PIROXICAM- piroxicam capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Micro Labs Limited

INN (International Name):

PIROXICAM

Composition:

PIROXICAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Piroxicam capsule is indicated: - For relief of the signs and symptoms of osteoarthritis. - For relief of the signs and symptoms of rheumatoid arthritis. Piroxicam is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see Warnings and Precautions (5.7, 5.9)] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see  Warnings and Precautions (5.7,  5.8)] - In the setting of CABG surgery [see Warnings and Precautions (5.1)] Risk Summary Use of NSAIDs, including piroxicam, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neo

Product summary:

Piroxicam Capsules USP for oral administration: Piroxicam capsules USP, 10 mg  are maroon opaque cap with imprinting 'PR' and blue opaque body with imprinting '10', size “4” hard gelatin capsules filled with off-white to light tan or light yellow powder. Bottles of 15                           NDC 42571-176-15 Bottles of 100                         NDC 42571-176-01 Bottles of 500                         NDC 42571-176-05 Bottles of 1000                       NDC 42571-176-10 Piroxicam capsules USP, 20 mg are maroon opaque cap with imprinting 'PR' and maroon opaque body with imprinting '20', size “2” hard gelatin capsules filled with off-white to light tan or light yellow powder. Bottles of 15                           NDC 42571-177-15 Bottles of 100                         NDC 42571-177-01 Bottles of 500                         NDC 42571-177-05 Bottles of 1000                       NDC 42571-177-10 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Micro Labs Limited
----------
MEDICATION GUIDE
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:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
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:
•
anytime during use
•
without warning symptoms
•
that may cause death
•
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids,” “antiplatelet
drugs,” “anticoagulants,” “SSRIs” or “SNRIs”
•
increasing doses of NSAIDs
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
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 healthc

Summary of Product characteristics

PIROXICAM - PIROXICAM CAPSULE
MICRO LABS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIROXICAM CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIROXICAM
CAPSULES.
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._
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)
PIROXICAM 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)
INDICATIONS AND USAGE
Piroxicam capsule, is a nonsteroidal anti-inflammatory drug indicated
for
Relief of the signs and symptoms of osteoarthritis (OA) ( 1)
Relief of the signs and symptoms of rheumatoid arthritis (RA) ( 1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
( 2)
OA and RA: 20 mg once daily ( 2)
DOSAGE FORMS AND STRENGTHS
Piroxicam capsules: 10 mg and 20 mg ( 3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Inform patients of warning signs and symptoms of
hepatotoxicity. Discontinue if
abnormal liv