Vardenafil Hydrochloride Tablets Technical Specification:
| Product Name: | Vardenafil Hydrochloride Tablets 10mg |
| Brand Name: | Generic |
| Strength: | 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg |
| Dosage Form: | Tablet (Film-coated Tablets) |
| Route of Administration: | Via Oral Route |
| Packing: | 2s, 4s, 8s, 10s, 30s, 40s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristic) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSC and CTD Dossier |
| Therapeutic use: | For erectile dysfunction & phosphodiesterase 5 (PDE5) inhibitors |
| Indication: | Vardenafil is used to treat men with erectile dysfunction (sexual impotence). It belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. |
| Storage: | Store at 20℃ to 25℃ (68 °F to 77 °F)(See USP Control Room Temperature) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Vardenafil Hydrochloride Tablets 2.5mg
Vardenafil Hydrochloride Tablets 5mg
Vardenafil Hydrochloride Tablets 10mg
Vardenafil Hydrochloride Tablets 20mg
Vardenafil Hydrochloride Tablets 40mg
Vardenafil Hydrochloride Tablets 60mg
Vardenafil Hydrochloride Tablets 80mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated Tablet contains:
Vardenafil Hydrochloride Trihydrate USP
Eq. to Vardenafil………….10mg
Excipients……………..q.s.
THERAPEUTIC INDICATIONS:
Vardenafil is used to treat men with erectile dysfunction (sexual impotence). It belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly.
CAUTION:
Keep out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 20℃ to 25℃ (68 °F to 77 °F) (See USP Control Room Temperature)
Dosage: Store cool, dry place, protect from light.
