MELOXICAM tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Proficient Rx LP

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Meloxicam tablets, USP is indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies ( 14.1) ]. Meloxicam tablets, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies ( 14.1) ]. Meloxicam tablets, USP is 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 is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions

製品概要:

Meloxicam is available as a pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg or 15 mg. The 7.5 mg tablet is impressed with “5” mark on one side, and the 15 mg tablet is impressed with “100” mark on one side. Meloxicam Tablets, USP 7.5 mg is available as follows: NDC 71205-923-07; Bottles of 7 NDC 71205-923-14; Bottles of 14 NDC 71205-923-15; Bottles of 15 NDC 71205-923-28; Bottles of 28 NDC 71205-923-30; Bottles of 30 NDC 71205-923-60; Bottles of 60 NDC 71205-923-90; Bottles of 90 NDC 71205-923-00; Bottles of 100 NDC 71205-923-72; Bottles of 120 NDC 71205-923-55; Bottles of 500 NDC 71205-923-11; Bottles of 1000 Meloxicam Tablets, USP 15 mg is available as follows: NDC 71205-924-07; Bottles of 7 NDC 71205-924-14; Bottles of 14 NDC 71205-924-15; Bottles of 15 NDC 71205-924-28; Bottles of 28 NDC 71205-924-30; Bottles of 30 NDC 71205-924-60; Bottles of 60 NDC 71205-924-90; Bottles of 90 NDC 71205-924-00; Bottles of 100 NDC 71205-924-72; Bottles of 120 NDC 71205-924-55; Bottles of 500 NDC 71205-924-11; Bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. 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.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

MELOXICAM- meloxicam tablet
Proficient Rx LP
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MEDICATION GUIDE
MELOXICAM Tablets, USP
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 seri- ous side effects. Keep a list of your medicines to
show to your healthcare provider and

製品の特徴

MELOXICAM- MELOXICAM TABLET
PROFICIENT RX LP
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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 FOR ORAL USE
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 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
•
•
•
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
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 or o