MELOXICAM capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Lupin Pharmaceuticals, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Meloxicam capsules are indicated for management of osteoarthritis pain. Meloxicam capsules 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 of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] 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 capsules use between about 20 and 30 weeks of gestation, and avoid meloxica

Vörulýsing:

Meloxicam capsules are supplied as:     •    5 mg - yellow opaque cap and yellow opaque body (imprinted "M76" on the body and "LU" on the cap in black ink)            NDC (68180-188-06), Bottles of 30 capsules            NDC (68180-188-09), Bottles of 90 capsules            NDC (68180-188-02), Bottles of 500 capsules     •    10 mg - green opaque cap and green opaque body (imprinted "M78" on the body and "LU" on the cap in black ink)            NDC (68180-189-06), Bottles of 30 capsules            NDC (68180-189-09), Bottles of 90 capsules            NDC (68180-189-02), Bottles of 500 capsules Storage Store at 25 °C (77 °F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

MELOXICAM- MELOXICAM CAPSULE
Lupin Pharmaceuticals, Inc.
----------
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:
ο with increasing doses of NSAIDs
ο 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:
ο anytime during use
ο without warning symptoms
ο that may cause death
The risk of getting an ulcer or bleeding increases with:
ο past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
ο taking medicines called "corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
ο increasing doses of NSAIDs ο older age
ο longer use of NSAIDs ο poor health
ο smoking ο advanced liver disease
ο drinking alcohol ο bleeding problems
NSAIDs should only be used:
ο exactly as prescribed
ο at the lowest dose possible for your treatment
ο 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 cond

Vara einkenni

MELOXICAM- MELOXICAM CAPSULE
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MELOXICAM CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MELOXICAM
CAPSULES.
MELOXICAM CAPSULES, 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 CAPSULES 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
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS)
(5.10) 04/2021
Warnings and Precautions, Fetal Toxicity (5.11) 04/2021
INDICATIONS AND USAGE
Meloxicam capsule is a non-steroidal anti-inflammatory drug indicated
for management of osteoarthritis
(OA) pain. (1)
DOSAGE AND ADMINISTRATION
• Start with 5 mg orally once daily. May increase dose to 10 mg in
patients who require additional
analgesia (2.1)
• Use the lowest effective dose for shortest duration consistent
with individual patient treatment goals
(2.1)
• Meloxicam capsules are not interchangeable with other formulations
of oral meloxicam even if the
milligram strength is the same. (2.2)
DOSAGE FORMS AND STRENGTHS
Meloxicam Capsules: 5 mg or 10 mg (3)
CONTRAINDICATIONS
•