Active Ingredient: Sodium oxybate
Treatment of narcolepsy with cataplexy in adult patients, adolescents and children from the age of 7 years.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 4.5 grams sodium oxybate, divided 2 times daily at the end of the day, over the duration of 1 week. Afterwards, oral, 6 grams sodium oxybate, divided 2 times daily at the end of the day. The maximum allowed total dose is 9 grams sodium oxybate daily.
The recommended starting dose is 4.5 g/day sodium oxybate divided into two equal doses of 2.25 g/dose. The dose should be titrated to effect based on efficacy and tolerability up to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by adjusting up or down in dose increments of 1.5 g/day (i.e. 0.75 g/dose). A minimum of one to two weeks is recommended between dose increments. The dose of 9 g/day should not be exceeded due to the possible occurrence of severe symptoms at doses of 18 g/day or above.
Single doses of 4.5 g should not be given unless the patient has been titrated previously to that dose level.
If sodium oxybate and valproate are used concomitantly, a decrease in sodium oxybate dose by 20% is recommended. The recommended starting dose for sodium oxybate, when used concomitantly with valproate, is 3.6 g per day administered orally in two equal divided doses of approximately 1.8 g. If concomitant use is warranted, patient response and tolerability should be monitored and dose should be adapted accordingly.
The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials.
If the patient stops taking the medicinal product for more than 14 consecutive days, titration should be restarted from the lowest dose.
Elderly patients should be monitored closely for impaired motor and/or cognitive function when taking sodium oxybate.
Sodium oxybate should be taken orally upon getting into bed and again between 2.5 to 4 hours later. It is recommended that both doses of sodium oxybate should be made up at the same time upon retiring to bed. Because food significantly reduces the bioavailability of sodium oxybate, patients should eat at least several (2-3) hours before taking the first dose of sodium oxybate at bedtime. Patients should always observe the same timing of dosing in relation to meals. Doses should be taken within 24 hours after preparation, or else discarded.
For:
Regimen A: In case that patient age in years is ≥ 7 and patient weight is ≥ 15 kg and patient weight is < 20 kg, oral, 1 grams sodium oxybate, divided 2 times daily at the end of the day, over the duration of 1 week. Afterwards, in case that patient age in years is ≥ 7 and patient weight is ≥ 15 kg and patient weight is < 20 kg, oral, 1.5 grams sodium oxybate, divided 2 times daily at the end of the day.
Regimen B: In case that patient age in years is ≥ 7 and patient weight is ≥ 20 kg and patient weight is < 30 kg, oral, 2 grams sodium oxybate, divided 2 times daily at the end of the day, over the duration of 1 week. Afterwards, in case that patient age in years is ≥ 7 and patient weight is ≥ 20 kg and patient weight is < 30 kg, oral, 3 grams sodium oxybate, divided 2 times daily at the end of the day. The maximum allowed total dose is 6 grams sodium oxybate daily.
Regimen C: In case that patient age in years is ≥ 7 and patient weight is ≥ 30 kg and patient weight is < 45 kg, oral, 3 grams sodium oxybate, divided 2 times daily at the end of the day, over the duration of 1 week. Afterwards, in case that patient age in years is ≥ 7 and patient weight is ≥ 30 kg and patient weight is < 45 kg, oral, 4 grams sodium oxybate, divided 2 times daily at the end of the day. The maximum allowed total dose is 7.5 grams sodium oxybate daily.
Regimen D: In case that patient age in years is ≥ 7 and patient weight is ≥ 45 kg, oral, 4.5 grams sodium oxybate, divided 2 times daily at the end of the day, over the duration of 1 week. Afterwards, in case that patient age in years is ≥ 7 and patient weight is ≥ 45 kg, oral, 6 grams sodium oxybate, divided 2 times daily at the end of the day. The maximum allowed total dose is 9 grams sodium oxybate daily.
Sodium oxybate is administered orally twice nightly. Dosing recommendations are provided in Table 1.
Table 1. Sodium Oxybate Recommended Dose Initiation and Titration for Paediatric Patients:
| Patient weight | Initial total daily dose (taken in 2 divided doses)* | Titration regimen (to clinical effect) | Recommended maximum total daily dose |
|---|---|---|---|
| 15kg - < 20kg | ≤ 1g/day | ≤ 0.5g/day/week | 0.2g/kg/day |
| 20kg - < 30kg | ≤ 2g/day | ≤ 1g/day/week | |
| 30kg - < 45kg | ≤ 3g/day | ≤ 1g/day/week | |
| ≥ 45kg | ≤ 4.5g/day | ≤ 1.5g/day/week | 9g/day |
* At bedtime and 2.5 to 4 hours later. For children who sleep more than 8 hours per night, sodium oxybate may be given after bedtime, while the child is in bed, in two equally divided doses 2.5 to 4 hours apart.
The dose should be gradually titrated to effect based on efficacy and tolerability. A minimum of one to two weeks is recommended between dosage increments. Sodium oxybate dose recommendations (initial dose, titration regimen and maximum dose) for paediatric patients are based on body weight. Therefore, patients should have their body weight checked at regular intervals especially during titration to ensure that the appropriate dose of sodium oxybate is administered.
The recommended maximum total daily dose is 0.2g/kg/day in paediatric patients weighing less than 45kg. For paediatric patients weighing 45kg or more the maximum total daily dose is 9g/day.
If sodium oxybate and valproate are used concomitantly, a decrease in sodium oxybate dose by 20% is recommended e.g. 4.8g/day instead of 6g/day.
The safety and efficacy of sodium oxybate in children below 7 years of age has not been established and therefore sodium oxybate is not recommended below 7 years of age. Children below 15kg should not receive sodium oxybate.
The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials.
If the patient stops taking the medicinal product for more than 14 consecutive days, titration should be restarted from the lowest dose.
Sodium oxybate should be taken orally upon getting into bed and again between 2.5 to 4 hours later. It is recommended that both doses of sodium oxybate should be made up at the same time upon retiring to bed. Because food significantly reduces the bioavailability of sodium oxybate, patients should eat at least several (2-3) hours before taking the first dose of sodium oxybate at bedtime. Patients should always observe the same timing of dosing in relation to meals. Doses should be taken within 24 hours after preparation, or else discarded.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.