MELOXICAM tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Advanced Rx Pharmacy of Tennessee, LLC

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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) surgery [see Warnings and Precautions (5.1) ] 8.1 Pregnancy Risk Summary Use of NSAIDs, including meloxicam, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of meloxicam use between about 20 and 30 weeks of gestation, and avoid meloxicam use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data). Pr

Резиме производа:

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 80425-0045-01 in bottles of 30 tablets NDC 80425-0045-02 in bottles of 60 tablets Storage Store at 20° to 25° C (68° 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.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

MELOXICAM- MELOXICAM TABLET
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE SECTION
MEDICATION GUIDE
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 older age
o longer use of NSAIDs
o poor health o smoking
o advanced liver disease
o drinking alcohol
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

Карактеристике производа

MELOXICAM- MELOXICAM TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
MELOXICAM 15MG TABLETS
BOXED WARNING
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 is 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
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 [see
Warnings and
Precautions (5.2)].
DOSAGE FORMS AND STRENGTHS
Meloxicam Tablets, USP:
15 mg: yellow, round-shaped, flat beveled edge, uncoated tablet
debossed with ‘ZC’
and ‘26’ on one side and plain on other side
CONTRAINDICATIONS
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) surgery [see
Warnings and
Precautions (5.1) ]
WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs