Vardamate 20 mg (Tablet)

Indications

• Treats erectile dysfunction (ED)

Pharmacology

• Selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5)
• Increases synthesis of cGMP in smooth muscle cells of the corpus cavernosum
• Triggers smooth muscle relaxation, allowing increased blood flow into the penis

Dosage & Administration

• Recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity
• Dose may be increased to a maximum of 20 mg or decreased to 5 mg based on efficacy and side effects
• Maximum recommended dosing frequency is once per day
• Can be taken with or without food
• Geriatrics: Consider a starting dose of 5 mg in patients >65 years of age
• Renal impaired patients: No dose adjustment required
• Hepatic impaired patients: A starting dose of 5 mg is recommended for moderate impairment, and maximum dose should not exceed 10 mg. Not to be used in severe hepatic impairment

Interaction

• Can potentiate the blood pressure lowering effect of antihypertensive agents
• Caution with co-administration with other vasodilators including alpha blockers
• Does not potentiate the hypotensive effect of alcohol
• CYP3A4 inhibitors may reduce excretion from body

Contraindications

• Contraindicated with nitrates and nitric oxide donors
• Contraindicated for patients with hypersensitivity to Vardenafil or any of the product's ingredients

Side Effects

• Headache
• Flushing
• Stuffy or runny nose
• Indigestion
• Upset stomach
• Dizziness
• Back pain

Pregnancy & Lactation

• Not indicated for women

Precautions & Warnings

• Consider the cardiovascular status of patients due to the degree of cardiac risk associated with sexual activity
• Generally not recommended for men for whom sexual activity is not recommended because of their underlying cardiovascular status

Overdose Effects

• Maximum dose for which human data are available: a single 120 mg
• Majority of subjects experienced blurred vision and back pain at this dose
• In cases of overdose, contact a doctor immediately

Therapeutic Class

• Drugs for Erectile Dysfunction

Storage Conditions

• Store at room temperature
• Protect from light and moisture
• Keep out of the reach of children

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