MELOXICAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MedVantx, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meloxicam tablets, USP are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)] . Meloxicam tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)] . Meloxicam tablets, USP are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)] . Meloxicam tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) 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 and Precautions (5.7, 5.13)]. Meloxicam tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary

Product summary:

Meloxicam Tablets USP, 7.5 mg are pastel yellow, round, biconvex, uncoated tablet debossed with ‘C’ on one side and ‘79’ on the other side, and is supplied as follows:          Bottles of 100                                          NDC 65862-097-01          Bottles of 500                                          NDC 65862-097-05          Bottles of 1000                                        NDC 65862-097-99 Meloxicam Tablets USP, 15 mg are pastel yellow, oblong, biconvex, uncoated tablet debossed with ‘C’ on one side and ‘80’ on the other side, and is supplied as follows:          Bottles of 100                                          NDC 65862-098-01          Bottles of 500                                          NDC 65862-098-05          Bottles of 1000                                        NDC 65862-098-99 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Keep in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MELOXICAM- MELOXICAM TABLET
MedVantx, Inc.
----------
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 p

Summary of Product characteristics

MELOXICAM- MELOXICAM TABLET
MEDVANTX, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MELOXICAM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MELOXICAM TABLETS.
MELOXICAM TABLETS, USP
INITIAL U.S. APPROVAL: 2000
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
_ _
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
INDICATIONS AND USAGE
Meloxicam is a non-steroidal anti-inflammatory drug indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
Use the lowest effective dose for the shortest duration consistent
with individual treatment goals for the individual patient.
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
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. (5.1)
MELOXICAM IS CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE PAIN
IN THE SETTING OF CORONARY
ARTERY BYPASS GRAFT (CABG) SURGERY. (4.2, 5.1)
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. (5.2)
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or
older (1.3)
OA (2.2) and RA (2.3):
Starting dose: 7.5 mg once daily
Dose may be increased to 15 mg once daily
JRA (2.4):
0.125 mg/kg once daily up to a maximum of 7.5 mg. (2.4)
Tablets: 7.5 mg, 15 mg (3)
Known hypersensitivity (e.g., anaphylactoid reactions and serious skin
reactions) to meloxicam (4.1)
History of asthma, urticaria, or other allergic-type reactions after
taking aspirin o