MIOSTAT
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
- MIOSTAT
- Generic name
- CARBACHOL
- Manufacturer
- Alcon Laboratories, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- f28d7a56-e079-4a8b-ad81-9a97c780de67
- SPL ID
- a76a34d0-2e07-408d-a8c8-d00f2715cad7
- Version
- 12
- Effective date
- 2023-02-10
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:54:51
| Harmonized routes |
|---|
| OPHTHALMIC |
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 | 016968 | derived:openfda.application_number |
| application number | NDA016968 | openfda.application_number | |
| brand name | MIOSTAT | openfda.brand_name | |
| generic name | CARBACHOL | openfda.generic_name | |
| manufacturer name | Alcon Laboratories, Inc. | openfda.manufacturer_name | |
| ndc | package | 0065-0023-15 | openfda.package_ndc |
| ndc | product | 0065-0023 | openfda.product_ndc |
| ndc11 | package | 00065002315 | derived:openfda.package_ndc |
| rxcui | 308966 | openfda.rxcui | |
| rxcui | 991606 | openfda.rxcui | |
| spl id | a76a34d0-2e07-408d-a8c8-d00f2715cad7 | id | |
| spl set id | f28d7a56-e079-4a8b-ad81-9a97c780de67 | set_id | |
| unii | 8Y164V895Y | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: For single-dose intraocular use only. Discard unused portion. Intraocular carbachol 0.01% should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, G.I. spasm, urinary tract obstruction and Parkinson's disease. The vial stopper contains natural rubber (latex) which may cause severe allergic reactions.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Ocular: Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported. Systemic: Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, and headache have been reported with topical or systemic application of carbachol. The following additional reactions have been identified during post-approval use of MIOSTAT (carbachol intraocular solution, USP) 0.01% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to MIOSTAT, or a combination of these factors, include: corneal edema, drug effect prolonged (miosis), eye inflammation, eye pain, intraocular pressure increased, ocular hyperemia, vision blurred, visual impairment, and vomiting.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.