Dimercaptosuccinic Acid

Manufacturer
AnazaoHealth Corporation
Effective date
2012-07-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:16:20

Label at a glance#

ProductDimercaptosuccinic Acid DMSA
Active ingredient2,3-DIMERCAPTOSUCCINIC ACID
Label structure7 sections

Indications and uses

Technetium Tc 99m DMSA by intravenous administration is indicated as a static kidney imaging agent.

Dosage and administration

Preparation of Technetium Tc 99m DMSA is done by the following aseptic procedure: Waterproof gloves should be worn during the preparation Snap off the plastic lid and place room temperature reaction vial in an appropriate lead shield. Swab the rubber closure of the vial with a germicide Inject as close to 1 cc as possible of sterile additive free sodium pertechnetate Tc 99m injection containing up to 1480 MBq (40 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dear Medical Professional,

Per your order, we have compounded DMSA as a sterile freeze-dried mixture. The characteristics of this preparation are:

DESCRIPTION

DESCRIPTION SECTION

AnazaoHealth supplies DMSA as a compounded kit for preparing Tc 99m DMSA. Each Reaction vial contains 1.1 mg meso-2, 3-dimercaptosuccinic acid, 0.2 mg tin as stannous chloride, and 0.7 mg ascorbic acid. The vial is back filled with inert gas and may contain a partial vacuum.

Each Acetate buffer vial contains 1.2 ml Sodium Acetate .25 N. pH 5.2 to 5.6.

LDO normal saline included for dilution of prepared kit, if required

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Technetium Tc 99m DMSA, when administered intravenously apparently binds to plasma proteins in the blood and collects in the renal cortex.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Technetium Tc 99m DMSA by intravenous administration is indicated as a static kidney imaging agent.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

There are no known contraindications.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Preparation of Technetium Tc 99m DMSA is done by the following aseptic procedure:

  1. Waterproof gloves should be worn during the preparation
  2. Snap off the plastic lid and place room temperature reaction vial in an appropriate lead shield.
  3. Swab the rubber closure of the vial with a germicide
  4. Inject as close to 1 cc as possible of sterile additive free sodium pertechnetate Tc 99m injection containing up to 1480 MBq (40 mCi) into the vial freshly eluded within 2 hours from a technetium generator. Be sure to maintain inert atmosphere in vial by introducing as little air as possible during reconstitution. NOTE: If sodium pertechnetate Tc 99m injection must be diluted, use  only Low Dissolved Oxygen (LDO)
  5. Secure the lead shield cover. Swirl the vial gently to mix contents and let stand for 15 minutes. Add 1 ml Acetate buffer at this time. (This will interfere with the tagging process if introduced any earlier). Buffer must be added (May be added up to 1 hour after Tc 99m)
  6. Examine vial contents; if the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used
  7. Measure the radioactivity by a suitable calibration system and record prior to patient administration
  8. Buffered material should be used within 2 hours
  9. Appropriate quality control is recommended

Tagging Tips

  • If you need only a one or two mCi dose for your patient, use about 10 mCi of Tc 99m for your kit. Do not stretch your kit to 40 mCi if you do not need to. We have tested the kits to 40 mCi with a Friday generator eluted on Monday but recommend using only what you need
  • Keep your volumes low. Take your Tc 99m and dilute to about 1cc with the Low Dissolved Oxygen saline and inject into the DMSA kit
  • Let the kit stand for about 15 minutes with just the Tc 99m and DMSA (NO BUFFER)
  • After 15 minutes, then add the buffer. This is only for patient comfort and will interfere with the tagging process if introduced any earlier
  • After buffering you can add additional “Low Dissolved Oxygen” saline to dilute the kit
  • You should inject the dose within 2 hours after making the kit for best results

Storage and Handling

Store the kit at 2°-8°C (36°-46°F) and protect from light

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

ec657ecb-figure-01
ec657ecb-figure-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51808-211-012019-11-27C16284748780-19855d018-deec-cd31-e053-dbdaa90ab51aDMSA (Dimercaptosuccinic acid)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51808-211-01Dimercaptosuccinic AcidDMSA1 in 1 KITINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51808-211DIMERCAPTOSUCCINIC ACID DMSA (DIMERCAPTOSUCCINIC ACID) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ANAZAOHEALTH CORPORATION]1Legacy NDC, 1 package rows20121203_5b11e596-3044-429b-9e48-33ba00946151.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
2,3-DIMERCAPTOSUCCINIC ACIDACTIVE INGREDIENT4S9JU7XF011
2,3-DIMERCAPTOSUCCINIC ACIDACTIVE MOIETY4S9JU7XF011
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
STANNOUS CHLORIDEINACTIVE INGREDIENT1BQV3749L51

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51808-21151808-211-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.11 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET / ORAL80 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2 mgExact identifier — unii candidate
25 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION / INTRAVENOUS3.4 mgExact identifier — unii candidate
5 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRACAVITARY5 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / ORAL600 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCONCENTRATE / ORAL6 mg/1mlExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RPOWDER, FOR SOLUTION / ORAL560 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INFILTRATION0.2 %w/vExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUSPENSION / ORAL520 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, ORALLY DISINTEGRATING / ORAL2.35 mgExact identifier — unii candidate
25 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / RESPIRATORY (INHALATION)0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE / ORAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE, DELAYED RELEASE / ORAL12 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUSPENSION, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAMUSCULAR192 mgExact identifier — unii candidate
25 equally ranked IID candidates
STANNOUS CHLORIDESTANNOUS CHLORIDE1BQV3749L5INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.42 mgExact identifier — unii candidate
5 equally ranked IID candidates

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ec657ecb-6327-464c-8aab-6d61a0546b835b11e596-3044-429b-9e48-33ba009461512012-07-01Exact identifier
spl id: ec657ecb-6327-464c-8aab-6d61a0546b83
spl set id: 5b11e596-3044-429b-9e48-33ba00946151

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.