| Product Name: | Piroxicam Capsules USP |
| Brand Name: | Generic |
| Strength: | 10mg, 20mg |
| Dosage Form: | Capsules (Hard gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antirheumatic, Analgesic and Anti-inflammatory |
| Indication: | Piroxicam is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Piroxicam is in a class of medications called NSAIDs. |
| Storage: | Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Piroxicam Capsules USP 10mg
- Piroxicam Capsules USP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Piroxicam Capsules USP 10mg
Each hard gelatin capsule contains:
Piroxicam USP……………………….10mg
Excipients………………………………q.s
Approved Colours are used in capsule shells. - Piroxicam Capsules 20mg
Each hard gelatin capsule contains:
Piroxicam USP……………………….20mg
Excipients………………………………q.s
Approved Colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
Piroxicam is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Piroxicam is in a class of medications called NSAIDs.
CAUTION & WARNING:
CAUTION:
This drug should be used with caution in patients suffering from Coronary Heart Disease (CHD)/ Cardiovascular Disorder.
Read enclosed leaflet before use.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Keep the container tightly closed.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician