BRANCHED-CHAIN AMINO ACID PREPARATION

BRANCHED-CHAIN AMINO ACID FOR LIVER CIRRHOSIS

Branched-Chain Amino Acid Preparation

(L-Isoleucine, L-Leucine and L-Valine Granules JP (Japanese Pharmacopoeia)

DESCRIPTION

1. Composition: Each packet (4.15 g) of LIVACT® Granules contains the following ingredients. L-Isoleucine 952 mg, L-Leucine 1904 mg, L-Valine 1144 mg. Excipients: Povidone, polyvinyl alcohol (partly saponified), tartaric acid, saccharin sodium hydrate and flavoring agents as additives.

2.Product description LIVACT® Granules is white coated granules having a slightly fragrant odor.

INDICATIONS

LIVACT® Granules is indicated for improvement of hypoalbuminemia in patients with decompensated hepatic cirrhosis with an albumin level of 3.5 g/dL or less despite adequate dietary intake.

DOSAGE AND ADMINISTRATION

The usual adult dose for oral use is one packet three times a day after meals or as prescribed by physician.

CONTRAINDICATIONS

LIVACT® Granules is contraindicated in the following patients. Patients with congenital branched-chain amino acid metabolic abnormality [The use of LIVACT® Granules may be induced with convulsions or respiratory disturbances in patients with maple syrup urine disease.] Do not use for patient who is allergic to any ingredient of LIVACT® Granules.

PRECAUTIONS

Read carefully the instructions before use. For further information please consult your doctor. This drug is used upon doctor’s prescription only.
1. Use in the Elderly LIVACT® Granules should be administered to elderly patients with caution since such patients often have decreased physiological functions, and metabolic disorders such as blood ammonia elevation can be more sensitive to develop during LIVACT® Granules therapy.

2. Use during Pregnancy, Delivery, or Lactation. The safety of LIVACT® Granules in pregnant women and nursing mothers has not been established. Therefore, the product should not be used in pregnant women, women suspected of being pregnant, and nursing mothers unless the expected benefits outweigh the potential risks.

3. Pediatric Use The safety of LIVACT® Granules in children has not been established. (no clinical experience).

INTERACTION WITH OTHER DRUGS AND OTHER FORMS OF INTERACTIONS
There is no report to indicate the interaction with other drugs.

EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINE

In case of LIVACT® Granules, no instance which ability to drive or operate machinery might be affected, has been reported.

ADVERSE REACTIONS

Among 420 cases studied prior to the time of approval, 40 adverse reactions were reported in 27 cases (6.4%). The commonly reported adverse reactions by the time of approval included abdominal distension (9 reactions, 2.1%), diarrhea (5reactions, 1.2%) and constipation (4 reactions, 1.0%).(At the approval)267 adverse reactions were reported in 178 cases (6.2%) of 2,877 cases surveyed in the post marketing surveillance. The commonly reported adverse reactions included hyperammonemia (23 reactions, 0.8%), queasy (15 reactions, 0.5%),diarrhea (14 reactions, 0.5%), increased BUN (14 reactions, 0.5%) and abdominal pain (12 reactions, 0.4%).(Data from the result of re-examination)63 adverse reactions were reported in 41 cases (12.3%) of 334 cases in post marketing clinical studies (including long-term studies). The commonly reported adverse reactions included abdominal distension (13 reactions, 3.9%),constipation (9 reactions, 2.7%), diarrhea (5 reactions, 1.5%), itching (4 reactions,1.2%), queasy (3 reactions, 0.9%) and vomiting (3 reactions, 0.9%).(Data from the result of re-examination)

PACKING SIZE

Box of 84 sachets x 4.15 g.

STORAGE

Store at temperature below 30°C

SHELF-LIFE

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