Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3939
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Iodotope (Capsule, Gelatin Coated)
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| dailymed-instance:dosage |
Hyperthyroidism: The total amount of sodium iodide I 131 needed to achieve a clinical
remission without destruction of the entire thyroid gland has been found to vary
widely; the usual dose range is 148 to 370 megabecquerels (4 to 10 millicuries).
Toxic nodular goiter and other special situations will require the use of larger doses. Carcinoma of the thyroid: Dosage must be determined individually. The usual dose
for ablation of normal thyroid tissue is 1850 megabecquerels (50 millicuries), with
subsequent therapeutic doses usually 3700 to 5550 megabecquerels (100 to 150 millicuries). The patient dose should be measured by a suitable radioactivity calibration system
immediately prior to administration.<br/>Radiation Dosimetry: Following oral administration of sodium iodide I 131, about 40 percent of the activity
has an effective half-life of 0.34 days and 60 percent has an effective half-life of
7.61 days. On this basis the estimated absorbed radiation doses to an average adult
(70 kg) from an oral dose of 370 MBq (10 mCi) of sodium iodide I 131 are shown
in Table 4. Method of Calculation: A Schema for Absorbed-Dose Calculations for Biologically
Distributed Radionuclides, MIRD Pamphlet No. 1. J Nucl Med Suppl 1:7, 1968
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| dailymed-instance:descripti... |
Iodotope preparations for therapeutic use are radiopharmaceuticals containing sodium
iodide I 131 in capsules for oral administration. Capsules are available in units
of 37 to 4810 megabecquerels (1 to 130 millicuries) at the time of calibration. Sodium iodide I 131 is designated chemically as NaI (MW 153.99).
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| dailymed-instance:clinicalP... |
Sodium iodide I 131 is readily absorbed from the gastrointestinal tract. Following
absorption, the iodide is primarily distributed within the extracellular fluid of the
body. It is trapped and rapidly converted to protein bound iodine by the thyroid; it
is concentrated, but not protein bound, by the stomach and salivary glands. It is also
promptly excreted by the kidneys. About 90 percent of the local irradiation is caused
by beta radiation and 10 percent is caused by gamma radiation.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Preexisting vomiting and diarrhea represent contraindications to the therapeutic use
of radioiodide. Iodotope therapeutic capsules (Sodium Iodide I 131 USP) may cause fetal harm
when administered to a pregnant woman. Permanent damage to the fetal thyroid can
occur. Iodotope therapeutic capsules (Sodium Iodide I 131 USP) are contraindicated in
women who are or may become pregnant. If this drug is used during pregnancy, or
if the patient becomes pregnant while taking this drug, the patient should be
appraised of the potential hazard to the fetus. Animal reproduction studies have not been conducted with sodium iodide I 131.
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| dailymed-instance:supply |
Iodotope (Sodium Iodide I 131 Capsules USP) blue/buff therapeutic capsules containing
37 to 4810 megabecquerels (1 to 130 millicuries) sodium iodide I 131 at the
time of calibration are available in packages of 37 to 5550 megabecquerels (1 to 150
millicuries) at the time of calibration.<br/>Storage: Sodium Iodide I 131 Capsules should be stored as supplied at 25��C (77��F), excursions
permitted to 15-30��C (59-86��F) [See USP Controlled Room Temperature]. The U.S. Nuclear Regulatory Commission has approved this preparedradiopharmaceutical for distribution to persons licensed to use byproductmaterial identified in��35.300 of 10 CFR Part 35, to persons whohold an equivalent license issued by an Agreement State, and, outsidethe United States, to persons authorized by the appropriate authority.
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| dailymed-instance:precautio... |
General: The uptake of radioiodide will be affected by recent intake of stable iodine in any
form, or by the use of thyroid, anti-thyroid and certain other drugs. Accordingly, the
patient should be questioned carefully regarding previous medication and procedures
involving radiographic contrast media. This drug should not be used after the expiration date stated on the container label.
Radiopharmaceuticals should be used only by physicians who are qualified by training
and experience in the safe use and handling of radionuclides, and whose experience
and training have been approved by the appropriate government agency authorized
to license the use of radionuclides. As in the use of any radioactive material, care should be taken to minimize radiation
exposure to the patient consistent with proper patient management and to insure
minimum radiation exposure to occupational workers.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term animal studies have been performed to evaluate carcinogenic potential.<br/>Pregnancy Category X: See CONTRAINDICATIONS.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk. As a general rule nursing
should not be undertaken when a patient is administered radioactive material.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
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| dailymed-instance:overdosag... |
In the treatment of hyperthyroidism, overdosage may result in hypothyroidism, the
onset of which may be delayed. Appropriate replacement therapy is recommended
if hypothyroidism occurs. Radiation absorbed doses to various tissues for any
administered dose may be calculated by reference to Table 4 (Absorbed Radiation
Doses).
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| dailymed-instance:genericMe... |
Sodium Iodide, I-131
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| dailymed-instance:fullName |
Iodotope (Capsule, Gelatin Coated)
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| dailymed-instance:adverseRe... |
The immediate adverse reactions following sodium iodide I 131 treatment of hyperthyroidism
are usually mild. Following the larger doses used in treating thyroid carcinoma,
adverse reactions may be much more severe and present special problems.
Untoward effects which may be associated with the use of sodium iodide I 131
include depression of the hematopoietic system when large doses are employed,
radiation sickness (some degree of nausea and vomiting), increase in clinical symptoms,
bone marrow depression, severe sialoadenitis, acute leukemia, anemia, chromosomal
abnormalities, acute thyroid crises, blood dyscrasia, leukopenia, or
thrombocytopenia. Tenderness and swelling of the neck, pain on swallowing, sore throat, and cough
may occur around the third day after treatment and are usually amenable to analgesics. Temporary thinning of the hair may occur two to three months after treatment.
Allergic type reactions have been reported infrequently following the administration
of iodine-containing radiopharmaceuticals.
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| dailymed-instance:warning |
Sodium iodide I 131 is not usually used for the treatment of hyperthyroidism in
patients under 30 years of age unless circumstances preclude other methods of treatment.
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| dailymed-instance:indicatio... |
Therapeutic doses of Iodotope (Sodium Iodide I 131 Capsules USP) are indicated
for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
Palliative effects may be seen in patients with papillary and/or follicular carcinoma
of the thyroid. Stimulation of radioiodide uptake may be achieved by the administration
of thyrotropin. (Radioiodide will not be taken up by giant celland spindle
cell carcinoma of the thyroid or by amyloid solid carcinomas.)
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| dailymed-instance:name |
Iodotope
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