KETOPROFEN- ketoprofen capsule
Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Informace pro uživatele
(PIL)
22-05-2017
Charakteristika produktu
(SPC)
12-05-2018
Aktivní složka:
KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)
Dostupné s:
Bryant Ranch Prepack
INN (Mezinárodní Name):
KETOPROFEN
Složení:
KETOPROFEN 75 mg
Podání:
ORAL
Druh předpisu:
PRESCRIPTION DRUG
Terapeutické indikace:
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
Přehled produktů:
Product: 63629-1836 NDC: 63629-1836-6 24 CAPSULE in a BOTTLE NDC: 63629-1836-7 42 CAPSULE in a BOTTLE NDC: 63629-1836-1 20 CAPSULE in a BOTTLE NDC: 63629-1836-5 21 CAPSULE in a BOTTLE NDC: 63629-1836-2 30 CAPSULE in a BOTTLE NDC: 63629-1836-3 60 CAPSULE in a BOTTLE NDC: 63629-1836-4 90 CAPSULE in a BOTTLE NDC: 63629-1836-0 9 CAPSULE in a BOTTLE NDC: 63629-1836-8 6 CAPSULE in a BOTTLE NDC: 63629-1836-9 120 CAPSULE in a BOTTLE
Stav Autorizace:
Abbreviated New Drug Application
Informace pro uživatele
KETOPROFEN CAPSULES USP
31933195
Rx only
KETOPROFEN-
ketoprofen capsule
Bryant Ranch
Prepack
----------
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:
-
coronary artery bypass graft (CABG).
-
Increased risk of bleeding, ulcers,
and te
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Charakteristika produktu
KETOPROFEN- KETOPROFEN CAPSULE
BRYANT RANCH PREPACK
----------
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 demonstrated in
classi
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