MELOXICAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

International Laboratories, LLC

INN (International Name):

MELOXICAM

Composition:

MELOXICAM 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: • 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 Warnings and Precautions (5.7,5.8) ] • In the setting of coronary artery bypass graft (CABG) surger

Product summary:

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: NDC 54458-965-16 in bottles of 30 tablets 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: NDC 54458-964-16 in bottles of 30 tablets Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Keep meloxicam tablets in a dry place. Keep this and all medications out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MELOXICAM- MELOXICAM TABLET
International Laboratories, LLC
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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:
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 or 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 a

Summary of Product characteristics

MELOXICAM- MELOXICAM TABLET
INTERNATIONAL LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MELOXICAM TABLETS SAFETY 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 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 (5.2)
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:
• Osteoarthritis (OA) (1.1)
• Rheumatoid Arthritis (RA) (1.2)
• Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥ 60
kg (1.3) (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent
with individua