IBUPROFEN tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

ibuprofen (UNII: WK2XYI10QM) (ibuprofen - UNII:WK2XYI10QM)

Saatavilla:

RxChange Co.

INN (Kansainvälinen yleisnimi):

ibuprofen

Koostumus:

ibuprofen 600 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. 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, Anaph

Tuoteyhteenveto:

Ibuprofen tablets are available in the following strengths : 400 mg (White to off white, round, biconvex, film coated tablets debossed with ‘121’ on one side and plain on other side) Bottles of 100     (NDC 67877-294-01) Bottles of 500     (NDC 67877-294-05) 600 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on one side and plain on other side) Bottles of 30       (NDC 67877-295-30) Bottles of 50       (NDC 67877-295-50) Bottles of 100     (NDC 67877-295-01) Bottles of 500     (NDC 67877-295-05) 800 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side) Bottles of 30       (NDC 67877-296-30) Bottles of 50       (NDC 67877-296-50) Bottles of 100     (NDC 67877-296-01) Bottles of 500     (NDC 67877-296-05) Store at 20° to 25°C(68° to 77°F)[see USP Controlled Room Temperature] Rx only Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Marksans Pharma Ltd. Verna, Goa-403 722, India Rev. 07/13

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

RxChange Co.
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
• with longer use of NSAID medicines
• in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
• can happen without warning symptoms
• may cause death
The chance of a person getting an ulcer or bleeding increases with:
• taking medicines called “corticosteroids” and
“anticoagulants”
• longer use
• smoking
• drinking alcohol
• older age
• having poor health
NSAID medicines should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
• if you had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery
Tell your healthcare provider:
• about all your medical conditions
• about all of the medicines you take. NSAIDs and some other
medicines can interact with each other and
cause serious side effects. Keep a list of your medicines to show to
your healthcare provider and
pharmacist.
• if you are pregnant. NSAID medicines should not be

Valmisteyhteenveto

IBUPROFEN- IBUPROFEN TABLET
RXCHANGE CO.
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IBUPROFEN TABLETS, USP
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
(See WARNINGS).
Ibuprofen tablets are contraindicated for treatment of peri-operative
pain in the setting of
coronary artery bypass graft (CABG) surgery (see 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).
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:
Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), are
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 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 as