MELOXICAM tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

RedPharm Drug, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

1.1 Osteoarthritis (OA) Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) Meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weighs ≥ 60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)]. Meloxicam is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see Warnings and Precautions (5.7,5.9) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see W

Ապրանքի ամփոփագիր:

Meloxicam tablets, USP 7.5 mg are yellow coloured, round, biconvex tablets, debossed with "158" on one side and "C" on the other. Meloxicam tablets, USP 15 mg are yellow coloured, round, flat bevelled tablets, debossed with "CIPLA" on one side and "159" on the other. Meloxicam tablets, USP 7.5 mg are available as follows: NDC 69097-158-07 Bottles of 100 NDC 69097-158-12 Bottles of 500 NDC 69097-158-15 Bottles of 1000 Meloxicam tablets, USP 15 mg are available as follows: NDC 69097-159-07 Bottles of 100 NDC 69097-159-12 Bottles of 500 NDC 69097-159-15 Bottles of 1000 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.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

MELOXICAM- meloxicam tablet
RedPharm Drug, Inc.
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MEDICATION GUIDE
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:
with increasing doses of NSAIDs
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:
anytime during use
without warning symptoms
that may cause death
The risk of getting an ulcer or bleeding increases with:
○ past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
○ older age
○ taking medicines called “corticosteroids”,
“anticoagulants”, “SSRIs”, or “SNRIs”
○ poor health
○ increasing doses of NSAIDs
○ advanced liver disease
○ longer use of NSAIDs
○ bleeding problems
○ smoking
○ drinking alcohol
NSAIDs should only be used:
exactly as prescribed
at the lowest dose possible for your treatment
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 condition

Ապրանքի հատկությունները

MELOXICAM- MELOXICAM TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which
can be fatal. This risk may occur early in treatment and may increase
with duration
of use [see Warnings and Precautions (5.1) ].
Meloxicam is contraindicated in the setting of coronary artery bypass
graft (CABG)
surgery [see Contraindications (4) and Warnings and Precautions (5.1)
].
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI)
adverse events
including bleeding, ulceration, and perforation of the stomach or
intestines, which
can be fatal. These events can occur at any time during use and
without warning
symptoms. Elderly patients and patients with a prior history of peptic
ulcer disease
and/or GI bleeding are at greater risk for serious GI events [see
Warnings and
Precautions (5.2) ].
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.
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which can
be fatal. This risk may occur early in treatment and may increase with
duration of use
(5.1)
Meloxicam is contraindicated in the setting of coronary artery bypass
graft (CABG)
surgery (4,5.1)
NSAIDs cause an increased risk of serious gastrointestinal (GI)
adverse events including
bleeding, ulceration, and perforation of the stomach or intestines,
which can be fatal.
These events