Edysta 20 mg

Description

Indications

Edysta is used for the treatment of the following conditions:

• Erectile Dysfunction (ED)
• Benign Prostatic Hyperplasia (BPH)
• A combination of Erectile Dysfunction and symptoms of Benign Prostatic Hyperplasia

Use the medication as per the advice of a registered physician.

Pharmacology

Tadalafil, the active ingredient in Edysta, is a selective inhibitor of phosphodiesterase type 5 (PDE5). By inhibiting PDE5, Tadalafil increases cyclic GMP (cGMP) levels in smooth muscle cells. Elevated cGMP levels lead to the relaxation of smooth muscles, improving blood flow into the corpus cavernosum, resulting in an erection. PDE5 is also present in the smooth muscles of the prostate and bladder wall. Inhibition of PDE5 in these areas increases cGMP levels, leading to smooth muscle relaxation in the prostate and bladder. This relaxation may improve urinary tract blood flow and help widen the bladder neck, easing the voiding process.

Dosage & Administration

• Erectile Dysfunction (ED): The typical starting dose is 10 mg, which can be adjusted based on patient needs, either increased to 20 mg or decreased to 5 mg. The maximum recommended dose is once per day, and Tadalafil remains effective for up to 36 hours.

• Benign Prostatic Hyperplasia (BPH): The usual dose is 5 mg, taken once daily at the same time each day.

• Erectile Dysfunction and Benign Prostatic Hyperplasia Combined: The recommended dose is 5 mg daily at the same time each day.

Use the medication as per the advice of a registered physician.

Interaction

Edysta may interact with various medications, including but not limited to:

• Nitrates (e.g., Isosorbide, Nitroglycerin)
• Alpha adrenergic blockers
• Antihypertensives
• Alcohol
• Antacids (e.g., magnesium hydroxide/aluminum hydroxide)
• Antifungal agents (e.g., Ketoconazole, Itraconazole)
• HIV protease inhibitors (e.g., Ritonavir)
• Erythromycin
• Rifampin
• Anticonvulsants (e.g., Carbamazepine, Phenytoin, Phenobarbital)
• Grapefruit juice

Contraindications

• Nitrate usage (e.g., Nitroglycerine, Isosorbide): Combining with Nitrates may enhance the hypotensive effects.
• Hypersensitivity to Tadalafil.

Side Effects

Common side effects of Edysta include:

• Headache
• Indigestion (Dyspepsia)
• Back pain
• Muscle pain (Myalgia)
• Nasal congestion or pharyngitis

Serious, but rare side effects may include:

• Vision changes, including sudden loss of vision
• Hearing loss
• Severe skin reactions like Stevens-Johnson Syndrome and exfoliative dermatitis
• Cardiovascular issues such as Angina, Stroke, and Myocardial infarction
• Severe low blood pressure (hypotension)
• Rapid heartbeat (Tachycardia)

Pregnancy & Lactation

Tadalafil is classified as pregnancy category B by the US FDA. It is recommended for use during pregnancy only when the potential benefits outweigh the risks. There is limited data on the excretion of Tadalafil in human milk, so caution is advised when administering it to breastfeeding women.

Precautions & Warnings

Exercise caution when using Edysta in individuals with:

• Angina or heart conditions
• Renal or hepatic impairment
• Bleeding disorders, especially when using it alongside Nitrates, Alpha Blockers, Alcohol, or CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole, Itraconazole)
• Concomitant use with other PDE5 inhibitors

Therapeutic Class

Medications for Erectile Dysfunction.

Storage Conditions

Store in a dry place, away from light and heat. Keep out of reach of children.

Pack Information

Edysta 20 mg Tablets (1 x 10)