- ACRONYMS AND DEFINITIONS
- PDE-5Is - Phosphodiesterase type 5 inhibitors
- PDE-5 INHIBITORS
Avanafil (Stendra®)
Dosage forms
Tablet
- 50 mg
- 100 mg
- 200 mg
Dosing
Erectile dysfunction
- Starting: 100 mg as early as 15 minutes before intercourse
- Maintenance: 50 - 200 mg before intercourse
- May take without regard to food
- Do not take more than once a day
- When using 50 mg dose, take 30 minutes before intercourse
Generic / Price
- NO/$$$$Pharmacokinetics
- Tmax: 30 - 45 minutes
- Half-life: 5 hours
Mechanism of action
- Inhibits PDE-5 which leads to an increase in intracellular cGMP. cGMP decreases calcium concentrations which causes smooth muscle relaxation.
- See ED drug mechanism of action
FDA-approved indications
- Erectile dysfunctionSide effects
Side effect | Avanafil 100mg | Placebo |
---|---|---|
Headache | 7% | 1.7% |
Flushing | 4.3% | 0% |
Nasal congestion | 3% | 1.1% |
Drug interactions
- Nitrates - DO NOT COMBINE. May cause dangerously low blood pressure. When nitrates are deemed medically necessary in a patient who has taken avanafil, at least 12 hours should elapse after the last dose of avanafil before giving a nitrate.
- Guanylate cyclase stimulators - DO NOT COMBINE avanafil with guanylate cyclase stimulators (e.g. Riociguat, Adempas®, vericiguat, Verquvo®) because severe hypotension may occur
- Strong CYP3A4 inhibitors - DO NOT COMBINE. Avanafil is a CYP3A4 sensitive substrate.
- Moderate CYP3A4 inhibitors - dose of avanafil should not exceed 50 mg once every 24 hours. Avanafil is a CYP3A4 sensitive substrate.
- CYP3A4 inducers - CYP3A4 inducers may decrease the effectiveness of avanafil. Concomitant use is not recommended.
- Alpha blockers - use caution. May cause low blood pressure resulting in fainting, lightheadedness, etc. Initiate avanafil at a dose of 50 mg.
- Amlodipine - amlodipine increased the exposure to avanafil by 70% in one study. Use caution.
- Blood pressure medications - avanafil lowers blood pressure (SBP -8 mmHg, DBP -3.3 mmHg one hour after 200 mg dose) This may potentiate the effects of blood pressure agents.
- Alcohol - alcohol and avanafil both act as vasodilators. When taken with alcohol, avanafil may cause an increase in heart rate, decreased blood pressure, dizziness, and headache.
- Alprostadil - combination has not been studied. Concomitant use is not recommended.
Contraindications / Precautions
- Concomitant guanylate cyclase stimulators - DO NOT COMBINE avanafil with guanylate cyclase stimulators (e.g. Riociguat, Adempas®, vericiguat, Verquvo®) because severe hypotension may occur
- Cardiovascular disease - patients with significant cardiovascular disease may be at increased risk of cardiac events during sexual activity. The BP lowering-effect of PDE-5Is may increase this risk.
- Hypotension (low blood pressure) - avanafil lowers blood pressure. In studies, average SBP decreased by 8 mmHg and DBP decreased by 3.3 mmHg one hour after a 200 mg dose. Susceptible patients may experience symptoms of hypotension.
- Prolonged erection - if an erection lasts longer than 4 hours, patients should seek medical help
- Sickle cell disease - may increase risk of priapism (painful erection lasting ≥ 6 hours)
- Multiple myeloma - may increase risk of priapism (painful erection lasting ≥ 6 hours)
- Leukemia - may increase risk of priapism (painful erection lasting 6 hours)
- Penile deformities - use caution in patients with angulation, cavernosal fibrosis, or Peyronie's disease
- Vision loss - in rare cases, PDE-5Is have been associated with a condition known as non-arteritic anterior ischemic optic neuropathy (NAION) which can cause sudden, permanent vision loss (incidence 2.5 - 11.8 cases per 100,000 males ≥ 50 years old)
- Eye disorders - avanafil has not been studied in patients with hereditary degenerative retinal disorders, including retinitis pigmentosa, and its use in not recommended in this population
- Hearing loss - PDE-5Is have been associated with rare cases of sudden hearing loss
- Bleeding disorders - PDE-5Is may inhibit platelet aggregation and worsen bleeding disorders
- Kidney disease
- CrCl ≥ 30 ml/min: no dose adjustment necessary
- CrCl < 30 ml/min: has not been studied. Do not use.
