MELOXICAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

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 ar

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 68382-050-16 in bottles of 90 tablets with child-resistant closure NDC 68382-050-01 in bottles of 100 tablets NDC 68382-050-05 in bottles of 500 tablets NDC 68382-050-40 in bottles of 5000 tablets NDC 68382-050-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose 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 68382-051-16 in bottles of 90 tablets with child-resistant closure NDC 68382-051-01 in bottles of 100 tablets NDC 68382-051-05 in bottles of 500 tablets NDC 68382-051-40 in bottles of 5000 tablets NDC 68382-051-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20°C to 25° C (68°F 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Pharmaceuticals USA Inc.
----------
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
○ taking medicines called "corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
○ increasing doses of NSAIDs
○ older age
○ longer use of NSAIDs
○ poor health o smoking
○ advanced liver disease
○ drinking alcohol
○ bleeding problems
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 conditions,
inclu

Summary of Product characteristics

MELOXICAM- MELOXICAM TABLET
ZYDUS PHARMACEUTICALS USA 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_.
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)
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)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent
with individual patient treatment goals
(2.1).
OA (2.2) and RA (2.3):
ο Starting dose: 7.5 mg once daily
ο Dose may be increased to 15 mg once daily
JRA (2.4):
7.5 mg once daily in children ≥ 60 kg
Meloxicam tablets are not interchangeable with approved formulations
of oral
meloxicam even if the total milligram strength is the same (2.6)
DOSAGE FORMS AND STRENGTHS
Meloxicam Tablets, USP: 7.5 mg and 15 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to meloxicam or any components of the drug
produ