KETOPROFEN capsule

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Sterling-Knight Pharmaceuticals LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 USP 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 andPRECAUTIONS, Preexisting Asthma ). Ketoprofen capsules are contraindicate

Sommarju tal-prodott:

Ketoprofen capsules USP are available as follows: 25 mg: Dark green color cap and body, size "4" imprinted with "KETO 25" on cap with an edible white ink containing white to off-white crystalline powder supplied as: NDC 69336-127-10 Bottles of 100 NDC 69336-127-11 Bottles of 1000 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). PON/DRUGS/16 13 4193 Manufactured by: Strides Pharma Science Limited Puducherry - 605 014, India Manufactured for: Sterling Knight Pharmaceuticals, LLC Ripley, MS 38663 Revised: 03/2021

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

Sterling-Knight Pharmaceuticals LLC
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MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
RX ONLY
What is the most important information I should know about medicines
called Non-Steroidal 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:
ο with increasing doses of NSAIDs
ο 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:
ο anytime during use
ο without warning symptoms
ο what may cause death
The risk of getting an ulcer or bleeding increases with:
ο past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
ο taking medicines called “corticosteroids” and
“anticoagulants”, “SSRIs”, or “SNRIs
ο increasing doses of NSAIDS
ο longer use of NSAIDs
ο smoking
ο drinking alcohol
ο older age
ο poor health
ο advanced liver disease
ο 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
me

Karatteristiċi tal-prodott

KETOPROFEN- KETOPROFEN CAPSULE
STERLING-KNIGHT PHARMACEUTICALS LLC
----------
KETOPROFEN CAPSULES USP
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 _Warnings and 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_).
Throughout this package insert, the term NSAID refers to a non-aspirin
non-
steroidal anti-inflammatory drug.
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:
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 USP contain 25 mg, 50 mg or 75 mg of Ketoprofen
USP for oral
administration.
1
INACTIVE INGREDIENTS
Drug Product
Colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
povidone, sodium
starch glycolate.
Capsule Shell Constituents
D&C yellow 10, edible printing ink, FD&C blue 1, FD&C yellow 6,
gelatin, sodium lauryl
sulfate, and titanium dioxide.
CLINICAL PHARMACOLOGY
Ketoprofen is a non-steroidal anti-inflamma