KETOPROFEN- ketoprofen capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

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 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

Product summary:

Ketoprofen capsules USP are available as follows: 75 mg: Blue cap and white body, imprinted “TEVA” on the cap and “3195” on the body, in bottles of 100 Bottle of 30 - 68788-9088-3 Bottle of 60 - 68788-9088-6 Bottle of 90 - 68788-9088-9 Bottle of 100 -68788-9088-1 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). Distributed By: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. L 7/2015 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals, Inc.
----------
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 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:
•
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

Summary of Product characteristics

KETOPROFEN- KETOPROFEN CAPSULE
PREFERRED PHARMACEUTICALS, INC.
----------
KETOPROFEN CAPSULES USP
3193
3195
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
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
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).
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).
16
14
3
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 properties.
The anti-inflammatory, analgesic and antipyretic properties of
ketoprofen have been demonstrate