Cialis 5 mg

Cialis 5 mg

tadalafil

Manufacturer:

Eli Lilly

Distributor:

Zuellig
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction. Signs & symptoms of benign prostatic hyperplasia.
Dosage/Direction for Use
Erectile dysfunction (ED) 5 mg once daily at approx the same time every day. Co-administration w/ an α-blocker for ED Initiate at the lowest recommended dose; patient should be stable on α-blocker therapy prior to initiating treatment. Benign prostatic hyperplasia (BPH) 5 mg once daily at approx the same time every day. Initiated BPH therapy w/ finasteride 5 mg once daily at approx the same time every day for up to 26 wk. ED & BPH 5 mg once daily at approx the same time every day w/o regard to timing of sexual activity. Renal impairment CrCl <30-50 mL/min 5 mg once daily.
Administration
May be taken with or without food: Take at approx the same time every day. Swallow whole, do not split.
Contraindications
Hypersensitivity. Concomitant use w/ any form of organic nitrate (either regularly &/or intermittently); guanylate cyclase stimulators.
Special Precautions
Not indicated for use in females. Not to be used in men for whom sexual activity is inadvisable as a result of their underlying CV status. At least 48 hr should have elapsed after the last dose before nitrate administration. Patients w/ left ventricular outflow obstruction (eg, aortic stenosis & idiopathic hypertrophic subaortic stenosis); severely impaired autonomic control of BP. Not recommended in 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. Priapism-predisposing conditions (eg, sickle cell anemia, multiple myeloma or leukemia) or anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease). Discontinue in the event of sudden loss of vision in one or both eyes which may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); sudden decrease or loss of hearing. Not recommended in patients w/ known hereditary degenerative retinal disorders, including retinitis pigmentosa; w/ CrCl <30 mL/min or on hemodialysis; severe hepatic impairment (Child Pugh class C). Bleeding disorders or significant active peptic ulceration. Offers no protection against sexually transmitted diseases. Concomitant use w/ nitrates, α-blockers, anti-hypertensives, potent CYP3A4 inhibitors, & alcohol. Mild or moderate hepatic impairment (Child Pugh class A or B). Not indicated for use in childn <18 yr. Elderly. BPH: Consider other urological conditions that may cause similar symptoms prior to initiating treatment; may coexist w/ prostate cancer. Not recommended in combination w/ α-blockers.
Adverse Reactions
Headache, dyspepsia, nasopharyngitis, back pain, upper resp tract infection, flushing, myalgia, cough, diarrhea, nasal congestion, pain in extremity, GERD, abdominal pain, HTN, nasal congestion, dizziness.
Drug Interactions
Potentiated hypotensive effects of nitrates. Additive effect on BP w/ α-blockers (doxazosin, tamsulosin or alfuzosin). Small reductions in BP w/ amlodipine, angiotensin II receptor blockers, enalapril, & metoprolol. Increased potential for orthostatic signs & symptoms including increase in heart rate, decrease in standing BP, dizziness & headache w/ substantial consumption of alcohol (eg, ≥5 u). Reduced apparent rate of absorption w/o altering exposure (AUC) w/ antacids (Mg hydroxide/Al hydroxide). Increased exposure w/ CYP3A4 inhibitors (eg, ketoconazole, erythromycin, itraconazole, & grapefruit juice) & HIV PIs (eg, ritonavir). Reduced exposure w/ CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin, & phenobarb).
MIMS Class
Drugs for Bladder & Prostate Disorders / Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Cialis 5 mg FC tab 5 mg
Packing/Price
28's
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