Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**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).
ORAL
Medical Information
**4\. Indication** Used for treatment of erectile dysfunction (ED).
**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).
G04BE03
sildenafil
Manufacturer Information
JOYSON PTE. LTD.
The Government Pharmaceutical Organization
Active Ingredients
Documents
Package Inserts
Sedeogra Film-Coated Tablet 100mg PI.pdf
Approved: February 18, 2022