IBUPROFEN tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Advanced Rx Pharmacy of Tennessee, LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

INDICATIONS AND USAGE 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. 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

Povzetek izdelek:

Ibuprofen Tablets, USP are available in the following strengths, colors and sizes: Ibuprofen Tablets USP, 800 mg are white, capsule-shaped, biconvex, aqueous film-coated tablets, debossed "IP 466" on obverse and plain on reverse. They are available as follows: Bottles of 30 Tablets NDC: 80425-0047-04 Bottles of 60 Tablets NDC: 80425-0047-03 Bottles of 90 Tablets NDC: 80425-0047-01 Bottles of 100 Tablets NDC: 80425-0047-05 Bottles of 120 Tablets NDC: 80425-0047-02 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2021-05

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

IBUPROFEN- IBUPROFEN TABLET
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE SECTION
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.
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, includi

Lastnosti izdelka

IBUPROFEN- IBUPROFEN TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
IBUPROFEN 800MG TABLETS
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].
DESCRIPTION
Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which
is (±)-2-(p-
isobutylphenyl) propionic acid. Ibuprofen is a white powder with a
melting point of 74° to
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, USP, 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, magnesium stearate,
microcrystalline
cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized
starch, talc, stearic acid,
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 aspiri