Posology : מינונים

4.2 Posology and method of administration
Posology
Adult patients
For all adult indications except diabetic gastroparesis and facilitation of diagnostic procedures (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 patients
For all pediatric indications except facilitation of diagnostic procedures (see below): - 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 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).

Facilitation of diagnostic procedures (adults and pediatric patients) a) To Facilitate Small Bowel Intubation: If the tube has not passed the pylorus with conventional maneuvers in 10 minutes, a single dose of Pramin® Injection 10 mg may be administered slowly by the intravenous route over a 3-minute period, in adults. For single doses in pediatric patients, please refer to the pediatric dosage recmmendations above.
b) To Aid in Radiological Examinations: In patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine, a single dose of Pramin® Injection 10 mg may be administered slowly by the intravenous route over a 3- minute period, in adults. For single doses in pediatric patients, please refer to the pediatric dosage recommendations above.


Method of administration:
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).
Pramin® Injection can be administered intravenously or intramuscularly. The intravenous dose must be administered as a slow bolus (over a duration of at least 3 minutes) in order to reduce the risk of adverse effects (e.g., low blood pressure, akathisia). The duration of treatment by injection must be as short as possible and treatment must be continued orally as soon as possible.
Pramin_injection-SPC- August_2024-02


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).

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