Urofi5 mg+5 mg

Urofi is a fixed-dose combination that is not FDA-approved as a single co-formulated product, but the individual components are approved and are frequently prescribed together (off-label combination) for men who have both benign prostatic hyperplasia (BPH) and erectile dysfunction (ED).

• Established/guideline-supported use: Symptomatic benign prostatic hyperplasia (finasteride reduces prostate volume by lowering dihydrotestosterone; tadalafil, separately FDA-approved for BPH symptoms and for BPH with ED, relaxes smooth muscle in the prostate and bladder neck).
• Established use: Erectile dysfunction (tadalafil component), including in men who also have BPH, where combined therapy addresses both urinary symptoms and erectile function with a single regimen.
• Off-label/adjunct use: Some men being treated for male-pattern hair loss with finasteride who also have ED are prescribed this combination so that one product addresses both concerns; this is a clinician-directed off-label combination rather than a separate approved indication.

Use of Urofi should always be individualized by a physician based on symptom severity, prostate size, and cardiovascular status.

Each capsule of Finasteride + Tadalafil typically contains Finasteride 5 mg and Tadalafil 5 mg, though strengths may vary by manufacturer. Confirm the exact strength on the product label before use.

Urofi combines two drugs with complementary mechanisms for men with an enlarged prostate: finasteride, a 5-alpha-reductase inhibitor that shrinks prostate tissue over months, and tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor that provides more rapid relief of urinary symptoms and also treats erectile dysfunction. Together they are used in men with BPH who also experience erectile difficulties, allowing a single once-daily regimen to address both conditions.

Urofi belongs to a combination therapeutic class comprising a 5-alpha-reductase inhibitor (finasteride) and a phosphodiesterase-5 (PDE5) inhibitor (tadalafil), used together for urological indications.

Finasteride competitively and selectively inhibits Type II (and to a lesser extent Type I) 5-alpha-reductase, the enzyme that converts testosterone to dihydrotestosterone (DHT). Since DHT drives prostatic enlargement, lowering DHT levels (by roughly 70%) leads to gradual shrinkage of prostate tissue and improvement in urinary flow over several months.

Tadalafil selectively inhibits PDE5, the enzyme responsible for degrading cyclic guanosine monophosphate (cGMP). By preserving cGMP levels, tadalafil promotes smooth muscle relaxation in the corpus cavernosum (improving erectile response to sexual stimulation) and in the lower urinary tract and prostate smooth muscle (improving BPH symptoms such as urinary frequency and hesitancy).

In Finasteride + Tadalafil, these two mechanisms act on different aspects of prostate-related disease, offering symptomatic relief (tadalafil) alongside disease-modifying prostate volume reduction (finasteride).

Take Urofi orally, once daily, at about the same time each day, with or without food. Swallow the capsule whole; do not crush or chew unless the product labeling specifically permits it. Continue taking the medicine even if symptoms are not immediately noticeable, since the finasteride component works gradually.

Because Urofi contains a PDE5 inhibitor, it has clinically significant interactions inherited mainly from the tadalafil component:

• Nitrates (e.g., nitroglycerin, isosorbide) and nitric-oxide donors (recreational amyl/butyl nitrite, e.g. ‘poppers’): concurrent use can cause severe, potentially fatal hypotension. Concomitant use is contraindicated (see Contraindications).
• Alpha-blockers (e.g., tamsulosin, doxazosin): combined use can cause symptomatic hypotension; if co-prescribed, use the lowest effective doses and initiate cautiously under medical supervision.
• Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, itraconazole): can increase tadalafil exposure, raising the risk of tadalafil-related side effects; dose adjustment or avoidance may be needed.
• Potent CYP3A4 inducers (e.g., rifampin): may reduce tadalafil efficacy.
• Antihypertensive agents: additive blood-pressure-lowering effect is possible; monitor blood pressure.
• Alcohol: may increase the risk of orthostatic hypotension symptoms (dizziness, headache) when combined with the tadalafil component.

Always inform your physician or pharmacist of all medicines, herbal products, and supplements being used before starting Urofi.

