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Kidmin

Kidmin

Manufacturer:

Otsuka

Distributor:

Zuellig Pharma

Marketer:

Thai Otsuka
Full Prescribing Info
Contents
Amino acids.
Description
KIDMIN is a 7.2% amino acid containing large amounts of branched-chain amino acids, such as L-Leucine, L-Isoleucine, and L-Valine which inhibit the breakdown of muscle protein and promote muscle protein synthesis. KIDMIN also contains some non-essential amino acids, except for Glycine, the demand for which is increased in renal insufficiency. The ratio of essential to non-essential amino acids of this solution is 2.6 and each 100 mL contains 1 g of nitrogen with no chloride and a small amount of sodium, and it is thus easy to calculate the nitrogen content of a given dose and to adjust the amount of electrolytes for electrolyte balance. (See table.)

Click on icon to see table/diagram/image

pH: Approx. 7.0 (mentioned immediately after manufacture) and 6.5-7.5 (specification).
Specific gravity (20°C): 1.022.
Osmolarity: Approx. 600 mOsm/L.
Action
Pharmacology: KIDMIN administered by TPN, exerted the following nutritional effects in animals such as chronic renal failure animals (7/8 nephrectomy rats and 7/8 renal artery-ligated dogs) and acute renal failure animals (mercuric chloride-induced renal failure rats and total nephrectomy rats): Favorable body weight gain and nitrogen balance.
Normalized aminogram in blood and BCAA levels in muscle.
Increased uptake of N-leucine into blood protein fraction.
Smaller increase in blood urea nitrogen.
The amino acid-providing effect of KIDMIN was studied in 7/8 nephrectomized rats on a low-protein diet and the following nutritional effects were observed.
Improvement in nutritional status as evidenced by body weight gain, nitrogen balances and normalized blood aminogram.
No increase in blood urea nitrogen.
CLINICAL STUDIES: Clinical trials were conducted in 218 patients with acute or chronic renal failure, mainly those who needed blood purification treatment and the following results were obtained.
In the total parenteral nutrition (central vein infusion) in patients in whom oral nutrition was not tolerated, KIDMIN showed favorable effect on serum total protein, albumin and rapid-turnover protein with smaller changes in serum aminograms and alleviated an increase in blood urea nitrogen.
In the peripheral use of KIDMIN as a supplement to the oral intake of protein, the nutritional parameters such as serum total protein, transferrin and Val/Gly ratio were favorably maintained.
Pharmacokinetics: When 14C-labeled KIDMIN was infused to normal 12 week-old rats and to 7/8 nephrectomized rats by TPN, the radioactivity was rapidly distributed throughout the body, with 50 - 90% incorporation to the protein fractions of the plasma, muscle and major organs such as liver, kidney and spleen from 3 to 72 hours after infusion. The expiratory excretion relative to the administered radioactivity was 32% in normal rats and 34% in nephrectomized rats up to 72 hours after infusion and the urinary excretion relative to the administered radioactivity was 4.6% and 4.9%, respectively.
Indications/Uses
KIDMIN is indicated for the provision of amino acids in the following instances in patients with acute or chronic renal failure: Hypoproteinemia, malnutrition and before and after surgery.
Dosage/Direction for Use
Chronic Renal Failure: Peripheral vein infusion: The usual adult dosage is 200 mL per day, infused via a peripheral vein. The usual infusion rate in adults is 100 mL over 60 minutes (approx. 25 drops per minute) and it should be slowly infused in children, the elderly and seriously ill patients. The dosage may be adjusted according to the patient's condition, body weight and age. When administered during hemodialysis, it should be infused via the vein side injection port of dialysis circuit starting 90-60 minutes before the end of hemodialysis therapy. Regarding calories, more than 1500 kcal per day is recommended to be provided for the efficiency of amino acid utilization.
Central vein infusion: The usual adult dosage is 400 mL per day, Infused via a central vein by total parenteral nutrition. The dosage may be adjusted according to the patient's condition, body weight and age. More than 300 kcal of non-protein calories should be administered per 1 g of nitrogen (100 mL of this product) for the efficiency of amino acids utilization.
Acute Renal Failure: The usual adult dosage is 600 mL per day, infused via a central vein by total parenteral nutrition. The dosage may be adjusted according to the patient's condition, body weight and age. More than 300 kcal of non-protein calories should be administered per 1 g nitrogen (100 mL of this product) for the efficiency of amino acid utilization.
