IBUPROFEN tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Amneal Pharmaceuticals LLC

INN:

IBUPROFEN

composition:

IBUPROFEN 400 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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, Anaphylac

leaflet_short:

Ibuprofen Tablets, USP are available in the following strengths, colors and sizes: Ibuprofen Tablets USP, 400 mg are white, round, biconvex, aqueous film-coated tablets, debossed "IP 464" on obverse and plain on reverse. They are available as follows: Bottles of 30:              NDC 65162-464-03    Bottles of 60:              NDC 65162-464-06    Bottles of 90:              NDC 65162-464-09 Bottles of 100:            NDC 65162-464-10    Bottles of 500:            NDC 65162-464-50 Ibuprofen Tablets USP, 600 mg are white, oval-shaped, biconvex, aqueous film-coated tablets, debossed "IP 465" on obverse and plain on reverse. They are available as follows: Bottles of 30:              NDC 65162-465-03    Bottles of 50:              NDC 65162-465-05    Bottles of 60:              NDC 65162-465-06 Bottles of 90:              NDC 65162-465-09    Bottles of 100:            NDC 65162-465-10    Bottles of 500:            NDC 65162-465-50 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:              NDC 65162-466-03    Bottles of 50:              NDC 65162-466-05    Bottles of 60:              NDC 65162-466-06 Bottles of 90:              NDC 65162-466-09    Bottles of 100:            NDC 65162-466-10    Bottles of 500:            NDC 65162-466-50 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. 02-2022-06

authorization_status:

Abbreviated New Drug Application

SPC

IBUPROFEN- IBUPROFEN TABLET
AMNEAL PHARMACEUTICALS LLC
----------
IBUPROFEN TABLETS, USP
(400 MG, 600 MG AND 800 MG)
RX ONLY
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 comparabl