Side effects reflect both components of Urofi:

• Common: headache, dyspepsia (indigestion), back pain, myalgia (muscle aches), flushing, nasal congestion, and decreased libido or other sexual side effects (e.g., erectile dysfunction, ejaculation disorders) attributable to the finasteride component.
• Less common: dizziness, gynecomastia (breast tenderness/enlargement), and testicular pain.
• Rare but serious: priapism (a painful erection lasting more than 4 hours, requiring emergency care); sudden decrease or loss of vision, including cases of non-arteritic anterior ischemic optic neuropathy (NAION); sudden decrease or loss of hearing, sometimes with tinnitus and dizziness; and severe hypotension, especially if taken with nitrates or alpha-blockers.

Seek urgent medical attention for any of the rare but serious effects listed above.

Urofi is intended for use in men only and must not be used by women, especially those who are pregnant or breastfeeding. Finasteride can be absorbed through the skin or via semen and is associated with a risk of abnormal development of external genitalia in a male fetus if a pregnant woman is exposed. Pregnant women, or women who may be pregnant, should avoid handling crushed or broken tablets/capsules of this product and should avoid contact with the semen of a male partner using it, as a precaution; use a condom if pregnancy is possible. There is no indication for use of this product in women, and it should never be taken during pregnancy or lactation.

Use Urofi only under medical supervision, with particular caution in the following situations:

• Cardiovascular disease: sexual activity carries cardiac risk; the tadalafil component should be used with caution in men with unstable angina, recent myocardial infarction or stroke (within the last 3–6 months), uncontrolled arrhythmias, or severe heart failure — physicians should assess cardiovascular fitness before prescribing.
• Blood pressure: avoid use in men with resting hypotension or uncontrolled hypertension; caution with concurrent alpha-blockers or antihypertensives (see Interactions).
• Vision or hearing changes: discontinue and seek immediate medical attention if sudden vision loss or sudden hearing loss/tinnitus occurs.
• Priapism risk: men with conditions that may predispose to priapism (e.g., sickle cell disease, multiple myeloma, leukemia, or anatomical deformation of the penis) should use this medicine with caution.
• Prostate cancer screening: finasteride lowers PSA levels; inform your physician that you are taking this medicine before any PSA test, as results must be adjusted for accurate interpretation, and report any change in PSA to your doctor promptly.
• Hepatic/renal impairment: dose adjustment of the tadalafil component may be needed (see Use in Special Populations).
• Mood changes: finasteride has been associated with reports of depression and, rarely, suicidal ideation; seek medical advice if mood changes occur.

This product is not intended for use by women or children.

Overdose of Urofi may increase the risk and severity of side effects such as headache, back pain, flushing, dizziness, low blood pressure, or prolonged/painful erection. There is no specific antidote. If an overdose is suspected, seek immediate medical attention or contact a poison control center; do not attempt home treatment. Supportive care will be provided by medical professionals as needed, including monitoring of blood pressure.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal impairment: In men with mild-to-moderate renal impairment, the tadalafil component of Urofi generally does not require dose adjustment for once-daily use, but caution and lower starting exposure are advised in severe renal impairment; consult a physician for individualized dosing.

Hepatic impairment: Use with caution in mild-to-moderate hepatic impairment; not recommended in severe hepatic impairment (Child-Pugh Class C) due to limited safety data on the tadalafil component.

Elderly: No overall dose adjustment is required based on age alone, but elderly men are more likely to have comorbid cardiovascular disease or be on interacting medications, so use with additional caution.

Women and children: Not indicated; see Contraindications and Pediatric Uses.

Treatment duration with Urofi is individualized. Urinary symptom relief from the tadalafil component may become apparent within days to a few weeks, while measurable prostate-shrinkage benefit from the finasteride component generally requires continuous use for 3 to 6 months or longer. Long-term daily use is common for chronic BPH management, with periodic physician review of benefit and tolerability.

Finasteride + Tadalafil is classified under a combination of a 5-alpha-reductase inhibitor and a phosphodiesterase type 5 (PDE5) inhibitor.

Finasteride + Tadalafil works through two mechanisms: finasteride inhibits 5-alpha-reductase to reduce conversion of testosterone to dihydrotestosterone (DHT), shrinking prostate tissue over time, while tadalafil inhibits PDE5 to increase cyclic GMP, relaxing smooth muscle in the penis, prostate, and bladder neck to improve both erectile function and urinary flow.

Urofi is not indicated for use in children or adolescents. Safety and efficacy in the pediatric population have not been established, and this product must not be given to children under any circumstances.