Torfil 2.5/Torfil 5/Torfil 10/Torfil 20

Erectile dysfunction in adult males. Torfil 2.5/Torfil 5 Signs & symptoms of benign prostatic hyperplasia in adult males.

Torfil 2.5 Erectile dysfunction & benign prostatic hyperplasia 5 mg daily at same time every day w/o regard to timing of sexual activity. Benign prostatic hyperplasia w/ finasteride therapy initiation 5 mg once daily for 26 wk. Patient w/ CrCl <30-50 mL/min 5 mg based on individual response. Torfil 5 Erectile dysfunction Once-daily dosing: Initially 2.5 mg daily at same time every day w/o regard to timing of sexual activity, may be increased to 5 mg based on individual efficacy & tolerability. Benign prostatic hyperplasia 5 mg daily at same time every day. Benign prostatic hyperplasia w/ finasteride therapy initiation 5 mg daily at same time every day for up to 26 weeks. Torfil 10/Torfil 20 20 mg prior to anticipated sexual activity. Max daily dosing frequency: 1 tab.

May be taken with or without food: Torfil 2.5 Swallow whole. Torfil 5 Do not split tab.

Hypersensitivity. Patients taking any form of organic nitrates. Torfil 2.5 Not recommended for concomitant use w/ guanylate cyclase (GC) stimulator. Torfil 5 Men for whom sexual activity is inadvisable as a result of underlying CV status. Patients who have loss of vision in 1 eye because of non-arteritic ischemic neuropathy (NAION).

Not recommended in patients w/ cardiac diseases for whom sexual activity is inadvisable. Administer nitrate at least 48 hr after last dose of tadalafil if administration is deemed necessary for life-threatening situation. Reports of prolonged erection lasting >4 hr & priapism. Caution in patients w/ risk factors to priapism (sickle cell anemia, multiple myeloma, or leukemia) & anatomical deformation of penis (angulation, cavernosal fibrosis or Peyronie's disease); bleeding disorders or significant active peptic ulceration. Co-administration w/ α-1 blockers (eg, doxazosin); alcohol. Discontinue medication if vision impairment (potential sign of NAION); sudden hearing loss occurs. Contraindicated in patients w/ known hereditary degenerative retinal disorders (eg, retinitis pigmentosa). Caution in concomitant use w/ α-blockers; alcohol. Not recommended in concomitant use w/ α-blocker in patients w/ benign prostatic hyperplasia. Not recommended in combination w/ other agent for treatment of erectile dysfunction. No protection against STD. Consideration to patients w/ other urological conditions prior to initiating treatment for benign prostatic hyperplasia. Not recommended in patients w/ CrCl <30 mL/min, on hemodialysis, or severe hepatic impairment (Child-Pugh class C). Caution if daily use is prescribed to patients w/ mild to moderate hepatic impairment (Child-Pugh class A or B). May affect ability to drive & use machines. Not recommended in childn <18 yr. Not indicated for use by women. Torfil 5 Rule out presence of carcinoma of the prostate & carefully assess CV conditions prior to initiating treatment for benign prostatic hyperplasia. Do not use in patients using GC stimulator eg, riociguat. Caution in concomitant use w/ potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, & erythromycin). Patients w/ galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this product. Avoid use during pregnancy. Not to be used during breastfeeding. Decreased sperm conc in some men.

Headache, myalgia. Torfil 2.5 Upper abdominal pain. GERD, nausea, vomiting, arthralgia & muscle spasm. Torfil 10/Torfil 20 Nasal congestion. Torfil 5/Torfil 10/Torfil 20 Dyspepsia, back pain, flushing.

Increased exposure w/ CYP3A4 inhibitors (eg, ketoconazole, erythromycin, itraconazole & grapefruit juice). Reduced exposure w/ CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin & phenobarb). Reduced rate of absorption w/o modifying tadalafil exposure w/ antacids (eg, Mg &/or Al hydroxide). Reduced gastric pH w/ nizatidine. Increased hypotensive effects of nitrate. Increased exposure w/ ritonavir (CYP3A4, CYP2C19, & CYP2D6 inhibitor) & likely w/ other HIV PIs. Additive effect on BP w/ α-blockers (eg, doxazosin, tamsulosin & alfuzosin). Potentiated BP-lowering effects of selected antihypertensive agents (eg, amlodipine, ARBs, enalapril, & metoprolol). Increased potential of orthostatic signs & symptoms w/ alcohol (≥5 u).

Drugs for Erectile Dysfunction & Ejaculatory Disorders / Drugs for Bladder & Prostate Disorders

G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.

Rx