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.

EPHEDRINE SULFATE (NDA-208609)

(EPHEDRINE SULFATE)

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

Download Data

06/10/2024 (SUPPL-12)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Newly added information:

In animal reproduction studies, decreased fetal survival and body weights, developmental delays, and decreased learning were observed in the presence of maternal toxicity after normotensive pregnant rats were administered intravenous ephedrine sulfate (3.5 times the maximum recommended human dose (MRHD) of 50 mg/day) via a slow bolus (i.e., 2 to 3 min). No malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous ephedrine sulfate during organogenesis at doses 3.4 and 12.4 times the MRHD, respectively [see data].

. . .

Data

Animal Data

Decreased fetal body weights were observed when pregnant rats were administered an intravenous dose of 28 mg/kg ephedrine sulfate (5.4 times the maximum recommended human dose (MRHD) of 50 mg based on body surface area) via a slow bolus (i.e., 2 to 3 min) from Gestation Day 6 to 17. This dose was associated with evidence of maternal toxicity (decreased body weight of dams). No malformations of fetal deaths were noted at this dose. No effects on fetal body weight were noted at 18 mg/kg (3.5 times the MRHD of 50 mg).

No evidence of malformations of embryo-fetal toxicity were noted when pregnant rabbits were administered intravenous doses up to 32 mg/kg ephedrine sulfate (12.4 times the MRHD of 50 mg based on body surface area) via a slow bolus (i.e., 2 to 3 min) from Gestation Day 7 to 19. This dose was associated with maternal effects (increased mortality, increased respiration rate, dilated pupils, piloerection, heart rate).

Decreased fetal survival and body weights and developmental delays (delayed acquisition of acoustic startle and righting reflex), and decreased learning in passive avoidance task were observed in the presence of maternal toxicity (decreased maternal body weight and food consumption) when pregnant dams were administered intravenous doses of 18 and 28 mg/kg epinephrine sulfate (approximately 3.5 and 5.4 times the MRHD based on body surface area) from Gestation Day 6 through Lactation Day 20. No adverse effects were noted at 9 mg/kg (1.7 times the MRHD).