Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany
For the treatment of metabolic acidosis and for maintenance treatment against recurrence of metabolic acidosis in adults with chronic renal impairment.
The dosage depends on the severity of metabolic acidosis, based on the results of blood gas analysis or determination of serum bicarbonate.
The mean dosage is 3 to 5 g sodium hydrogen carbonate per day, equivalent to 40-65 mg sodium hydrogen carbonate per kg body weight per day.
The daily dose can be achieved by taking 6 to 10 capsules of Nephrotrans 500 mg.
No data available. The safety and efficacy of Nephrotrans 500 mg in children and adolescents has not been established.
To be swallowed whole throughout the day with sufficient liquid.
This medicinal product should not be taken without medical supervision for prolonged periods, as there is a possibility for the development of hypernatremia or alkalosis.
Note: Patients with a blood pH level below 7.2 require the correction of acidosis by infusion.
In the event of an absolute or relative overdose (e.g. in renal impairment), even oral administration of sodium hydrogen carbonate can lead to alkalosis with dizziness, muscle weakness, fatigue, cyanosis, hypoventilation and symptoms of tetany. Apathy, confusion, ileus and circulatory collapse may subsequently follow. Treatment consists in correcting the fluid and electrolyte balance, particularly with the supply of calcium, potassium and, if necessary, chloride. In individual cases, symptoms of acute hypernatremia may also predominate, with confusion, increased excitability and even seizures and coma. In such cases, fluid administration (e.g. glucose solutions and hypo-osmolar electrolyte solutions) and diuretics are crucial.
3 years.
Do not store above 25°C.
Store in the original package in order to protect from light.
Boxes containing capsules in PVC/PVDC clear blisters sealed to aluminium foil.
Packs with 100 gastro-resistant capsules, soft.
Hospital packs with 500 gastro-resistant capsules, soft.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
