Caliberi

Tadalafil

Erectile dysfunction (ED) in adult males (in order to be effective sexual stimulation is required). Signs & symptoms of benign prostatic hyperplasia (BPH). ED & signs & symptoms of BPH (ED/BPH).

ED Use as needed: 10 mg to be taken prior to anticipated sexual activity. Max: 20 mg once daily. May be taken from 30 min to 36 hr prior to sexual activity. Not recommended for continuous daily use. Once daily use: Max: 5 mg once daily, taken at approx the same time daily, w/o regard to sexual activity timing. BPH 5 mg to be taken approx the same time daily. ED & BPH 5 mg to be taken approx the same time daily, w/o regard to sexual activity timing. Renal impairment (use as needed): Moderate (CrCl 31-50 mL/min) Initially 5 mg not more than once daily. Max: 10 mg not more than once in every 48 hr; severe (CrCl <30 mL/min or on hemodialysis) Max: 5 mg not more than once in every 72 hr. Hepatic impairment (use as needed) 10 mg to be taken prior to anticipated sexual activity. Patient taking potent CYP3A4 inhibitors (use a needed) 10 mg, not more than once every 72 hr.

Should be taken on an empty stomach.

Hypersensitivity. Patients who are using any form of organic nitrate. Not to be used in men w/ cardiac disease for whom sexual activity is inadvisable; consider potential cardiac risk of sexual activity in patients w/ pre‐existing CV disease. Patients w/ MI w/in the last 90 days; unstable angina or angina occurring during sexual intercourse; NYHA class ≥2 heart failure in the last 6 mth; uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled HTN; stroke w/in the last 6 mth. Patients who have vision loss in 1 eye because of non‐arteritic anterior ischaemic optic neuropathy, in connection or not w/ previous PDE5 inhibitor exposure. Co-administration w/ guanylate cyclase stimulators (eg, riociguat) as it may potentially lead to symptomatic hypotension.

Consider medical history & physical exam to diagnose ED or BPH & determine potential underlying causes prior to treatment. Consider CV status prior to initiating any treatment for ED. Patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Examine patients to rule-out presence of prostate carcinoma & assess CV conditions prior to treating BPH. Patients w/ pre-existing CV risk factors. Concomitant administration w/ anti-hypertensives; α1 blockers (eg, doxazosin). Discontinue treatment in case of sudden visual defect; sudden decrease or hearing loss. Seek immediate medical assistance if patients experience erections lasting ≥4 hr. Patients w/ anatomical penis deformation; pre-disposing conditions to priapism. Concomitant use w/ potent CYP3A4 inhibitors (eg, ritonavir, saquinavir, ketoconazole, itraconazole & erythromycin); other PDE5 inhibitors or treatments for ED. May affect ability to drive & use machines. Once daily use is not recommended in patients w/ severe renal impairment or on hemodialysis. Hepatic impairment. Not indicated for use by women. Not for childn <18 yr.

Headache. Dizziness; flushing; nasal congestion; dyspepsia, GERD; back & extremity pain, myalgia.

Increased exposure by ketoconazole, ritonavir. Increased plasma conc by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, itraconazole & grapefruit juice). Potential interactions mediated by transporters inhibition. Reduced AUC by rifampicin. Plasma conc may be decreased by CYP3A4 inducers (eg, phenobarb, phenytoin & carbamazepine). May augment hypotensive effects of nitrates; anti-hypertensives. Not recommended to be combined w/ α blockers. Co-administration w/ 5-α reductase inhibitors; CYP1A2 substrates (eg, theophylline). Increased oral bioavailability of ethinylestradiol & terbutaline. Additive systemic BP lowering effect when combined w/ riociguat.

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

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

POM