Sodium iodide, 131-I (Sodium iodide with 131-I)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSodium iodide [131I]Sodium iodide [131I]
Dosage form: & nbsp

capsules

Composition:

On the capsule:

Active substance:

Iodine-131 0.5; 1.0; 2.0; 4.0 GBq (in the form of sodium iodide [1311]).

Auxiliary substancesa:

Sodium diphosphate 237 mg.

Capsule (size 1) (body: titanium dioxide - 2.00%, gelatin - up to 100%;

lid: titanium dioxide - 1.33%, dye sunset yellow - 0.44%, gelatin - up to 100%)

Description:

Hard gelatin capsule (size 1), consisting of a white body and an orange lid. The contents of the capsule are white powder.

Pharmacotherapeutic group:Radiopharmaceutical therapeutic agent
ATX: & nbsp

V.09.F.X   Other radiopharmaceuticals for diagnosing thyroid diseases

Pharmacodynamics:

Physicochemical characteristics

Sodium iodide, 131I - the preparation is obtained by applying a solution of sodium iodide, 131I on sodium diphosphate, contained in a capsule. The activity of iodine-131 is 0.5; 1.0; 2.0; 4,0 GBq on the set date and time of delivery of the drug. Iodine-131 decays with a half-life of 8.02 days; the most intense component of gamma radiation has an energy of 365.0 keV (81.7%), β- radiation - 606.0 keV (89.7%).

Pharmacodynamics

The capsule, administered on an empty stomach through the mouth with 25-30 ml of distilled water, dissolves in the stomach, on average, for 15 min, sodium iodide, 131I enters the blood with a half-life from the cavity of the stomach for 8-10 minutes. Subsequently, radioactive iodine-131 accumulates mainly in the thyroid gland.

Radioactive iodine-131 is selectively captured by the thyroid gland and due to P-radiation, which has a short range of particles, causes destruction of cells with minimal effect on surrounding healthy tissues.

Pharmacokinetics:

The kinetics of absorption of iodine-131 by the thyroid gland (in relation to the amount administered) is, on average, 10% after 2 hours, 19% after 4 hours, and 27% after 24 hours. During the day, about 60% of the drug is excreted in urine and feces. Values ​​of the quantities accumulation and release rate of the drug depend on the functional state of the thyroid gland and the age and sex of the patient.

Indications:

The drug is used to treat hyperthyroidism in diffuse toxic goiter and multisite, and for the treatment of thyroid cancer and its metastases.

Contraindications:

Hypersensitivity nodular goiter, retrosternal goiter, euthyroid goiter, mild forms of hyperthyroidism, mixed toxic goiter, hematopoietic disorders (leykopoeza and thrombocytopoiesis) expressed hemorrhagic syndrome, gastric ulcer and duodenal ulcer 12- (in the acute stage), pregnancy, lactation, age up to 20 years.

Carefully:Age from 20 to 40 years.
Dosing and Administration:

The drug "Sodium iodide,131I "is intended for oral administration.

For treatment differentiated thyroid cancer, as well as distant metastases. Treatment is carried out 3-4 weeks after thyroidectomy or withdrawal L-tiroxine 20 days before the administration of the drug. The capsule is administered orally at the rate of 37 MBq per kilogram body weight, and the patients are transferred to the specialized chambers which are equipped with autonomous supply and sewer system, coupled with special purification plants.Patients are withdrawn from the "closed" regime when the gamma radiation power is reduced to the permissible level of radiation safety (ZmkSv / h).

The value of a single therapeutic activity of iodine-131 for adults is 37-56 MBq per kilogram of body weight. The duration of intervals between injections of the drug is 3 - 6 months.

For the treatment of thyrotoxicosis in diffuse and multinodal toxic goiter. Radioactive iodine-131 is captured only by the tissue of the thyroid gland, causing cell destruction, is excreted by urine with minimal effect on surrounding healthy tissues.

