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Iodinated I-131 Albumin

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Overview

What is Megatope?

Megatope (Iodinated I 131 Albumin Injection) is a diagonostic radiopharmaceuticalcontaining iodinated I 131 albumin for intravenous use. Each mL of sterile, nonpyro-genic, aqueous, colorless to very pale yellow solution provides approximate 10 mgprotein (albumin human), 16 mg dibasic sodium phosphate, 1.6 mg monobasicsodium phosphate, not more than 0.4 guanidine hydrochloride, sodium chloridefor isotonicity, and 9 mg benzyl alcohol as a preservative. The pH has been adjustedto 7.2 to 7.8 with sodium hydroxide or hydrochloric acid.Megatope was prepared from blood that was nonreactive when tested for hepatitisB surface antigen (HBsAg).The structure of the complex is unknown.



What does Megatope look like?



What are the available doses of Megatope?

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What should I talk to my health care provider before I take Megatope?

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How should I use Megatope?

Megatope (Iodinated I 131 Albumin Injection) is indicated for use in determinations of 

total blood and plasma volumes, cardiac output, cardiac and pulmonary blood

volumes and circulation times, and in protein turnover studies, heart and great vessel

dilineation, localization of the placenta, and localization of celebral neospasms.

Megatope  (Iodinated I 131 Albumin Injection) is administered intravenously.

drug products should be inspected visually for particulate matter and abnormal 

coloration prior to administration whenever solution and container permit.

Megatope (Iodinated I 131 Albumin Injection) may be colorless to very pale yellow. 

Solutions with excessive colorations should not be used.

    When a procedure such as blood volume or a circulation time determination is to 

be repeated, the total dosage administered in any one week should not exceed 200

microcuries.

    To minimize the uptake of radioactive Iodine by the thyroid, prior administration of 

Lugol's Solution (Strong Iodine Solution USP) may be used. Ten drops of Lugol's 

Solution three times daily, beginning at least 24 hours before administration of 

Megatope and continuing for one or two weeks thereafter, is a suitable dose.

     Complete assay data for each vial are provided on the container.

     Note: 

of the material and not to the radioactivity level. It is important to make certain that the 

radioactivity in the dose at the time of administration is sufficient for the intended use.

    The patient dose should be measured by a suitable radioactivity calibration system

immediately prior to administration.

   Note:

I 131 albumin

Total Blood and Plasma Volumes

Dosage may range from 5 to 50 microcuries.

Blood Volume Determination

A. Preparation of Reference Solution

Remove an aliquot of the contents of the vial to be used in the procedure identical in

volume to the dose to be administered to the patient. Prepare a reference solution

using normal saline as a diluent. The recommended dilution is 1:4000 [Dilution Factor

(DF) = 4000]. Determine the radioactivity concentration (net cpm/ml) of the

reference solution. Care must be taken to assure that the reference solution and the

blood samples (Step B3) are assayed using the same geometric configuration.

A. Administration of Dose

1. Inject the dose into a large vein in patient's arm. Measure the residual radioactivity

    in the syringe and needle.

2. Destroy the syringe after injecting. Do not attempt to resterilize.CAUTION: The

    syringe should be disposed of in accordance with the US Nuclear Regulatory

    Commission or Agreement State regulations pertaining to the disposal of

    radioactive waste.

3. At 5 and 15 minutes after injecting the dose, withdraw blood samples

    patient's other arm

B. Calculation of Blood Volume

1. Take a known aliquot from each blood sample and determine radioconcentration

    in net cpm/mL.

2. Plot the 5- and 15-minute sample counts (net cpm/mL) on semilog graph paper

    using the average count value of each sample and determine the

    radioconcentration at injection time (zero time) by drawing a straight line through

    the 15- and 5- minute points to zero time. The x ordinate iof the graph is the sample

    withdrawal time and the logarithmic y ordinate is radioconcentration in

    net cpm/mL.

