Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/578
| Predicate | Object |
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| rdf:type | |
| rdfs:label |
Rubratope-57 (Capsule, Gelatin Coated)
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| dailymed-instance:dosage |
The suggested oral dose range for the average patient
(70 kg) when performing a Schilling urinary excretion
test is between 18.5 to 37 kBq (0.5 to 1 microcurie) of
cyanocobalamin Co 57. The patient dose in each Cyanocobalamin Co 57
Capsule should be measured by a suitable radioacttivity
calibration system immediately prior to
administration.<br/>Schilling Urinary Excretion Test: Test Procedure The patient should be instructed to fast (patient may have water) for 12 hours prior to the test. Vitamin Bshould not be administered orally or parenterally during
the preceding 24 hours. It is important to establish
the absence of any potentially interfering gamma-emitting
radioisotopes in the patient's urine prior to
starting the study. After the patient voids, administer one Rubratope-
57 (Cyanocobalamin Co 57) capsule. Inject 1000��g
non-radioactive Cyanocobalamin Injection USP intramuscularly
as a flushing dose two hours following
administration of the capsule. Collect and pool all
urine for 24 hours and mix thoroughly. Collect an additional
24 hour sample separately if renal function is
impaired or if urinary excretion is delayed. Determine 10-minute net radioactivity counts for a
4 mL sample of urine from each excretion period, and
a 4 mL sample of diluted Cobatope-57 (Cobaltous
Chloride Co 57 Reference Standard Solution). The
working standard is prepared by diluting 0.5 mL
Cobatope-57, which contains the equivalent of
1 percent of the total radioactivity in the oral dose, with
3.5 mL of water. Calculate as follows: counts per
volumeminute
x
of urineper mL of urinecollected
of������������������������������������������������x 100 = % administeredcounts per
doseminute
x
100of standard Results Values of 9 percent or more for samples excreted during
either the first 24 hour period or first and second
24 hour periods combined, are generally considered
to represent a normal state for vitamin Babsorption.
The test should be repeated if a lower result is
obtained. Retest Procedure The need for repeating a test should be carefully evaluated,
especially in younger patients. A retest can be
conducted four or five days following the primary test.
Administer one Intrinsic Factor Concentrate capsule
with a Rubratope-57 (Cyanocobalamin Co 57) capsule.
Repeat all other steps of the primary procedure.
Retest values greater than 9 percent are indicative of
pernicious anemia; values of less than 9 percent are
indicative of bacterialinterference, malabsorption or
ileal lesion. An additional retest can be conducted to determine
malabsorption or bacterial interference. Administer
antibiotics, in lieu of Intrinsic Factor, 10 to 14 days
prior to the second retest. Repeat all other steps of the
primary procedure. Values greater than 9 percent are
indicactive of bacterial interference; values of less
than 9 percent are indicative of lack of ileal absorption
sites.
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| dailymed-instance:descripti... |
DESCRIPTION
Rubratrope-57 diagnostic capsules for oral administration
provide radioactive cyanocobalamin in which a
portion of the molecules contain Co 57 in the molecular
structure vitamin B-Co. The chemical structure
of cyanocobalamin is given below: Each Rubratope-57 capsule contains approximately
18.5 to 37 kBq (0.5 to 1.0 microcurie) of cyanocobalamin
Co 57; the cyanocobalamin content of each
capsule will vary with the specific activity of the
cyanocobalamin Co 57 used. Complete assay data
are provided on the vial label.
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| dailymed-instance:clinicalP... |
After oral administration, cyanocobalamin is normally
bound by intrinsic factor and absorbed by the distal
ileum. It is then bound to plasma proteins, stored in the
liver, and slowly released when needed to carry out
normal cellular metabolic functions. Absorbed
cyanocobalamin is ultimately excreted in the urine; any
cyanocobalamin not bound by intrinsic factor is excreted
in the stool.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
None known.
