Công văn 4396/QLD-ĐK hướng dẫn cách ghi chỉ định, liều lượng-cách dùng của thuốc chứa Arginin do Cục Quản lý dược ban hành

THE MINISTRY  OF HEALTH
DRUG ADMINISTRATION OF VIETNAM
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence– Freedom – Happiness
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No. 4396/QLD-DK
Ref.: Guiding the methods for writing indications, dosage and use of medicines containing Arginine

Hanoi, April 03, 2012

Indications

Dosage and use

Assist diagnosis of a number of diseases e.g Hypopituitarism, growth retardation due to pituitary gland, chromopobe cell tumors, Craniopharyngeal duct tumor, removal of the pituitary gland, pituitary injury, acromegaly, giantism (overgrowth) and issues related to body and stature growth.

Adults: 30g (300ml of 10% solution) by venoclysis for 30 min.

Children: 0.5g/kg (5ml of 10%/kg solution) by venoclysis for 30 min. Total dosage shall not exceed 30g.

Treatment of acute blood ammonia elevation for patients with carbamoyl phosphate synthetase deficiency, ornithine carbamyl transferase deficiency.

By venoclysis:

Newborn: 200mg/kg for 90min for the first dose; then 8mg/kg/h

1-18 month babies: 200mg/kg for 90min for the first dose; then 8mg/kg/h.

Treatment of acute blood ammonia elevation for patients elevated blood citrulline and urinary argininosuccinic.

By venoclysis:

Newborn: 600mg/kg for 90min for the first dose; then 25mg/kg/h

1-18 month babies: 600mg/kg for 90min for the first dose; then 25mg/kg/h

Treatment of Metaboiic alkalosis

Under the following formula:

Dosage of Arginine hydrochloride by venoclysis = the bicarbonate concentration in blood plasma (mEq/L) x {body weight (kg) / 9.6}

Indications

Dosage and use

Treatment of keeping blood ammonia levels increased for patients with carbamoyl phosphate synthetase deficiency, ornithine carbamyl transferase deficiency.

Via oral route:

 Newborn: 100mg/kg per day total, given in 3-4 equally divided doses

1-18 month babies: 100mg/kg per day total, given in 3-4 equally divided doses.

Treatment of keeping blood ammonia levels increased for patients suffered from blood citrulline, urinary argininosuccinate.

Via oral route:

 Newborn: 100-175mg/kg/time; 3-4 times per day with meals; adjust according to responses.

1-18 month babies: 100-175mg/kg/time; 3-4 times per day with meals; adjust according to responses.

Assist treatment of dyspeptic disorders

Adults: 3-6g per day via oral route

Assist treatment of improving excersise capacity for patients with stable cardiovascular disease

Adults: 6-21g per day via oral route; not exceeding 8g each time

Supplement of nutrition for those having Urea Cycle Disorders e.g elevated blood ammonia level type I and II, elevated blood citrulline, urinary argininosuccinate and N - Acetyl Glutamate Synthetase Deficiency.

Adults: take 3-20g per day via oral route depending on seriousness of the disease.

FOR THE DIRECTOR GENERAL
DEPUTY DIRECTOR GENERAL




Nguyen Viet Hung