Precautions in dosage and administration: Since it has been reported that hyperammonemia or consciousness disorder occurred when an amino acid injection for renal failure was administered as the sole amino acid source, discontinue use of this product immediately when abnormalities including slow reaction to being called or greetings or reduction in spontaneous motor activity or expressing opinions are observed.
Since azotemia or metabolic acidosis may be enhanced in case of inadequate administration of calories, the patients must be carefully observed during administration. If abnormalities are found, institute appropriate measures such as withdrawing administration.
Contraindications
Patients with hepatic coma or risk of hepatic coma. (Administration may enhance amino acid imbalance and hepatic coma may be worsened or induced.)
Patients with hyperammonemia. (Because of excess load of nitrogen, hyperammonemia may be worsened)
Patients with inherited abnormal amino acid metabolism. (Since the infused amino acids are not adequately metabolized, the patient's clinical condition may be worsened.)
Special Precautions
Careful administration (KIDMIN should be administered with care in the following patients): Patients with cardiovascular dysfunction. (An increase in the circulating blood volume may worsen the patient's clinical condition).
Patients with hepatic disorder or gastrointestinal bleeding. (Excess accumulation of amino acids or hyperammonemia may be induced).
Patients with severe electrolyte imbalance or abnormal acid-base balance. (The patient's clinical condition may be worsened).
Patients with severe acidosis. (The patient's clinical condition may be worsened).
Important precautions: This product should be used in patients who need parenteral nutrition because oral or enteral nutrition is inadequate or not possible.
Use in Children: The safety of KIDMIN in children has not been established (insufficient clinical experience).
Physiological systems for the metabolism of various amino acids may not be fully developed in children. It is therefore advisable to take special precautions such as reducing the infusion rate when administering KIDMIN to pediatric patients.
KIDMIN may induce hyperkalemia in low birth weight infants. If hyperkalemia develops, discontinue administration and take appropriate measures to reduce serum potassium levels.
Use in the Elderly: Since elderly patients often have reduced physiological function and are likely to develop hepatic or cardiovascular dysfunction, the solution should be administered under careful supervision, such as reducing the dose by decreasing the infusion rate.
Use in Pregnancy & Lactation: The safety in pregnant women has not been established. Therefore, this product should be used in pregnant women and woman who may possibly be pregnant only if the expected therapeutic benefits outweigh any possible risk.
Use In Pregnancy & Lactation
The safety in pregnant women has not been established. Therefore, this product should be used in pregnant women and woman who may possibly be pregnant only if the expected therapeutic benefits outweigh any possible risk.
Adverse Reactions
Hypersensitivity: Eruption, skin rash, in the event of skin rash, discontinue the administration and institute appropriate treatment.
Gastrointestinal: Nausea, vomiting.
Cardiovascular: Chest discomfort, palpitations.
Hepatic: Increases in GOT, GPT, γ-GTP, ALP, LDH, LAP, total bilirubin, or ammonia.
Renal: Increases in blood urea nitrogen or creatinine.
Large dose and rapid administration: Acidosis.
Other: Chills, fever, feeling of warmth, headache, vascular pain, lower extremity edema, hyperpotassemia or dry mouth.
Caution For Usage
At the time of preparation: Physicochemical changes of the solution such as precipitation may occur when this product is combined with the following drugs. Changes should be observed.
Drugs which are designed to be stable in alkaline conditions.
Drugs which are not soluble in water.
Before administration: To prevent associated infection, carry out all procedures under aseptic conditions.
Use the solution after warming to near body temperature during cold environmental conditions.
Use the solution immediately after opening the container. After use, discard all unused solution.
During administration: Since the solution contains approximately 46 mEq/L of acetate, a large dose or concomitant use with an electrolyte solution requires careful monitoring of electrolyte balance.
Administer slowly via vein.
When vascular pain occurs, use an alternate site or discontinue the administration.
Precaution for handling: 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.
Do not use the product if the solution is discolored or precipitate that cannot be dissolved by shaking has formed.
Use immediately after opening.
Do not use if bag is leaking, solution is 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.
Presentation/Packing
Form
Kidmin soln for inj 200 mL
Packing/Price
200 mL x 10 × 1's
Form
Kidmin soln for inj 500 mL
Packing/Price
500 mL x 10 × 1's
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