| Product Name: | Tolvaptan Tablet |
| Brand Name: | Generic |
| Strength: | 15mg, 30mg |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 150s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Diuretic |
| Indication: | Tolvaptan is used to treat hyponatremia (low sodium in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). Tolvaptan is also used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Tolvaptan Tablet 15mg
B) Tolvaptan Tablet 30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Tolvaptan Tablet 15mg
Each Un-coated tablet contains:
Tolvaptan ……………………………………15mg
Excipients………………………………………..q.s.
B) Tolvaptan Tablet 30mg
Each Un-coated tablet contains:
Tolvaptan ……………………………………30mg
Excipients………………………………………..q.s.
THERAPEUTIC INDICATIONS:
Tolvaptan is used to treat hyponatremia (low sodium in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). Tolvaptan is also used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
CAUTION & WARNING:
CAUTION: Read the 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).
Dosage: As directed by the Physician.