Aminoleban EN Full Prescribing Information, Dosage & Side Effects

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Aminoleban EN肝美靈 Aminoleban EN

Manufacturer:

Otsuka

Distributor:

Zuellig

/

Agencia Lei Va Hong

SELECT Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing The information highlighted (if any) are the most recent updates for this brand. Full Prescribing Info Contents Amino acids, vitamins and minerals. Description Each package (50 g) of AMINOLEBAN EN powder contains: L-Isoleucine 1.9225 g; L-Leucine 2.037 g; L-Lysine hydrochloride 0.2425 g; L-Threonine 0.133 g; L-Valine 1.602 g; L-Arginine hydrochloride 0.302 g; L-Histidine hydrochloride hydrate 0.1875 g; L-Tryptophan 73.5 mg; Hydrolyzed gelatin 6.5 g; Rice oil 3.6855 g; Dextrin 31.4593 g; Vitamin A oil 464.835 μg; Ergocalciferol 1.165 μg; Bisbentiamine 0.145 mg; Riboflavin 0.155 mg; Pyridoxine hydrochloride 0.245 mg; Cyanocobalamin 0.5 μg; Folic acid 50 μg; Sodium L-ascorbate 6.9 mg; Tocopherol acetate 9.3 mg; Phytonadione 5.5 μg; Calcium pantothenate 1.19 mg; Nicotinamide 1.515 mg; Biotin 25 μg; Choline bitartrate 12.3 mg; Magnesium sulfate hydrate 0.205 g; Calcium glycerophosphate 0.305 g; Sodium dihydrogen phosphate dihydrate 0.195 g; Sodium ferrous citrate 12.5 mg; Cupric sulfate 0.515 mg; Zinc sulfate hydrate 3.755 mg; Potassium iodide 12.5 μg; Manganese sulfate 0.815 mg; Potassium chloride 0.1875 g. When AMINOLEBAN EN powder is mixed with water, a white to light yellow suspension occurs. The pH of the suspension in the usual concentration for ingestion (about 1 kcal/mL) is 5.5-7.0 and the osmolarity ratio is about 2. Each package (50 g) of AMINOLEBAN EN powder contains the following nutrients: See Table 1. Click on icon to see table/diagram/image Excipients/Inactive Ingredients: Each package contains the following inactive ingredients: sodium caseinate, potassium sorbate, sucrose, thaumatin, silicon resin, sucrose fatty acid ester, dipotassium phosphate, sucralose and flavor*. * AMINOLEBAN EN powder is available with premix flavor (fruit taste). Action Pharmacology: In experiments using rats and dogs with portacaval shunts (PCS) as a chronic hepatic insufficiency model, AMINOLEBAN EN powder normalized the imbalanced plasma and brain free amino acid concentration patterns, and in particular, improved abnormal intracerebral serotonin metabolism. In experimental coma induced by loading ammonia on normal rats, AMINOLEBAN EN powder tended to prevent the onset of coma and to reduce the duration of coma. In ammonia-loaded PCS rats, AMINOLEBAN EN powder inhibited the decrease in electroencephalographic voltage. In hepatic devascularized rats used as an acute hepatic insufficiency model, AMINOLEBAN EN powder improved plasma and brain free amino acid concentration imbalances and abnormal intracerebral amine metabolism. In PCS rats used as a chronic hepatic insufficiency model, repeated administration of AMINOLEBAN EN powder increased body weight and produced a positive nitrogen balance. Also, the protein efficiency ratio tended to increase. In a postoperative injury catabolic state in the PCS rats, repeated administration of AMINOLEBAN EN powder increased body weight and produced a positive nitrogen balance. In rats with hepatic disorder induced by treatment with carbon tetrachloride, AMINOLEBAN EN powder suppressed the decrease in body weight and produced a positive nitrogen balance. In rats with obstructive jaundice produced by ligation of the common bile duct, AMINOLEBAN EN powder increased body weight and produced a positive nitrogen balance. Clinical Studies: Usefulness: The clinical dietary value of AMINOLEBAN EN powder was compared with that of a conventional liver diet alone in hepatic insufficiency patients, mostly those with hepatic encephalopathy. Usefulness was assessed based on global improvement of EEG findings, neuropsychiatric symptoms, subjective and objective symptoms and Fischer's ratio, and safety. According to the results, AMINOLEBAN EN powder was determined to be useful in 65.5% (74 of 113) of the patients studied. In a long-term study with AMINOLEBAN EN powder using decompensated cirrhosis patients, usefulness was assessed based on the quality of life, including coma scale, Karnofsky's performance score and change in patient status from inpatient to outpatient. Usefulness was demonstrated in 72.9% (70 of 96) of the patients studied. Effect on Patient Survival: The cumulative survival rate in the patients treated with AMINOLEBAN EN powder for 6 month was significantly greater than that in the patients of historical data group. Nutritional Improvement: AMINOLEBAN EN powder produced a positive nitrogen balance and improved serum protein levels. Indications/Uses Improvement of the nutritional state of chronic hepatic insufficiency patients including those with hepatic encephalopathy. Dosage/Direction for Use Usually for adults, reconstitute one package (50 g) of AMINOLEBAN EN powder in about 180 mL of water or warm water (approximately 200 kcal/200 mL) and ingest with meals three times a day. The dosage may be adjusted according to the age of the patient and symptoms. The regular daily dosage (150 g) of AMINOLEBAN EN powder provides 40.5 g of protein and a total of 639 kcal. When the patient needs more protein and calories, the balance should be supplemented in the patient's diet. When a patient rejects AMINOLEBAN EN powder due