ZELNORM- tegaserod tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

tegaserod (UNII: 458VC51857) (tegaserod - UNII:458VC51857)

Tersedia dari:

US WorldMeds, LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use - The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)] . ZELNORM is contraindicated in patients with: - A history of myocardial infarction (MI), stroke, transient ischemic attack (TIA), or angina [see Warnings and Precautions (5.1)] - A history of ischemic colitis or other forms of intestinal ischemia [see Warnings and Precautions (5.2)] - Severe renal impairment (eGFR< 15 mL/min/1.73 m2 ) or end-stage renal disease [see Use in Specific Populations (8.6)] - Moderate and severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7)] - A history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions [see Adverse Reactions (6.2)] - Hypersensitivity to tegaserod [see Adverse Reactions (6.2)] Risk Summary Availabl

Ringkasan produk:

ZELNORM is supplied as 6 mg tegaserod whitish to slightly yellowish, round flat tablets with a beveled edge engraved with "ZEL" and "6" . Unit Dose (blister pack) Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Protect from moisture.

Status otorisasi:

New Drug Application

Selebaran informasi

US WorldMeds, LLC
----------
Medication Guide
ZELNORM™ (ZEL-norm)
(tegaserod) tablets, for oral use
What is the most important information I should know about ZELNORM?
ZELNORM can cause serious side effects, including:
•
Major heart (cardiovascular) events. Major cardiovascular events such
as stroke, heart attack, and
death from stroke or heart attack have happened in adults taking
ZELNORM who had an
increased risk of having a cardiovascular event.
Risk factors that increase your risk of a major cardiovascular event
include:
•
currently smoke
•
high blood pressure or your blood pressure is controlled with medicine
that lowers your
blood pressure
•
high blood cholesterol levels or your blood cholesterol levels are
controlled with medicine
that lowers your blood cholesterol levels
•
have or have had diabetes mellitus
•
age 55 years or older
•
obesity
Talk to your healthcare provider about risk factors you may have for a
major cardiovascular event
before you start taking ZELNORM.
Get emergency medical help right away if you have signs or symptoms of
a heart attack, stroke,
mini stroke (transient ischemic attack or TIA) or angina (chest pain
that happens because your
heart is not getting enough oxygen), including:
•
chest pain that may spread to the arms,
neck, jaw, back, or stomach area
(abdomen)
•
feeling sweaty
•
shortness of breath
•
feeling sick or vomiting
•
sudden numbness or weakness, especially
on one side of the body
•
severe headache or confusion
•
problems with vision, speech, or balance
Tell your healthcare provider right away if you are told that you have
narrowing in the blood
vessels that carry blood to your heart (coronary artery disease).
•
Inflammation and injury of the intestines caused by reduced blood flow
to the intestines (ischemic
colitis). Ischemic colitis and other problems of the intestines caused
by reduced blood flow to the
intestines, that sometimes required hospitalization, have happened in
some people taking
ZELNORM. Stop taking ZELNORM and call your he

Karakteristik produk

ZELNORM- TEGASEROD TABLET
US WORLDMEDS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZELNORM™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZELNORM™.
ZELNORM™ (TEGASEROD) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Indications and Usage (1)
03/2019
Contraindications (4)
03/2019
Warnings and Precautions (5.1, 5.4)
03/2019
INDICATIONS AND USAGE
ZELNORM is a serotonin-4 (5-HT ) receptor agonist indicated for the
treatment of adult women less than 65 years of age
with irritable bowel syndrome with constipation (IBS-C). (1)
Limitations of Use:
The safety and effectiveness of ZELNORM in men with IBS-C have not
been established. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage in adult women less than 65 years of age is 6
mg taken twice daily orally at least 30 minutes
before meals. Discontinue ZELNORM in patients who have not had
adequate control of symptoms after 4 to 6 weeks of
treatment. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 6 mg tegaserod. (3)
CONTRAINDICATIONS
ZELNORM is contraindicated in patients with:
A history of myocardial infarction, stroke, transient ischemic attack,
or angina. (4, 5.1)
A history of ischemic colitis or other forms of intestinal ischemia.
(4, 5.2)
Severe renal impairment (eGFR< 15 mL/min/1.73 m ) or end-stage renal
disease. (4, 8.6)
Moderate or severe hepatic impairment (Child-Pugh B or C). (4, 8.7)
A history of bowel obstruction, symptomatic gallbladder disease,
suspected sphincter of Oddi dysfunction, or abdominal
adhesions. (4)
Hypersensitivity to tegaserod. (4)
WARNINGS AND PRECAUTIONS
Cardiovascular Ischemic Events, Including Major Adverse Cardiovascular
Events (MACE): The potential risks of
treatment must be balanced with expectations in improvements in
symptoms of IBS-C. Discontinue ZELNORM
treatment in patients who experience a myocardial infarction, stroke,
transient ischemic attack or angina. (4) Evaluate
the risks and benefits of continued treatment in pa