Drug profile of piroxicam

Dr.Ahad Nawaz
Dr.Ahad NawazPharmacist (Pharm.D) en Fazal Din's Pharma Plus
Drug profile of piroxicam
DRUG PROFILE OF
  PIROXICAM
PRESENTED TO:
     Dr. Samreen Faisal

PRESENTED BY:
       Ahad Nawaz

      Pharm-D   4th Prof
•
           Contents
    Introduction
•   Product Description
•   Chemistry of Drug
•   Pharmacokinetics
•   Clinical Pharmacology
•   Dosage Schedule
•   Precautions
•   Side Effects
•   Administration Guidelines
•   Drug-drug Interactions
•   Drug Food Interactions
•   Therapeutic Drug Monitoring
•   Toxicology
•   References
Introduction
• Generic Name: Piroxicam

• Drug Category: Prescribed

• National Essential Drug List: Present

• WHO Essential Drug List: Present
Product Description
Feldene
• Generic: Piroxicam
• Dosage form: Tab/Cap/Gel/Inj
• Available strength:
        10- 20mg/0.5%w/w& 20mg/ml
• Manufactured By: Pfizer
Oricam
•   Generic: Piroxicam
•   Dosage form: Tab & Cap
•   Available strength:10-20mg
•   Manufactured By: Axis Pharma
Diodex
•   Generic: Piroxicam
•   Dosage form: Tab/Cap & Gel
•   Available strength: 20mg/ 0.5% w/w
•   Manufactured by: Pearl Pharma
CHEMISTRY OF DRUG
Chemical class:
                Enolic acid derivative
Chemical Nature:
                        Acidic
Molecular formula/weight:
                 C15H13N3O4S / 331.35

Physical Properties:
 Off-white to yellow crystalline powder
 Melting Point is198° to 200°c
Pharmacokinetics
Absorption
Piroxicam is absorbed completely
after oral administration and
undergoes enterohepatic
circulation.
Peak concentrations in plasma
occur within 3-5hours
Distribution
• Bioavailability:
                65-90%
• Protein Binding:
                     99%
• Blood Brain Barrier:
      Not cross the BBB
• Secreted in Milk:
                      Yes
• Volume of Distribution:
                      0.14L/kg
Elimination
Half   Metabolism      Active     Route of
Life                   Metabolite Excretion

50h    Metabolise in the Yes     Excreted
       liver. The major          through
       metabolic
                                 Urine and
       transformation is
       CYP-mediated              Feces
       hydroxylation to
       an inactive
       metabolite and
       its glucuronide
       conjugate.
Clinical
Pharmacology
Pharmacologic   NSAIDs
al Class

Therapeutic     Analgesic, Anti-inflammatory,
Class           Antipyretic


MOA             It inhibits cyclooxygenase and
                blocked the synthesis of
                prostaglandins.


Contra-         Inflammatory bowel disease ,
indications     Pregnancy, Hypersensitivity to
                drug

FDA Pregnancy Pregnancy Category D
Class
Dosage Schedule
Rheumatoid Arthritis

• Route of Administration:
               Oral / Parenteral
• Recommended Dose:
               20mg Once daily
• Duration of Therapy:
               7 to 12 Days
Osteoarthritis

• Route of Administration:
               Oral / Parenteral
• Recommended Dose:
               20mg Once daily
• Duration of Therapy:
               7 to 12 Days
Ankylosing Spondylitis

• Route of Administration:
               Oral / Parenteral
• Recommended Dose:
               20mg Once daily
• Duration of Therapy:
               7 to 12 Days
Juvenile Rheumatoid
          Arthritis
• Route of Administration:
              Oral / Parenteral
• Recommended Dose:
     5-15mg Once daily according
      to body weight of the child
• Duration of Therapy:
               5 to 8 Days
Drug profile of piroxicam
Side Effects
GI disturbances including
 Discomfort, Nausea, Diarrhoea,
 Heartburn, bleeding& Ulceration.

