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.

ROBINUL (NDA-012827)

(GLYCOPYRROLATE)

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

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09/27/2022 (SUPPL-59)

Approved Drug Label (PDF)

5 Warnings and Precautions

The following subsections created to comply with Physician Labeling Rule (PLR); please refer to label for complete information

5.1 Precipitation of Acute Glaucoma

5.2 Partial or Complete Mechanical Intestinal Obstruction

5.3 Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility

5.4 Cognitive and Visual Adverse Reactions

5.5 Heat Prostration at High Environmental Temperatures

5.6 Other Conditions Exacerbated by Anticholinergic Adverse Reactions

5.7 Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients

7 Drug Interactions

The following subsections created to comply with Physician Labeling Rule (PLR); please refer to label for complete information

7.1 Other Anticholinergic Drugs

7.2 Drugs with Altered Absorption due to Decreased Gastrointestinal Motility and Increased Transit Time

7.3 Gastrointestinal Toxicity with Solid Oral Dosage Forms of Potassium Chloride

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion

Risk Summary

Over decades of use, there is an absence of published data on orally administered glycopyrrolate in pregnant women, including an absence of any reports of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, at non-maternally toxic doses of oral glycopyrrolate, there were no adverse developmental effects in rats or rabbits. A pre- and post-natal development study of oral glycopyrrolate in rats showed a decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage inclinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

At non-maternally toxic doses of oral glycopyrrolate, there were no effects on embryo-fetal developmentor toxicity in rats or rabbits. A pre- and post-natal development study of oral glycopyrrolate in rats showed a decrease in pup mean bodyweight that recovered post nursing, with no other developmental effects observed.

In a published reproductive and developmental study, male and female rats were administered glycopyrrolate in the diet at 0 mg/kg/day, 32.5 mg/kg/day, 63 mg/kg/day, and 130 mg/kg/day for 3 weeks to 5 weeks and through up to three consecutive litters. There was no indication of abnormalities in the pups of treated dams. There was adecreased rate of conception and in survival rate at weaning for all treated animals in a dose-related manner. Diminished rates of conception may be due to diminished seminal secretion [see NonclinicalToxicology (13.1)].

8.2 Lactation

PLLR conversion

Risk Summary

There are no data on the presence of glycopyrrolate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. As with other anticholinergic drugs, glycopyrrolate may cause suppression of lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ROBINUL and ROBINUL FORTE and any potential adverse effectson the breastfed infant from ROBINUL and ROBINUL FORTE.

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

PATIENT COUNSELING INFORMATION

New section added to comply with Physician Labeling Rule (PLR)

Precipitation of Acute Glaucoma

Advise patients to discontinue ROBINUL and ROBINUL FORTE and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilatedpupils) [see Warnings and Precautions (5.1)].

Partial or Complete Mechanical Intestinal Obstruction

Advise patients to contact their healthcare provider if diarrhea occurs, especially in patients withileostomy or colostomy [see Warnings and Precautions (5.2)].

Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility

Inform patients that ROBINUL and ROBINUL FORTE may cause adverse reactions related to decreased gastrointestinalmotility and report to their healthcare provider if they experience symptoms such as vomiting, early satiety, abdominal distention, and constipation [see Warnings and Precautions (5.3)].

Cognitive and Visual Adverse Reactions

Inform patients that ROBINUL and ROBINUL FORTE may cause cognitive or visual impairment and not operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonablycertain that ROBINUL and ROBINUL FORTE do not affect them adversely. Advise patients to discontinue ROBINUL and ROBINUL FORTE immediately and contact their healthcare provider if symptoms develop (e.g., drowsiness or blurred vision) [see Warnings and Precautions (5.4)].

Heat Prostration at High Environmental Temperatures

Inform patients that ROBINUL and ROBINUL FORTE can reduce sweating, leading to the possibility of heat exhaustionor heat stroke. Advise patients to avoid exposure to hot or very warm environmental temperatures [see Warnings and Precautions (5.5)].

Other

Physician Labeling Rule (PLR) conversion