Entafi Capsule
Finasteride + Tadalafil
5 mg+5 mg
General Pharmaceuticals Ltd.
| Pack size | 20's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 15.00 AED |
Indications
Entafi Capsule is used for:
Benign Prostatic Hyperplasia
Adult Dose
Oral
Benign Prostatic Hyperplasia
Indicated to initiate treatment for signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks
1 capsule (5 mg/5 mg) PO once daily
Not recommended for >26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and incremental benefit >26 weeks is unknown
Hepatic impairment
Mild-to-moderate (Child-Pugh A or B): Caution; finasteride extensively metabolized in liver
Severe: (Child-Pugh C): Not recommended; insufficient data
Child Dose
Renal Dose
Renal impairment
CrCl <50 mL/min or on hemodialysis: Not recommended; increased tadalafil exposure (AUC), limited clinical experience, and inability of dialysis to influence clearance
Administration
Take on empty stomach without food at about the same time each day
Contra Indications
Known hypersensitivity to finasteride, tadalafil, or capsule components; hypersensitivity reactions have included Stevens-Johnson syndrome, exfoliative dermatitis, pruritus, urticaria, and angioedema
Pregnancy
Coadministration with nitrates or soluble guanylate cyclase (sGC) stimulators (eg, riociguat)
Precautions
Hypersensitivity reported; contraindicated with history of hypersensitivity to finasteride, tadalafil, or capsule components; discontinue immediately if hypersensitivity occurs
Before initiating, rule out other urologic conditions that may cause similar symptoms; prostate cancer and BPH may coexist
5-alpha-reductase inhibitors may increase risk of developing high-grade prostate cancer
Carefully monitor patients with large residual urinary volume and/or severely diminished urinary flow for obstructive uropathy; these patients may not be candidates for this therapy
Prolonged erection and priapism may occur; instruct patients who have an erection lasting >4 hr, whether painful or not, to seek emergency medical attention; caution with conditions that may predispose patient to priapism (eg, sickle cell anemia, multiple myeloma, leukemia) or with anatomic deformation of penis (eg, angulation, cavernosal fibrosis, Peyronie disease)
If sudden decrease or loss of hearing occurs, advise patients to stop taking finasteride/tadalafil and seek prompt medical care; these events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with PDE5 inhibitors
Cardiovascular risks
Patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis) can be sensitive to vasodilator actions, including PDE5 inhibitors
Patients not included in safety/efficacy trials
Until further information is available, not recommended for the following patients
Myocardial infarction within last 90 days
Unstable angina or angina occurring during sexual intercourse
NYHA class 2 or greater heart failure in last 6 months
Uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension
Stroke within last 6 months
Pregnancy-Lactation
Pregnancy
Contraindicated in pregnant females and not indicated for use in females
Based on animal studies and finasteride mechanism of action, may cause abnormal development of external genitalia in a male fetus if administered to pregnant females
Pregnant females should not handle crushed or open capsules owing to possible absorption of finasteride and subsequent potential risk to a male fetus
If contact with crushed or broken capsules occurs, wash contact area immediately with soap and water
Lactation
Not indicated for use in females
Interactions
Organic nitrates
Contraindicated
Do not use finasteride/tadalafil in patients taking any form of organic nitrate or nitric oxide donors, either regularly and/or intermittently
PDE5 inhibitors may potentiate the hypotensive effects of nitrates
Guanylate cyclase stimulators
Contraindicated
Tadalafil may potentiate hypotensive effects of guanylate cyclase stimulators
Alpha-blockers or antihypertensives
Not recommended
Coadministration with other vasodilators may have additive and significant blood pressure–lowering effect, which may lead to symptomatic hypotension
Discontinue alpha-blockers at least 1 day before starting finasteride/tadalafil
Alcohol
Caution
Alcohol and tadalafil act as mild vasodilators
Substantial alcohol consumption (eg, ≥5 units) with tadalafil may cause orthostatic signs and symptoms, including increase in heart rate, decreased standing blood pressure, dizziness, and headache
Strong CYP3A4 inhibitors
Not recommended
Tadalafil is metabolized primarily by CYP3A4; coadministration with strong CYP3A4 inhibitors may increase tadalafil systemic absorption and increase risk for adverse effects
Adverse Effects
Side effects of Finasteride + Tadalafil :
>10%
Finasteride
Impotence (5.1-18.5%)
1-10%
Finasteride
Decreased libido (2.6-10%)
Postural hypotension (9.1%)
Dizziness (7.4%)
Abnormal ejaculation (7.2%)
Asthenia (5.3%)
Decreased ejaculate volume (1.5-3.7%)
Sexual function abnormal (2.5%)
Gynecomastia (2.2%)
Headache (2%)
Breast enlargement (0.5-1.8%)
Somnolence (1.7%)
Peripheral edema (1.3%)
Hypotension (1.2%)
Rhinitis (1%)
Tadalafil
Headache (4.1%)
Dyspepsia (2.4%)
Back pain (2.4%)
Nasopharyngitis (2.1%)
Diarrhea (1.4%)
Pain in extremity (1.4%)
Myalgia (1.2%)
Dizziness (1%)
<2% (uncertain causality)
Body as a whole: Asthenia, face edema, fatigue, pain, peripheral edema
Cardiovascular: Angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia
Digestive: Abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, gamma-glutamyl transpeptidase (GGTP) increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage
Musculoskeletal: Arthralgia, neck pain
Nervous: Dizziness, hypoesthesia, insomnia, paresthesia, somnolence, vertigo
Renal and urinary: Renal impairment
Respiratory: Dyspnea, epistaxis, pharyngitis
Skin and appendages: Pruritus, rash, sweating
Ophthalmologic: Blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids
Otologic: Sudden decrease in or loss of hearing, tinnitus
Urogenital: Erection increased, spontaneous penile erection
Mechanism of Action
Finasteride: Selective inhibitor of type1 and type 2 isoforms of 5-alpha-reductase, which results in inhibiting conversion of testosterone to dihydrotestosterone by alpha receptors located in stromal muscle cells;, this decreases prostate volume and improves voiding symptoms
Tadalafil: Phosphodiesterase-5 (PDE5) enzyme inhibitor; inhibits PDE5, thereby increasing cyclic guanosine monophosphate (cGMP) to allow smooth muscle relaxation of the corpus cavernosum, prostate, and bladder
The combination of tadalafil and finasteride has the greatest benefit in patients with large prostates, owing to the mechanism of tadalafil relaxing smooth muscle of the prostate and finasteride shrinking the prostate; this allows for alleviation of urinary symptoms
Note
Entafi 5 mg+5 mg Capsule manufactured by General Pharmaceuticals Ltd.. Its generic name is Finasteride + Tadalafil. Entafi is availble in Bangladesh.
Farmaco BD drug index information on Entafi Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.