Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2421
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Sinografin (Injection, Solution)
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As a convenience to the physician, the
following guidelines which have proven
satisfactory are provided . Patients
should be counseled prior to
radiographic examination (seePRECAUTIONS, Information for the
Patient). Preparation of the patient:
Hysterosalpingography should be
performed three to five days after the
cessation of the patient's menstrual
period as a precautionary measure. An
enema and vaginal douche one hour
before the examination are helpful, but
not essential. The patient should empty
her bladder before the examination.
Since the procedure is remarkably free
of pain when Sinografin (Diatrizoate
Meglumine and lodipamide Meglumine
Injection) is used, the use of a narcotic
or anesthesia is unnecessary. Dosage: 3 to 4 mL of Sinografin,
administered in fractional doses of
approximately 1 mL, are usually
adequate to visualize the uterus; an
additional 3 to 4 mL will demonstrate
the tubes. Total doses varying from
1.5 to 10 mL have been employed with
satisfactory results. Administration: The patient is placed in
the lithotomy position and the vulva is
cleansed with a suitable antiseptic
solution. A Graves-type vaginal
speculum is introduced, the cervix is
exposed, and the vaginal vault is
sponged with antiseptic solution. A tenaculum is placed on the cervical
lip, usually the anterior lip. A sterile
sound may be passed to determine the
position of the uterus and the direction
of the cervical canal, and, when
necessary, the cervical canal may be
dilated. (Sounding the uterine cavity
and dilatation of the canal are not
usually required when a flexible cannula
tip is used.) A sterile syringe containing the
Sinografin is attached by Luer-Lok to a
uterine cannula. The two-way cannula
valve is opened and all air bubbles in
the cannula and syringe are expressed.
About 1.5 to 2 mL of Sinografin
(Diatrizoate Meglumine and lodipamide
Meglumine Injection) are required to fill
the cannula. (If preferred, a tubal
insufflator under controlled pressure
with a salpingogram attachment may be
used instead of the syringe.) The cannula tip is inserted into the
cervical canal so that the adjustable
rubber acorn obturator fits snugly at the
external os. Careful placement of the
cannula is important to avoid trauma
and pain. Squeezing the trigger of the
cannula to provide simultaneous
traction on the tenaculum and forward
pressure on the cannula should give a
nonleaking cervical seal. Sinografin
flows freely so that only gentle pressure
on the plunger is necessary; however,
the medium should be used as
promptly as possible following
withdrawal into the syringe. The syringe
should be rinsed as soon after the
procedure as possible to prevent
freezing of the plunger. The connection at the external os is
checked for leakage. If the acorn
obturator is inadequate, an inflatable
balloon-obturator may be used to seal
the cervical canal. When the equipment
has been positioned satisfactorily, the
tenaculum and cannula may be fixed in
position until the procedure is
terminated. Radiography: A scout film may be
made before the medium is
administered. After the initial fractional
injection, a film should be made using a
Bucky diaphragm. After each successive
injection of 1 mL, a film is taken,
developed immediately, and inspected
in the dark room before the next
fractional dose of Sinografin (Diatrizoate
Meglumine and lodipamide Meglumine
Injection) is given, until the procedure
is completed. Further injection and
subsequent films can be made as
required using posterior-anterior or
oblique angles. Clinical experience indicates that tubal
patency, if present, will be demonstrable
at the time of the injection and delayed
films have not been required.<br/>General: Diatrizoate Meglumine and lodipamide
Meglumine Injection should be
inspected visually for particulate matter
and discoloration prior to instillation
whenever solution and container permit.
The solution may vary in color from
essentially colorless to pale yellow.
Solutions which may have become
substantially darker should not be used. In the event that crystallization occurs,
the solution may be clarified by placing
the vial in hot water and shaking gently
for several minutes or until the solution
is clear. If cloudiness persists, the
preparation should not be used. Allow
the solution to cool to body temperature
before administering.
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| dailymed-instance:descripti... |
Sinografin (Diatrizoate Meglumine and
lodipamide Meglumine Injection) is a
sterile, nonpyrogenic, essentially
colorless to pale yellow, aqueous
radiopaque contrast medium for
intrauterine instillation. Each mL
provides 527 mg diatrizoate meglumine
and 268 mg iodipamide meglumine with
3.2 mg sodium citrate as a buffer, and
0.4 mg edetate disodium; pH has been
adjusted to 7.0 to 7.8 with meglumine
and diatrizoic acid. Each mL contains
approximately 0.91 mg (0.04 mEq)
sodium and 380 mg organically bound
iodine. At the time of manufacture, the
air in the container is replaced with
nitrogen. Diatrizoate meglumine is designated
chemically as 1-deoxy-1-( methylamino)-D-glucitoI 3,5-diacetamido-2,4,6-
triiodobenzoate (salt); iodipamide
meglumine is 1-deoxy-1-
(methylamino)-D-glucitoI 3,3��-(adipoyldiimino)bis[2,4,6-
triiodobenzoate] (2:1) (salt). Structural
formulas: diatrizoate meglumine
CHINO���CHNOMW 809.13 Organically Bound Iodine: 47.1%
CAS-131-49-7 iodipamide meglumine
CHINO���2CHNOMW 1530.20 Organically Bound Iodine: 49.8%
CAS-3521-84-4
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The most important characteristic of
contrast media is the iodine content.
