** Revised in April 2016 (8th edition)* Revised in April 2012
S t o r a g e : Store at room temperature.
After opening the inner package, store in a tight container protected from light.
Expiration Date: 1 year and 3 months(Use before the expiration date indicated on the outer case.)

Elemental diet

ELENTAL

Standard Commodity Classification No. of Japan
873259Approval No.

22100AMX00868

Entry in NHI Drug Price List

September 2009

Initial Marketing

September 1981

Reexamination Results

December 1986
D0209311[Contraindications (Elental® Is Contraindicated in the FollowingPatients.)]1. Patients who have a history of hypersensitivity to any component of thepresent drug.
2. Among patients who have severe diabetes mellitus or are receiving high dosesteroids, those patients who are suspected of having glucose metabolism
disorder. (Hyperglycemia may develop.)
3. Administration of 5000 IU per day or more of vitamin A to women in the first
3 months of pregnancy or women who want to become pregnant. (See thesection 5 “Administration to pregnant women, parturient women,nursing women, etc.")
4. Patients with amino acid metabolism disorder. (Elental® may cause
hyperaminoacidemia etc.)* [Composition and Description]
1. Composition
In 1 bag or 1bottle (80 g)(300 kcal)
L-isoleucine
803 mg642 mgL-leucine1124 mg
899 mgL-lysine hydrochloride
1110 mg
888 mgL-methionine
810 mg648 mgL-phenylalanine
1089 mg
871 mgL-threonine
654 mg523 mgL-tryptophan
189 mg
151 mgL-valine
876 mg
701 mgL-histidine hydrochloride hydrate
626 mg
501 mgL-arginine hydrochloride
1406 mg1125 mg
L-alanine1124 mg
899 mgMagnesium/potassium L-aspartate
1295 mg1036 mg
Sodium L-aspartate monohydrate1084 mg
867 mgL-glutamine
2415 mg1932 mg
Glycine631 mg505 mgL-proline
788 mg630 mgL-serine
1449 mg1159 mg
L-tyrosine
138 mg
110 mgDextrin79.26 g63.41 gSodium citrate dehydrate
770 mg
616 mgPotassium chloride
188 mg
150 mgCalcium glycerophosphate
1031 mg
825 mgFerrous gluconate dihydrate
19.4 mg15.5 mg
Zinc sulfate hydrate
9.85 mg7.88 mg
Manganese sulfate pentahydrate
1.63 mg1.30 mg
Copper sulfate
1.03 mg
0.82 mg
Potassium iodide
24.5 µg19.6 µg
Thiamine hydrochloride
242 µg194 µgRiboflavin sodium phosphate
320 µg
256 µgPyridoxine hydrochloride
334 µg267 µgCyanocobalamin
0.9 µg0.7 µgCalcium pantothenate
1.49 mg1.19 mg
Nicotinamide
2.75 mg2.20 mg
Folic acid
55 µg
44 µg
Biotin49 µg
39 µg
Choline bitartrate
22.41 mg17.93 mg
Ascorbic acid9.75 mg7.80 mg
Retinol acetate
810 IU648 IU
Tocopherol acetate
4.13 mg3.30 mg
Ergocalciferol
1.6 µg1.3 µgPhytonadione
11 µg
9 µg
Soybean oil
636 mg509 mgElental® contains potassium sorbate, polysorbate 80, aspartame (anL-phenylalanine compound), flavor, soy lecithin, citric acid hydrate,
lactose hydrate, and carmellose sodium as additives.
2. Product Description
This drug is a white powder with a slight characteristic odor and acharacteristic taste. Dissolve this drug in the proper amounts of wateror lukewarm water, the solution becomes slightly turbid.
Component[Indications]

In 100 g(375 kcal)

