MELOXICAM- meloxicam tablet MELOXICAM- meloxicam tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Meloxicam (UNII: VG2QF83CGL) (Meloxicam - UNII:VG2QF83CGL)

Available from:

Rebel Distributors Corp.

INN (International Name):

Meloxicam

Composition:

Meloxicam 7.5 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. Meloxicam is contraindicated in patients with known hypersensitivity to meloxicam. Meloxicam should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS , Anaphylactoid Reactions , and PRECAUTIONS , Pre-existing Asthma ). Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Product summary:

Meloxicam Tablets USP are available as light yellow, round, flat, uncoated tablets containing meloxicam 7.5 mg or as light yellow, oblong, biconvex, uncoated tablets containing meloxicam 15 mg. The 7.5 mg tablet is impressed with letter U and L on one side and tablet code 7.5 on the other side. The 15 mg tablet is impressed with letter U and L on one side and tablet code 15 on the other side. Meloxicam Tablets USP 7.5 mg are available as follows: NDC 21695-076-14; Bottles of 14 NDC 21695-076-15; Bottles of 15 NDC 21695-076-30; Bottles of 30 NDC 21695-076-60; Bottles of 60 NDC 21695-076-90; Bottles of 90 Meloxicam Tablets USP 15 mg are available as follows: NDC 21695-077-14; Bottles of 14 NDC 21695-077-15; Bottles of 15 NDC 21695-077-30; Bottles of 30 NDC 21695-077-60; Bottles of 60

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Rebel Distributors Corp.
----------
Meloxicam Tablets USP 7.5 mg and 15 mg
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines).
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist
•
if you are

Summary of Product characteristics

MELOXICAM - MELOXICAM TABLET
REBEL DISTRIBUTORS CORP.
----------
MELOXICAM TABLETS
7.5 MG AND 15 MG
[Unichem Pharmaceuticals (USA), Inc.]
RX ONLY
PRESCRIBING INFORMATION
WARNING
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see WARNINGS and CLINICAL TRIALS).
Meloxicam is contraindicated for the treatment of peri-operative pain
in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS ).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk
for serious gastrointestinal events (see WARNINGS).
DESCRIPTION
Meloxicam, an oxicam derivative, is a member of the enolic acid group
of nonsteroidal anti-
inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam tablet USP
contains 7.5 mg or 15 mg
meloxicam for oral administration. Meloxicam is chemically designated
as 4-hydroxy-2-methyl-_N_-(5-
methyl-2-thiazolyl)-_2H_-1,2-benzothiazine-3-carboxamide-1,1-dioxide.
The molecular weight is 351.4.
Its empirical formula is C
H N O S and it has the following structural formula.
Meloxicam is a pastel yellow solid, practically insoluble in water,
with higher solubility observed in
strong acids and bases. It is very slightly soluble in methanol.
Meloxicam has an apparent partition
coefficient (log P)app = 0.1 in _n_-octanol/buffer pH 7.4. Meloxicam
has pKa values of 1.1 and 4.2.
Meloxicam is available as a tablet for oral administration containing
7.5 mg or 15 mg meloxicam.
The inactive ingredients in Meloxicam tablets USP include colloidal
silicon dioxide, crospovidone,
lactose monohydrate, magnesium stearate, mic