Rash, Dizziness, Tinnitus

Hepatic damage

Alveolitis, Pulmonary eosinophilia, Apnea

Dyspepsia, Increase bleeding time
Storage
Keep medicine out of the reach of
 children.

Store in a dry place,
 Protect from sunlight and
 moisture

Store below 30°C
Precautions
• Piroxicam should be used with caution
  in patients with coagulation defects &

• Patients on anticoagulant therapy.

• Discontinue drug if skin reaction
  occurs.
Administration
        Guidelines

• Give with milk, antacids, or food to
  minimize GI upset.
Drug-Drug Interactions
Interacting      Mechanism                Outcome
Drug
Methorexate    Piroxicam have been        Eenhance the
               competitively inhibit      toxicity of
               methotrexate               methotrexate
               accumulation in kidney
               slices.

Diuretics      Also Inhibits the renal    Reduce the
               prostaglandin synthesis    netriuretic effect of
 (Thiazide &   which is responsible for   diuretics
Furosemide )   netriuretic effect.

Warfarin       It also inhibit the        Increase bleeding
               platelets aggregation .    time

ACE            Its have the maximum       Reduce the
               protein binding then ace   antihypertensive
inhibitors     inhibitors                 effect ace
                                          inhibitors
Drug-Food Interactions
Piroxicam have not shown any
food interaction.
Therapeutic Drug Monitoring
• NSAIDs have the wide therapeutic
  index so due to this reason they don’t
  require therapeutic drug monitoring
Toxicology
Toxic Dose      Symptoms           Treatment

60-80mg for 3   Lethargy,          No specific
days            Drowsiness,        antidotes
                 Nausea,
                vomiting,          Emesis or
                Epigastric pain.   activated
                Hypotension,       charcoal or
                Acute Renal        osmotic
                failure,           cathartic may
                Respiratory        be used to
                depression and     overcome the
                Coma may           toxicity
                occur
REFERENCES
 Basic & Clinical Pharmacology_
  Bertram_G._Katzung- 9th Edition Page 823

 Goodman & Gillman's Manual of
  Pharmacology &
  therapeutics-2008 Page-453

 BNF 61st Edition Page-639

 Clarke's Analysis of Drugs and Poisons 3rd
  Edition Page-521
Drug profile of piroxicam
Drug profile of piroxicam
1 de 33

