PIROXICAM capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Piroxicam (UNII: 13T4O6VMAM) (Piroxicam - UNII:13T4O6VMAM)

Dostupno od:

Vensun Pharmaceuticals, Inc.

INN (International ime):

Piroxicam

Sastav:

Piroxicam 10 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Piroxicam capsules, USP are indicated: - For relief of the signs and symptoms of osteoarthritis. - For relief of the signs and symptoms of rheumatoid arthritis. Piroxicam capsules are 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 capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including piroxicam capsules, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequa

Proizvod sažetak:

Piroxicam capsules, USP 10 mg and 20 mg for oral administration: 10 mg White Opaque/Red Opaque Size 2 Capsules printed with “P” on cap and “233” on body. NDC 42543-114-01: Bottles of 100 capsules 20 mg Red Opaque/Red Opaque Size 2 Capsules printed with “P” on cap and “234” on body. NDC 42543-115-01: Bottles of 100 capsules NDC 42543-115-05: Bottles of 500 capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Vensun Pharmaceuticals, Inc.
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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
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
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 healthcare

Svojstava lijeka

PIROXICAM- PIROXICAM CAPSULE
VENSUN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIROXICAM CAPSULES, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIROXICAM CAPSULES,
USP.
PIROXICAM CAPSULES, USP, 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 CAPSULES ARE 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Gastrointestinal Bleeding, Ulceration, and
Perforation (5.2)
5/2019
INDICATIONS AND USAGE
Piroxicam capsules are 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, USP: 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 s