IBUPROFEN tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Blenheim Pharmacal, Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

IBUPROFEN tablets are available in the following strengths, colors and sizes: 400 mg (white, round, engraved with IBU 400)                      Bottles of 100                                          NDC 67877-119-01                      Bottles of 500                                          NDC 67877-119-05 600 mg (white, oval, engraved with IBU 600)                      Bottles of 100                                          NDC 67877-120-01                      Bottles of 500                                          NDC 67877-120-05 800 mg (white, capsule shaped, engraved with IBU 800)                      Bottles of 100                                          NDC 67877-121-01                      Bottles of 500                                          NDC 67877-121-05 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Mfd. for: Ascend Laboratories, LLC. Montvale, NJ 07465 Mfd. by: Shasun Chemicals And Drugs Ltd., Unit II, PIMS Road, Periyakalapet, Pudicherry. India. Revised February 2009

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

IBUPROFEN- IBUPROFEN TABLET
Blenheim Pharmacal, Inc.
----------
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

Svojstava lijeka

IBUPROFEN- IBUPROFEN TABLET
BLENHEIM PHARMACAL, INC.
----------
IBUPROFEN TABLETS, USP 400MG, 600MG AND 800MG
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), is
available in 400 mg, 600 mg,
and 800 mg tablets for oral administration. Inactive ingredients:
colloidal silicon dioxide, magnesium
stearate, microcrystalline cellulose, OPADRY® II,
pregelatinizedstarch, sodium starch glycollate, talc.
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 wi