Tadalafil Stella

Tadalafil Stella

tadalafil

Manufacturer:

Stellapharm

Marketer:

Stadpharm
Concise Prescribing Info
Contents
Tadalafil
Dosage/Direction for Use
Adult 10 mg once daily at least 30 min prior to sexual activity, may be increased to 20 mg once daily if 10 mg does not produce adequate effect. Patient who anticipate frequent use eg, at least twice wkly 5 mg once daily, may be decreased to 2.5 mg once daily. Severe renal & hepatic impairment Max recommended dose: 10 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Men w/ cardiac disease for whom sexual activity is inadvisable. CV disease eg, 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 due non-arteritic anterior ischaemic optic neuropathy (NAION). Co-administration w/ guanylate cyclase stimulators eg, riociguat; organic nitrates.
Special Precautions
Discontinue use if sudden vision defect, decreased or hearing loss occur. Increased risk of NAION. Anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions predisposing to priapism eg, sickle cell anaemia, multiple myeloma or leukemia. Serious CV events eg, MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations & tachycardia. Assess CV status prior to treatment; patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Not to be used in combination w/ other PDE5 inhibitors or other treatments for erectile dysfunction. Not recommended in combination w/ doxazosin. Concomitant use w/ α1-blockers, potent CYP3A4 inhibitors eg, ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin. Not to be used in galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe hepatic insufficiency (Child-Pugh class C). Not to be used in women. Avoid use during pregnancy. Not to be used during lactation.
Adverse Reactions
Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity.
Drug Interactions
Increased exposure & Cmax w/ CYP3A4 inhibitors. Increased plasma conc w/ other PIs eg, saquinavir, other CYP3A4 inhibitors eg, erythromycin, clarithromycin, itraconazole, grapefruit juice. Potential drug interactions mediated by transport inhibitors. Decreased efficacy w/ CYP3A4 inducers eg, rifampicin, phenobarb, phenytoin, carbamazepine. Augmented hypotensive effects of nitrates, riociguat. Increased BP-lowering effect of doxazosin. Increased oral biovailability of ethinylestradiol. Concomitant use w/ α1-blockers, 5α-reductase inhibitors, CYP1A2 substrates eg, theophylline.
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
2's
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