Piroxicam

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• PIROXICAM DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• PIROXICAM CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• LABOR & DELIVERY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• PIROXICAM ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

PIROXICAM DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

• ●For relief of the signs and symptoms of osteoarthritis.

• ●For relief of the signs and symptoms of rheumatoid arthritis.

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PIROXICAM CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

• ●Piroxicam capsules, like other NSAIDs, may cause CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS, Cardiovascular Effects).

• ●Piroxicam capsules, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS, Gastrointestinal EffectsRisk of Ulceration,Bleeding,andPerforation).

• ●Piroxicam capsules, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS and TEN, which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.

• ●Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.

• ●Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.

• ●Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS).

• ●In late pregnancy, as with other NSAIDs, piroxicam capsules should be avoided because they may cause premature closure of the ductus arteriosus.

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LABORATORY TESTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

PIROXICAM ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

SPL MEDGUIDE

• ●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 acoronary artery bypass graft (CABG).

• ●may cause death

• ●The chance of a person getting an ulcer or bleeding increases with:

• ●longer use

• ●smoking

• ●drinking alcohol

• ●older age

• ●having poor health

• ●NSAID medicines should only be used:

• ●at the lowest dose possible for your treatment

• ●for the shortest time needed

• ●What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

• ●menstrual cramps and other types of short-term pain

• ●Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

• ●for pain right before or after heart bypass surgery

• ●Tell your healthcare provider:

• ●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 provider and pharmacist.

• ●if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.

• ●if you are breastfeeding. Talk to your doctor.

• ●What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

• ●chest pain

• ●weakness in one part or side of your body

• ●slurred speech

• ●swelling of the face or throat

• ●Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

• ●more tired or weaker than usual

• ●itching

• ●your skin or eyes look yellow

• ●stomach pain

• ●flu-like symptoms

• ●vomit blood

• ●there is blood in your bowel movement or it is black and sticky like tar

• ●unusual weight gain

• ●skin rash or blisters with fever

• ●swelling of the arms and legs, hands and feet

• ●These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

• ●Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION