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Tadalis

Tadalis

tadalafil

Manufacturer:

Fahrenheit Synthon
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction in adult men.
Dosage/Direction for Use
Adult men Erectile dysfunction Take 10 mg prior to anticipated sexual activity. Patient in whom 10 mg does not produce an adequate effect 20 mg may be taken at least 30 min prior to sexual activity. Max dosing frequency: Once daily. Patient who anticipate frequent use (ie, at least twice wkly) 5 mg once daily at approximately the same time each day, may be decreased to 2.5 mg once daily based on individual tolerability. Severe renal impairment Max: 10 mg. Hepatic impairment 10 mg prior to anticipated sexual activity.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients who are using any form of organic nitrate. Men w/ cardiac disease for whom sexual activity is inadvisable. Patients w/ MI w/in the last 90 days; unstable angina or angina occurring during sexual intercourse; NYHA class ≥2 heart failure in the last 6 mth; uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled HTN; stroke w/in the last 6 mth; who have loss vision in 1 eye due to non-arteritic anterior ischemic optic neuropathy (NAION) w/ or w/o previous PDE5 inhibitor exposure.
Special Precautions
Not recommended for continuous daily use. Discontinue use in case of visual defects; sudden decrease or loss of hearing. Perform medical history & physical exam, & determine potential underlying causes before treatment. Consider CV status of patients prior to initiating any treatment. Patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Serious CV events including MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations & tachycardia; HTN & hypotension (including postural hypotension); visual defects & cases of NAION; sudden decrease or loss of hearing, which may be accompanied by tinnitus. Seek immediate medical assistance if patients experience erections lasting ≥4 hr. Caution in patients w/ anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease), pre-disposing conditions to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia). Concomitant use w/ antihypertensives; α1-blockers; potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, traconazole, & erythromycin); other PDE5 inhibitors or treatments for erectile dysfunction. Not recommended in combination w/ guanylate cyclase stimulators, doxazosin. Not to be taken in patients w/ rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended in patients w/ severe renal impairment. Severe hepatic impairment (Child-Pugh Class C). Not indicated for use by women. Avoid use during pregnancy. Not to be used during breastfeeding. Not to be used in childn <18 yr.
Adverse Reactions
Headache; flushing; nasal congestion; dyspepsia, diarrhoea in elderly (≥65 yr), nausea; back pain, myalgia; fatigue.
Drug Interactions
Increased AUC & Cmax w/ ketoconazole. Increased AUC w/ ritonavir. Increased plasma conc w/ other PIs (eg, saquinavir), & CYP3A4 inhibitors (eg, erythromycin, clarithromycin, itraconazole, & grapefruit juice). Reduced AUC w/ rifampicin. Decreased plasma conc w/ other CYP3A4 inducers (eg, phenobarb, phenytoin, & carbamazepine). Augmented hypotensive effect of nitrates. Increased BP lowering effect of doxazosin. Consider small increase in heart rate when co-administered w/ CYP1A2 substrates (eg, theophylline). Increase oral bioavailability of ethinylestradiol & terbutaline. Simultaneous administration w/ antacid (Mg hydroxide/Al hydroxide) reduced rate of tadalafil absorption.
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
Tadalis FC tab 10 mg
Packing/Price
1 × 4's
Form
Tadalis FC tab 20 mg
Packing/Price
1 × 4's
Form
Tadalis FC tab 5 mg
Packing/Price
3 × 10's
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