TORROKS

INSTRUCTIONS FOR USE

TORROX

TORROC

Trade name of the drug: TORROX

Dosage form: solution for infusion

Composition:

NO	Amino acid	Directions on the label g/100 ml	Specification
1	L-Aspartic acid	0,250	No. F
2	L-Threonine	0,250	F.USA
3	L-Serine	0,100	F.USA
4	L-Glutamic acid	0,075	F.USA
5	Glycine	0,760	No. F
6	L-Alanya	0.200	F.USA
7	L-Valine	0,360	F.USA
8	L-Methionine	0,225	F.USA
9	L-Isoleucine	0,352	F.USA
10	L-Leucine	0,490	F.USA
11	L-Tyrosine	0,025	F.USA
12	L-Phenylalanine	0,533	F.USA
13	L-Histidine	0,250	No. F
14	L-Tryptophan	0,090	F.USA
15	L-Lysine hydrochloride	0,430	F.USA
16	L-Arginine	0,500	F.USA
17	L-Proline	0,100	F.USA
18	L-Cysteine	0,010	No. F
19	Sorbitol	5,000	No. F
20	Sodium metabisulfite	0,020	No. F
21	Sodium hydroxide	0,140	No. F
22	Water for injections	Q.S.	No. F

Description : clear, colorless or pale yellow solution

Pharmacotherapeutic group: drug for parenteral nutrition, amino acids.

Code ATH: V05VA10

Pharmacological properties

«TORROX» is intended for parenteral nutrition of patients with various pathologies with low, normal or increased protein requirements, when enteral nutrition is ineffective or impossible. The non-essential and essential L-amino acids contained in TORROX are natural physiological compounds. Like dietary amino acids obtained through the breakdown of proteins, parenterally administered amino acids enter the general pool of free amino acids in the blood plasma, and from it into cells for protein synthesis and various metabolic pathways. All amino acids are in the L form, which makes it possible for them to directly participate in the biosynthesis of proteins. Contains all eight essential amino acids, as well as conditionally essential L-arginine and L-histidine. L-arginine promotes the conversion of ammonia into urea, binds toxic ammonium ions, which are formed during the catabolism of proteins in the liver. The main source of energy in these drugs is sorbitol, which is phosphorylated in the liver into fructose-6-phosphate. Insulin does not take part in the absorption of sorbitol and fructose, which makes them insulin-independent sources of energy — their use does not cause hyperglycemic acidosis, which can occur when drugs containing glucose are used for parenteral nutrition. In addition, sorbitol is a better solvent for amino acids than glucose, since it does not contain aldehyde and ketone groups, does not interact with amino groups and does not reduce the digestibility of amino acids.

Pharmacokinetics

Amino acids administered parenterally are used in the body in the process of protein synthesis. The amino acids not used in this process undergo deamination to form urea, which is then excreted in the urine. T1 _/2 amino acids (in healthy people) is 5–15 minutes. With a rapid increase in the concentration of amino acids in the blood, they may be excreted in the urine without being absorbed by the body, without having time to biotransform.

“TORROX” is biotransformed in the body into the enzyme flavin mononucleotide, and then into flavin adenine dinucleotide. TORROX metabolites are 60% bound to plasma proteins. TORROX is excreted in the urine, partly in the form of metabolites. Sorbitol is initially metabolized in the liver to fructose, but can be metabolized directly to glucose.

Indications for use

Parenteral nutrition

• if enteral nutrition is not possible;
• for severe diseases of the digestive system (gastrointestinal tract obstruction, malabsorption syndrome, inflammatory bowel disease, pancreatitis, intestinal fistulas);
• for injuries;
• for burns
• in sepsis;
• for malignant tumors;
• in the pre- and postoperative period.

Directions for use and doses

They are installed individually, taking into account the patient’s condition. The dosage should be prescribed according to the amino acid requirement depending on the age, body weight and condition of the patient. The drug is used as an intravenous infusion (administration rate
3-4 ml/min) of body weight per day, which corresponds to 1-2 g of amino acids/kg/day.

Side effects

Digestive system: increased activity of liver enzymes.

Local reactions: skin irritation at the injection site, thrombophlebitis.

Amino acids can cause changes in blood composition and an increase in ammonia levels in the blood.

Nausea, vomiting, abdominal pain, fatigue, urticaria, arterial hypertension, tachycardia, paresthesia, breathing problems, increased sweating and body temperature may occur.

Contraindications

• violation of protein synthesis;
• severe renal dysfunction;
• severe liver dysfunction;
• severe forms of heart failure;
• fructose intolerance;
• methanol poisoning;
• hyperkalemia;
• acidosis

Drug interactions

Simultaneous administration of arginine with thiazide diuretics and aminophylline increases the level of insulin in the blood. Severe hyperkalemia may occur when arginine is used concomitantly with spironolactone. When used together, isoniazid, penicillamine, and oral contraceptives reduce the metabolism of pyridoxine. When used simultaneously, TORROX significantly reduces the activity of doxycycline, tetracycline, oxytetracycline, erythromycin and lincomycin.

When administering the drug, it should be taken into account that arginine is not compatible with thiopental.

Amikacin, ampicillin, cefotaxime, ceftriaxone, chloramphenicol, clindamycin, doxycycline, erythromycin in the form of gluceptate or lactobionate, gentamicin, netilmicin, penicillin, piperacillin, tetracycline, tobramycin, vancomycin can be added to the solution. Such solutions remain stable at room temperature for up to 6-24 hours.

You can also add aminophylline, calcium gluconate, chlorpromazine, cimetidine, nizatidine, famotidine, ranitidine, cyclophosphamide, cytarabine, digoxin, dopamine, fluorouracil, folic acid, furosemide, heparin, insulin, propranolol, norepinephrine, lidocaine, morphine, methotrexate, methyldopa to the solution , methylprednisolone, metoclopamide, phytomenadione. The stability of such solutions at room temperature is up to 24 hours.

special instructions

The drug should be prescribed with caution in case of sepsis, arterial hypertension of unknown origin, liver disease, as well as in patients who need to limit fluid intake.

When prescribing the drug, it should be taken into account that arginine, which is part of the drug, can cause a decrease in the concentration of phosphorus and an increase in the concentration of potassium in the blood plasma, especially in patients with diabetes mellitus. Therefore, prescribing TORROX to patients with diabetes mellitus of any type is possible only against the background of insulin therapy.

Use during pregnancy and lactation: Data on the possibility of using the drug «TORROX» during pregnancy and lactation are not provided.

The drug should be stored out of the reach of children and not used after the expiration date.

Overdose

Symptoms: increased side effects.

Treatment: symptomatic.

Release form

In glass bottles of 100 ml, 200 ml, 250 ml and 500 ml, sealed with rubber stoppers and aluminum caps for rolling.

Food conditions

In a place protected from light at a temperature not exceeding 25°C. Do not freeze.

Best before date

2 years

Conditions for dispensing from pharmacies

On prescription.

Manufacturer

Jiangsu Pengyao Pharmaceutical Co., Ltd.