Fluvastatin Sodium Capsules Technical Specification:
| Product Name: | Fluvastatin Capsules USP 40mg |
| Brand Name: | Generic |
| Strength: | 20mg, 40mg |
| Dosage Form: | Capsules |
| Route of Administration: | Via Oral Route |
| Packing: | 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet),SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSC and CTD Dossier |
| Therapeutic use: | Anti-hypercholesterolemia/ HMG-CoA reductase inhibitors |
| Indication: | Fluvastatin is works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. |
| Storage: | Store at 20℃ to 25℃ (69°F to 77°F).(See USP Controlled Room Temperature) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Fluvastatin Sodium 20mg Capsule
Fluvastatin Sodium 40mg Capsule
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each capsule contains:
Fluvastatin Sodium USP
Eq. to Fluvastatin ……………………………….40mg
THERAPEUTIC INDICATIONS:
Fluvastatin is works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.
CAUTION:
Keep out of reach of children.
Keep container tightly closed.
Dispense in tight, light-resistance container as defined in USP with child resistance closure.
STORAGE & DOSAGE:
Storage: Store at 20℃ to 25℃ (69°F to 77°F). (See USP Controlled Room Temperature).
Dosage: See package insert for full prescribing information.