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HSA Approval

SEDEOGRA FILM-COATED TABLET 100MG

SIN16406P

SEDEOGRA FILM-COATED TABLET 100MG

SEDEOGRA FILM-COATED TABLET 100MG

December 23, 2021

JOYSON PTE. LTD.

JOYSON PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantJOYSON PTE. LTD.
Licence HolderJOYSON PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

Sildenafil Citrate eqv Sildenafil

100 mg

Sildenafil

Documents

Package Inserts

Sedeogra Film-Coated Tablet 100mg PI.pdf

Approved: February 18, 2022

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