they know how the drug affects them.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture and light.

Avoid Interactions

Sodium Oxybate can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Central nervous system depressants: concurrent use with alcohol, benzodiazepines or opioids may cause profound respiratory depression.
  • Sodium‑containing medications: may increase total sodium load, requiring monitoring in patients with cardiovascular disease.

Moderate Interactions (Monitor Closely)

  • Antidepressants (especially SSRIs): may enhance serotonergic effects, requiring observation for serotonin syndrome.
  • Antihypertensives: sodium oxybate can lower blood pressure, potentially necessitating dose adjustment.
  • Anticonvulsants: may alter seizure threshold, requiring clinical vigilance.

Frequently Asked Questions

Natriumoxybat Kalceks contains sodium oxybate and is prescribed for adults with narcolepsy who experience cataplexy and excessive daytime sleepiness. It helps reduce the frequency of cataplexy attacks and improves overall wakefulness during the day.

Sodium oxybate acts as an agonist at GHB receptors and modulates GABA_B receptors in the brain. This dual activity dampens neuronal firing in sleep‑regulating pathways, enhances deep slow‑wave sleep, and stabilizes the sleep‑wake cycle, thereby alleviating cataplexy and daytime sleepiness.

The dose of sodium oxybate is individualized by the prescribing clinician based on the patient’s response, tolerability, and clinical condition. The prescriber determines the appropriate starting dose, titration schedule, and total nightly volume to be taken.

Safety data for sodium oxybate during pregnancy and lactation are limited. It should only be used if the potential benefit outweighs the possible risk to the fetus, and breastfeeding is generally discouraged because the drug is excreted in breast milk.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

The primary alternative class includes wake‑promoting agents such as modafinil or armodafinil, which improve daytime alertness but do not treat cataplexy. Sodium oxybate uniquely targets both cataplexy and excessive sleepiness by enhancing nocturnal slow‑wave sleep, offering a broader therapeutic effect.

Store the oral solution at ambient temperature, preferably below 25 °C. Keep the container tightly closed, protect it from moisture and direct light, and retain it in the original packaging until use.

The medication is supplied as an oral solution that is measured with a calibrated syringe or dosing cup. It is taken at night, typically in two divided doses separated by 2‑4 hours, as directed by the prescribing clinician.

The most critical safety concerns include respiratory depression, severe hypotension, seizures, and the potential for abuse or dependence. Patients should be monitored closely for breathing difficulties, blood‑pressure changes, and any signs of misuse.

Sodium oxybate is contraindicated in individuals with known hypersensitivity to the drug or other GHB compounds, in patients with severe respiratory disorders, and in those who are pregnant or breastfeeding unless the benefits clearly outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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