KETOPROFEN capsule

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 and PRECAUTIONS, Preexisting Asthma ). Ketoprofen capsules are contraindica

পণ্য সারাংশ:

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 and containing white to off-white crystalline powder supplied as: Bottles of 100 NDC 23155-020-01 Bottles of 500 NDC 23155-020-05 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 23155-021-01 Bottles of 500 NDC 23155-021-05 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 23155-022-01 Bottles of 500 NDC 23155-022-05 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: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG(3784) Revised: 05/2021

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
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SPL MEDGUIDE
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:
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 before or after heart bypass surgery
Before taking NSAIDs, tell your healthcare provider about all of your
m

পণ্য বৈশিষ্ট্য

KETOPROFEN - KETOPROFEN CAPSULE
HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS LABS INC.
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KETOPROFEN CAPSULES USP
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:
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
1
16
14
3
°
°
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