KETOPROFEN capsule KETOPROFEN capsule, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

KETOPROFEN

Compoziție:

KETOPROFEN 50 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea. Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are contraindicated in patients who have sho

Rezumat produs:

Ketoprofen Immediate-release Capsules are available containing 50 mg or 75 mg of ketoprofen, USP. The 50 mg capsule is a hard-shell gelatin capsule with a light celery opaque cap and a light celery opaque body filled with a white to off-white powder. The capsule is axially printed with MYLAN over 4070 in black ink on both the body and cap. They are available as follows: The 75 mg capsule is a hard-shell gelatin capsule with a light aqua opaque cap and a light aqua opaque body filled with a white to off-white powder. The capsule is axially printed with MYLAN over 5750 in black ink on both the body and cap. They are available as follows: Ketoprofen Extended-release Capsules, USP are available containing 200 mg of ketoprofen, USP. The 200 mg extended-release capsule is a hard-shell gelatin capsule with a blue green opaque cap and a iron gray opaque body axially printed with MYLAN over 8200 in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from direct light and excessive heat and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED FEBRUARY 2011 KETO:R9mc Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma         74146

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

KETOPROFEN - KETOPROFEN CAPSULE, EXTENDED RELEASE
Physicians Total Care, Inc.
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MEDICATION GUIDE
FOR
NON-STEROIDAL ANTI-INFLAMMATORY
DRUGS
(NSAIDS)
(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)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist

Caracteristicilor produsului

KETOPROFEN - KETOPROFEN CAPSULE
KETOPROFEN - KETOPROFEN CAPSULE, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction (MI), and stroke, which can be fatal. This risk may
increase with duration of use.
Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at
greater risk (see WARNINGS).
Ketoprofen immediate-release capsules and ketoprofen extended-release
capsules are
contraindicated for the treatment of perioperative pain in the setting
of coronary artery bypass
graft (CABG) surgery (see 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).
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:
Its empirical formula is C
H O , with a molecular weight of 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
soluble in benzene and strong alkali,
but practically insoluble in water at 20°C.
Each ketoprofen immediate-release capsule for oral administration
contains 50 mg or 75 mg of
ketoprofen, USP. In addition, each capsule contains the following
inactive ingredients: colloidal silicon
dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium
lauryl sulfate, sodium starch
glycolate. In addition, each of the empty gelatin capsules contains
gelatin and titanium dioxide and the