IBUPROFEN tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Northwind Pharmaceuticals

INN (mednarodno ime):

IBUPROFEN

Sestava:

IBUPROFEN 800 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted. Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen 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 patie

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

IBUPROFEN- IBUPROFEN TABLET
NORTHWIND PHARMACEUTICALS
----------
IBUPROFEN 800 MG
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofen
Tablets, USP and other treatment options
before deciding to use Ibuprofen Tablets, USP. Use the lowest
effective dose for the shortest duration
consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen Tablets, USP are indicated for relief of the signs and
symptoms of rheumatoid arthritis and
osteoarthritis.
Ibuprofen Tablets, USP are indicated for relief of mild to moderate
pain.
Ibuprofen Tablets, USP are also indicated for the treatment of primary
dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness
of Ibuprofen Tablets, USP in children
have not been conducted.
CONTRAINDICATIONS
Ibuprofen tablets are contraindicated in patients with known
hypersensitivity to ibuprofen.
Ibuprofen 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, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting
Asthma).
Ibuprofen tablets are contraindicated for the treatment of
peri-operative pain in the setting of coronary
artery bypass graft (CABG) surgery (see WARNINGS).
WARNINGS
CARDIOVASCULAR EFFECTS
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of
up to three years duration have
shown an increased risk of serious cardiovascular (CV) thrombotic
events, myocardial infarction, and
stroke, which can be fatal. All NSAIDs, both COX-2 selective and
nonselective, may have a similar
risk. Patients with known CV disease or risk factors for CV disease
may be at greater risk. To minimize
the potential risk for an adverse CV event in patients treated with an
NSAID, the lowest effective dose
should be used for the shortest duration possible. Physicians and
patients should remain