MELOXICAM tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Belcher Pharmaceuticals,LLC

ИНН (Международная Имя):

MELOXICAM

состав:

MELOXICAM 15 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Meloxicam Tablets USP are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)] . Meloxicam Tablets USP are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)] . Meloxicam tablets,USP are 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 Tablets USP are contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam Tablets USP 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 USP are contraindicated for the treatment of peri-operative pain in the setting of cor

Обзор продуктов:

Meloxicam Tablets USP are available as 7.5 mg pastel yellow, round, uncoated, debossed tablets with ‘B404’ on one side and plain on the other side, and as 15 mg pastel yellow, capsule-shaped, uncoated, debossed tablets with‘B419’ on one side and plain on the other side. Meloxicam Tablets USP 7.5 mg: NDC 62250-675-30; Bottles of 30 NDC 62250-675-10; Bottles of 100 NDC 62250-675-03; Bottles of 1000 Meloxicam Tablets USP 15 mg: NDC 62250-676-30; Bottles of 30 NDC 62250-676-10; Bottles of 100 NDC 62250-676-03; Bottles of 1000 Storage Store at 25°C (77°F); excursions permitted to 15°C -30°C (59°F -86°F). 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
BELCHER PHARMACEUTICALS,LLC
----------
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 7.5 MG AND 15 MG
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 USP 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, USP is a non-steroidal anti-inflammatory drug
indicated for:
•Osteoarthritis (OA) (1.1)
•Rheumatoid Arthritis (RA) (1.2)
•Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or
older (1.3)
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
•JRA (2.4):
•0.125 mg/kg once daily up to a maximum of 7.5 mg.
DOSAGE FORMS AND STRENGTHS
TABLETS: 7.5 mg, 15 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•Serious and potentially fatal cardiovascular (CV) thrombotic
events, myocardial