MELOXICAM tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Blenheim Pharmacal, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Meloxicam tablet is indicated for relief of the signs and symptoms of osteoarthritis [See CLINICAL STUDIES (14.1)]. Meloxicam tablet is indicated for relief of the signs and symptoms of rheumatoid arthritis [See CLINICAL STUDIES (14.1)]. Meloxicam is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam 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 is 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 placental barrier. Prior to 30 week

Produkt oppsummering:

Meloxicam Tablets USP, are available as a light yellow coloured, round, biconvex tablet plain on one side and debossed with ‘7.5’ on other side containing meloxicam 7.5 mg or as a light yellow coloured, oval shaped, biconvex tablets plain on one side and debossed with ‘15’ on other side containing meloxicam 15 mg. Meloxicam Tablets USP, 7.5 mg are available as follows:            Bottles of 100                      NDC 68180 – 501 – 01            Bottles of 1000           NDC 68180 – 501 – 03 Meloxicam Tablets USP, 15 mg are available as follows:            Bottles of 100                      NDC 68180 – 502 – 01            Bottles of 1000           NDC 68180 – 502 – 03 Storage Store at 20 °C 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MELOXICAM - MELOXICAM TABLET
BLENHEIM PHARMACAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MELOXICAM 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
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 TABLET 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 tablet is 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):
o Starting dose: 7.5 mg once daily
o 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 PRECA