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Drug profile of piroxicam

  • 2. DRUG PROFILE OF PIROXICAM
  • 3. PRESENTED TO: Dr. Samreen Faisal PRESENTED BY: Ahad Nawaz Pharm-D 4th Prof
  • 4. Contents Introduction • Product Description • Chemistry of Drug • Pharmacokinetics • Clinical Pharmacology • Dosage Schedule • Precautions • Side Effects • Administration Guidelines • Drug-drug Interactions • Drug Food Interactions • Therapeutic Drug Monitoring • Toxicology • References
  • 5. Introduction • Generic Name: Piroxicam • Drug Category: Prescribed • National Essential Drug List: Present • WHO Essential Drug List: Present
  • 7. Feldene • Generic: Piroxicam • Dosage form: Tab/Cap/Gel/Inj • Available strength: 10- 20mg/0.5%w/w& 20mg/ml • Manufactured By: Pfizer
  • 8. Oricam • Generic: Piroxicam • Dosage form: Tab & Cap • Available strength:10-20mg • Manufactured By: Axis Pharma
  • 9. Diodex • Generic: Piroxicam • Dosage form: Tab/Cap & Gel • Available strength: 20mg/ 0.5% w/w • Manufactured by: Pearl Pharma
  • 10. CHEMISTRY OF DRUG Chemical class: Enolic acid derivative Chemical Nature: Acidic Molecular formula/weight: C15H13N3O4S / 331.35 Physical Properties:  Off-white to yellow crystalline powder  Melting Point is198° to 200°c
  • 12. Absorption Piroxicam is absorbed completely after oral administration and undergoes enterohepatic circulation. Peak concentrations in plasma occur within 3-5hours
  • 13. Distribution • Bioavailability: 65-90% • Protein Binding: 99% • Blood Brain Barrier: Not cross the BBB • Secreted in Milk: Yes • Volume of Distribution: 0.14L/kg
  • 14. Elimination Half Metabolism Active Route of Life Metabolite Excretion 50h Metabolise in the Yes Excreted liver. The major through metabolic Urine and transformation is CYP-mediated Feces hydroxylation to an inactive metabolite and its glucuronide conjugate.
  • 16. Pharmacologic NSAIDs al Class Therapeutic Analgesic, Anti-inflammatory, Class Antipyretic MOA It inhibits cyclooxygenase and blocked the synthesis of prostaglandins. Contra- Inflammatory bowel disease , indications Pregnancy, Hypersensitivity to drug FDA Pregnancy Pregnancy Category D Class
  • 18. Rheumatoid Arthritis • Route of Administration: Oral / Parenteral • Recommended Dose: 20mg Once daily • Duration of Therapy: 7 to 12 Days
  • 19. Osteoarthritis • Route of Administration: Oral / Parenteral • Recommended Dose: 20mg Once daily • Duration of Therapy: 7 to 12 Days
  • 20. Ankylosing Spondylitis • Route of Administration: Oral / Parenteral • Recommended Dose: 20mg Once daily • Duration of Therapy: 7 to 12 Days
  • 21. Juvenile Rheumatoid Arthritis • Route of Administration: Oral / Parenteral • Recommended Dose: 5-15mg Once daily according to body weight of the child • Duration of Therapy: 5 to 8 Days
  • 23. Side Effects GI disturbances including Discomfort, Nausea, Diarrhoea, Heartburn, bleeding& Ulceration. Rash, Dizziness, Tinnitus Hepatic damage Alveolitis, Pulmonary eosinophilia, Apnea Dyspepsia, Increase bleeding time
  • 24. Storage Keep medicine out of the reach of children. Store in a dry place, Protect from sunlight and moisture Store below 30°C
  • 25. Precautions • Piroxicam should be used with caution in patients with coagulation defects & • Patients on anticoagulant therapy. • Discontinue drug if skin reaction occurs.
  • 26. Administration Guidelines • Give with milk, antacids, or food to minimize GI upset.
  • 27. Drug-Drug Interactions Interacting Mechanism Outcome Drug Methorexate Piroxicam have been Eenhance the competitively inhibit toxicity of methotrexate methotrexate accumulation in kidney slices. Diuretics Also Inhibits the renal Reduce the prostaglandin synthesis netriuretic effect of (Thiazide & which is responsible for diuretics Furosemide ) netriuretic effect. Warfarin It also inhibit the Increase bleeding platelets aggregation . time ACE Its have the maximum Reduce the protein binding then ace antihypertensive inhibitors inhibitors effect ace inhibitors
  • 28. Drug-Food Interactions Piroxicam have not shown any food interaction.
  • 29. Therapeutic Drug Monitoring • NSAIDs have the wide therapeutic index so due to this reason they don’t require therapeutic drug monitoring
  • 30. Toxicology Toxic Dose Symptoms Treatment 60-80mg for 3 Lethargy, No specific days Drowsiness, antidotes Nausea, vomiting, Emesis or Epigastric pain. activated Hypotension, charcoal or Acute Renal osmotic failure, cathartic may Respiratory be used to depression and overcome the Coma may toxicity occur
  • 31. REFERENCES  Basic & Clinical Pharmacology_ Bertram_G._Katzung- 9th Edition Page 823  Goodman & Gillman's Manual of Pharmacology & therapeutics-2008 Page-453  BNF 61st Edition Page-639  Clarke's Analysis of Drugs and Poisons 3rd Edition Page-521