Indications of Vardena 20 mg
Vardena 20 mg is used to treat erectile dysfunction (ED).
Theropeutic Class
Drugs for Erectile Dysfunction
Pharmacology
Does not directly cause penile erections, but affects the response to sexual stimulation. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation and inflow of blood to the corpus cavernosum. Vardena 20 mg enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE-5), which is responsible for degradation of cGMP in the corpus cavernosum; when sexual stimulation causes local release of NO, inhibition of PDE-5 by Vardena 20 mg causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum; at recommended doses, it has no effect in the absence of sexual stimulation.
Dosage & Administration of Vardena 20 mg
Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability.Maximum dose: 20 mg once a dayUsual Geriatric Dose for Erectile Dysfunction (65 years or older): 5 mg orally once a day, as needed, approximately 60 minutes before sexual activityPatients on stable alpha blocker therapy: 5 mg orally once a day
Dosage of Vardena 20 mg
The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardena 20 mg can be taken with or without food.Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.Renal impaired patients: In patients with renal impairment, no dose adjustment is required.Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.
Interaction of Vardena 20 mg
Vardena 20 mg can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardena 20 mg 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardena 20 mg does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardena 20 mg excretion from body
Contraindications
Administration of Vardena 20 mg with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardena 20 mg may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardena 20 mg or any of the ingredients of this product.
Side Effects of Vardena 20 mg
The most common side effects with Vardena 20 mg are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.
Pregnancy & Lactation
Pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Precautions & Warnings
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardena 20 mg generally should not be used.
Overdose Effects of Vardena 20 mg
The maximum dose of Vardena 20 mg for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
Storage Conditions
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
Use In Special Populations
Patients stabilised on α-blocker therapy: max daily dose 5 mg and not to be taken within 6 hr of the α-blocker (except tamsulosin). Patients on erythromycin: Max: 5 mg daily.Renal Impairment: Haemodialysis: Avoid.Hepatic Impairment:
Child Pugh A-B (mild to moderate) impairment: Initiate with 5 mg.
Max dose in moderate impairment: 10 mg.
Child-Pugh C (severe impairment): No studies done.
Drug Classes
Drugs for Erectile Dysfunction
Mode Of Action
Vardena 20 mg is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.
Pregnancy
Vardena 20 mg is not indicated for women.