IBUPROFEN tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

MARKSANS PHARMA LIMITED

INN (Rahvusvaheline Nimetus):

IBUPROFEN

Koostis:

IBUPROFEN 400 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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  ,  Anap

Toote kokkuvõte:

Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121’ on one side and plain on other side) Bottles of 30             (NDC 25000-121-03) Bottles of 500           (NDC 25000-121-12) Bulk  (6 x 3500)        (NDC 25000-121-29) 600 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on one side and plain on other side) Bottles of 30             (NDC 25000-122-03) Bottles of 500            (NDC 25000-122-12)  Bulk  (6 x 2500)        (NDC 25000-122-28)  800 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side)   Bottles of 30             (NDC 25000-123-03) Bottles of 500            (NDC 25000-123-12) Bulk  (6 x 1900)        (NDC 25000-123-27) “Preserve in well-closed containers” Store at 20 ° to 25°C (68°to 77°F) [See USP Controlled Room Temperature] Rx only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate Verna, Goa-403 722, India Iss. 02/22

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

MARKSANS PHARMA LIMITED
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SPL Medguide
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 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
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
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

Toote omadused

IBUPROFEN - IBUPROFEN TABLET
MARKSANS PHARMA LIMITED
----------
IBUPROFEN TABLETS 400 MG, 600 MG, AND 800 MG
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 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 ),
are available in 400
mg, 600 mg, and 800 mg tablets for oral administration. Inactive
ingredients: silicon
dioxide, croscarmellose sodium, magnesium stearate, microcrystalline
cellulose,
polyethylene glycols, polyvinyl alcohol, pregelatinized starch, talc
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 aspirin in controlling