KETOPROFEN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

KETOPROFEN

Composition:

KETOPROFEN 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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. 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. K 12/2010 Repackaged by: PROFICIENT RX LP Westlake Village, CA 91362

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOPROFEN- KETOPROFEN CAPSULE
Proficient Rx LP
----------
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 y

Summary of Product characteristics

KETOPROFEN- KETOPROFEN CAPSULE
PROFICIENT RX LP
----------
KETOPROFEN CAPSULES
3193
3195
RX ONLY
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
1
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.
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).
1
Ketoprofen capsules are contraindicated for the treatment of
peri-operative pain in the
setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
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).
Throughout this package insert, the term NSAID refers to a non-aspirin
non-steroidal anti-inflammatory
drug.
16
14
3
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.
CLINICAL PHARMACOLOGY
Ketoprofen is a non-steroidal anti-inflammatory drug with analgesic
and antipyretic