Essential Amino Acids for Renal Failure

ESSENTIAL AMINO ACID PREPARATION

Essential amino acid preparation for renal failure

DESCRIPTION AND COMPOSITION

AMIYU Granules is packaged granules containing 2.5 g per pack. The contents are white-coated granules with aromatic odour and slightly sweet taste. Composition AMIYU Granules contains the following ingredients in a pack (2.5 g).

Contains the following ingredients in a pack (2.5g)

Active Ingredients	Content of EAA/ sachet
L-isoleucine	203.9 mg
L-leucine	320.3 mg
L-lysine hydrochloride	291.0 mg
L-methionine	320.3 mg
L-phenylalanine	320.3 mg
L-threonine	145.7 mg
L-tryptophan	72.9 mg
L-valine	233.0 mg
L-histidine hydrochloride	216.2 mg
Essential Amino acids total	2123.6 mg

PHARMACOLOGICAL PROPERTIES Pharmacodynamics

1. Effects and actions Clinical experiments: In clinical tests on 20 patients with chronic renal failure, such effects were noted as improvements of nitrogen balance, decrease of serum urea nitrogen, increase of total serum protein, albumin and hemoglobin,inhibition of production of uremic toxins and the delay of the aggravation ofrenal failure state.

2. Mechanism of action The therapy with AMIYU Granules is based on when 8 kinds of essential amino acids and L-histidine which is necessary in patients with renal failure are administrated, non-essential amino acids are biosynthesized from urea nitrogen with sufficient energy, the subsequent protein is synthesized, and the accumulation of waste nitrogen metabolites is inhibited. It is confirmed the therapy with AMIYU Granules makes the improvement clinical symptom and the delay of disease aggravation.

INDICATIONS

Supply of amino acids in chronic renal failure

CONTRAINDICATIONS

Patients with severe hepatic function disorder [Imbalance of amino acids may be aggravated with the use of AMIYU Granules, resulting in the induction of hepatic coma.]

DOSAGE AND ADMINISTRATION Dosage

The usual adult dosage for oral use is each pack for one time and three times daily after meals. The dosage should be adjusted depending on the patient’s age, severity of symptoms, and body weight. Method of administration Oral use.

PRECAUTIONS

Read carefully the instructions before use. For further information please consult your doctor. This drug is used upon doctor's prescription only.
Important Precautions AMIYU Granules should be used for maintenance therapy for the patients with chronic renal failure. Use in the Elderly In general, since physiological function is decreased in the elderly, AMIYU Granules should be carefully administered, such as reducing the dose. Use during Pregnancy, Delivery or Lactation(1) AMIYU Granules should only be used in pregnant women or women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. [The safety of this product during pregnancy has not been established.](2) Use of AMIYU Granules in nursing women is not recommended. If use of AMIYU Granules is judged to be essential, breast feeding must be discontinued during treatment. [The safety of this product in nursing women has not been established.] Pediatric Use The safety of AMIYU Granules in children has not been established. [There is insufficient clinical data.] Precautions concerning Use At the time of administration, patients must be provided with low-protein diet according to their renal function and their calorie intake should be 1,800 Kcal or more.

INTERACTION WITH OTHER DRUGS AND OTHER FORMS OF INTERACTIONS

There is no report to indicate the interaction with other drugs.

ADVERSE REACTIONS

Adverse reactions to AMIYU Granules was observed in 132 (2.37%) of total5564 cases. The most frequently observed adverse reactions were nausea/queasy in 70reactions (1.26%), anorexia in 41 reactions (0.74%), vomiting in 24 reactions(0.43%), abdominal bloating in 19 reactions (0.34%), oral discomfort (including mouth feeling dry, thirst) in 14 reactions (0.25%), and increased AST (GOT) and ALT (GPT) in 9 reactions (0.16%). (At the end of the re-examination)

SHELF-LIFE

36 months from manufacturing date.

STORAGE

Store below 30C.

PACKING SIZE

Box of 210 aluminum sachets x 2.5 g Box of 630 aluminum sachets x 2.5 g

Keep out of reach of children. Do not use the medicine after the expiry date stated on the package.