3. Calculate the patient's blood volume (in mL) using the following formula:

      Net cpm/mL reference solution        

   Net cpm/mL patient's blood sample

Sample Blood Volume Calculations

Volume of blood sample aliquot                                = 1.0 mL

Volume of reference solution aliquot                         = 1.0 mL

Net counts at zero time                                         = 48,100

Net counts obtained from reference solution aliquot    = 52,430

Using the formula above gives x 4000 = 4360 mL                                                 48,100

Serial Blood Volume Determinations

Iodinated I 131 Albumin Injection is administered in sufficiently low dosage to permit

repetitions as often as required by clinical circumstances. It must be remembered that

it is always necessary to correct for background radioactivity remaining in the blood

from former determinations. Therefore, for each determination after the first one, a

background blood sample must be taken just the iodinated I 131 albumin is

injected.

Background Blood Sample:

1. Withdraw background blood sample from large vein in patient's arm with a sterile

    heparinized syringe.

2. Leaving needle in patient's vein, detach syringe containing blood sample.

3. Attach syringe containing the dose of Megatope to the indwelling needle and

    administer (see instructions under

    Dose

4. Determine radioconcentration in net cpm/mL of aliquots taken from background

    and postinjection blood samples, and from the reference solution.

   The radioconcentration (net cpm/mL) per aliquot of the blood sample

must be subtracted from the radioconcentration per aliquot of the blood sample

obtained the injection of Iodinated I 131 albumin. The formula for calculating

each blood volume determination after the first one thus becomes:

     Net cpm/mL reference solution          

Plasma Volume Determination

The procedure is essentially the same as that for blood volume determination, except

that the blood sample drawn from the patient is centrifuged, the red blood cells are

removed, and net cpm/mL of the plasma is determined. The formula for calculation of

plasma volume, therefore is:

     Net cpm/mL reference solution       

Cardiac Output

Dosage generally ranges from 3 to 50 microcuries.

Cardiac and Pulmonary Blood Volumes; Circulation Times

Dosages used have generally been 75 to 130 microcuries.

Protein Turnover Studies

Dosages used have ranged from 10 to 150 microcuries. After injection, a period of

seven days should be allowed before determinations are made to permit the

elimination of any degraded protein in the dose.

Heart and Great Vessel Delineation

The suggested dosage is 5 microcuries per kg of body weight, although doses up to

750 microcuries have been used, depending on the instrumentation available and the

scanning technique employed.

Localization of the Placenta

For localization of the placenta in the differential diagnosis of placenta praevia, a 3 to 5

microcurie dose is recommended; this dose has proved adequate for excellent

localization, and the fetal total body radiation is a fraction of that received during x-ray

placentography. While fetal thyroid irradiation is higher with Iodinated I 131 Albumin

Injection than with x-ray placentography, the administration of Lugol's Solution is

reported to eliminate this hazard.

Localization of Celebral Neospasms

The suggested dosage is 5 microcuries per kg of body weight. Although doses as

large as 500 microcuries of Iodinated I 131 Albumin Injection have been used, the

dose should be kept as small as possible. Dosage is administered six hours before the

initial examination, and scans are repeated at periodic intervals.

Radiation Dosimetry

The estimated absorbed radiation doses to an average patient (70 kg) from an

intravenous injection of 50 microcuries of Iodinated I 131 Albumin Injection USP are 

shown in Table 4.


What interacts with Megatope?

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What are the warnings of Megatope?

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What are the precautions of Megatope?

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What are the side effects of Megatope?

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What should I look out for while using Megatope?

None Known.

A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have 

been reported with the use of iodinated I 131 in cisternography. Iodinated I

131 Albumin injection is for use in cisternography.


What might happen if I take too much Megatope?

Sorry No Records found


How should I store and handle Megatope?

