Talafil

Talafil

tadalafil

Manufacturer:

Millimed

Distributor:

Prosp Pharma

Marketer:

Prosp Pharma
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction in adult men. 5 mg: Symptomatic treatment of benign prostatic hyperplasia in adult males including those w/ erectile dysfunction.
Dosage/Direction for Use
Erectile dysfunction Recommended dose: 10 mg taken at least 30 min prior to anticipated sexual activity, may be increased to 20 mg once daily in patient whom tadalafil 10 mg does not produce adequate effect. Max dose frequency: Once daily. Patient who anticipate frequent use (ie, at least twice wkly) Recommended dose: 5 mg once daily at the same time of the day, may be decreased to 2.5 mg once daily. Benign prostatic hyperplasia Recommended dose: 5 mg daily at the same time of the day. Severe renal impairment Max recommended dose: 10 mg for on-demand treatment. Impaired hepatic function Recommended dose: 10 mg prior to anticipated sexual activity.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Not to be used in men whom sexual activity is inadvisable due to underlying CV status. Patients w/ 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. Concomitant use w/ organic nitrate or nitrate. 5 mg: History of loss of vision in 1 eye because of non-arteritic anterior ischaemic optic neuropathy (NAION).
Special Precautions
Not for sexual stimulation. Not to be used more than once daily. Serious CV event including MI, sudden cardiac death, unstable angina, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations, tachycardia, HTN; visual disturbance/sudden loss of vision, bone pain, sweating, fainting. Increased risk of NAION w/ patients who have already experienced NAION. Patients w/ CV disease taking nitrate vasodilator agent; erections lasting ≥4 hr; anatomical penis deformation (angulation, cavernosal fibrosis, or Peyronie's disease); conditions which may predispose to priapism eg, sickle cell anemia, multiple myeloma, leukemia. Assess CV status prior to therapy. Not recommended in combination w/ other PDE5 inhibitors. Concomitant use w/ α-blockers; potent CYP3A4 inhibitors eg, PIs, ketoconazole, itraconazole. Not recommended in combination w/ other therapies for erectile dysfunction. Severe renal & hepatic impairment (Child-Pugh class C). Not to be used in women or pregnant women. Childn <18 yr.
Adverse Reactions
Headache; dyspepsia. Flushing; back pain, myalgia. SJS. 5 mg: Nasal congestion. 20 mg: Dizziness; palpitations; abdominal pain, GERD.
Drug Interactions
Increased hypotensive effect of any form of organic nitrate; antihypertensives eg, α-adrenergic blockers, AIIA, amlodipine, enalapril, metoprolol. Additive effect w/ SL nitroglycerin. Concomitant use w/ alcohol; theophylline. Reduced rate of absorption w/ antacids.
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
Talafil FC tab 10 mg
Packing/Price
1 × 4's
Form
Talafil FC tab 20 mg
Packing/Price
1 × 4's
Form
Talafil FC tab 5 mg
Packing/Price
2 × 15's
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