Piroxicam description, usages, side effects, indications, overdosage, supplying and lots more!

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Piroxicam

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING


  • ●     NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
  • ●     Piroxicam capsules are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

  • ●     NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events (see WARNINGS).

PIROXICAM DESCRIPTION


Piroxicam





CLINICAL PHARMACOLOGY

Pharmacodynamics


Pharmacokinetics

Absorption



Distribution


Metabolism



Excretion


Pharmacogenetics


Special Populations

Pediatric


Race


Hepatic Insufficiency


Poor Metabolizers of CYP2C9 Substrates


Renal Insufficiency


Other Information





INDICATIONS & USAGE

INDICATIONS AND USAGE


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

PIROXICAM CONTRAINDICATIONS





WARNINGS

WARNINGS

Cardiovascular Effects

Cardiovascular Thrombotic Events




Hypertension


Congestive Heart Failure and Edema


Gastrointestinal EffectsRisk of Ulceration, Bleeding, and Perforation




Renal Effects


Advanced Renal Disease


Anaphylactoid Reactions


Skin Reactions


Other Hypersensitivity Reactions


Pregnancy


PRECAUTIONS

PRECAUTIONS

General



Hepatic Effects



Hematological Effects



Ophthalmologic Effects


Preexisting Asthma


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.

LABORATORY TESTS

Laboratory Tests


DRUG INTERACTIONS

Drug Interactions

Highly Protein Bound Drugs


Aspirin


Methotrexate


ACE-Inhibitors


Diuretics


Lithium


Warfarin


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility



PREGNANCY

Pregnancy

Teratogenic Effects

Pregnancy category C


Nonteratogenic Effects


LABOR & DELIVERY

Labor and Delivery


NURSING MOTHERS

Nursing Mothers


PEDIATRIC USE

Pediatric Use


GERIATRIC USE

Geriatric Use




PIROXICAM ADVERSE REACTIONS

ADVERSE REACTIONS































OVERDOSAGE

OVERDOSAGE



DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION




HOW SUPPLIED

HOW SUPPLIED












SPL MEDGUIDE






  • ●     with longer use of NSAID medicines
  • ●     in people who have heart disease


  • ●     can happen without warning symptoms
  • ●     may cause death

  • ●     taking medicines calledcorticosteroidsandanticoagulants
  • ●     longer use
  • ●     smoking
  • ●     drinking alcohol
  • ●     older age
  • ●     having poor health

  • ●     exactly as prescribed
  • ●     at the lowest dose possible for your treatment
  • ●     for the shortest time needed


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


  • ●     if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • ●     for pain right before or after heart bypass surgery

  • ●     about all of your medical conditions.
  • ●     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.



  • ●     shortness of breath or trouble breathing
  • ●     chest pain
  • ●     weakness in one part or side of your body
  • ●     slurred speech
  • ●     swelling of the face or throat

  • ●     nausea
  • ●     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


  • ●     Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • ●     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.


**


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Piroxicam

Piroxicam

Piroxicam

Piroxicam CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-155(NDC:0093-0757-01)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
piroxicam PIROXICAM 20 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C GREEN NO. 3
GELATIN
LACTOSE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
green 18 mm 93;757 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-155-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074131 2011-04-25


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