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ENTADFI (finasteride/tadalafil)
- enlarged prostate
5 mg-5 mg capsule
- 1 capsule by oral route once daily at approximately the same time each day
Default screening record
- 1 capsule by oral route once daily at approximately the same time each day
- Adempas
- Bidil
- Dilatrate-sr
- Imdur
- Isochron
- Isoditrate
- isosorbide dinitrate
- isosorbide mononitrate
- isosorbide-hydralazine
- Minitran
- Nithiodote
- Nitro-bid
- Nitro-dur
- Nitro-time
- nitroglycerin
- nitroglycerin in 5 % dextrose
- Nitrolingual
- Nitromist
- Nitropress
- nitroprusside
- Nitrostat
- riociguat
- sodium nitrite
- sodium nitrite-sod thiosulfate
Contraindicated
- None
Severe
Moderate
- alfuzosin
- boceprevir
- Cardura
- Cardura Xl
- Dibenzyline
- doxazosin
- dutasteride-tamsulosin
- Flomax
- Incivek
- Jalyn
- Minipress
- phenoxybenzamine
- phentolamine
- prazosin
- tamsulosin
- telaprevir
- terazosin
- Uroxatral
- Victrelis
- Child-pugh class C hepatic impairment
- Lactation
- Pregnancy
Contraindicated
- Alcohol intoxication
- Anterior ischemic optic neuropathy
- Aortic valve stenosis
- Cerebrovascular accident
- Child-pugh class A hepatic impairment
- Child-pugh class B hepatic impairment
- Chronic heart failure
- Chronic kidney disease stage 2 (mild) GFR 60-89 ml/min
- Chronic kidney disease stage 3A (moderate) GFR 45-59
- Chronic kidney disease stage 3B (moderate) GFR 30-44
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Fibrosis of corpus cavernosum
- Hypertrophic cardiomyopathy
- Hypotension
- Life-threatening cardiac arrhythmias
- Penile angulation
- Peptic ulcer
- Peyronie's disease
- Pigmentary retinopathy
- Restrictive cardiomyopathy
- Severe uncontrolled hypertension
- Suicidal ideation
- Unstable angina pectoris
Severe
Moderate
- Disease of liver
- Hearing loss
- High-grade prostate cancer
- Increased risk of bleeding
- Increased risk of bleeding due to coagulation disorder
- Kidney disease with likely reduction in GFR
- Leukemia
- Malignant tumor of male breast
- Multiple myeloma
- Seizure disorder
- Sickle cell disease
ENTADFI (finasteride/tadalafil)
- enlarged prostate
- None
- Disorder of ejaculation
- Erectile dysfunction
- Gynecomastia
- Headache disorder
- Libido changes
- Mastalgia
More Frequent
Severe
Less Severe
- High-grade prostate cancer
- Hypersensitivity drug reaction
- Acute abdominal pain
- Back pain
- Cough
- Decrease ejaculate volume
- Diarrhea
- Dyspepsia
- Flushing
- Gastroesophageal reflux disease
- Hypotension
- Myalgia
- Nasal congestion
- Nausea
- Pain in extremities
- Peripheral edema
- Pharyngitis
- Skin rash
- Upper respiratory infection
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Acute myocardial infarction
- Angina
- Angioedema
- Anterior ischemic optic neuropathy
- Blurred vision
- Cerebrovascular accident
- Chest pain
- Conjunctivitis
- Dysphagia
- Dyspnea
- Esophagitis
- Exfoliative dermatitis
- Facial edema
- Hearing loss
- Hypertension
- Hypotension
- Kidney disease with reduction in GFR
- Malignant tumor of male breast
- Orthostatic hypotension
- Palpitations
- Priapism
- Rectal bleeding
- Retinal vascular occlusion
- Rhabdomyolysis
- Seizure disorder
- Stevens-johnson syndrome
- Suicidal
- Suicidal ideation
- Syncope
- Tachycardia
- Urticaria
- Vision loss
- Visual field defect
Less Severe
- Acquired chromatopsia
- Arthralgia
- Conjunctival hyperemia
- Depression
- Dizziness
- Drowsy
- Epistaxis
- Eye tearing
- Eyelid edema
- Fatigue
- Frequent erections
- Gastritis
- General weakness
- Hematospermia
- Hyperhidrosis
- Hypoesthesia
- Insomnia
- Loose stools
- Migraine
- Muscle weakness
- Myalgia
- Myopathy
- Neck pain
- Ocular pain
- Oligospermia
- Orgasm disorder
- Pain
- Paresthesia
- Peripheral edema
- Pruritus of skin
- Skin rash
- Testicular pain
- Tinnitus
- Transient global amnesia
- Urticaria
- Vertigo
- Visual changes
- Vomiting
- Xerostomia
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Finasteride
Not indicated in pediatrics. No safety and efficacy studies.
No efficacy demonstrated in trials of Duchenne muscular dystrophy. Not indicated in pediatrics.
- 1 Day – 18 Years
- Not indicated in pediatrics. No safety and efficacy studies.
Tadalafil
Not indicated in pediatrics. No safety and efficacy studies.
No efficacy demonstrated in trials of Duchenne muscular dystrophy. Not indicated in pediatrics.
- 1 Day – 18 Years
- No efficacy demonstrated in trials of Duchenne muscular dystrophy. Not indicated in pediatrics.
Finasteride
- Severity Level:
1
- Additional Notes: Contraindicated during pregnancy; may cause harm to male fetus
Tadalafil
- Severity Level:
2
- Additional Notes: Insufficient human data available
Contraindicated
Finasteride
Not indicated in women; potential for serious adverse effects in infant.
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Not indicated in women; potential for serious adverse effects in infant. |
Precaution Exists
Tadalafil
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Tadalafil
Hepatic-Use caution with hepatic impairment. Renal-Adjust dose for moderate to severe renal impairment.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | Y | Y | Y | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| Benign prostatic hyperplasia | |
| N40 | Benign prostatic hyperplasia |
| N40.0 | Benign prostatic hyperplasia without lower urinary tract symptoms |
| N40.1 | Benign prostatic hyperplasia with lower urinary tract symptoms |
| N40.2 | Nodular prostate without lower urinary tract symptoms |
| N40.3 | Nodular prostate with lower urinary tract symptoms |
| 0-9 | A-Z |
|---|---|
| N40 | Benign prostatic hyperplasia |
| N40.0 | Benign prostatic hyperplasia without lower urinary tract symptoms |
| N40.1 | Benign prostatic hyperplasia with lower urinary tract symptoms |
| N40.2 | Nodular prostate without lower urinary tract symptoms |
| N40.3 | Nodular prostate with lower urinary tract symptoms |
Formulary Reference Tool