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SEDEOGRA FILM-COATED TABLET 100MG [SIN16406P]

Active ingredients: SEDEOGRA FILM-COATED TABLET 100MG

Last updated 26 October 2025

Product Info

SEDEOGRA FILM-COATED TABLET 100MG

[SIN16406P]

Product information

Active Ingredient and Strength

SILDENAFIL CITRATE EQV SILDENAFIL - 100 MG

Dosage Form

TABLET, FILM COATED

Manufacturer and Country

THE GOVERNMENT PHARMACEUTICAL ORGANIZATION - THAILAND

Registration Number

SIN16406P

Licence Holder

JOYSON PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

G04BE03

4. Indication
Used for treatment of erectile dysfunction (ED).

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).

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).