IBUPROFEN tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Доступна с:

McKesson Contract Packaging

ИНН (Международная Имя):

IBUPROFEN

состав:

IBUPROFEN 400 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

IBUPROFEN- IBUPROFEN TABLET
MCKESSON CONTRACT PACKAGING
----------
IBUPROFEN TABLETS, USP
RX ONLY
CARDIOVASCULAR RISK
GASTROINTESTINAL RISK
DESCRIPTION
Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which
is (±) – 2 – (_p _– isobutylphenyl)
propionic acid. Ibuprofen is a white powder with a melting point of
74-77° C and is very slightly
soluble in water (<1 mg/mL) and readily soluble in organic solvents
such as ethanol and acetone.
The structural formula is represented below:
Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID),
is available in 400 mg, 600
mg, and 800 mg tablets for oral administration. Inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl
alcohol, pregelatinized starch, talc, stearic acid, and titanium
dioxide.
CLINICAL PHARMACOLOGY
Ibuprofen tablets contain ibuprofen which possesses analgesic and
antipyretic activities. Its mode of
action, like that of other NSAIDs, is not completely understood, but
may be related to prostaglandin
synthetase inhibition.
In clinical studies in patients with rheumatoid arthritis and
osteoarthritis, ibuprofen tablets have been
shown to be comparable to aspirin in controlling pain and inflammation
and to be associated with a
statistically significant reduction in the milder gastrointestinal
side effects (see ADVERSE
REACTIONS).
Ibuprofen tablets may be well tolerated in some patients who have had
gastrointestinal side effects with
aspirin, but these patients when treated with ibuprofen tablets should
be carefully followed for signs
and symptoms of gastrointestinal ulceration and bleeding. Although it
is not definitely known whether
ibuprofen tablets causes less peptic ulceration than aspirin, in one
study involving 885 patients with
rheumatoid arthritis treated for up to one year, there were no reports
of gastric ulceration with
ibuprofen tablets whereas frank ulceration was reported in 13 patients
in the aspirin group (statisti