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Cedafil

Cedafil

tadalafil

Manufacturer:

Centurion Lab

Distributor:

Philgen
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction in adult males.
Dosage/Direction for Use
Adult 10 mg taken at least 30 min prior to anticipated sexual activity, may be increased to 20 mg if 10 mg does not produce adequate effect. Max dose frequency: Once daily. Severe renal impairment Max dose: 10 mg. Hepatic impairment 10 mg taken prior to anticipated sexual activity.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Not to be used in men w/ cardiac disease for whom sexual activity is inadvisable. Patients using any form of organic nitrate. Coadministration w/ guanylate cyclase stimulators eg, riociguat.
Special Precautions
Discontinue use in case of sudden visual defect; event of sudden decrease or loss of hearing. Not recommended for continuous daily use. Serious CV events eg, MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations & tachycardia. Patients w/ anatomical deformation of penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions which may predispose them to priapism (eg, sickle cell anemia, multiple myeloma or leukemia). Consider CV status of patients prior to initiating treatment. Not recommended in combination w/ doxazosin. Not to be taken w/ other PDE5 inhibitors or other treatments for erectile dysfunction. Concomitant use w/ antihypertensive medicinal products; α1 blockers; potent CYP3A4 inhibitors eg, ritonavir, saquinavir, ketoconazole, itraconazole & erythromycin. Severe hepatic impairment (Child-Pugh class C). Not recommended as once-daily dosing in severe renal impairment. Not indicated for use by women. Avoid use during pregnancy. Not to be used during lactation. No relevant use w/ regard to erectile dysfunction in childn.
Adverse Reactions
Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity.
Drug Interactions
Increased AUC & Cmax w/ ketoconazole. Increased AUC w/ ritonavir. Increased plasma conc w/ PIs (eg, saquinavir) & CYP3A4 inhibitors (eg, erythromycin, clarithromycin, itraconazole & grapefruit juice). Potential interaction w/ drugs mediated by inhibition of transporters eg, P-gp. Reduced AUC w/ rifampicin. Plasma conc may be decreased w/ CYP3A4 inducers eg, phenobarb, phenytoin & carbamazepine. Augmented hypotensive effects of nitrates. Increased BP-lowering effect of doxazosin. May potentially lead to symptomatic hypotension w/ riociguat. Increased oral bioavailability of ethinylestradiol & terbutaline. Concomitant use w/ 5-α reductase inhibitors; CYP1A2 substrates (eg, theophylline).
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
Cedafil FC tab 20 mg
Packing/Price
100's;10's
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