MELOXICAM- meloxicam tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)

Доступна с:

Preferred Pharmaceuticals, Inc.

ИНН (Международная Имя):

MELOXICAM

состав:

MELOXICAM 7.5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies  (14.1)]. Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies  (14.1)]. Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2) ]. Meloxicam is contraindicated in the following patients: Risk Summary Use of NSAIDs, including meloxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including meloxicam, in pregnant women starting at 30 weeks of gestation (third trimester) [see Warnings and Precautions (5.10) ]. There are no adequate and well-controlled studies of meloxicam in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women

Обзор продуктов:

Meloxicam Tablets USP, 7.5 mg are yellow, round-shaped, flat beveled edge, uncoated tablets debossed with 'ZC' and '25' on one side and plain on other side and are supplied as follows: Bottle of 15 – 68788-9898-1 Bottle of 20 - 68788-9898-2 Bottle of 28 - 68788-9898-8 Bottle of 30 - 68788-9898-3 Bottle of 60 - 68788-9898-6 Bottle of 90 - 68788-9898-9 Bottle of 100 - 68788-9898-0 Meloxicam Tablets USP, 15 mg are yellow, round-shaped, flat beveled edge, uncoated tablet debossed with 'ZC' and '26' on one side and plain on other side and are supplied as follows: Bottle of 15 – 68788-9897-1 Bottle of 20 - 68788-9897-2 Bottle of 28 - 68788-9897-8 Bottle of 30 - 68788-9897-3 Bottle of 60 - 68788-9897-6 Bottle of 90 - 68788-9897-9 Bottle of 100 - 68788-9897-0 Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Keep meloxicam tablets in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

MELOXICAM- MELOXICAM TABLET
Preferred Pharmaceuticals, Inc.
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Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death .
This risk may happen early in
treatment and may increase:
o with increasing doses of NSAIDs
o with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
"coronary artery
bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth
to the stomach), stomach and intestines:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of
NSAIDs
o taking medicines called "corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
o increasing doses of NSAIDs
o older age
o longer use of NSAIDs
o poor health o smoking
o advanced liver disease
o drinking alcohol
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, including i

Характеристики продукта

MELOXICAM- MELOXICAM TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MELOXICAM TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MELOXICAM TABLETS.
MELOXICAM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
•
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RECENT MAJOR CHANGES
Boxed Warning
5/2016
Indications and Usage, Juvenile Rheumatoid Arthritis (JRA)
Pauciarticular and Polyarticular Course (1.3)
6/2016
Dosage and Administration, General Dosing Instructions (2.1)
6/2016
Dosage and Administration, Juvenile Rheumatoid Arthritis (JRA)
Pauciarticular and Polyarticular Course (2.4)
6/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5)
5/2016
INDICATIONS AND USAGE
Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated
for:
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DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent
with individual patient treatment goals (2.1).
•
ο Starting dose: 7.5 mg once daily
ο Dose may be increased to 15 mg once daily
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DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
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•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ZYDUS PHARMACEUTICALS
(USA) INC. AT 1-877-993-8779
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
•
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USE IN SPECIFIC POPULATIONS
•
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 11/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
1 INDICATIONS AND USAGE
1.1 Osteoarthritis (OA)
1.2 Rheumatoid Arthritis (RA)
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and
Polyarticular Course
2 DOSAGE AND ADMINISTRATION
2.1