FELDENE- piroxicam capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Pfizer Laboratories Div Pfizer Inc

INN (International Adı):

PIROXICAM

Kompozisyon:

PIROXICAM 10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

FELDENE is indicated: FELDENE is contraindicated in the following patients: Risk Summary Use of NSAIDs, including FELDENE, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of FELDENE use between about 20 and 30 weeks of gestation, and avoid FELDENE use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including FELDENE, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of N

Ürün özeti:

FELDENE® (piroxicam) 10 mg capsules are maroon and blue #322, supplied as: 0069-3220-66 bottles of 100 FELDENE® (piroxicam) 20 mg capsules are maroon #323, supplied as: 0069-3230-66 bottles of 100 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

Pfizer Laboratories Div Pfizer Inc
----------
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Revised November 2022
What is the most important information I should know about medicines
called Nonsteroidal 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," "antiplatelet drugs,"
"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:
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
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

Ürün özellikleri

FELDENE- PIROXICAM CAPSULE
PFIZER LABORATORIES DIV PFIZER INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FELDENE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FELDENE.
FELDENE (PIROXICAM) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
FELDENE is a nonsteroidal anti-inflammatory drug indicated for
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
FELDENE (piroxicam) capsules: 10 mg and 20 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
®
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 (5.1)
FELDENE IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS
GRAFT (CABG)
SURGERY (4, 5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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 AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER
DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS
(5.2)
Relief of the signs and symptoms of osteoarthritis (OA) (1)
Relief of the signs and symptoms of rheumatoid arthritis (RA) (1)
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment
goals (2)
OA and RA: 20 mg once daily (2)
Known hypersensitivity to piroxicam or any components of the drug
product (4)
History of asthma, urticaria, or other allergic-type reactions after
taking aspirin or other NSAIDs (4)
In the setting of CABG surgery (4)
Hepatotoxicity: Inform patients of warning signs and s