- Approval Id
- ecf6dfd1cd7c0185
- Drug Name
- SEDEOGRA FILM-COATED TABLET 100MG
- Product Name
- SEDEOGRA FILM-COATED TABLET 100MG
- Approval Number
- SIN16406P
- Approval Date
- 2021-12-23
- Registrant
- JOYSON PTE. LTD.
- Licence Holder
- JOYSON PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **5\. Recommended Dose**
Adults:
- _Usual dosage:_ 50 mg taken as needed, approximately 1 hour before sexual activity. However, sildenafil may be taken anywhere from 30 minutes to 4 hours before sexual activity.
- _Maximum dose:_ 100 mg once daily. The maximum recommended dosing frequently is once daily.
- _Dosage adjustment:_ May be increased to a maximum recommended dose of 100 mg or decreased to 25 mg, based on efficacy and toleration.
**Elderly > 65 years:** Use with caution. Starting dose 25 mg should be considered.
**Dosage considerations for patients stable on alpha-blockers:** Initial 25 mg.
**Dosage adjustment for concomitant use of potent CYP3A4 inhibitors:**
Erythromycin, itraconazole, ketoconazole, saquinavir: Starting dose of 25 mg for sildenafil should be considered.
Ritonavir: Not to exceed a maximum single dose of sildenafil 25 mg in a 48-hour period.
**Dosage adjustment in renal impairment:**
Clcr < 30 mL/minute: Starting dose of 25 mg should be considered.
**Dosage adjustment in hepatic impairment:**
Starting dose of 25 mg should be considered; not studied in severe impairment (Child-Pugh class C).
- Route Of Administration
- ORAL
- Indication Info
- **4\. Indication**
Used for treatment of erectile dysfunction (ED).
- Contraindications
- **7\. Contraindications**
Sildenafil is contraindicated in patients with known hypersensitivity to sildenafil or any component of the formulation; concurrent use (regularly/intermittently) of organic nitrates in any form (e.g., nitroglycerin, isosorbide dinitrate).
- Atc Code
- G04BE03
- Atc Item Name
- sildenafil
- Pharma Manufacturer Name
- JOYSON PTE. LTD.
- Company Detail Path
- /organization/fb1f651554f66c98/joyson-pte-ltd
