Tadalafil Stella

Tadalafil Stella

tadalafil

Manufacturer:

Stellapharm

Distributor:

HK Medical Supplies
/
Health Express
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Dosage/Direction for Use
10 mg taken at least 30 min prior to anticipated sexual activity; may increase dose to 20 mg if effect is inadequate. Max frequency: Once daily. Patient w/ severe renal impairment Max: 10 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients using any form of organic nitrate. Men w/ cardiac disease for whom sexual activity is inadvisable. Patients w/ MI w/in the last 90 days; unstable angina or angina occurring during sexual intercourse; NYHA class 2 or greater heart failure in the last 6 mth; uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled HTN; stroke w/in the last 6 mth. Patients w/ vision loss in 1 eye due to non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not w/ previous PDE5 inhibitor exposure. Co-administration w/ guanylate cyclase stimulators eg, riociguat.
Special Precautions
Not recommended for continuous daily use. Consider patient's CV status before treatment w/ tadalafil. Has vasodilator properties, resulting in mild & transient decreases in BP. Not known if effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Reports of serious CV events, including MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations & tachycardia. Reports of visual defects & cases of NAION; cases of sudden hearing loss. Discontinue treatment in case of sudden visual defect or sudden decrease or loss of hearing. Caution in patients w/ anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, or Peyronie's disease) or in patients w/ conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia). Concomitant administration w/ α1 blockers may lead to symptomatic hypotension in some patients. Combination w/ doxazosin is not recommended. Caution when prescribing to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, & erythromycin). Do not take in combination w/ other PDE5 inhibitors or other treatments for erectile dysfunction. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Patients w/ severe hepatic impairment (Child-Pugh class C). Not indicated for use by women. No relevant use in the paed population.
Adverse Reactions
Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir, saquinavir, erythromycin, clarithromycin, & grapefruit juice. Potential drug interactions mediated by inhibition of transporters. Decreased plasma conc w/ CYP3A4 inducers eg, rifampicin, phenobarb, phenytoin, & carbamazepine. Augmented hypotensive effects of nitrates. Increased BP-lowering effect of doxazosin. Additive systemic BP-lowering effect w/ riociguat. Small increase in heart rate w/ theophylline. Increased oral bioavailability of ethinylestradiol & terbutaline.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Tadalafil Stella FC tab 20 mg
Packing/Price
1 × 2's
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