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.

INNOPRAN XL (NDA-021438)

(PROPRANOLOL HYDROCHLORIDE)

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

Download Data

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12/22/2023 (SUPPL-32)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Hypoglycemia

Subsection title revised

Newly added information:

Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Advise patients not to interrupt or discontinue using INNOPRAN XL without a physician’s advice.
Advise patients with heart failure to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
Inform patients or caregivers that there is a risk of hypoglycemia when INNOPRAN XL is given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia [see Warnings and Precautions (5.4)].

08/16/2021 (SUPPL-25)

Approved Drug Label (PDF)

Boxed Warning

(Effective 8/17/2021, Boxed Warning in Supplement 25 has been removed)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion. Please refer to label for complete information.)

8.2 Lactation

(PLLR conversion. Please refer to label for complete information.)

8.3 Females and Males of Reproductive Potential

(Newly added section)

Infertility

Males

Based on the published literature, beta-blockers, including propranolol, may cause erectile dysfunction. In rats, propranolol inhibits spermatogenesis [see Nonclinical Toxicology (13.1)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Advise patients not to interrupt or discontinue using INNOPRAN XL without a physician’s advice.
Advise patients with heart failure to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
Advise diabetic patients that hypoglycemia may be masked and to report any changes in blood sugar levels to their physician.
For further product information, please visit www.anipharmaceuticals.com or call 1-800-308- 6755.