Currently, there are two most common methods for calculating the input activity of iodine-131.

1. Individual calculation based on thyroid volume, iodine-131 capture rate during diagnostic scan 24 hours after drug administration and given activity per gram of tissue (range 0.1 to 0.3 MBq / g) according to the formula:

Aat = As x V / C x 10, where

A3 - given activity, MBq / g; V - volume of the thyroid gland, cm3; C - iodine-131 capture rate after 24 hours after drug administration 10 - coefficient.

2. Purpose of the fixed activity of iodine-131:

190 MBq - small glands,

380 MBq - a gland of medium size,

570 MBq - large glands

Before the start of treatment, a preliminary determination of the absorption of iodine-131 by the thyroid gland is necessary, which guarantees the correctness of treatment, excludes the possibility of an error associated with the use of fixed activity in a patient with a large but poorly absorbing iodine-131 gland.

In the therapeutic use of the drug, a mandatory condition is the constant monitoring of the state of peripheral blood.

Radiation loads on the organs and tissues of the patient when using the drug "Sodium iodide, 131I ".

Organs

Absorbed dose, mGy / MBq

stomach

0,39

red marrow

0,015

lungs

0,02

bladder

0,38

liver

0,04

pancreas

0,03

kidneys

0,03

spleen

0,03

small intestine

0,05

thyroid

25,0

testicles

0,08

ovaries

0,81

Equivalent dose, mSv / MBq

11,0
Side effects:

In the treatment of thyrotoxicosis and metastasis of thyroid cancer, exacerbations of thyrotoxicosis, hypothyroidism and myxedema, the appearance or intensification of exophthalmos, radiothyroidism, nausea, vomiting, thrombocytopenia, leukopenia, acute gastritis, amenorrhea, ulcerous cystitis, parotitis, alopecia, jet changes in the skin thyroid gland, pharyngeal mucosa and larynx. Treatment is symptomatic.

When applying the drug, it is possible to suppress bone marrow hematopoiesis, the restoration of which is carried out by known means: leukogen, lenograstim, methyluracil, mogratostim, epoetin alfa.

Overdose:

Overdose of the drug is unlikely in connection with the careful control of the injected activity in the conditions of a specialized hospital.

Interaction:

In the dosages used, no interaction with other drugs was noted.

Special instructions:

Treatment with this drug (radiotherapy) should be carried out under the supervision of a radiologist in specialized departments that have special canalization or conditions for the collection and storage of radioactive urine and feces, in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99 / 20Yu), " Norms of Radiation Safety "(NRB-99/2009) and" Hygienic requirements for ensuring radiation safety during radiotherapy using open radionuclide sources "(SanPiN 2.6.1.2368-08).

Effect on the ability to drive transp. cf. and fur:not described
Form release / dosage:

Capsules with activity 0,5; 1.0; 2.0; 4,0 GBq for the set date and time of delivery. Admissible deviation of iodine-131 activity values ​​in each capsule from the nominal value is ± 10%.

Packaging:1 capsule put into vials for drugs glass 1st hydrolytic class capacity of 10 or 15 ml, hermetically sealed with rubber stoppers and crimped caps medical aluminum. The bottle, passport, instructions for use are placed in a packaging transport package for radioactive substances.
Storage conditions:

At a temperature of 15 to 25 ° C. In accordance with the current "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB - 99/2010).

Shelf life:

20 days from the date of manufacture. Do not use after expiry date.

Terms of leave from pharmacies:For hospitals
Registration number:LSR-003509/07
Date of registration:31.10.2007 / 25.12.2017
Expiration Date:Unlimited
The owner of the registration certificate:Federal State Unitary Enterprise "Federal Center for Design and Development of Nuclear Medicine Facilities" FMBA of RussiaFederal State Unitary Enterprise "Federal Center for Design and Development of Nuclear Medicine Facilities" FMBA of Russia Russia
Manufacturer: & nbsp
Information update date: & nbsp26.05.2018
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