Amiparen-10 Full Prescribing Information, Dosage & Side Effects

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Amiparen-10 Amiparen-10

Manufacturer:

Otsuka

Distributor:

Zuellig Pharma

Marketer:

Thai Otsuka

SELECT Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Full Prescribing Info Contents Amino acids. Description Each 500 mL of AMIPAREN contains following ingredients: see table. Click on icon to see table/diagram/image AMIPAREN is a new sterile injection solution of total amino acids intended for use in hyperalimentation and general parenteral nutrition. AMIPAREN contain relatively larger amounts of branched - chain amino acids (L-Leucine, L-Isoleucine and L-Valine), which suppress protein breakdown and promote protein synthesis in the muscle and smaller amounts of aromatic and acidic amino acids. A series of preclinical and clinical studies established that AMIPAREN was effective in sparing protein in various types of insults and malnutritional state. AMIPAREN was also carefully formulated to contain no chloride ions and minimum sodium ions to facilitate easy supplementation of electrolytes. pH: about 6.9 (mentioned immediately after manufacture) and 6.5 - 7.5 (specification). Specific gravity (20°C): 1.032. Osmolarity: Approx. 900 mOsm/L. Excipients/Inactive Ingredients: Sodium bisulfate is added as a stabilizer. Action Pharmacology: The value of AMIPAREN as a source of amino acids in the nutritional support was assessed in hyperalimentation therapy using normal rate and insulted rats. AMIPAREN promptly improved and maintained nitrogen balance and exhibited a pronounced nitrogen sparing effect in these models. The solution promoted synthesis of plasma total protein and albumin. The urinary 3-methylhistidine/creatinine ratio, an indicator of protein catabolism in the muscle under insult, was low after infusion treatment, indicating a very potent inhibitory effect of the solution on muscle protein breakdown. The plasma concentrations of free amino acids including branched-chain amino acids showed minor fluctuation during infusion treatment. Amino acid metabolism was judged to be steady during AMIPAREN therapy. CLINICAL STUDIES: Clinical studies of AMIPAREN were conducted in a total of 546 patients undergoing central of peripheral venous nutritional management. These studies provided evidence of the high clinical value of the solution as a source of amino acids in terms of major protein metabolism-related indexes including nitrogen balance, serum total protein and albumin levels, rapid turnover protein level and urinary 3-methylhistidine/creatinine ratio. Adverse reactions and Abnormal Laboratory Values: In 546 patients treated, 17 cases of side effects were reported, Complaints included vascular pain (0.4%) and nausea and vomiting (0.4%). Abnormal laboratory tests showed an increase in GOT and/or GPT (0.7%), an increase in BUN (0.5%) and an increase in total bilirubin (0.4%). Pharmacokinetics: 14C-Amino acids formulated in AMIPAREN were readily taken up into plasma protein fraction after intravenous infusion in all normal rats at 3, 7 and 57 weeks of age. The radioactivity was distributed in higher concentrations to protein fractions of the spleen, liver and kidneys as well as muscles. Respiratory excretion accounted for 37.1%-44.2% over 72 hours postinfusion. As other major routes of elimination, 3.9%-5.2% and 1.2%-3.1% of the radioactivity were recovered from the urine and feces, respectively. Amino acid fractions in the urine contained only 1.1%-1.5% of the amino acids given. The overall retention of amino acids in the body amounted to more than 98.5% of the dose. Toxicology: Acute toxicity: LD50 values (intravenous, infusion rate: 4 mL/minute): 170 mL/kg male rabbits; 120 mL/kg female rabbits. Long term toxicity studies (rabbits, intravenous, 13 weeks and 26 weeks, an antigenicity study and a local irritation study did not reveal any AMIPAREN related specific toxic symptoms). Indications/Uses AMIPAREN is indicated for amino acid supply in the following instances: hypoproteinemia, malnutrition and pre and/or postoperative condition. Dosage/Direction for Use Central vein infusion: The usual adult dosage is 400-800 mL per day by drip infusion via the central vein; the dosage may be increased or decreased depending on the patient's age, symptoms and body weight. Peripheral vein infusion: The usual adult dosage is 200-400 mL per dose by drip infusion via the peripheral vein. The usual peripheral infusion rate is such a rate as to provide about 10 g of amino acids over 60 minutes of infusion in order to achieve optimal physiological utilization of amino acids. A typical infusion rate in adults is 100 mL over 60 minutes (about 25 drops per minute) and the rate should be adjusted downward in the case of children, elderly patients and severely ill patients. The dosage may be increased or decreased depending on the patient's age, symptoms and body weight. Combination of AMIPAREN with a carbohydrate solution is highly recommended for efficient utilization of amino acids in the body. Contraindications Use is contraindicated in the following instances: Patients with hepatic coma or a risk of hepatic coma. Patients with severely impaired renal function or a risk of hypernatremia. Patients with abnormal amino acid metabolism. Special Precautions The solution should be infused with care in the following instances: Patients with severe acidosis. Patients with congestive heart failure. Patients with hyponatremia. Precautions in use: Acetic acid is formulated in an amount of about 120 mEq/L. Concomitant use of the solution with electrolyte solutions and administration of the solution in large doses require careful supervision of electrolyte balance. Infusion should be slow. Use in Children: Use in immature infants, newborns and infants: The safety of the solution in immature infants, newborns and infants has not been established yet. Adverse Reactions Hypersensitivity: Rare eruption or other hypersensitive reactions were reported, if such reactions occur, the solution should be discontinued. Cardiovascular: Occasional chest discomfort and palpitation were reported. Gastrointestinal: Occasional nausea and vomiting were reported. Hepatic: An occasional increase in GOT, GPT and total bilirubin levels was reported. Renal: An occasional increase in blood urea nitrogen was reported. Large and acute administration: Acidosis was reported after large and acute administration of the solution. Other: Occasional chills, fever, hot flush, headache and vascular pain were reported. View ADR Monitoring Form Caution For Usage PRECAUTION FOR HANDLING: 1. A crystalline precipitate may form due to temperature changes during storage. Shake the solution at temperature of 15-25°C to dissolve precipitate before use. 2. Do not use the product if the solution is discolored, or a precipitate that cannot be dissolved by shaking has formed. 3. Open the wrap just before use. 4. Do not use if bag is leaking, solution cloudy or contains foreign matters. Storage Store below 30°C, protect from light. MIMS Class Parenteral Nutritional Products ATC Classification B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions. Thai FDA Category D Presentation/Packing Form Amiparen-10 inj soln Packing/Price 500 mL x 10 × 1's Register or sign in to continue Asia's one-stop resource for medical news, clinical reference and education

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