MELOXICAM tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Cipla USA Inc.

INN (Tarptautinis Pavadinimas):

MELOXICAM

Sudėtis:

MELOXICAM 7.5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. Meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1) ]. Meloxicam is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weighs ≥ 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

Produkto santrauka:

Meloxicam tablets, USP 7.5 mg are yellow coloured, round, biconvex tablets, debossed with "158" on one side and "C" on the other. Meloxicam tablets, USP 15 mg are yellow coloured, round, flat bevelled tablets, debossed with "CIPLA" on one side and "159" on the other. Meloxicam tablets, USP 7.5 mg are available as follows: NDC 69097-158-07                  Bottles of 100                             NDC 69097-158-12                  Bottles of 500                             NDC 69097-158-15                  Bottles of 1000                            Meloxicam tablets, USP 15 mg are available as follows: NDC 69097-159-07                  Bottles of 100                               NDC 69097-159-12                  Bottles of 500                               NDC 69097-159-15                  Bottles of 1000 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.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Cipla USA Inc.
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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
○ older age
○ taking medicines called "corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
○ poor health
○ increasing doses of NSAIDs
○ advanced liver disease
○ longer use of NSAIDs
○ bleeding problems
○ smoking
○ drinking alcohol
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, including if
yo

Prekės savybės

MELOXICAM - MELOXICAM TABLET
CIPLA 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)
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 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 milligram strength is the same (2.6)
DOSAGE FORMS AND STRENG