ibuprofen- 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:

Dr. Reddy's Laboratories Limited

INN (International Name):

Ibuprofen

Pharmaceutical form:

TABLET, FILM COATED

Composition:

400 mg

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, biconvex film coated tablets embossed 'C101' on one side and '400' on other side).   Bottles of 100          (NDC 55111-101-01)   Bottles of 500          (NDC 55111-101-05) 600 mg (white, modified capsule shaped film coated tablets embossed 'C102' on one side and '600' on other side).   Bottles of 100          (NDC 55111-102-01)   Bottles of 500          (NDC 55111-102-05) 800 mg (white, capsule shaped, biconvex film coated tablets embossed 'C103' on one side and '800' on other side).   Bottles of 100          (NDC 55111-103-01)   Bottles of 500          (NDC 55111-103-05) Store at controlled room temperature 20° to 25°C (68° to 77° F) [see USP]. Manufactured by: Dr. Reddy's Laboratories Limited Bachepalli – 502 325 INDIA Rev: 0306

Patient Information leaflet

Dr. Reddy's Laboratories Limited
----------
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 Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID medicines shoul

Summary of Product characteristics

IBUPROFEN- IBUPROFEN TABLET, FILM COATED
DR. REDDY'S LABORATORIES LIMITED
----------
IBUPROFEN TABLETS, USP
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(See WARNINGS).
Ibuprofen tablets are contraindicated for treatment of peri-operative
pain in the setting of
coronary artery bypass graft (CABG) surgery (see 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), is
available in 400 mg, 600 mg, and
800 mg tablets for oral administration. Inactive ingredients:
microcrystalline cellulose, copovidone
(plasdone-S630), sodium starch glycolate, colloidal silicon dioxide,
magnesium stearate, opadry white
(OY-LS-58900), polysorbate 80.
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 infla