MELOXICAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

INN (International Name):

MELOXICAM

Composition:

MELOXICAM 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. Meloxicam tablet is contraindicated in patients with known hypersensitivity to meloxicam. Meloxicam tablets 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 tablet 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, 7.5 mg, yellow colored, circular, biconvex tablets, debossed with “512” on one side and plain on the other side are available as follows: Bottle of 30             NDC 42549-604-30 Bottle of 60             NDC 42549-604-60 Bottle of 90             NDC 42549-604-90 Bottle of 120           NDC 42549-604-12 Meloxicam Tablets, 15 mg, yellow colored, oval, biconvex tablets, debossed with “513” on one side and plain on the other side are available as follows: Bottle of 30             NDC 42549-519-30 Bottle of 60             NDC 42549-519-60 Bottle of 90             NDC 42549-519-90 Bottle of 120           NDC 42549-519-12 Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Keep Meloxicam tablets in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children. Manufactured by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive Detroit, MI 48202                                                                                                                                                                            C.S.No. 5481T05

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

STAT Rx USA LLC
----------
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 pregnant. NSAID medicines should no

Summary of Product characteristics

MELOXICAM - MELOXICAM TABLET
STAT RX USA LLC
----------
MELOXICAM
ATTENTION DISPENSER: ACCOMPANYING MEDICATION GUIDE MUST BE DISPENSED
WITH THIS
PRODUCT.
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 TABLET 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 tablet 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)-2_H_-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)
= 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 include: colloidal
silicon dioxide, crospovidone, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone
and sodium