The relatively high atomic weight of
iodine contributes sufficient
radiodensity for radiographic contrast of
the uterus and uterine tubes with
surrounding tissues. Diagnostic intrauterine radiopaque
agents have few known
pharmacological effects. Most of the
medium within the uterine cavity is
discharged immediately upon
termination of the procedure. Any
medium retained in the uterine cavity is
completely absorbed within one hour,
unless there is an obstruction and large
hydrosalpinx, inwhich case absorption
is generally complete within 24 hours.
Any medium spilled into the peritoneal
cavity is absorbed within 20 to
60 minutes and excreted by both the
hepatic and renal systems.
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Hysterosalpingographic agents are
contraindicated in pregnant women and
those suspected of being pregnant.
Hysterosalpingography should not be
performed during the menstrual period
nor when infection of the external
genitalia or genital tract is present. The
procedure should not be attempted
within 30 days following curettage or
conization or within six months
following the termination of pregnancy.
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Sinografin (Diatrizoate Meglumine and
lodipamide Meglumine Injection) Packages of ten single-dose 10 mL vials
(NDC 0270-0523-30).<br/>Storage: Store at 20-25��C (68-77��F) [See USP].
Protect from light.
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General: Diagnostic procedures which involve
the use of radiopaque diagnostic agents
should be carried out under the
direction of personnel with the
prerequisite training and with a
thorough knowledge of the particular
procedure to be performed. In patients having or suspected of
having carcinoma of the uterus and/or
uterine tubes, the possible dispersion of
carcinogenic cells during
hysterosalpingography should be borne
in mind. The possibility of a reaction should
always be considered. Patients at
increased risk include those with a
history of a previous reaction to a
contrast medium, patients with a known
sensitivity to iodine per se, and patients
with a known clinical hypersensitivity:
bronchial asthma, hay fever, and food
allergies. A positive history of allergies
or hypersensitivity does not arbitrarily
contraindicate the use of a contrast
agent where a diagnostic procedure is
thought essential, but caution should be
exercised (see ADVERSE REACTIONS,
and PRECAUTIONS, Information for the
Patient).<br/>Information for the Patient: Patients receiving diagnostic agents for
intrauterine radiography should be
given the following information:<br/>Drug/Laboratory Test Interactions:<br/>Thyroid Function Tests: Because a small amount of this medium
may be absorbed, thyroid function tests
such as protein bound iodine (PBI) and
radioactive iodine uptake, if indicated,
generally should be performed prior to
instillation. However, thyroid function
can be evaluated after use of any
iodinated contrast agents by using Tresin uptake or free thyroxine assays.<br/>Pregnancy: See CONTRAINDICATIONS.<br/>Nursing Mothers: Diatrizoate meglumine and iodipamide
meglumine administered intravascularly
has been found to be excreted in breast
milk. Because small amounts of these agents
may be absorbed following intrauterine
instillation, caution should be exercised
when any diagnostic intrauterine
radiopaque agent is administered to a
nursing woman.<br/>Pediatric Use: Safety and effectiveness of
hysterosalpingography has not been
established in pediatric patients.
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| dailymed-instance:genericMe... |
Diatrizoate Meglumine and Iodipamide meglumine
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| dailymed-instance:fullName |
Sinografin (Injection, Solution)
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Sudden onset of bradycardia,
hypotension, cardiac arrest and death
have rarely been reported.
Hypersensitivity reactions, which
include sweating, flushing, pruritus,
urticaria, skin rashes, arthralgia,
respiratory distress, and circulatory
collapse have occurred. Dizziness,
syncope, hypotension, chills, fever,
nausea, vomiting, and abdominal pain
and tenderness are occasionally seen
following instillation of the contrast
medium. It should be kept in mind that the
serious or anaphylactoid reactions that
may occur with intravascular
administration of radiopaque contrast
agents are theoretically possible
following administration by other
routes.
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| dailymed-instance:indicatio... |
Sinografin (Diatrizoate Meglumine and
lodipamide Meglumine Injection) is
indicated for use in
hysterosalpingography.
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| dailymed-instance:name |
Sinografin
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