Protopam Chloride
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Protopam Chloride
- Generic name
- PRALIDOXIME CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 2741d8fd-51c2-46be-880b-99f2b20a6137
- SPL ID
- ce0e8c50-0a21-4dbe-bdc6-e64a26a120c7
- Version
- 15
- Effective date
- 2026-04-01
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:27:16
| Harmonized routes |
|---|
| INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 014134 | derived:openfda.application_number |
| application number | NDA014134 | openfda.application_number | |
| brand name | Protopam Chloride | openfda.brand_name | |
| generic name | PRALIDOXIME CHLORIDE | openfda.generic_name | |
| manufacturer name | Baxter Healthcare Corporation | openfda.manufacturer_name | |
| ndc | package | 60977-141-01 | openfda.package_ndc |
| ndc | package | 60977-141-27 | openfda.package_ndc |
| ndc | product | 60977-141 | openfda.product_ndc |
| ndc11 | package | 60977014101 | derived:openfda.package_ndc |
| ndc11 | package | 60977014127 | derived:openfda.package_ndc |
| rxcui | 208969 | openfda.rxcui | |
| rxcui | 312576 | openfda.rxcui | |
| spl id | ce0e8c50-0a21-4dbe-bdc6-e64a26a120c7 | id | |
| spl set id | 2741d8fd-51c2-46be-880b-99f2b20a6137 | set_id | |
| unii | 38X7XS076H | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS PROTOPAM Chloride is not effective in the treatment of poisoning due to phosphorus, inorganic phosphates, or organophosphates not having anticholinesterase activity. PROTOPAM Chloride is not indicated as an antidote for intoxication by pesticides of the carbamate class since it may increase the toxicity of carbaryl.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Forty to 60 minutes after intramuscular injection, mild to moderate pain may be experienced at the site of injection. Pralidoxime chloride may cause blurred vision, diplopia and impaired accommodation, dizziness, headache, drowsiness, nausea, tachycardia, increased systolic and diastolic blood pressure, hyperventilation, and muscular weakness when given parenterally to normal volunteers who have not been exposed to anticholinesterase poisons. In patients, it is very difficult to differentiate the toxic effects produced by atropine or the organophosphate compounds from those of the drug. Elevations in SGOT and/or SGPT enzyme levels were observed in 1 of 6 normal volunteers given 1200 mg of pralidoxime chloride intramuscularly, and in 4 of 6 volunteers given 1800 mg intramuscularly. Levels returned to normal in about 2 weeks. Transient elevations in creatine phosphokinase were observed in all normal volunteers given the drug. When atropine and pralidoxime chloride are used together, the signs of atropinization may occur earlier than might be expected when atropine is used alone. This is especially true if the total dose of atropine has been large and the administration of pralidoxime chloride has been delayed. Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases. However, similar behavior has occurred in cases of organophosphate poisoning that were not treated with pralidoxime chloride.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.