MELOXICAM tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

New Horizon Rx Group, LLC

ИНН (Международная Имя):

MELOXICAM

состав:

MELOXICAM 15 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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)]. Pregnancy Category C; Category D starting 30 weeks gestation There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the placent

Обзор продуктов:

Meloxicam Tablets USP are available as light yellow, oblong, biconvex, uncoated tablets containing meloxicam 15 mg. 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 15 mg are available as follows: NDC 58517-260-30 Bottles of 30 STORAGE Store at Controlled Room Temperature 20°-25°C (68°-77°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.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

MELOXICAM - MELOXICAM TABLET
NEW HORIZON RX GROUP, LLC
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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.
MELOXICAM (MELOXICAM) TABLET 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: 15 mg (3)
CONTRAINDICATIONS
Known hypersensitivity (e.g., analphylactoid 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 PREC