- Liver disease
- Child Pugh A and B: no dose adjustment necessary
- Child Pugh C: has not been studied. Do not use.
Sildenafil (Viagra®)
Dosage forms
Tablet
- 25 mg
- 50 mg
- 100 mg
Dosing
Erectile dysfunction
- Starting: 50 mg taken 1 hour before intercourse
- Maintenance: 25 - 100 mg before intercourse
- Elderly (≥ 65 years) - consider starting dose of 25 mg
- May take without regard to food
- Do not take more than once a day
- May be taken anywhere from 30 minutes to 4 hours before intercourse
Generic / Price
- YES/$ (30 tablets)Pharmacokinetics
- Tmax: 60 minutes
- Half-life: 4 hours
Mechanism of action
- Inhibits PDE-5 which leads to an increase in intracellular cGMP. cGMP decreases calcium concentrations which causes smooth muscle relaxation.
- See ED drug mechanism of action
FDA-approved indications
- Erectile dysfunctionSide effects
- NOTE: Only side effects that occurred at an incidence of ≥ 2% and ≥ 2% more than placebo are presented
Side effect | Sildenafil 50 mg | Placebo |
---|---|---|
Headache | 21% | 7% |
Flushing | 19% | 2% |
Upset stomach | 9% | 2% |
Nasal congestion | 4% | 2% |
Back pain | 4% | 2% |
Nausea | 3% | 1% |
Dizziness | 4% | 2% |
Drug interactions
- Nitrates - DO NOT COMBINE. May cause dangerously low blood pressure. The AHA says that nitrates should not be given within 24 hours of sildenafil.
- Riociguat (Adempas®) - DO NOT COMBINE. May cause severe hypotension.
- Alpha blockers - use caution. May cause low blood pressure resulting in fainting, lightheadedness, etc. Initiate sildenafil at a dose of 25 mg.
- Ritonavir - maximum dose of sildenafil is 25 mg every 48 hours when taken with ritonavir. Ritonavir is a strong CYP3A4 inhibitor.
- Strong and Moderate CYP3A4 inhibitors - sildenafil is a CYP3A4 sensitive substrate, and CYP3A4 inhibitors may increase its exposure. Consider a starting dose of 25 mg when taken with strong or moderate CYP3A4 inhibitors.
- Amlodipine - when sildenafil 100 mg was taken with amlodipine, average SBP decreased by 8 mmHg and DBP decreased by 7 mmHg. Use caution.
- CYP3A4 inducers - CYP3A4 inducers may decrease the effectiveness of sildenafil
- Blood pressure medications - sildenafil lowers blood pressure (average maximum decrease: SBP -8.4 mmHg, DBP -5.5 mmHg) This may potentiate the effects of blood pressure agents.
- Alcohol - alcohol can lower blood pressure. Sildenafil may potentiate this effect.
- Alprostadil - combination has not been studied. Concomitant use is not recommended.
Contraindications / Precautions
- Cardiovascular disease - patients with significant cardiovascular disease may be at increased risk of cardiac events during sexual activity. The BP lowering-effect of PDE-5Is may increase this risk.
- Hypotension (low blood pressure) - sildenafil lowers blood pressure (average maximum decrease: SBP -8.4 mmHg, DBP -5.5 mmHg). Susceptible patients may experience symptoms of hypotension.
- Prolonged erection - if an erection lasts longer than 4 hours, patients should seek medical help
- Sickle cell disease - may increase risk of priapism (painful erection lasting ≥ 6 hours)
- Multiple myeloma - may increase risk of priapism (painful erection lasting ≥ 6 hours)
- Leukemia - may increase risk of priapism (painful erection lasting 6 hours)
- Penile deformities - use caution in patients with angulation, cavernosal fibrosis, or Peyronie's disease
- Vision loss - in rare cases, PDE-5Is have been associated with a condition known as non-arteritic anterior ischemic optic neuropathy (NAION) which can cause sudden, permanent vision loss (incidence 2.5 - 11.8 cases per 100,000 males ≥ 50 years old)
- Hearing loss - PDE-5Is have been associated with rare cases of sudden hearing loss
- Bleeding disorders - PDE-5Is may inhibit platelet aggregation and worsen bleeding disorders
- Kidney disease
- CrCl ≥ 30 ml/min: no dose adjustment necessary
- CrCl < 30 ml/min: clearance is reduced. Consider starting dose of 25 mg.
