MELOXICAM tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

NuCare Pharmaceuticals, Inc.

INN (nemzetközi neve):

MELOXICAM

Összetétel:

MELOXICAM 15 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 2 years of age and older [ see Clinical Studies ( 14.2) ]. 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 Warni

Termék összefoglaló:

Meloxicam Tablets USP are available as light yellow, round, flat, uncoated tablets containing meloxicam uncoated tablets. Meloxicam 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 68071-1993-5 Bottles of 15 NDC 68071-1993-8 Bottles of 28 NDC 68071-1993-3 Bottles of 30 NDC 68071-1993-6 Bottles of 60 NDC 68071-1993-9 Bottles of 90 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

NuCare Pharmaceuticals, Inc.
----------
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.
Revised: 2/2021
Document Id: bc06aac1-92fe-7cd3-e053-2995a90aa148
34391-3
Set id: 4925f194-c924-242c-e054-00144ff88e88
Version: 4
Effective Time: 20210223
NuCare Pharmaceuticals, Inc.

Termékjellemzők

MELOXICAM- MELOXICAM TABLET
NUCARE PHARMACEUTICALS, INC.
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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: 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 GASTROINTESTINAL 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 ARE AT GREATER RISK FOR SERIOUS
GASTROINTESTINAL EVENTS.(
5.2)
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 2 years of age or
older ( 1.3)
DOSAGE AND ADMINISTRATION
Use the lowest effective dose for the shortest duration consistent
with individual treatment goals for the
individual patient.
OA ( 2.2) and RA ( 2.3):
о Starting dose: 7.5 mg once daily
о Dose may be increased to 15 mg once daily
JRA ( 2.4):
о 0.125 mg/kg once daily up to a maximum of 7.5 mg. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 7.5 mg, 15 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity (e.g., anaphylactoid reactions and serious skin
reactions) to meloxicam ( 4.1)
History of asthma, urticaria, or ot