Avanafil & Dapoxetine HCl Tablets Technical Specification:
| Product Name: | Avanafil & Dapoxetine HCl Tablets |
| Brand Name: | Generic |
| Strength: | 50mg+30mg, 100mg+60mg, 200mg+60mg |
| Dosage Form: | Tablets (Uncoated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 4s, 10s, 30s |
| 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: | For erectile dysfunction & high selectivity for PDE5 isoenzyme than other PDE5 inhibitor. |
| Indication: | Avanafil is a second-generation PDE5 inhibitor that has been licensed by the FDA and EMA for the treatment of erectile dysfunction. Because it has high selectivity for PDE5 isoenzyme than other PDE5 inhibitors. |
| Storage: | Store in cool, dry place, below 30℃ temperature, protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Avanafil 50mg & Dapoxetine HCl 30mg Tablet
Avanafil 100mg & Dapoxetine HCl 60mg Tablet
Avanafil 200mg & Dapoxetine HCl 60mg Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Avanafil USP…….50mg
Dapoxetine HCl
Eq. to Dapoxetine……30mg
Excipients……q.s.
Color: Titanium Dioxide USP, Brilliant Blue Lake USP-NF, Tartrazine Lake USP-NF
THERAPEUTIC INDICATIONS:
Avanafil is a second-generation PDE5 inhibitor that has been licensed by the FDA and EMA for the treatment of erectile dysfunction. Because it has high selectivity for PDE5 isoenzyme than other PDE5 inhibitors.
CAUTION:
Keep out of reach of children.
STORAGE & DOSAGE:
Storage: Store in cool, dry place, below 30℃ temperature, protect from light.
Dosage: As directed by the Physician.