Posology : מינונים

4.2 Posology and method of administration
Posology
Adult patients
For all adult indications except diabetic gastroparesis (see below):
- The recommended dose is 10 mg, 1 to 3 times a day.
- The maximum recommended daily dose is 30 mg or 0.5 mg/kg bodyweight whichever is lower.
- The maximum recommended treatment period is usually 5 days.

Pediatric population
Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).

Pediatric patients
For all pediatric indications:
- The recommended dose is 0.1 mg to 0.15 mg/kg bodyweight, 1 to 3 times a day.
- The maximum recommended daily dose is 0.5 mg/kg bodyweight. The tablets are not suitable for use in children weighing less than 30 kg. Other pharmaceutical forms are more appropriate for use in this population group. (Note: The tablets may be cut in half using the scored line).
- The maximum recommended treatment period is usually 5 days.
Diabetic gastroparesis (adults): Use of Pramin® for diabetic gastroparesis may involve a treatment duration longer than 5 days. Therefore, use in this clinical setting should be limited to those patients for whom the potential benefit outweighs the risk acording to the judgement of the treating physician. The recommended dose for diabetic gastroparesis is 10 mg half an hour before each meal (which is 10 mg X 3 daily) for 2-8 weeks, depending on the response and the likelihood of continued well-being on cessation of treatment. The initial route of administration depends on the severity of the observable symptoms. If only the earliest manifestations of gastric stasis are present, the oral route is indicated. However, if the symptoms are more severe, 10 mg i.v. therapy by slow injection should be instituted (for up to 10 days) until symptoms subside. After 10 days, oral administration should be used for maintenance. Since diabetic gastric stasis is frequently recurrent, Pramin® therapy should be reinstituted at the earliest manifestation. In patients with diabetic gastroparesis, the maximum recommended treatment period is usually 3 months. Treatment for longer than 3 months should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia (see section 4.4).

Special populations
Elderly
In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.
Renal impairment
In patients with end stage renal disease (creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%. In patients with moderate to severe renal impairment (Creatinine clearance 15-60 ml/min), the dose should be reduced by 50% (see section 5.2).
Hepatic impairment
In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).


Other pharmaceutical forms/strengths may be more appropriate for administration to these populations.

Method of administration:
For oral use only.
A minimum interval of 6 hours must be observed between 2 doses, even in case of vomiting or rejection of the dose (see section 4.4).