KETOPROFEN capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Misemer Pharmaceuticals, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. 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. Ketoprofen capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Resumen del producto:

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 0276-0504-10 Bottles of 100 50 mg: Light green color cap and body, size “1” imprinted with “KETO 50” on cap with an edible blue ink and containing white to off-white crystalline powder supplied as: Bottles of 100 NDC 0276-0506-10 75 mg: White color cap and body, size “1” imprinted with “KETO 75” on cap with an edible blue ink and containing white to off-white crystalline powder supplied as: Bottles of 100 NDC 0276-0507-10 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). Manufactured for: Misemer Pharmaceuticals, Inc. Ripley, MS 38663 Revised: 09/2021

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

KETOPROFEN- KETOPROFEN CAPSULE
Misemer Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
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)?
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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called “corticosteroids” and
“anticoagulants”, “SSRIs”, or “SNRIs”
o increasing doses of NSAIDS
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o 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 bef

Fitxa tècnica

KETOPROFEN- KETOPROFEN CAPSULE
MISEMER PHARMACEUTICALS, INC.
----------
KETOPROFEN CAPSULES USP
BOXED WARNING
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.
Ketoprofen capsules are contraindicated in the setting of coronary
artery
bypass graft (CABG) surgery.
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.
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:
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,
1
16
14
3
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.
Inactive Ingredients
Drug Product
Colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
povidone, sodium
starch glycolate.
Capsule Shell Constituents
25 mg: D&C yellow 10, edible printing ink, FD&C blue 1, FD&C yellow 6,
gelatin, sodium
lauryl
sulfate, and titanium dioxide.
50 mg: D&C yellow 10, edible printing ink, FD&C green 3, gelatin,
sodium lauryl sulfate,
and
titanium dioxide.
75 mg: Edi