MELOXICAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

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 tablet 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)]. There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the placental barrier. Prior to 30 weeks gestation, use meloxicam during

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 63187-082-10; Bottles of 10 NDC 63187-082-14; Bottles of 14 NDC 63187-082-15; Bottles of 15 NDC 63187-082-20; Bottles of 20 NDC 63187-082-30; Bottles of 30 NDC 63187-082-60; Bottles of 60 NDC 63187-082-90; Bottles of 90 Meloxicam Tablets USP 15 mg are available as follows: NDC 63187-083-10; Bottles of 10 NDC 63187-083-14; Bottles of 14 NDC 63187-083-15; Bottles of 15 NDC 63187-083-20; Bottles of 20 NDC 63187-083-30; Bottles of 30 NDC 63187-083-60; Bottles of 60 NDC 63187-083-90; Bottles of 90 Storage Store at Controlled Room Temperature 200 -250 C (680 -770 F) [See USP]. Keep Meloxicam Tablets USP 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
Proficient Rx LP
----------
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 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 time during treatment. Ulcers
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

Summary of Product characteristics

MELOXICAM- MELOXICAM TABLET
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MELOXICAM TABLETS USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MELOXICAM
TABLETS USP
MELOXICAM TABLETS USP
INITIAL U.S. APPROVAL: 2000
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
INDICATIONS AND USAGE
Meloxicam tablets are 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.
• OA (2.2) and RA (2.3):
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT UNICHEM PHARMACEUTICALS
(USA), INC.,
PHARMACOVIGILANCE AT 1-866-562-4616 OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 5/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
1. INDICATIONS AND USAGE
1.1 Osteoarthritis (OA)
1.2 Rheumatoid Arthritis (RA)
2. DOSAGE AND ADMINISTRATION
2.1 General Instructions
2.2 Osteoarthritis
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 TABLETS ARE 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