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.

NICOTROL (NDA-020385)

(NICOTINE)

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

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08/29/2019 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

(additions/revisions are underlined)

General

The patient should be urged to stop smoking completely when initiating NICOTROL NS therapy. Patients should be informed that if they continue to smoke while using the product, they may experience adverse effects due to peak nicotine levels higher than those experienced from smoking alone. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the treatment should be discontinued. Physicians should anticipate that concomitant medications may need dosage adjustment.

Sustained use (beyond 6 months) of NICOTROL NS by patients who stop smoking is not recommended and should be discouraged.

Care should be taken not to spray the eyes while administering NICOTROL NS.

Asthma, Bronchospasm and Reactive Airway Disease

Exacerbation of bronchospasm in patients with pre-existing asthma has been reported. Use of NICOTROL NS in patients with severe reactive airway disease is not recommended. In a small clinical study of 33 subjects, use of NICOTROL NS by smokers with chronic rhinitis and sinusitis was associated with irritant effects with no significant impairment in nasal condition.

…

Renal or Hepatic Insufficiency

Pharmacokinetic studies in patients with moderate to severe renal impairment or moderate to severe hepatic impairment have shown decreased nicotine clearance. The pharmacokinetics of nicotine have not been studied in the elderly. Given that nicotine is extensively metabolized and that its total system clearance is dependent on liver blood flow, some influence of hepatic impairment on drug kinetics (reduced clearance with potential for increased adverse effects) are anticipated. Moderate and severe renal impairment would be expected to affect the clearance of nicotine or its metabolites from the circulation. Consider dose reduction and monitoring patients for adverse events (such as nausea or dizziness) associated with elevated levels of nicotine.

Endocrine Diseases

NICOTROL NS therapy should be used with caution in patients with hyperthyroidism, pheochromocytoma or insulin-dependent diabetes, since nicotine causes the release of catecholamines by the adrenal medulla.

Peptic Ulcer Disease

Nicotine delays healing in peptic ulcer disease; therefore, NICOTROL NS therapy should be used with caution in patients with esophagitis, active gastric or peptic ulcers and only when the benefits of including nicotine replacement in a smoking cessation program outweigh the risks.

WARNINGS

(additions/revisions are underlined)

Safety Note Concerning Children

The amounts of nicotine that are tolerated by adult smokers can produce signs and symptoms of poisoning and could prove fatal if NICOTROL NS is used or ingested by children or pets. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately. A full bottle of NICOTROL NS contains 100 mg of nicotine, some of which will still be in the bottle when it is discarded. Therefore, patients should be cautioned to keep both used and unused containers of NICOTROL NS out of the reach of children and pets.

6 Adverse Reactions

(additions/revisions are underlined)

…

Adverse events reported with a frequency of <1% among active spray users are listed below:

Body as a Whole: edema peripheral, pain, numbness, allergy

Gastrointestinal: dry mouth, hiccup, diarrhea

Hematologic: purpura

Neurological: aphasia, amnesia, migraine, numbness

Respiratory: bronchitis, bronchospasm, sputum increased

Skin and appendages: rash, purpura

Special Senses: vision abnormal

Adverse reactions not listed above that have been identified during post-marketing experience with the nicotine nasal spray formulation are listed below:

General disorders and administration site conditions: chest pain

Immune system disorders: anaphylactic reaction

Gastrointestinal disorders: dysphagia

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

PATIENT INFORMATION

(extensive additions/revisions; please refer to labeling)