Edysta 5 mg

Description

Indications
Edysta is used for the treatment of:

• Erectile Dysfunction (ED)
• Benign Prostatic Hyperplasia (BPH)
• Both Erectile Dysfunction and the signs and symptoms of Benign Prostatic Hyperplasia

Please follow the advice of a registered healthcare provider when using this medication.

Pharmacology
Tadalafil is a selective inhibitor of the phosphodiesterase type 5 (PDE5) enzyme. By inhibiting PDE5, Tadalafil increases the levels of cyclic guanosine monophosphate (cGMP) within smooth muscle cells. Elevated cGMP levels induce relaxation of the smooth muscles and enhance blood flow to the corpus cavernosum, leading to an erection. PDE5 is also found in the smooth muscle cells of the prostate and bladder wall. Inhibiting PDE5 increases cGMP levels in these tissues, causing muscle relaxation and improved blood flow to the urinary tract. This effect can help in reducing the symptoms of Benign Prostatic Hyperplasia (BPH) by widening the bladder neck and improving urine flow.

Dosage & Administration

• Erectile Dysfunction: The recommended initial dose is 10 mg. This dose may be adjusted between 5 mg and 20 mg based on individual needs. The maximum recommended dose is once daily, and Tadalafil remains effective for up to 36 hours.
• Benign Prostatic Hyperplasia: The suggested dosage is 5 mg, taken once daily at the same time.
• Combined Erectile Dysfunction and Benign Prostatic Hyperplasia: The recommended dose is 5 mg once daily at the same time.

Please follow the advice of a registered healthcare provider when using this medication.

Interactions
Tadalafil may interact with several substances, including:

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

Contraindications

• Use of Nitrates (e.g., Nitroglycerin, Isosorbide) due to the potential for increased hypotensive effects.
• Known hypersensitivity to Tadalafil.

Side Effects
Common side effects may include:

• Headache
• Indigestion (Dyspepsia)
• Back pain
• Muscle pain (Myalgia)
• Nasal inflammation (Nasal Pharyngitis)
• Nasal congestion

Less common but serious side effects may include:

• Changes in color vision
• Sudden vision loss
• Hearing loss
• Stevens-Johnson Syndrome
• Severe skin reactions like Exfoliative Dermatitis
• Angina
• Stroke
• Heart attack (Myocardial Infarction)
• Severe low blood pressure (Hypotension)
• Rapid heart rate (Tachycardia)

Pregnancy & Lactation
Tadalafil is classified as pregnancy category B by the US FDA. It is only recommended during pregnancy if the potential benefit justifies the potential risk to the fetus. There is insufficient data on whether Tadalafil is excreted in human breast milk, so caution is advised when administering this drug to nursing women.

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

• Angina (chest pain)
• Kidney impairment (Renal impairment)
• Liver impairment (Hepatic impairment)
• Use of Nitrates or Alpha Blockers
• Use of Alcohol or CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole, Itraconazole)
• Use of 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.

Pack Size
Edysta 5 mg Tablet (2 x 10 Tablets)