This drug is a very low residual, easily absorbable high-calorie enteralnutrient called elemental diet or elemental nutrition, which consists ofingredients requiring minimum digestion. Generally, the drug is usedpreoperatively or postoperatively in patients in whom managing nutrition
is difficult when tube feeding nutrition containing undigested proteins. In
particular, the drug is used for the following purposes:
1. Postoperative nutritional management in patients in whom the use oftube feeding nutrition containing undigested proteins is difficult.
2. Nutritional management in patients with a disease that requires cleanintestines.
3. Nutritional management in the immediate postoperative period.
4. Nutritional management in patients with abnormal gastrointestinalconditions (such as ruptured suture, short bowel syndrome, andvarious gastrointestinal fistulae).
5. Nutritional management in patients with special gastrointestinal
diseases (such as Crohn's disease, ulcerative colitis, dyspepsia
syndrome, pancreatic disease, and protein-losing enteropathy).
6. Nutritional management in patients in whom the use of intravenous
hyperalimentation is difficult (such as patients with extensive burns).
[Dosage and Administration]
Usually, 80 g of Elental® is dissolved in water or lukewarm water tomake 300 mL (1 kcal/mL), and the resulting solution is continuously
infused into the duodenum or jejunum through a nasogastric tube,
gastrostomy tube, or enterostomy tube at an infusion rate of 75 to 100
mL per hour. If necessary, the solution may be orally administered insingle or divided doses.
The standard dose for adults is 480 to 640 g (1800 to 2400 kcal) per day.
The dose is appropriately adjusted depending on age, body weight, andsymptoms. Generally, a solution of about one-eighth (60 to 80 g) of thedaily dose is administered at a concentration that is about one-half (0.5kcal/mL) of the specified concentration as the initial dose. Theconcentration and the dose are gradually increased depending on thecondition of the patient until the standard dose is reached 4 to 10 days
later.
<Method of Preparation>
Preparation of 1 kcal/mL solution from a bag of Elental® (80 g)
Add a bag of Elental® to about 250 mL of water or lukewarm waterin a container and stir immediately. After dissolution, the quantity ofthe solution should be about 300 mL (1 kcal/mL).
Preparation of 1 kcal/mL solution from a bottle of Elental® (80 g) in aplastic container
Add water or lukewarm water to the container and dissolve thecontents to prepare about 300 mL of a solution as measured by thescale (salient).
<Precautions Regarding Dosage and Administration>
The solution prepared from this drug must not be
administered intravenously.
[Precautions]
1.Careful Administration (This drug should be administeredwith care to the following patients:)
Patients with short bowel syndrome caused by extensive resection of
the small intestine. (Be especially careful not to cause diarrhea. Since
the absorptive ability of the intestinal tract may have been particularly
lowered after this surgery, start administration carefully—about 4 days
after the surgery as a rough standard.)
2.Important Basic Precaution(1) Supply vitamins, electrolytes, and trace elements as needed because
these nutrients may become insufficient. Selenium deficiency(reduced cardiac function, white discoloration of nails, muscular
weakness, etc.) has been reported during long-term administration.
(2) In patients receiving this drug through feeding tubes, dumping
syndrome-like hypoglycemia may occur after administration when
the dosing concentration or the rate of administration is too high.
Thus, carefully select the dosing concentration and the rate ofadministration (see Dosage and Administration).

3.Adverse Reactions
A total of 2339 adverse reactions were reported in 8170 patients who
were surveyed in clinical studies that had been conducted up to the timeof approval and in post-marketing drug use-results surveys. Common
adverse reactions included diarrhea in 1057 patients (12.9%), bloating in
359 patients (4.4%), increased blood AST (GOT)/ALT (GPT)/Al-P in
301 patients (3.7%), nausea in 168 patients (2.1%), vomiting in 134
patients (1.6%) and abdominal pain in 123 patients (1.5%) (as of thetime when reexamination was completed).
When the following adverse reactions occur, take appropriate
precautions, such as discontinuation of administration, dose reduction,or change to administration at a lower concentration or a lower rate ofadministration.
** (1) Clinically significant adverse reactions
1) Shock/anaphylaxis(unknown frequency): Since this drug may
cause shock/anaphylaxis, observe the patient closely. Whendecreased blood pressure, disturbed consciousness, dyspnea,cyanosis, nausea, chest discomfort, flushed face, itching, sweating,etc., occur, immediately discontinue administration and takeappropriate precautions.
2) Hypoglycemia (less than 0.1%): Dumping syndrome-like
hypoglycemia (malaise, sweating, cold sweat, facial pallor,convulsion, decreased consciousness, etc.) may occur afteradministration. When these symptoms occur, take appropriate
precautions (see Dosage and Administration).
(2) Other adverse reactions
Not less
Not less than 0.1%
Less than 0.1%
than 5%and less than 5%
Digestive
Diarrhea Abdominal distension,organsnausea, vomiting,abdominal pain
Liver
Increased blood AST
Increased LDH,(GOT), increased blood increased γ-GTP
ALT (GPT), increased
blood AL-P
KidneyIncreased blood urea
nitrogenCarbohydrat
Increased blood glucose Increased
e/lipidlevel
triglyceride
metabolism
levelsAutonomic
Sweating
nervoussystem
Skin
Rash
OthersPyrexia
4.Use in the Elderly
Since the elderly generally have reduced physiological function,
carefully select the rate of administration when administering to theelderly.
5.Use During Pregnancy, Delivery, or Lactation
An overseas epidemiologic study has estimated that malformation
mainly in the cranial neural crest increased in children born fromwomen who ingested 10,000 IU per day or more of vitamin A starting 3
months before pregnancy through the first trimester of pregnancy. Thus,
when administering to women within the first trimester or women whowish to become pregnant, carefully select the dosage and take thenecessary precautions, such as limiting the dose of vitamin A that isadministered through this drug to less than 5000 IU per day.
6.Pediatric Use
Safety in low-birth-weight babies has not been established. (There areno use results.)
7.Precautions Concerning Use(1)At the time of administration
1) Since this drug contains only a minimal amount of fat, fatty aciddeficiency may rarely occur particularly when administering tochildren, when Elental® alone is administered for a long period oftime, and when the total dose is low. In these cases,
supplementation of fat is required.
2) Although this drug contains minimal amounts of electrolytes, therequired amounts of electrolytes differ depending on thepathological conditions. Thus, administration of this drug may
cause an excess of electrolytes. In such cases, take such precautions
as adjusting the dose of the drug as needed.
3) When this drug is continuously infused through a nasogastric tube,
reflux may rarely occur depending on the location of the placementof the tube end, the rate of infusion, and the condition of the patient.
Thus, carefully select the location of the placement of the tube end
and the rate of infusion.

