KETOPROFEN capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Aidarex Pharmaceuticals LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Carefully consider the potential benefits and risks of ketoprofen capsules USP and other treatment options before deciding to use ketoprofen capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules USP are indicated for the management of pain. Ketoprofen capsules USP 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 contraindicate

Produkto santrauka:

Ketoprofen capsules USP are available as follows: 50 mg: Blue cap and light blue body, imprinted “93” over "3193" on the cap and on the body. 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).

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Aidarex Pharmaceuticals LLC
----------
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:
•
owith increasing doses of NSAIDs
•
owith 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:
•
oanytime during use
•
owithout warning symptoms
•
othat may cause death
•
The risk of getting an ulcer or
bleeding increases with:
•
opast history of stomach ulcers, or
stomach or intestinal bleeding with
use of NSAIDs
•
otaking medicines called
“corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
oincreasing
doses of
NSAIDs
•
oolder age
•
olonger use
of NSAIDs
•
opoor health
•
osmoking
•
oadvanced liver
disease
•
odrinking
alcohol
•
obleeding
problems
NSAIDs should only be used:
•
oexactly as prescribed
•
oat the lowest dose possible for your
treatment
•
ofor 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

Prekės savybės

KETOPROFEN- KETOPROFEN CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
KETOPROFEN CAPSULES USP
3193
3195
RX ONLY
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
WARNINGSand PRECAUTIONS).
•Ketoprofen capsules 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 (GI) events (see WARNINGS).
DESCRIPTION
Ketoprofen capsules USP are a non-steroidal anti-inflammatory drug.
The chemical name for
ketoprofen, USP 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, USP is a white or practically white, crystalline 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 USP contain 50 mg or 75 mg of ketoprofen, USP for
oral administration.
INACTIVE INGREDIENTS
Drug Product
Lactose, magnesium stearate, and sodium starch glycolate.
16
14
3
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 properties.
The anti-inflammatory, analgesic and antipyretic properties of
ketoprofen have been demonstrated in
cl