VIVLODEX- meloxicam capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

meloxicam (UNII: VG2QF83CGL) (meloxicam - UNII:VG2QF83CGL)

Available from:

Iroko Pharmaceuticals, LLC

INN (International Name):

meloxicam

Composition:

meloxicam 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VIVLODEX is indicated for management of osteoarthritis pain. VIVLODEX 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) ] Risk Summary Use of NSAIDs, including VIVLODEX, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including VIVLODEX, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of VIVLODEX in pregnant women. Data from observational studies rega

Product summary:

VIVLODEX (meloxicam) capsules are supplied as: Storage Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F 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.

Authorization status:

New Drug Application

Patient Information leaflet

VIVLODEX- MELOXICAM CAPSULE
Iroko Pharmaceuticals, LLC
----------
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
•
taking medicines called "corticosteroids", "anticoagulants", "SSRIs",
or "SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
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 y

Summary of Product characteristics

VIVLODEX- MELOXICAM CAPSULE
IROKO PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIVLODEX™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIVLODEX.
VIVLODEX (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)
VIVLODEX 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)
INDICATIONS AND USAGE
VIVLODEX 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)
VIVLODEX capsules are not interchangeable with other formulations of
oral meloxicam even if the milligram strength
is the same. (2.2)
DOSAGE FORMS AND STRENGTHS
VIVLODEX (meloxicam) Capsules: 5 mg or 10 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to meloxicam or any components of the drug
product (4)
History of asthma, urticaria, or other allergic-type reactions after
taking aspirin or other NSAIDs (4)
In the setting of CABG surgery (4)
WARNINGS