MELOXICAM tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

McKesson Contract Packaging

INN (mednarodno ime):

MELOXICAM

Sestava:

MELOXICAM 7.5 mg

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MELOXICAM- MELOXICAM TABLET
MCKESSON CONTRACT PACKAGING
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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
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)
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 a 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) surge