StorageStore Pantoprazole Sodium Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) see USP Controlled Room Temperature.StorageStore Pantoprazole Sodium Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) see USP Controlled Room Temperature.Megatope (Iodinated I 131 Albumin Injection USP) is available in multiple dose vialscontaining the following amounts of activity on the date of calibration: 500microcuries and 1.0 millicurie. Complete assay data for each vial are provided on the container.   The maximum concentration of Iodinated I 131 Albumin Injection does not exceed one millicurie per milliliter at a time of calibration.Megatope (Iodinated I 131 Albumin Injection USP) is available in multiple dose vialscontaining the following amounts of activity on the date of calibration: 500microcuries and 1.0 millicurie. Complete assay data for each vial are provided on the container.   The maximum concentration of Iodinated I 131 Albumin Injection does not exceed one millicurie per milliliter at a time of calibration.Megatope (Iodinated I 131 Albumin Injection USP) is available in multiple dose vialscontaining the following amounts of activity on the date of calibration: 500microcuries and 1.0 millicurie. Complete assay data for each vial are provided on the container.   The maximum concentration of Iodinated I 131 Albumin Injection does not exceed one millicurie per milliliter at a time of calibration.Megatope (Iodinated I 131 Albumin Injection USP) is available in multiple dose vialscontaining the following amounts of activity on the date of calibration: 500microcuries and 1.0 millicurie. Complete assay data for each vial are provided on the container.   The maximum concentration of Iodinated I 131 Albumin Injection does not exceed one millicurie per milliliter at a time of calibration.Megatope (Iodinated I 131 Albumin Injection USP) is available in multiple dose vialscontaining the following amounts of activity on the date of calibration: 500microcuries and 1.0 millicurie. Complete assay data for each vial are provided on the container.   The maximum concentration of Iodinated I 131 Albumin Injection does not exceed one millicurie per milliliter at a time of calibration.Megatope (Iodinated I 131 Albumin Injection USP) is available in multiple dose vialscontaining the following amounts of activity on the date of calibration: 500microcuries and 1.0 millicurie. Complete assay data for each vial are provided on the container.   The maximum concentration of Iodinated I 131 Albumin Injection does not exceed one millicurie per milliliter at a time of calibration.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Following intravenous injection, radioiodinated albumin human is uniformly

distributed throughout the intravascular pool within 10 minutes; extravascular

distribution takes place more slowly. Iodinated I 131 albumin can also be detected in

the lymph and in certain body tissues within 10 minutes after injection but maximum 

distribution of radioactivity throughout the extravascular space does not occur until

two to four days after administration.  The time at which extravascular activity is 

maximal has been designated as the "equilibrium time". When this point has been

reached, the radioactivity remaining in the intravascular and extravascular spaces

decreases slowly and exponentially in parallel fashion.

    The administered radioactivity is eliminated almost entirely in the urine, only about

2 percent of the total dose ultimately appearing in the feces.

    The biologic half-life of Iodinated I 131 albumin is dependent upon a number of 

factors, and published studies have varied considerably in their reporting of this 

figure. It has ranged, in the literature, from below 10 days to over 20 days. One

important factor affecting the biological half-life is the initial rate of excretion, and this

depends in part on the quality of the Iodinated I 131 albumin. With Megatope, the 

biologic half-life in normal individuals has been reported to be approximately 14 days.`

Non-Clinical Toxicology
None Known.

A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have 

been reported with the use of iodinated I 131 in cisternography. Iodinated I

131 Albumin injection is for use in cisternography.

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.

Carcinogenesis, Mutagenesis,

Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential 

or whether iodinate I 131 albumin affects fertility in males and females.

Pregnancy Category C

Animal reproduction studies have not been conducted with Iodinated I 131 Albumin

Injection. It is also not known whether this agent can cause fetal harm when adminis-

tered to a pregnant woman or can affect reproduction capacity. Iodinated I 131

Albumin injection should be administered to a pregnant woman only if clearly

needed.

   Ideally, examinations using radiopharmaceuticals, especially those elective in 

nature, of a woman of childbearing capability should be performed during the first few

(approximately 10) days following the onset of menses.

Nursing Mothers

Since iodine 131 is excreted in human milk during lactation, formula feedings should 

be substituted for breast feedings.

Pediatric Use

Safety and effectiveness in children have not been established.

Although the immunological properties of albumin human are believed to be virtually 

unaltered by the iodination process, there is a theoretical possibility that allergic

reactions may occur in patients receiving additional doses a number of weeks after an 

initial dose.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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