IBUPROFEN tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

RedPharm Drug, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets 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 patients (see WARNINGS, ANAPHYLACTOID REACT

Ringkasan produk:

Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white, round, debossed BI 4) Bottles of 100 NDC 58657-680-01 Bottles of 500 NDC 58657-680-50 600 mg (white, olive, debossed BI 6) Bottles of 100 NDC 58657-681-01 Bottles of 500 NDC 58657-681-50 800 mg (white, caplet, debossed BI 8) Bottles of 100 NDC 58657-682-01 Bottles of 500 NDC 58657-682-50 Store at room temperature. Avoid excessive heat 40°C (104°F). Manufactured for: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Manufactured by: Anshi Pharmaceutical (Zhongshan) Inc Zhongshan, Guangdong 528437 P.R. China Rev. 04/2017

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

IBUPROFEN- IBUPROFEN TABLET
RedPharm Drug, Inc.
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MEDICATION GUIDE
Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
° with increasing doses of NSAIDs
° with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth
to the stomach), stomach and intestines:
° anytime during use
° without warning symptoms
° that may cause death
The risk of getting an ulcer or bleeding increases with:
° past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
° taking medicines called “corticosteroids”,
“anticoagulants”, “SSRIs”, or “SNRIs”
° increasing doses of NSAIDs
° longer use of NSAIDs
° smoking
° drinking alcohol
° older age
° poor health
° advanced liver disease
° bleeding problems
NSAIDs should only be used:
° exactly as prescribed
° at the lowest dose possible for your treatment
° for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
right before or after heart bypass surgery.
How should I take NAPROSYN Suspension?
Use ONLY a calibrated measuring d

Ciri produk

IBUPROFEN- IBUPROFEN TABLET
REDPHARM DRUG, INC.
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IBUPROFEN
BOXED WARNING
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which can be fatal.
This risk may occur early in treatment and may increase with duration
of use (See WARNINGS
and PRECAUTIONS).
Ibuprofen tablets are contraindicated in the setting of coronary
artery bypass graft (CABG)
surgery (see CONTRAINDICATIONS and WARNINGS).
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. (See WARNINGS).
SPL UNCLASSIFIED SECTION
IBUPROFEN TABLETS, USP
DESCRIPTION
Ibuprofen tablets 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:
[The structural formula forIbuprofen, a nonsteroidal anti-inflammatory
drug (NSAID), is available in
400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive
ingredients: carnauba wax,
colloidal silicon dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline
cellulose, polydextrose, polyethylene glycol, polysorbate, titanium
dioxide.]
Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available
in 400 mg, 600 mg, and 800 mg
tablets for oral administration. Inactive ingredients: carnauba wax,
colloidal silicon dioxide,
croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose,
polyethylene glycol, polysorbate, titanium dioxide.
CLINICAL PHARMACOLOGY