Urapidil Capsules USP 60mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Urapidil Capsules USP 30mg
B. Urapidil Capsules USP 60mg
 C. Urapidil Capsules USP 90mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Urapidil Capsules USP 30mg
Each Prolonged-Release hard gelatin capsule contains:
Urapidil USP 30mg
Excipients q.s
Approved Colours are used in capsule shells.

B. Urapidil Capsules USP 60mg
Each Prolonged-Release hard gelatin capsule contains:
Urapidil USP 60mg
Excipients q.s
Approved Colours are used in capsule shells.

C. Urapidil Capsules USP 90mg
Each Prolonged-Release hard gelatin capsule contains:
Urapidil USP 90mg
Excipients q.s
Approved Colours are used in capsule shells.

THERAPEUTIC INDICATIONS:

Urapidil has been used successfully in the treatment of hypertensive emergencies, including eclampsia and pre-eclampsia, hypertensive crisis and hypertension occurring during general and cardiac surgery, rapidly lowering blood pressure without altering heart rate.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP 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° to 25°C (68° to 77°F).
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.

Urapidil Capsules USP 60mg Technical Specification:

Product Name:Urapidil Capsules USP
Brand Name:Generic
Strength:(30mg), (60mg), (90mg)
Dosage Form:Capsules (Prolonged-Release 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:Antihypertensive
Indication: Urapidil has been used successfully in the treatment of hypertensive emergencies, including eclampsia and pre-eclampsia, hypertensive crisis and hypertension occurring during general and cardiac surgery, rapidly lowering blood pressure without altering heart rate.
Storage:Store at 20° to 25°C (68° to 77°F). Protect from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Urapidil Capsules USP 30mg
  • Urapidil Capsules USP 60mg
  • Urapidil Capsules USP 90mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Urapidil Capsules USP 30mg
    Each Prolonged-Release hard gelatin capsule contains:
    Urapidil  USP                               30mg
    Excipients                              q.s
    Approved Colours are used in capsule shells.
  • Urapidil Capsules USP 60mg
    Each Prolonged-Release hard gelatin capsule contains:
    Urapidil  USP                               60mg
    Excipients                              q.s
    Approved Colours are used in capsule shells.
  • Urapidil Capsules USP 90mg
    Each Prolonged-Release hard gelatin capsule contains:
    Urapidil  USP                               90mg
    Excipients                              q.s
    Approved Colours are used in capsule shells.

THERAPEUTIC INDICATIONS:

Urapidil has been used successfully in the treatment of hypertensive emergencies, including eclampsia and pre-eclampsia, hypertensive crisis and hypertension occurring during general and cardiac surgery, rapidly lowering blood pressure without altering heart rate.

CAUTION & WARNING:

CAUTION:  Read enclosed leaflet before use.
Keep 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° to 25°C (68° to 77°F).
Protect from light and moisture.

Dosage: As directed by the Physician
Attach dispensing label as per end county.