KETOPROFEN capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

KETOPROFEN

Sammensetning:

KETOPROFEN 75 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carefully consider the potential benefits and risks of ketoprofen capsules and other treatment options before deciding to use ketoprofen capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules are indicated for the management of pain. Ketoprofen capsules are also indicated for treatment of primary dysmenorrhea. Ketoprofen capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. Ketoprofen capsules 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 reactions to ketoprofen have been reported in such patients (see WARNINGS , Anaphylactoid Reactions and PRECAUTIONS , Preexisting Asthma ). Ketoprofen capsules are contraindicated for the treatment

Produkt oppsummering:

Ketoprofen capsules are available as follows: 75 mg: Blue cap and white body, imprinted “TEVA” on the cap and “3195” on the body, in bottles of 30 and 60. Keep tightly closed. Store at 20 ° to 25 ° C (68 ° to 77 ° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. J 10/2010 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Rebel Distributors Corp
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
(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 of 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 m

Preparatomtale

KETOPROFEN- KETOPROFEN CAPSULE
REBEL DISTRIBUTORS CORP
----------
KETOPROFEN CAPSULES
RX ONLY
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction (MI), 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).
Ketoprofen capsules are contraindicated for the 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 (GI) events (see WARNINGS).
DESCRIPTION
Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical
name for ketoprofen is 2-(3-
benzoylphenyl)-propionic acid with the following structural formula:
C
H O M.W. 254.29
It has a pKa of 5.94 in methanol: water (3:1) and an n-octanol: water
partition coefficient of 0.97 (buffer
pH 7.4).
Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to
granular powder, melting at about
95°C. It is freely soluble in ethanol, chloroform, acetone, ether and
soluble in benzene and strong alkali,
but practically insoluble in water at 20°C.
Ketoprofen capsules contain 50 mg or 75 mg of ketoprofen for oral
administration.
INACTIVE INGREDIENTS
Drug Product
Lactose, magnesium stearate, and sodium starch glycolate.
Capsule Shell Constituents
Gelatin, printing ink, sodium lauryl sulfate, titanium dioxide, D&C
Red #28, and FD&C Blue #1.
16
14
3
CLINICAL PHARMACOLOGY
Ketoprofen is a non-steroidal anti-inflammatory drug with analgesic
and antipyretic properties.
The anti-inflammatory, analgesic and antipyretic properties of
ketoprofen have been demonstrated in
classical anima