MELOXICAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St. Mary's Medical Park Pharmacy

INN (International Name):

MELOXICAM

Composition:

MELOXICAM 15 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 tablets are 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 reac

Product summary:

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 15 mg are available as follows: NDC 60760-419-30 BOTTLE OF 30 60760-419-60 BOTTLE OF 60 60760-419-90 BOTTLE OF 90 60760-419-07 BOTTLE OF 7 Storage Store at 20 0 to 25 0 C (68 0 to 77 0 F) [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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

St. Mary's Medical Park Pharmacy
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Unichem Pharmaceuticals (USA), Inc.
meloxicam meloxicam MELOXICAM MELOXICAM CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30
SILICON DIOXIDE TRISODIUM CITRATE DIHYDRATE U;L;7;5
meloxicam meloxicam MELOXICAM MELOXICAM CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30
SILICON DIOXIDE TRISODIUM CITRATE DIHYDRATE U;L;15
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 tablets are 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)
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 tablets are 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 includin

Summary of Product characteristics

MELOXICAM- MELOXICAM TABLET
ST. MARY'S MEDICAL PARK PHARMACY
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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: 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 TABLETS ARE 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 a 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 consist