Fulove

Fulove

sildenafil

Manufacturer:

Yung Shin

Distributor:

Yung Shin
/
Yu Chun
Concise Prescribing Info
Contents
Sildenafil
Indications/Uses
Erectile dysfunction in adult men.
Dosage/Direction for Use
Adult 50 mg taken as needed approx 1 hr before sexual activity. May be increased to 100 mg, or decreased to 25 mg. Max dose: 100 mg. Max dosing frequency: Once daily. Severe renal impairment Consider 25 mg dose, may be increased step-wise to 50-100 mg as necessary. Hepatic impairment Consider 25 mg dose, may be increased step-wise to 50-100 mg as necessary. Patient receiving CYP3A4 inhibitors except ritonavir Consider 25 mg starting dose.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Co-administration w/ nitric oxide donors (eg, amyl nitrite) or nitrates in any form; guanylate cyclase stimulators eg, riociguat. Men for whom sexual activity is inadvisable (eg, patients w/ severe CV disorders eg, unstable angina or severe cardiac failure). Patients who have loss of vision in 1 eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not w/ previous PDE5 inhibitor exposure. Severe hepatic impairment, hypotension (BP < 90/50 mmHg), recent history of stroke or MI & known hereditary degenerative retinal disorders eg, retinitis pigmentosa.
Special Precautions
Consider CV status of patients prior to treatment initiation. Use w/ caution in patients w/ anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia). Cases of visual defects; discontinue immediately in the event of any sudden visual defect. Patients w/ bleeding disorders or active peptic ulceration. Concomitant use w/ other PDE5 inhibitors, or other pulmonary arterial HTN (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction; α-blockers. Co-administration w/ ritonavir is not advised. May affect ability to drive & use machines. Not indicated for use by women. Not indicated for individuals <18 yr.
Adverse Reactions
Headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia & vision blurred.
Drug Interactions
Increased Cmax & AUC w/ ritonavir & other CYP3A4 inhibitors (eg, saquinavir, ketoconazole, itraconazole, erythromycin, cimetidine). Modest increases in plasma levels w/ grapefruit juice. Decreased plasma conc w/ strong CYP3A4 inducers (eg, rifampin). Potential for serious interaction w/ nicorandil. Potentiated hypotensive effects of nitrates or nitric oxide donors. Additive systemic BP-lowering effect w/ riociguat. Symptomatic hypotension w/ α-blocker. Increased Cmax & AUC of bosentan.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Fulove tab 100 mg
Packing/Price
1 × 4's
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