IBUPROFEN tablet, film coated IBUPROFEN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, 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, Anaphylactoid Reac

Product summary:

Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white, round shaped, film-coated tablets engraved "IBU" over "400" on one side). 600 mg (white, oval shaped, biconvex film-coated tablets engraved "IBU" over "600" on one side) Blistercards of 30 NDC 0615-8310-39 800 mg (white, capsule shaped, film-coated tablets engraved "IBU" over "800" on one side) Blistercards of 30 NDC 0615-8311-39 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram — 603 110, Tamilnadu, India. Distributed by: Strides Pharma lnc . East Brunswick, NJ 08816 Revised: 09/2019 1039631

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
IBUPROFEN- IBUPROFEN TABLET, FILM COATED
NCS HealthCare of KY, Inc dba Vangard Labs
----------
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:
o with increasing
doses of NSAIDs
o 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:
o anytime during
use
o without
warning
symptoms
o that may cause
death
The risk of getting
an ulcer or
bleeding increases
with :
o past history of
stomach ulcers, or
stomach or
intestinal bleeding
with use of
NSAIDs
o taking
medicines called
"corticosteroids",
"anticoagulants",
"SSRls", or
"SNRls"
o increasing
doses of NSAIDs
o longer use of
NSAIDs
o smoking
o drinking
alcohol
o older age
o poor health
o advanced liver
disease
o bleeding
problems
NSAIDs should
only be used:
o exactly as
prescribed
o at the lowest
dose possible for
your treatment
o 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
NSAlDS, tell your

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
IBUPROFEN- IBUPROFEN TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
IBUPROFEN TABLETS, USP
BOXED WARNING
CARDIOVASCULAR THROMBOLIC 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 is 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 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, 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, microcrystalline
cellulose, pregelatinized starch, sodium starch glycolate, talc,
magnesium stearate, Opadry II contains
hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate
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 rheumat