(2)Method of preparation: This drug is prepared by dissolving inwater or lukewarm water before use. Use the solution within 12 hoursof preparation.
(3)Dosing concentration and rate of administration: Thesolution prepared from this drug has a standard concentration of 1
kcal/mL (80 g/300 mL) and is infused at a standard rate of 100 mL per
hour. When administering to children or patients at an early stage ofadministration, it is desirable to use a low concentration and a low
infusion rate at first and move up to the maintenance dose in steps.
In addition, dumping syndrome-like hypoglycemia may occur afteradministration when the dosing concentration or the rate ofadministration is too high. Thus, carefully select the dosing
concentration and the rate of administration.
(4)Others: When nutrition sets, feeding tubes, etc., made of polyvinyl
chloride containing DEHP (di-(2-ethylhexyl) phthalate) as a plasticizer
are used, DEHP is eluted into the drug. Thus, it is desirable to use
nutrition sets, feeding tubes, etc., containing no DEHP.
[Pharmacokinetics](For information) Absorption, distribution, metabolism, andexcretion in animals
The present drug containing amino acids, dextrin, or vitamin B6 thathave been labeled with 14C was administered to male Fisher rats. As aresult, it was inferred that each component was rapidly absorbed andused normally as protein components, energy sources, etc.1[Clinical Studies]
The present drug is effective mainly for the nutritional management inpatients with reduced digestive ability or patients requiring high-calorie
nutritional support.
The results of clinical studies involving a total of 606 patients showed
response rates of 68.0% (complete response/effective) and 85.4%(slightly effective or better).
[Pharmacology]
1. An experiment in healthy rats demonstrated that the present drug has
trophic effects that are equivalent to those of good-quality proteins.2
2. A free feeding experiment in rats that had undergone extensive
resection of the small intestine showed that the group treated with thepresent drug was superior to the group treated with casein feed in bodyweight gain and nitrogen balance and produced an extremely small
amount of feces.3
3. Comparison of administration of a commercial tube-feeding nutrients,
administration of intravenous hyperalimentation, and administration of
the present drug to rats that had undergone extensive resection of thesmall intestine revealed that the present drug was superior to thecommercial tube-feeding nutrients in the ease of absorption and theamount of residue (low) and produced a smaller amount of feces.
In addition, the present drug was equivalent to intravenous
hyperalimentation in the effect on body weight gain and nitrogenbalance.4
4. A study in rats that had undergone extensive resection of the small
intestine showed no difference between intravenous hyperalimentationand the present drug in the pressure resistance of the small intestinalsutures. In addition, there was no difference between administration ofhigh-calorie infusions and that of the present drug in the therapeutic
effect on the skin wounds of rats that had undergone peeling.5
5. The present drug and a 50% solution of dried whole egg feed wereadministered to male Fisher rats aged 6 weeks through a stomach tube.
The blood glucose level of hepatoportal blood reached maximum at 15
minutes after administration in both the group treated with the present
drug and the group treated with dried whole egg feed. The amino acidlevel of hepatoportal blood reached maximum at 15 minutes afteradministration in the group treated with the present drug and 2 hours
after administration in the group treated with dried whole egg feed.
The blood amino acid pattern was similar in both groups.6[Packaging]
80 g bag × 14 (1.12 kg)
80 g/plastic container/bag × 28 (2.24 kg)[References]
1)Matsuzawa Y, et al. Japanese Pharmacology and Therapeutics. 1979;7(11):3445
2) Nakatsuji H, et al. Japanese Pharmacology and Therapeutics. 1979;7(11):3459
3) Nakatsuji H, et al. Japanese Pharmacology and Therapeutics. 1979;7(11):3471
4) Nakatsuji H, et al. Japanese Pharmacology and Therapeutics. 1979;7(11):3499
5) Nakatsuji H, et al. Japanese Pharmacology and Therapeutics. 1979;7(11):3547
6) Nakatsuji H, et al. Japanese Pharmacology and Therapeutics. 1979;7(11):3551** [Reference requests]
EA Pharma Co., Ltd.
Drug Consultation
1-1, Irifune 2-chome, Chuo-ku, Tokyo 104-0042 Japan
Toll-Free Number 0120-917-719** Manufactured and Marketed by

EA Pharma Co., Ltd.
1-1, Irifune 2-chome, Chuo-ku, Tokyo 104-0042 Japan