Universal reference book for medicines
Product name: ORNILATEX ® (ORNILATEX)

Active substance: ornithine

Type: Hypoammonemic drug

Manufacturer: ФармФірма СОТЕКС (Russia)
Composition, form of production and packaging

Concentrate for the preparation of a solution for infusions in the form of a clear liquid of colorless or light yellow color.

1 amp.

Ornithine aspartate 5 g

Auxiliary substances: water d / and - up to 10 ml.

10 ml - ampoules of light-protective glass with a color fracture ring or with a colored dot and a notch (5) - packings, cellular outline (1) - packs of cardboard.

10 ml - ampoules of light-protective glass with a color fracture ring or with a colored dot and a notch (5) - packings, cellular outline (2) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Hypoazotemic drug.
Reduces the increased concentration of ammonia in the body, in particular, with liver diseases. The effect of the drug is associated with its participation in the ornithine cycle of urea formation Krebs (formation of urea from ammonia). Ornithine acts as a catalyst for the enzymes carbamoyl phosphate synthetase and ornithine carbamoyl transferase, and is also the basis for the synthesis of urea. In addition, the drug activates the ornithine cycle of urea formation, which also helps to lower the level of ammonia. Promotes the production of insulin and growth hormone. Improves protein metabolism in diseases requiring parenteral nutrition.
PHARMACOKINETICS

In vivo forms two active metabolites: aspartate and ornithine, having a short T 1/2 of 0.3-0.4 h, are excreted by the kidneys through a cycle of urea formation.
A small part of the aspartate is excreted by the kidneys unchanged


INDICATIONS

- acute and chronic liver disease, accompanied by hyperammonemia;

- hepatic encephalopathy, incl.
in the complex therapy of mental disorders (precoma and coma);
- as a corrective additive to preparations for parenteral nutrition in patients with protein deficiency.

DOSING MODE

In / in the drip.

The contents of the ampoules are mixed with 500 ml infusion solution (0.9% sodium chloride solution, 5%
a solution of dextrose (glucose) or Ringer's solution).
For adults, the average therapeutic dose of ornithine is 20 g / day.

In hepatic encephalopathy (depending on the degree of severity of the condition) IV is administered up to 40 g / day.

It is recommended to dissolve no more than 30 g in 500 ml of infusion solution.
The maximum infusion rate is 5 g / h.
The duration of therapy with the drug is determined in each case individually, based on the pathology and severity of the patient's condition.

In severe violations of liver function , strict monitoring of the patient's condition and correction of the rate of drug administration are necessary to prevent the development of nausea and vomiting.

There is no data on the use of the drug in pediatric practice.

SIDE EFFECT

Very rarely (less than 0.01%): nausea, vomiting;
allergic reactions.
CONTRAINDICATIONS

- Severe renal insufficiency (serum creatinine> 3 mg / dL);

- the period of breastfeeding;

- children's age till 18 years;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

During pregnancy, the use of the drug Ornilatex ® is possible only under the strict supervision of the doctor, taking into account the benefit / risk relationship for the mother and fetus.
For the duration of treatment, stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindication: severe renal insufficiency (serum creatinine> 3 mg / dL);

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In severe violations of liver function , strict monitoring of the patient's condition and correction of the rate of drug administration are necessary to prevent the development of nausea and vomiting.

SPECIAL INSTRUCTIONS

When administering the drug in high doses, the urea concentration in blood plasma and urine should be monitored.

In severe violations of the liver in accordance with the patient's condition, it is necessary to reduce the rate of infusion solution administration in order to prevent nausea or vomiting.

Impact on the ability to drive vehicles and mechanisms

Ornilatex ® does not affect the ability to drive a vehicle and potentially dangerous machinery.

OVERDOSE

Symptoms: increased severity of dose-dependent side effects.

Treatment: the drug should be stopped and symptomatic treatment should be given.

DRUG INTERACTION

Drug interaction of the drug Ornilitex ® is not revealed.

Ornilatex ® should not be mixed with other medications.
Use only the solutions listed above for dilution.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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