PIROXICAM - piroxicam capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

PIROXICAM (UNII: 13T4O6VMAM) (PIROXICAM - UNII:13T4O6VMAM)

Mevcut itibaren:

Unit Dose Services

INN (International Adı):

PIROXICAM

Kompozisyon:

PIROXICAM 20 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Carefully consider the potential benefits and risks of Piroxicam Capsules, USP and other treatment options before deciding to use Piroxicam Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Piroxicam Capsules, USP is indicated: - For relief of the signs and symptoms of osteoarthritis. - For relief of the signs and symptoms of rheumatoid arthritis. Piroxicam Capsules, USP is contraindicated in patients with known hypersensitivity to piroxicam. Piroxicam 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-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma ). Piroxicam Capsules, USP is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see W

Ürün özeti:

Product: 50436-5559 NDC: 50436-5559-1 30 CAPSULE in a BOTTLE

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Unit Dose Services
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MEDICATION GUIDE FOR NONSTEROIDAL 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 Nonsteroidal 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 increasing doses of NSAID medicines
•
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:
•
increasing doses of NSAID medicines
•
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 Nonsteroidal 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 Nonsteroidal 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

Ürün özellikleri

PIROXICAM - PIROXICAM CAPSULE
UNIT DOSE SERVICES
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_FOR ORAL USE_
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, 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).
Piroxicam Capsules, USP is contraindicated for the treatment of
peri-operative 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 events (see WARNINGS).
DESCRIPTION
Piroxicam Capsules, USP contains piroxicam which is a member of the
oxicam group of nonsteroidal
anti-inflammatory drugs (NSAIDs). Each ivory opaque/Swedish orange
opaque capsule contains 10 mg
piroxicam, each Swedish orange opaque/Swedish orange opaque capsule
contains 20 mg piroxicam for
oral administration. The chemical name for piroxicam is
4-hydroxyl-2-methyl-_N_-2-pyridinyl-2_H_-1,2,-
benzothiazine-3-carboxamide 1,1-dioxide. Piroxicam occurs as a white
crystalline solid, sparingly
soluble in water, dilute acid, and most organic solvents. It is
slightly soluble in alcohol and in aqueous
solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and
a weakly basic pyridyl nitrogen
(pKa 1.8).The molecular weight of piroxicam is 331.35. Its molecular
formula is C
H N O S and it
has the following structural formula:
The inactive ingredients in Piroxicam Capsules, USP include: hard
gelatin capsules (which may contain
FD&C Blue1, FD&C Red 40, D&C Yellow 10, titanium dioxide and gelatin
inactive ingredients), corn
starch, lactose, magnesium stearate and sodium lauryl sulfate.
CLINICAL PHARMACOLOGY
P