Cialis

Cialis

tadalafil

Manufacturer:

Eli Lilly

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction. 5 mg: Symptomatic treatment of benign prostatic hyperplasia (BPH).
Dosage/Direction for Use
Adult Erectile dysfunction Recommended dose: 10 mg once daily taken at least 30 min prior to anticipated sexual activity, may be increased to 20 mg once daily in patient whom tadalafil 10 mg does not produce an adequate effect. Patient who anticipate frequent use (ie, at least twice wkly) Recommended dose: 5 mg once daily. Severe renal impairment Max recommended dose: 10 mg. BPH Recommended dose: 5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Men w/ cardiac disease for whom sexual activity is inadvisable. Patients w/ MI w/in last 90 days, unstable angina or angina occurring during sexual intercourse, NYHA class ≥2 heart failure in last 6 mth, uncontrolled arrhythmias, hypotension (<90/50 mmHg) or uncontrolled HTN, stroke w/in last 6 mth. Loss of vision in 1 eye because of non-arteritic anterior ischaemic optic neuropathy (NAION). Co-administration w/ guanylate cyclase stimulators eg, riociguat; organic nitrates.
Special Precautions
Assess for CV conditions prior to treatment. Discontinue use if sudden visual defect or decreased or loss of hearing occur. Patients w/ preexisting CV risk factors. Increased risk of acute NAION. Patients w/ anatomical deformation of penis eg, angulation, cavernosal fibrosis or Peyronie's disease, or conditions predisposing to priapism eg, sickle cell anemia, multiple myeloma or leukemia. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ antihypertensives, α1-blockers, other PDE5 inhibitors, CYP3A4 inhibitors. May affect ability to drive & use machines. Hepatic impairment. Not recommended for once-daily dosing in severe renal impairment. Not to be used in women. Avoid use during pregnancy. Not to be used during lactation. 5 mg: Rule out prostate carcinoma prior to treatment.
Adverse Reactions
Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity.
Drug Interactions
Increased exposure w/ CYP3A4 inhibitors. Potential drug interactions mediated by inhibition of transporters. Decreased plasma conc by CY3A4 inducers. Augmented hypotensive effects of nitrates, antihypertensives. Increased BP-lowering effect of doxazosin, riociguat. Increased bioavailability of ethinylestradiol, terbutaline. 5α-reductase inhibitors, CYP1A2 substrates eg, theophylline.
ATC Classification
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Cialis FC tab 5 mg
Packing/Price
14's;28's
Form
Cialis FC tab 20 mg
Packing/Price
4's;8's
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