IBUPROFEN tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Mas Management Group, Inc.

INN (Isem Internazzjonali):

IBUPROFEN

Kompożizzjoni:

IBUPROFEN 600 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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, urticarial, 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 , Anaphyl

Sommarju tal-prodott:

Ibuprofen 600 mg (white to off-white, caplet, 'I 7' debossing on one side and plain on the other side) are supplied as follows: NDC 69677-225-15 Bottles of 15 NDC 69677-225-20 Bottles of 20 NDC 69677-225-30 Bottles of 30 NDC 69677-225-60 Bottles of 60 NDC 69677-225-90 Bottles of 90 NDC 69677-225-01 Bottles of 120 Ibuprofen 800 mg (white to off-white, caplet, 'I 10' debossing on one side and plain on the other side) are supplied as follows: NDC 69677-226-15 Bottles of 15 NDC 69677-226-20 Bottles of 20 NDC 69677-226-30 Bottles of 30 NDC 69677-226-60 Bottles of 60 NDC 69677-226-90 Bottles of 90 NDC 69677-226-01 Bottles of 120 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Avoid excessive heat above 40ºC (104ºF). Manufactured by: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Toll-free: 1-877-272-7901 Issued: October 2016

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

Mas Management Group, Inc.
----------
MEDGUIDE
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 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

Karatteristiċi tal-prodott

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
MAS MANAGEMENT GROUP, INC.
----------
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:
Ibuprofen, 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,
hypromellose 2910, hydroxypropyl cellulose, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium
lauryl sulphate, 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 (statistically significant p<0.001