Edysta5 mg

Erectile Dysfunction (ED)

Edysta is FDA-approved for the treatment of erectile dysfunction, used either on an as-needed basis before anticipated sexual activity or as a once-daily regimen.

Benign Prostatic Hyperplasia (BPH)

Edysta is FDA-approved for the treatment of the signs and symptoms of benign prostatic hyperplasia, and is also approved for the combined treatment of ED and BPH signs and symptoms when both conditions are present, using a once-daily regimen.

Pulmonary Arterial Hypertension (PAH)

Edysta is FDA-approved for the treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise ability, using a separate formulation/strength and dosing schedule than the ED and BPH indications.

Each dose contains Tadalafil as the active ingredient. In Bangladesh, Tadalafil is available as film-coated tablets in 2.5 mg, 5 mg, 10 mg, and 20 mg strengths.

Edysta is a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction, the urinary symptoms of benign prostatic hyperplasia (an enlarged prostate), and pulmonary arterial hypertension. It works by enhancing the effect of nitric oxide, a chemical the body normally releases in response to sexual stimulation, which relaxes smooth muscle and increases blood flow to specific areas of the body. Compared with other PDE5 inhibitors, Edysta has a notably longer half-life, which allows it to be taken either as a single dose before sexual activity or as a lower once-daily dose for continuous effect. Edysta does not increase sexual desire and only works in the presence of sexual stimulation; it does not protect against sexually transmitted infections.

Phosphodiesterase type 5 (PDE5) inhibitor

Tadalafil is rapidly absorbed after oral administration, with peak plasma concentrations typically reached in about 2 hours; absorption is not significantly affected by food. It is extensively metabolized in the liver, primarily by the CYP3A4 enzyme, into an inactive metabolite. Tadalafil has a mean terminal half-life of approximately 17.5 hours, considerably longer than other PDE5 inhibitors, which is the basis for its once-daily dosing option. It is eliminated mainly as metabolites, predominantly in the feces with a smaller portion excreted in the urine.

• Edysta tablets may be taken with or without food.
• Swallow the tablet whole with water.
• For on-demand use in erectile dysfunction, take Edysta at least 30 minutes before anticipated sexual activity; the effect can last up to 36 hours.
• For once-daily regimens (low-dose ED, BPH, or PAH), take Edysta at approximately the same time every day to maintain steady blood levels.
• Do not take more than the prescribed dose or more frequently than directed.
• If a once-daily dose is missed, take it as soon as remembered unless it is almost time for the next dose; do not double the dose.

• Nitrates: concomitant use with any form of organic nitrate, regularly or intermittently, can cause severe, potentially fatal hypotension; this combination is contraindicated (see Contraindications).
• Guanylate cyclase (GC) stimulators (e.g., riociguat): combined use can cause symptomatic hypotension through an additive mechanism on the nitric oxide/cGMP pathway; this combination is contraindicated (see Contraindications).
• Alpha-blockers (e.g., tamsulosin, doxazosin): concomitant use of Edysta with alpha-blockers can lead to symptomatic hypotension in some patients, as both drug classes cause vasodilation; for the ED indication, Edysta should generally be started at the lowest dose in patients on a stable alpha-blocker regimen, with attention to dose timing, while the BPH once-daily regimen has been studied with certain alpha-blockers under specific dosing guidance from a physician.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): these can substantially increase Edysta blood levels, raising the risk of adverse effects; dose reduction and lower maximum doses are recommended.
• Strong CYP3A4 inducers (e.g., rifampin): these can significantly reduce Edysta blood levels and its effectiveness.
• Antihypertensive medicines: Edysta can cause an additive blood-pressure-lowering effect with other antihypertensive drugs, requiring caution, particularly at treatment initiation.
• Alcohol: substantial alcohol intake with Edysta may increase the potential for orthostatic hypotension symptoms such as dizziness or fainting.

Common Side Effects

• Headache
• Indigestion (dyspepsia)
• Back pain and muscle aches (myalgia), typically delayed in onset and self-limited
• Flushing
• Nasal congestion
• Pain in the arms or legs

Serious Side Effects (Seek Medical Attention)

• Sudden decrease or loss of vision in one or both eyes (possible non-arteritic anterior ischemic optic neuropathy) - stop taking Edysta and seek immediate medical attention (see Precautions and Warnings).
• Sudden decrease or loss of hearing, sometimes with ringing in the ears or dizziness - stop taking Edysta and seek medical attention.
• An erection lasting longer than 4 hours (priapism) - seek immediate medical attention to prevent permanent damage.
• Chest pain, dizziness, or fainting during sexual activity, which may indicate a cardiovascular event (see Precautions and Warnings).
• Signs of a severe allergic reaction: rash, hives, swelling of the face/lips/tongue/throat, or difficulty breathing.

