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.

INN (International Name):

MELOXICAM

Composition:

MELOXICAM 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see CLINICAL STUDIES (14.1)]. Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see CLINICAL STUDIES (14.1)]. 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 artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS (5.1)]. Pregnancy Category C; Category D starting 30 weeks gestation. There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the place

Product summary:

Meloxicam Tablets, 7.5 mg are yellow, round-shaped, flat beveled edge, uncoated tablets debossed with ‘ZC’ and ‘25’ on one side and plain on other side and are supplied as follows: NDC 68382-050-16 in bottles of 90 tablets NDC 68382-050-01 in bottles of 100 tablets NDC 68382-050-05 in bottles of 500 tablets NDC 68382-050-31 in unit-of-use packages of 30 tablets Meloxicam Tablets, 15 mg are yellow, round-shaped, flat beveled edge, uncoated tablet debossed with ‘ZC’ and ‘26’ on one side and plain on other side and are supplied as follows: NDC 68382-051-16 in bottles of 90 tablets NDC 68382-051-01 in bottles of 100 tablets NDC 68382-051-05 in bottles of 500 tablets NDC 68382-051-31 in unit-of-use packages of 30 tablets Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Keep meloxicam tablets 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

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 orany 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
caninteract with each
other and cause serious side effects. Keep a list of yourmedicines to
show to your healthcare
provider and pharmacist
•
if you are pregnant. NSAID medicines should not be used by pre

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 TABLETS SAFETY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR MELOXICAM TABLETS
INITIAL U.S. APPROVAL: 2000
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED 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. (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)
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. (5.2)
INDICATIONS AND USAGE
Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated
for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
DOSAGE AND ADMINISTRATION
Use the lowest effective dose for the shortest duration consistent
with individual treatment goals for the individual patient.
OA (2.2) and RA (2.3):
Starting dose: 7.5 mg once daily
Dose may be increased to 15 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 7.5 mg, 15 mg (3)
CONTRAINDICATIONS
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 or other NSAIDs (4.1)
Use during the peri-operative period in the setting of coronary artery
bypass graft (CABG) surgery (4.2)
WARNINGS AND PRECAUTIONS
Serious and potentially fatal card