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| dailymed-instance:supply |
Rubratope-57 (Cyanocobalamin Co 57 Capsules) is
available in bottles of 5 and 10 capsules. Each two-piece
blue/red capsule contains approximately 18.5 to
37 kBq (0.5 to 1 microcurie) at the time of calibration.
Complete assay data are provided on the container.<br/>Also Available: Cobatope-57 (Cobaltous Chloride Co 57 Reference
Standard Solution), supplied in 10 mL vials, is manufactured
in companion lots to the diagnostic capsules.
Cobatope-57 is intended for laboratory use only as a
standard of comparison to the diagnostic capsules.
Each mL of aqueous solution provides activity equivalent
to 2 percent of the total radioactivity in each
capsule bearing the same lot number as the reference
standard solution. No decay corrections are necessary
when the capsules are used with a companion
vial of Cobatope-57 (Cobaltous Chloride Co 57
Reference Standard Solution). Rubratope-57 Diagnostic Kit (Cyanocobalamin
Co 57 Diagnostic Kit) provides material for primary
and initial retesting (Schilling test) for two patients.<br/>Storage: Rubratope-57 (Cyanocobalamin Co 57) capsules
should be stored at 20-25��C (68-77��F) [See USP].
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| dailymed-instance:activeMoi... | |
| dailymed-instance:precautio... |
General: In the use of any radioactive material, care should be
taken to insure minimum radiation exposure to the
patient and occupational workers consistent with
proper patient management. 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. Because a large parenteral dose of vitamin Bmay
temporarily affect subsequent intestinal absorption
and excretion of the vitamin, tests employing radioactive
vitamin Bshould not be performed for at least
24 hours after either a flushing dose for the Schilling
test or a therapeutic injection (1000 micrograms) of
vitamin B.<br/>Drug Interactions: Most antibiotics, methotrexate, pyrimethamine,
colchicine, para-aminosalicylic acid, or excessive
alcohol intake for longer than two weeks may result in
malabsorption of vitamin B.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility: No long-term animal studies have been performed to
evaluate carcinogenic potential or whether this agent
affects fertility in males or females.<br/>Pregnancy: Teratogenic Effects: Category C Animal reproduction studies have not been conducted
with Cyanocobalamin Co 57 Capsules. It is also not
known whether this agent can cause fetal harm when
administered to a pregnant woman or can affect reproduction
capacity. Since vitamin B-Co is taken up by
the fetus, radiocyanocobalamin absorption tests in
pregnant women should be postponed until after delivery
unless the potential benefit justifies the potential
risk to the fetus. Ideally, examinations using radiopharmaceuticals,
especially those elective in nature, in women of childbearing
capability should be performed during the first
few (approximately 10) days following the onset of
menses.<br/>Nursing Mothers: Since vitamin B-Co is excreted in human milk during
lactation, formula feedings should be substituted
for breast feedings.<br/>Pediatric Use: Safety and effectiveness in children have not been
established.
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| dailymed-instance:genericMe... |
cyanocobalamin, CO-57
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| dailymed-instance:fullName |
Rubratope-57 (Capsule, Gelatin Coated)
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| dailymed-instance:adverseRe... |
No adverse reactions specifically attributable to
Cyanocobalamin Co 57 Capsules have been
reported. The following adverse reactions have been reported
with nonradioactive cyanocobalamin: mild transient
diarrhea, polycythemia vera, peripheral vascular
thrombosis, itching, transitory exanthema, feeling of
swelling of the entire body, congestive heart failure
and pulmonary edema, anaphylactic shock, and
death.
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| dailymed-instance:warning |
None.
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| dailymed-instance:indicatio... |
Rubratope-57 (Cyanocobalamin Co 57 Capsules) is
intended for the diagnosis of pernicious anemia and as
a diagnostic adjunct in other defects of intestinal vitamin
Babsorption.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Rubratope-57
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