Edysta is indicated only for male-specific conditions (erectile dysfunction and benign prostatic hyperplasia) or for pulmonary arterial hypertension, and it is not indicated for use in women; there is no established therapeutic use of Edysta in pregnant or breastfeeding women, and it should not be used in pregnancy or during breastfeeding. There is no clinically relevant fetal or infant exposure to consider for its approved male indications.

• Cardiovascular risk of sexual activity: before prescribing Edysta for erectile dysfunction, a physician should assess the patient's cardiovascular status, since sexual activity carries a cardiac risk for patients with pre-existing cardiovascular disease.
• Hypotension with nitrates or GC stimulators: see Contraindications; patients must be counseled never to take nitrates or riociguat while using Edysta, including in an emergency setting (they should inform emergency personnel of recent Edysta use).
• Hypotension with alpha-blockers or other antihypertensives: see Interactions; caution and individualized dosing are required.
• Non-arteritic anterior ischemic optic neuropathy (NAION): rare cases of sudden vision loss have been reported with PDE5 inhibitors, including Edysta; patients should be advised to stop the medicine and seek immediate medical attention if sudden vision loss occurs, and Edysta should be used with caution in patients with a prior history of NAION.
• Sudden hearing loss: rare cases of sudden decrease or loss of hearing have been reported; patients should stop Edysta and seek prompt medical evaluation if this occurs.
• Priapism: patients with conditions that may predispose to priapism (e.g., sickle cell disease, multiple myeloma, leukemia, or anatomical deformation of the penis) should use Edysta with caution; a prolonged erection lasting more than 4 hours requires immediate medical attention.
• Severe hepatic or renal impairment: dose adjustment is required; see Dosage for details, and use in severe hepatic impairment is not recommended.
• Not for use in women or children: Edysta has no approved indication in women or in pediatric patients (see Use in Special Populations).

Overdose of Edysta may increase the frequency and severity of typical side effects, including headache, flushing, dizziness, indigestion, back pain, and nasal congestion, and may increase the risk of prolonged hypotension or priapism. There is no specific antidote for Edysta overdose. If an overdose is suspected, seek immediate medical attention or contact a poison control center or emergency services; treatment is generally supportive, and hemodialysis is not expected to meaningfully accelerate elimination since Edysta is highly protein-bound.

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

• Pediatric patients: safety and efficacy of Edysta have not been established in patients under 18 years of age; it is not indicated for use in this population.
• Elderly patients (65 years and older): no overall dose adjustment is generally required based on age alone, but older patients may have a higher likelihood of underlying cardiovascular disease or reduced renal/hepatic function, warranting individualized assessment.
• Renal impairment: dose reduction or altered dosing frequency is required; see Dosage.
• Hepatic impairment: dose limits apply in mild-to-moderate impairment, and use is not recommended in severe impairment; see Dosage.
• Women: Edysta has no approved indication in women (see Pregnancy and Lactation).

For erectile dysfunction treated on an as-needed basis, Edysta is taken only when needed before sexual activity, with a maximum of one dose per day. For once-daily regimens (low-dose ED, BPH, or pulmonary arterial hypertension), Edysta is intended for continuous, ongoing use as prescribed, with periodic medical review of continued need, dose, and tolerability. The physician will determine how long treatment should continue based on the indication and the patient's response.

Phosphodiesterase type 5 (PDE5) inhibitor

Tadalafil selectively inhibits the enzyme phosphodiesterase type 5 (PDE5), which is responsible for breaking down cyclic guanosine monophosphate (cGMP). During sexual stimulation, nitric oxide is released, activating guanylate cyclase to produce cGMP, which relaxes smooth muscle in the corpus cavernosum and increases blood inflow, producing an erection. By inhibiting PDE5, Tadalafil prolongs the smooth-muscle-relaxing effect of cGMP, enhancing the natural erectile response to sexual stimulation. In benign prostatic hyperplasia, a similar smooth-muscle-relaxing effect on the lower urinary tract and prostate is believed to underlie symptom improvement. In pulmonary arterial hypertension, PDE5 inhibition promotes pulmonary vascular smooth muscle relaxation and vasodilation, reducing pulmonary vascular resistance.

Edysta is not indicated for use in pediatric patients. Safety and efficacy have not been established in patients under 18 years of age for any approved indication (erectile dysfunction, benign prostatic hyperplasia, or pulmonary arterial hypertension), and Edysta should not be used in children or adolescents outside of the guidance of a specialist physician for a specific, medically justified reason.