MELOXICAM tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Strides Pharma Science Limited

INN（国际名称）:

MELOXICAM

组成:

MELOXICAM 7.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Meloxicam Tablets, USP is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1) ]. Meloxicam Tablets, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1) ]. Meloxicam Tablets, USP is 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 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

產品總結:

Meloxicam Tablets, USP 7.5 mg is available as light yellow colored, oval shaped uncoated tablet engraved S 160 on one side and plain on other side. Meloxicam Tablets, USP 15 mg is available as yellow colored, oval shaped uncoated tablet engraved S 161 on one side and plain on other side. Meloxicam Tablets, USP 7.5mg are available as follows: Bottles of 100 NDC: 64380-715-06 Bottles of 500 NDC: 64380-715-07 Meloxicam Tablets, USP 15mg are available as follows: Bottles of 100 NDC: 64380-716-06 Bottles of 500 NDC: 64380-716-07 Storage   Store at 25°C (77°F); excursions permitted to 15° to 30° C (59°to 86°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. 

授权状态:

Abbreviated New Drug Application

资料单张

Strides Pharma Science Limited
----------
SPL MEDGUIDE
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 longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
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 all of your
medical conditions,
including if you:
•

产品特点

MELOXICAM- MELOXICAM TABLET
STRIDES PHARMA SCIENCE LIMITED
----------
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)
RECENT MAJOR CHANGES
Warnings and precautions, Drug Reaction with Eosinophilia
and Systemic Symptoms (5.10)
04/2021
Warnings and Precautions, Fetal Toxicity (5.11)
04/2021
INDICATIONS AND USAGE
Meloxicam Tablets, USP is 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 dose for the shortest duration consistent
with individual patient treatment goals
(2.1).
● OA (2.2) and RA (2.3):
○ Starting dose: 7.5 mg once daily
○ 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 milli