brands

Class

• Phosphodiesterase-5 inhibitor (PDE-5 inhibitor)

Modula commonly prescribed for

(Bold for FDA approved)

How Modula works

• PDE-5 is responsible for degradation of cyclic guanosine monophosphate (cGMP); cGMP produces smooth muscle relaxation in the corpus cavernosum and allows inflow of blood.

• Inhibition of PDE-5 causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum.

How long until Modula works

• Maximum observed plasma concentrations are reached within 30 minutes to 6 hours (median 2 hours) of oral dosing

Notable Side Effects

• Headache

• Flushing

• Nasal congestion

• Dyspepsia (indigestion)

• Back pain and muscle aches

• Dizziness

• Blurred vision or changes in color vision

Life Threatening Side Effects

• Hypotension, especially when taken with nitrates or alpha-blockers

• Priapism (prolonged erection lasting more than 4 hours)

• Rare cardiovascular events such as myocardial infarction or stroke (often linked to pre-existing conditions)

weight gain

unusual

sedation

unusual

What to do about Modula side effects

• Reduce dose

usual dosage range

• Erectile Dysfunction (as-needed use)

• 10 mg taken prior to anticipated sexual activity, at least 30 minutes before.

• Dose can be increased to 20 mg or reduced to 5 mg based on efficacy and tolerability.

• Maximum frequency: once per day.

• Erectile Dysfunction (daily use) 2.5 mg to 5 mg once daily, taken at the same time each day.

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

• Pulmonary Arterial Hypertension (PAH) 40 mg (two 20 mg tablets) once daily.

Dosage Forms

• Tablets of 2.5 mg, 5 mg, 10 mg, and 20 mg

long term use

• Safe

habit forming

• No

Renal Impairment

• No adjustment for mild to moderate impairment

• For patients with severe impairment, consider a starting dose of 2.5 mg

Hepatic Impairment

• Consider a starting dose of 2.5 mg

Cardiac Impairment

• Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure

• Treatment for erectile dysfunction generally should not be instituted in men for whom sexual activity is inadvisable because of their underlying cardiovascular status

• There are no controlled clinical data on the safety or efficacy of sildenafil in patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; have resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg); or have cardiac failure or coronary artery disease causing unstable angina; use only with caution in these patients

• Use with caution in patients with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure

Elderly

• Some patients may tolerate lower doses better

• Consider a starting dose of 2.5 mg

Children and Adolescents

• Not recommended for use in pediatric patients

• Safety and efficacy have not been established

Pregnancy

• Not indicated for use in women

• Controlled studies have not been conducted in pregnant women.

Breast Feeding

• Some drug is found in mother’s breast milk