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Tadafil

Tadafil

tadalafil

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction (ED) in adult males. Signs & symptoms of benign prostatic hyperplasia (BPH).
Dosage/Direction for Use
ED (for as needed use) Adult male Recommended dose: 10 mg prior to anticipated sexual activity. Max dose: 20 mg once daily. Renal impairment CrCl 31-50 mL/min Starting dose: 5 mg not more than once daily. Max dose: 10 mg not more than once in every 48 hr, CrCl <30 mL/min or hemodialysis Max dose: 5 mg not more than once in every 72 hr. Hepatic impairment Recommended dose: 10 mg taken prior to anticipated sexual activity. Patient taking potent CYP3A4 inhibitors (eg, ketoconazole or ritonavir) Max dose: 10 mg, not to exceed once every 72 hr. ED (for once daily use) Recommended starting dose: 2.5 mg once daily taken at approx the same time every day, w/o regard to timing of sexual activity. May be increased to 5 mg once daily, based on individual efficacy & tolerability. Patient taking potent CYP3A4 inhibitors (eg, ketoconazole or ritonavir) Max dose: 2.5 mg. BPH Recommended dose: 5 mg taken at approx the same time every day. In combination w/ finasteride: 5 mg taken at approx the same time every day for up to 26 wk. ED & BPH Recommended dose: 5 mg taken at approx the same time every day, w/o regard to timing of sexual activity.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Use in women. In combination w/ any form of organic nitrate. Men w/ cardiac disease for whom sexual activity is inadvisable. Patients w/ CV disease (eg, patients w/ MI w/in the last 90 days, w/ unstable angina or angina occurring during sexual intercourse, w/ New York Heart Association Class ≥2 heart failure in the last 6 mth, w/ uncontrolled arrythmias, hypotension (<90/50 mmHg) or uncontrolled HTN, w/ stroke w/in the last 6 mth. Vision loss in one eye, or w/ previous phosphodiesterase type 5 inhibitor exposure. Co-administration w/ guanylate cyclase stimulators eg, riociguat. Childn <18 yr.
Special Precautions
Determine potential underlying causes before considering treatment. Prior to treatment initiation, CV status of patient should be considered; examine patients to rule out the presence of prostate carcinoma. Concomitant anti-hypertensives. Not recommended in combination w/ doxazosin. Discontinue in case of sudden visual defect; sudden decrease or loss of hearing. Renal & severe hepatic impairment. Patients who experience erections lasting ≥4 hr. Patients w/ anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or in patients who have conditions predisposing to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia). Use w/ potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole & erythromycin). Not for patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Adverse Reactions
Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity.
Drug Interactions
Increased plasma conc w/ other PIs (eg, saquinavir) & other CYP3A4 inhibitors (eg, erythromycin, clarithromycin, itraconazole & grapefruit juice). Decreased efficacy w/ CYP3A4 inducers eg, rifampicin. Augmented hypotensive efffects of nitrates. Increased BP-lowering effect of doxazosin. Additive BP-lowering effect w/ riociguat. Increased oral bioavailability of ethinylestradiol & terbutaline.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders / Drugs for Bladder & Prostate Disorders
ATC Classification
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Tadalafil FC tab 20 mg
Packing/Price
3 × 10's
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