Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

PHOSPHOLINE IODIDE (NDA-011963)

(ECHOTHIOPHATE IODIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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10/28/2021 (SUPPL-52)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

Active uveal inflammation.
Most cases of angle-closure glaucoma without iridectomy, due to the possibility of increasing angle block.
Hypersensitivity to the active or inactive ingredients.

5 Warnings and Precautions

PRECAUTIONS

(Additions and/or revisions underlined)

General

Digital compression of the nasolacrimal ducts for a minute or two following instillation to minimize drainage into the nasal chamber is recommended. To prevent possible skin absorption, hands should be washed following instillation.
Discontinue use of the medication if cardiac irregularities occur.
Anticholinesterase drugs should be used with caution, if at all, in patients with marked vagotonia, bronchial asthma, spastic gastrointestinal disturbances, peptic ulcer, pronounced bradycardia and hypotension, recent myocardial infarction, epilepsy, parkinsonism, and other disorders that may respond adversely to vagotonic effects.
Echothiophate iodide for ophthalmic solution should be used with caution, where there is a prior history of retinal detachment.
Temporary discontinuance of medication is necessary if salivation, urinary incontinence, diarrhea, profuse sweating, muscle weakness, or respiratory difficulties occur.
Patients receiving echothiophate iodide for ophthalmic solution who are exposed to carbamate- or organophosphate-type insecticides and pesticides should be warned of the additive systemic effects possible from absorption of the pesticide through the respiratory tract or skin. During periods of exposure to such pesticides, the wearing of respiratory masks, and frequent washing and clothing changes may be advisable.

WARNINGS

(Additions and/or revisions underlined)

Succinylcholine should be administered only with great caution, if at all, prior to or during general anesthesia to patients receiving anticholinesterase medication because of possible respiratory or cardiovascular collapse.
Caution should be observed in treating elevated IOP with echothiophate iodide for ophthalmic solution in patients who are at the same time undergoing treatment with systemic anticholinesterase medications, because of possible adverse additive effects.

6 Adverse Reactions

(Additions and/or revisions underlined)

Although the relationship, if any, of retinal detachment to the administration of echothiophate iodide for ophthalmic solution has not been established, retinal detachment has been reported in a few cases during the use of echothiophate iodide for ophthalmic solution in adult patients without a previous history of this disorder.
Stinging, burning, lacrimation, lid muscle twitching, conjunctival and ciliary redness, browache, induced myopia with visual blurring may occur.
Activation of latent iritis or uveitis may occur.
Iris cysts may form, and if treatment is continued, may enlarge and obscure vision. This occurrence is more frequent in children. The cysts usually shrink upon discontinuance of the medication or by reducing the frequency of instillation. Rarely, they may rupture or break free into the aqueous. Regular examinations are advisable when the drug is being prescribed for the treatment of accommodative esotropia.
Prolonged use may cause conjunctival thickening, obstruction of nasolacrimal canals.
Lens opacities have been reported with echothiophate iodide.
Paradoxical increase in IOP may follow anticholinesterase instillation. This may be alleviated by prescribing a sympathomimetic mydriatic such as phenylephrine.
Cardiac irregularities.

07/03/2018 (SUPPL-48)

4 Contraindications

(Additions and/or revisions are underlined)

2. Most cases of angle-closure glaucoma without iridectomy, due to the possibility of increasing angle block.

5 Warnings and Precautions

WARNINGS

(Additions and/or revisions are underlined)

2. Caution should be observed in treating elevated IOP with echothiophate iodide for ophthalmic solution in patients who are at the same time undergoing treatment with systemic anticholinesterase medications, because of possible adverse additive effects.

6 Adverse Reactions

(Additions and/or revisions are underlined)

4. Iris cysts may form, and if treatment is continued, may enlarge and obscure vision. This occurrence is more frequent in children. The cysts usually shrink upon discontinuance of the medication or by reducing the frequency of instillation. Rarely, they may rupture or break free into the aqueous. Regular examinations are advisable when the drug is being prescribed for the treatment of accommodative esotropia.

6. Lens opacities have been reported with echothiophate iodide.

7. Paradoxical increase in IOP may follow anticholinesterase instillation. This may be alleviated by prescribing a sympathomimetic mydriatic such as phenylephrine.