to its taste, the concentration of the reconstituted product may be reduced to approximately 0.8 kcal/mL (reconstitute one package [50 g] of AMINOLEBAN EN powder in approximately 230 mL of water or warm water). When a patient requires restriction of water intake, the concentration of the reconstituted product may be increased to approximately 2 kcal/mL (reconstitute one package [50 g] of AMINOLEBAN EN powder in approximately 80 mL of water or warm water). The appropriate dosage of AMINOLEBAN EN powder should be established based on sufficient confirmation of each individual patient's current treatment status, including dietary therapy. Switching from a low-protein diet (40 g/day of protein, 1600 kcal/day): Treatment should be switched to a combination of a low-protein diet (40 g/day of protein, 1000 kcal/day) and 3 packages/day of AMINOLEBAN EN powder (40.5 g/day of protein, 639 kcal/day). Switching from therapy with an amino acid injection for hepatic encephalopathy: Treatment should be switched to a combination of a low-protein diet (40 g/day of protein, 1000 kcal/day) and 3 packages/day of AMINOLEBAN EN powder (40.5 g/day of protein, 639 kcal/day). Switching from a conventional liver disease diet (80 g/day of protein, 2100 kcal/day): Treatment should be switched to a combination of a low-protein diet (40 g/day of protein, 1500 kcal/day) and 3 packages/day of AMINOLEBAN EN powder (40.5 g/day of protein, 639 kcal/day). Route of administration: AMINOLEBAN EN powder is intended for oral feeding and should not be administered into a blood vessel. Contraindications AMINOLEBAN EN powder is contraindicated in the following patients: Patients with a history of hypersensitivity to any ingredient of AMINOLEBAN EN powder; Patients with allergy to milk (AMINOLEBAN EN powder contains casein as an additive). Special Precautions Use in Pregnancy & Lactation: A foreign epidemiological study of vitamin A in pregnant women suggested an increased frequency of birth defects dominated by cranial neural crest defects in newborns delivered by women administered 10,000 IU/day or higher amounts of vitamin A during 3 months prior to pregnancy and the first 3 months of pregnancy. When AMINOLEBAN EN powder is administered to pregnant women during the first 3 months of pregnancy or women who have an intention to become pregnant, special attention should be paid to dosage, adjusting as necessary to achieve a reduction to less than 5,000 IU/day of vitamin A. Use in the Elderly: Dosage reduction or other appropriate measures should be considered when prescribing AMINOLEBAN EN powder to elderly patients because these patients often have reduced physiological function. Use in Children: The safety of AMINOLEBAN EN powder in low birth weight infants, newborns, suckling infants, infants, and children has not been established. Clinical experience is insufficient. Use In Pregnancy & Lactation A foreign epidemiological study of vitamin A in pregnant women suggested an increased frequency of birth defects dominated by cranial neural crest defects in newborns delivered by women administered 10,000 IU/day or higher amounts of vitamin A during 3 months prior to pregnancy and the first 3 months of pregnancy. When AMINOLEBAN EN powder is administered to pregnant women during the first 3 months of pregnancy or women who have an intention to become pregnant, special attention should be paid to dosage, adjusting as necessary to achieve a reduction to less than 5,000 IU/day of vitamin A. Adverse Reactions Adverse reactions to AMINOLEBAN EN powder, including abnormalities in laboratory data, were reported in 185 out of 2,628 patients treated (7.04%). (Figures are total cases reported at the time of approval and at the completion of reexamination.) The following summary of data includes adverse reactions voluntarily reported after marketing. Clinically significant adverse reactions: Hypoglycemia (<0.1%): Hypoglycemia (cold sweat, feeling abnormal, shivering, palpitations, etc.) may occur. If such signs or symptoms are observed, appropriate measures should be taken. Other adverse reactions: See Table 2. Click on icon to see table/diagram/image View ADR Monitoring Form Caution For Usage Preparation: Pour about 180 mL of water or warm water into a blender, add the entire contents of one AMINOLEBAN EN Powder package (50 g) and thoroughly reconstitute. The volume of the reconstitution is approximately 200 mL, and the reconstitution provides about 1 kcal/mL of energy. Method of preparation for administration: AMINOLEBAN EN powder should be reconstituted before use (within 10 hours). If necessary, the preparation should be stored in a cool place. Boiling water should not be used for reconstitution to avoid denaturation of the protein. Fibrous vegetables may be mixed with the preparation to improve palatability. Fresh fruit juice should not be combined since the acidity of the fruit juices may cause gel formation. Storage Do not store above 25°C. MIMS Class Enteral/Nutritional Products ATC Classification V06DE - Amino acids/carbohydrates/minerals/vitamins, combinations ; Used as general nutrients. Regulatory Classification NP Presentation/Packing Form Aminoleban EN powd for oral susp Packing/Price 50 g x 21 × 1's Exclusive offer for doctors Register for a MIMS account and receive free medical publications worth $768 a year.

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