Edysta 10 mg

Description

Indications
Edysta is used to treat the following conditions:

• Erectile Dysfunction (ED)
• Benign Prostatic Hyperplasia (BPH)
• Both Erectile Dysfunction and the signs and symptoms of Benign Prostatic Hyperplasia
  Use this medication according to the advice of a registered healthcare provider.

Pharmacology
Tadalafil, the active ingredient in Edysta, is a selective inhibitor of phosphodiesterase type 5 (PDE5). By inhibiting PDE5, it increases the levels of cGMP in smooth muscle cells. This leads to the relaxation of smooth muscle and enhanced blood flow into the corpus cavernosum, resulting in penile erection. PDE5 is also present in the smooth muscles of the prostate and bladder. When PDE5 is inhibited, cGMP levels rise, causing relaxation of the smooth muscle in the prostate and bladder. This relaxation may improve blood flow to the urinary tract and help widen the bladder neck, improving voiding.

Dosage & Administration

• Erectile Dysfunction: The typical starting dose for most patients is 10 mg. This can be adjusted to 20 mg or reduced to 5 mg depending on individual needs. The maximum frequency of dosing is once a day. Tadalafil remains effective for up to 36 hours.
• Benign Prostatic Hyperplasia: The recommended dose is 5 mg, taken once daily at the same time.
• Combined Erectile Dysfunction and Benign Prostatic Hyperplasia: The recommended dose is 5 mg, taken once daily at the same time.
  Use this medication according to the advice of a registered healthcare provider.

Interaction
Edysta may interact with the following substances:

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

Contraindications

• The use of nitrates (e.g., Nitroglycerine, Isosorbide) in combination with Edysta may amplify the hypotensive effects of nitrates.
• Hypersensitivity reactions to Tadalafil.

Side Effects
Common side effects include headache, dyspepsia, back pain, myalgia, nasal pharyngitis, and nasal congestion. Rare side effects may include changes in color vision, sudden vision loss, hearing loss, Stevens-Johnson syndrome, exfoliative dermatitis, angina, stroke, myocardial infarction, severe hypotension, and tachycardia.

Pregnancy & Lactation
Tadalafil is classified as pregnancy category B by the USFDA. It should only be used during pregnancy if the benefits outweigh the risks. There is no available data on whether Tadalafil is excreted in human milk. Caution should be exercised when administering Tadalafil to breastfeeding women.

Precautions & Warnings
Use caution in patients with the following conditions:

• Angina
• Renal impairment
• Hepatic impairment
• Bleeding, especially when taking nitrates
• Alpha blockers
• Alcohol
• CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole, Itraconazole)
• Other PDE5 inhibitors

Therapeutic Class
Drugs for Erectile Dysfunction

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

Packaging

• Edysta 10 mg Tablet (1 x 10)

Use this medication according to the advice of a registered healthcare provider.