PIROXICAM- piroxicam capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Nivagen Pharmaceuticals, Inc

INN (International Name):

PIROXICAM

Composition:

PIROXICAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation. Risk Summary Use of NSAIDs, including Piroxicam Capsules USP, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosu

Product summary:

Piroxicam Capsules USP, 10 mg are maroon cap and blue body imprinted with '10' on cap and 'FPL' on body in white ink, supplied as: NDC Number            Size 75834-103-01             bottles of 100 Piroxicam Capsules USP, 20 mg are maroon cap and body imprinted with '20' on cap and 'FPL' on body in white ink, supplied as: NDC Number            Size 75834-104-01             bottles of 100 75834-104-05             bottles of 500 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Nivagen Pharmaceuticals, Inc
----------
What is the most important information I should know about medicines
called Nonsteroidal Anti-inflammatory Drugs
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
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 bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth to the
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”, “anticoagulants”,
“SSRIs” or “SNRIs”
o increasing doses of NSAIDs o older age
o longer use of NSAIDs o poor health
o smoking o advanced liver disease
o drinking alcohol o bleeding problems
NSAIDs should only be used:
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
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 provider about all of your
medical conditions, including if you:
• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Talk to your healthcare
provider if you are considering taking NSAIDs
• are breastfeeding or plan to breast feed
Tell your healthcare provider about all of the me

Summary of Product characteristics

PIROXICAM- PIROXICAM CAPSULE
NIVAGEN PHARMACEUTICALS, INC
----------
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 USP 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)
RECENT MAJOR CHANGES
Boxed Warning 5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016
INDICATIONS AND USAGE
Piroxicam Capsules USP is a nonsteroidal anti-inflammatory drug
indicated for (1)
Relief of the signs and symptoms of osteoarthritis (OA)
Relief of the signs and symptoms of rheumatoid arthritis (RA)
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
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
taki