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.

SUTAB (NDA-213135)

(MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE)

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

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10/24/2023 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.8 Risk of Gastrointestinal Complications with Ingestion of Desiccant

Newly added subsection:

Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration (2.2)]. Postmarketing reports of patients ingesting the desiccant along with the SUTAB tablets has been reported and may be associated with risk of gastrointestinal complications and/or choking.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Risk of Gastrointestinal Complications with Ingestion of Desiccant [see Warnings and Precautions (5.8)]

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

How should I take SUTAB?

See the Instructions for Use for dosing instructions. You must read, understand, and follow these instructions to take SUTAB the right way.

Take SUTAB exactly as your healthcare provider tells you to take it.
Each bottle contains 12 tablets and a drying agent (desiccant) canister to keep the tablets dry. Remove and throw away (discard) the drying agent (desiccant) canister from both bottles. Use the second bottle for the second dose on the morning of the colonoscopy.
Each dose of SUTAB is 12 tablets that must be taken while drinking 16 ounces of water. Two doses of SUTAB (24 tablets) are required for a complete colonoscopy preparation.
It is important for you to drink the additional 32 ounces of water after each dose to prevent fluid loss (dehydration).

…

How should I store SUTAB?

Each SUTAB bottle contains a drying agent (desiccant) canister to help keep the tablets dry (protect from moisture).

Store SUTAB at room temperature between 68ºF to 77°F (20ºC to 25°C).

Keep SUTAB and all medicines out of the reach of children.

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Instruct patients:

Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy.
SUTAB is supplied as two bottles each containing 12 tablets. Twelve (12) tablets are equivalent to one dose.
Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration (2.2)].
Must consume water with each dose of SUTAB and an additional 32 ounces of water after each dose.
After breakfast, only clear liquids may be consumed until after the colonoscopy. Examples of clear liquids are coffee or tea (no cream or non-dairy creamer), fruit juices (without pulp), gelatin desserts (no fruit or topping), water, chicken broth, clear soda (such as ginger ale).
If preparation-related symptoms occur (e.g., nausea, bloating, cramping), pause or slow the rate of drinking the additional water until symptoms diminish.
Do not take other laxatives while they are taking SUTAB.
Do not drink milk or eat or drink anything colored red or purple.
Do not drink alcohol.
Administer oral medications at least one hour before starting each dose of SUTAB.
If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB.
Complete all SUTAB tablets and required water at least two hours prior to colonoscopy.
Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking SUTAB or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions (5.1, 5.2, 5.3)].
Seek immediate medical care should signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.7)]

…

01/28/2022 (SUPPL-3)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

Hypersensitivity to any ingredient in SUTAB [see Warnings and Precautions (5.7) and Description (11)]

6 Adverse Reactions

Additions and/or revisions underlined:

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:

Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions (5.1)]
Cardiac Arrhythmias [see Warnings and Precautions (5.2)]
Seizures [see Warnings and Precautions (5.3)]
Patients with Risk of Renal Injury [see Warnings and Precautions (5.4)]
Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions (5.5)]
Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.6)]

Hypersensitivity Reactions [see Warnings and Precautions (5.7)]

6.2 Postmarketing Experience

Newly added subsection:

The following adverse reactions have been identified during post-approval use of SUTAB. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal: gastric ulceration, gastritis

Hypersensitivity: anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria [see Warnings and Precautions (5.7)]

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

17 PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

To seek immediate medical care should signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.7)]

Medication Guide

Additions and/or revisions underlined:

Do not take SUTAB if your healthcare provider has told you that you have:

a blockage in your bowel (obstruction) or a problem with food moving too slowly through your intestines (ileus).
an opening in the wall of your stomach or intestine (bowel perforation).
a very dilated intestine (toxic colitis or toxic megacolon).
problems with food and fluid emptying from your stomach (gastric retention).
allergies to any ingredient in SUTAB. See the end of this Medication Guide for a complete list of ingredients in SUTAB.