MELOXICAM tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ixtrih issa

Ingredjent attiv:

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

Disponibbli minn:

MedVantx, Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Meloxicam tablets USP are available as follows: 7.5 mg - mottled yellow, capsule-shaped tablets, debossed with “93” on one side and “7234” on the other in bottles of 100 and 1000. 15 mg - mottled yellow, pillow-shaped tablets, debossed with “93” on one side and “7299” on the other in bottles of 100 and 1000. Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature]. Keep meloxicam tablets USP in a dry place. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

                                MELOXICAM- MELOXICAM TABLET
MedVantx, Inc.
----------
Medication Guide
for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
(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 ar
                                
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Karatteristiċi tal-prodott

                                MELOXICAM- MELOXICAM TABLET
MEDVANTX, INC.
----------
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 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.
•
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 TABLETS ARE CONTRAINDICATED FOR THE TREATMENT OF
PERI-OPERATIVE PAIN IN THE SETTING OF
CORONARY ARTERY BYPASSS 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)
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 other NSAIDs (4.1)
Use during the peri-operat
                                
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