Tadafil - Tablet Tadalafil - 10mg 1 Tablet(s) / Tablet Astra Biopharmaceuticals Ltd. Introduction: Tadafil is used to treat erectile dysfunction in men. It increases blood flow to the penis to help men get an erection. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Tadafil may be taken on an empty stomach or with a meal. It should be strictly taken as advised by your doctor. The medicine will only help you to get an erection if you are sexually stimulated. You should take it about one hour before you plan to have sex. The amount of time... Uses of Tadafil: Erectile dysfunction Side effects of Tadafil: HeadacheBlurred visionMuscle painNasal congestion (stuffy nose)Flushing (sense of warmth in the face, ears, neck and trunk)Nosebleeds How to use Tadafil: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tadafil may be taken with or without food, but it is better to take it at a fixed time. How Tadafil works: Tadafil is a phosphodiesterase (PDE-5) inhibitor. It works in erectile dysfunction by increasing blood flow to the penis by relaxing the muscles in penile blood vessels. What if you forget to take Tadafil?: If you miss a dose of Tadafil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Erectile dysfunction, signs and symptoms of benign prostatic hyperplasia (BPH) Administration: May be taken with or without food. In order for Tadalafil to be effective, sexual stimulation is required. It can be taken from 30 minutes to 12 hours prior to sexual activity. Efficacy of Tadalafil may persist up to 24 hours post-dose. Adult Dose: Oral Erectile dysfunction Adult: For Use as Needed The recommended starting dose of Tadalafil for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. For Once Daily Use The recommended starting dose of Tadalafil for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The IntimateTM dose for once daily use... Renal Dose: Renal impairment (erectile dysfunction) Mild (CrCl >51 mL/min): No dosage adjustment needed Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Renal impairment (pulmonary arterial hypertension) Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability Severe (CrCl <30 mL/min and on hemodialysis): Avoid use Contraindication: Concurrent use of organic nitrates, nitrates and nitric oxide donors. Men with cardiac disease for whom sexual activity is inadvisable. Recent MI (within 90 days) or stroke (within last 6 mth), hypotension (<90/50 mm Hg), unstable angina, heart failure, uncontrolled arrhythmias or hypertension. Mode of Action: Tadalafil is a phosphodiesterase type-5 inhibitor. Precaution: Use caution in patients with anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, myocardial infarction in preceding 90 days, unstable angina, angina occurring during sexual intercourse, NYHA class 2 or greater heart failure in preceding 6 months, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, cerebrovascular accident in preceding 6 months, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors Hepatic or renal impairment; CV diseases; anatomical penile deformation; predisposition to priapism; child 4 hr. Side Effect: >10% Headache (11-42%),Myalgia (1-14%),Respiratory tract infection (3-13%),Nasopharyngitis (2-13%),Dyspepsia (1-13%),Flushing (1-13%),Back pain (2-12%),Nausea (10-11%) 1-10% Nasal congestion (<9%),Gastroesophageal reflux disease (1-3%),Hypertension (1-3%),Bronchitis (<2%),Genitourinary tract infection (<2%) <1% Amnesia,Angina pectoris,Arthralgia,Change in color vision,Conjunctival hyperemia,Dyspnea,Epistaxis Potentially Fatal: Stevens-Johnson syndrome, exfoliative dermatitis, severe cardiovascular events e.g. MI, stroke, sudden cardiac death; Interaction: Concurrent use increased risk of hypotension with beta-blockers; increased risk of priapism with other drugs for erectile dysfunction, e.g. alprostadil; increased heart rate with theophylline; decreased tadalafil serum concentration with CYP 3A4 inducers e.g. rifampicin, efavirenz, carbamazepine, nevirapine, barbiturates, phenobarbital, phenytoin, ribabutin; increased tadalafil serum concentration with CYP3A4 inhibitors e.g. azole antifungals, protease inhibitors, cimetidine, macrolides. Potentially Fatal: Enhanced hypotensive effect with nitrates and nicorandil.