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 tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets are 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 tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)]. 4.1 Allergic Reactions Meloxicam tablets are contraindicated in patients with known hypersensitivity (e.g. anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings a

Ապրանքի ամփոփագիր:

Meloxicam Tablets USP are available as light yellow, round, flat, uncoated tablets containing meloxicam 7.5 mg or as light yellow, oblong, biconvex, uncoated tablets containing meloxicam 15 mg. The 7.5 mg tablet is impressed with letter U and L on one side and tablet code 7.5 on the other side. The 15 mg tablet is impressed with letter U and L on one side and tablet code 15 on the other side. Meloxicam Tablets USP 7.5 mg are available as follows: NDC 29300-124-13; Bottles of 30 NDC 29300-124-01; Bottles of 100 NDC 29300-124-10; Bottles of 1000 NDC 29300-124-50; Bottles of 5000 Meloxicam Tablets USP 15 mg are available as follows: NDC 29300-125-13; Bottles of 30 NDC 29300-125-01; Bottles of 100 NDC 29300-125-10; Bottles of 1000 NDC 29300-125-50; Bottles of 5000 Storage Store at 200 to 250C (680 to 770F) [See USP Controlled Room Temperature]. Keep Meloxicam Tablets USP 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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17. PATIENT COUNSELING
INFORMATION
See FDA-approved Medication Guide
Patients should be informed of the following information before
initiating therapy with an NSAID and
periodically during the course of ongoing therapy.
17.1 Medication Guide
Inform patients of the availability of a Medication Guide for NSAIDs
that accompanies each prescription
dispensed, and instruct them to read the Medication Guide prior to
using meloxicam tablets.
17.2 Cardiovascular Effects
NSAIDs including meloxicam tablets, may cause serious CV side effects,
such as MI or stroke, which may
result in hospitalization and even death. Although serious CV events
can occur without warning symptoms,
patients should be alert for the signs and symptoms of chest pain,
shortness of breath, weakness, slurring of
speech, and should ask for medical advice when observing any
indicative sign or symptoms. Patients should
be apprised of the importance of this follow-up [see Warnings and
Precautions (5.1)].
17.3 Gastrointestinal Effects
NSAIDs including meloxicam tablets, can cause GI discomfort and,
rarely, serious GI side effects, such as
ulcers and bleeding, which may result in hospitalization and even
death. Although serious GI tract ulcerations
and bleeding can occur without warning symptoms, patients should be
alert for the signs and symptoms of
ulcerations and bleeding, and should ask for medical advice when
observing any indicative sign or symptoms
including epigastric pain, dyspepsia, melena, and hematemesis.
Patients should be apprised of the importance
of this follow-up [see Warnings and Precautions (5.2)].
17.4 Hepatotoxicity
Inform patients of the warning signs and symptoms of hepatotoxicity
(e.g., nausea, fatigue, lethargy, pruritus,
jaundice, right upper quadrant tenderness, and "flu-like" symptoms).
If these occur, instruct patients to stop
therapy and seek immediate medical therapy [see Warnings and
Precautions (5.3)].
17.5 Adverse Skin Reactions
NSAIDs, including meloxicam tablets,

Ապրանքի հատկությունները

MELOXICAM- MELOXICAM TABLET
REDPHARM DRUG, INC.
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BOXED WARNING
BOXED WARNING
WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS
Cardiovascular Risk
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased
risk of
serious cardiovascular (CV) thrombotic events, myocardial infarction,
and stroke,
which can be fatal. This risk may increase with duration of use.
Patients with
cardiovascular disease or risk factors for cardiovascular disease may
be at greater
risk [see Warnings and Precautions (5.1) ].
Meloxicam tablets are contraindicated for the treatment of
peri-operative pain in the
setting of coronary artery bypass graft (CABG) surgery [see
Contraindications
(4.2) and Warnings and Precautions (5.1)].
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal (GI)
adverse reactions
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 are at greater risk for serious
gastrointestinal events
[see Warnings and Precautions (5.2)].
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Meloxicam Tablets USP
safely and effectively. See full prescribing information for Meloxicam
Tablets USP
Meloxicam Tablets USP, for oral use
Initial U.S. Approval: 2000
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with
duration of use. Patients with cardiovascular disease or risk factors
for cardiovascular
disease may be at greater risk. (5.1)
Meloxicam tablets are contraindicated for the treatment of
peri-operative pain in the
setting of coronary artery bypass graft (CABG) surgery. (4.2, 5.1)
Gastrointestinal Risk
NSAIDs cause an increased risk of serious