- Liver disease - clearance is reduced. Consider a starting dose of 25 mg in patients with any degree of liver disease.
Tadalafil (Cialis®)
Dosage forms
Tablet
- 2.5 mg
- 5 mg
- 10 mg
- 20 mg
Dosing
Erectile dysfunction (as needed dosing)
- Starting: 10 mg before intercourse
- Maintenance: 5 - 20 mg before intercourse
- May take without regard to food
- Do not take more than once a day
- Has been shown to improve ED up to 36 hours after dosing
Erectile dysfunction (daily dosing)
- Starting: 2.5 mg once daily
- Maintenance: 2.5 - 5 mg once daily
- May take without regard to food
Benign Prostatic Hyperplasia (BPH)
- Dosing: 5 mg once daily
- May take without regard to food
Generic / Price
- YES/$ (30 tablets)Pharmacokinetics
- Tmax: 2 hours
- Half-life: 17.5 hours
Mechanism of action
Erectile dysfunction
- Inhibits PDE-5 which leads to an increase in intracellular cGMP. cGMP decreases calcium concentrations which causes smooth muscle relaxation.
- See ED drug mechanism of action
Benign Prostatic Hyperplasia
- The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder, and their vascular supply. The mechanism for reducing BPH symptoms has not been established.
FDA-approved indications
- Erectile dysfunction
- Benign Prostatic Hypertrophy (BPH) - approved for treatment up to 26 weeks. Incremental benefit decreases from 4 weeks until 26 weeks. After 26 weeks, benefit is unknown.
Side effects
- NOTE: Only side effects that occurred at an incidence of ≥ 2% and ≥ 2% more than placebo are presented
Side effect | Tadalafil 10 mg | Placebo |
---|---|---|
Headache | 11% | 5% |
Upset stomach | 8% | 1% |
Back pain | 5% | 3% |
Muscle aches | 4% | 1% |
Nasal congestion | 3% | 1% |
Flushing | 3% | 1% |
Pain in limb | 3% | 1% |
Drug interactions
- Nitrates - DO NOT COMBINE. May cause dangerously low blood pressure. The AHA says that nitrates should not be given within 48 hours of tadalafil.
- Riociguat (Adempas®) - DO NOT COMBINE. May cause severe hypotension.
- Alpha blockers - use caution. May cause low blood pressure resulting in fainting, lightheadedness, etc. Initiate tadalafil at lowest recommended dosage. Tadalafil should not be combined with alpha blockers to treat BPH.
- Strong CYP3A4 inhibitors - may increase tadalafil levels. Maximum recommended as needed dose is 10 mg every 72 hours when taken with strong CYP3A4 inhibitors. Maximum recommended daily dose is 2.5 mg when taken with strong CYP3A4 inhibitors.
- Blood pressure medications - tadalafil lowers blood pressure slightly (average maximum decrease after 20 mg: SBP -1.6 mmHg, DBP -0.8 mmHg) This may potentiate the effects of blood pressure agents.
- Alcohol - alcohol can lower blood pressure. Tadalafil may potentiate this effect.
- CYP3A4 inducers - CYP3A4 inducers may decrease the effectiveness of tadalafil
- Alprostadil - combination has not been studied. Concomitant use is not recommended.
Contraindications / Precautions
- Cardiovascular disease - patients with significant cardiovascular disease may be at increased risk of cardiac events during sexual activity. The BP lowering-effect of PDE-5Is may increase this risk.
- Hypotension (low blood pressure) - tadalafil lowers blood pressure (average maximum decrease after 20 mg: SBP -1.6 mmHg, DBP -0.8 mmHg). Susceptible patients may experience symptoms of hypotension.
- Prolonged erection - if an erection lasts longer than 4 hours, patients should seek medical help
- Sickle cell disease - may increase risk of priapism (painful erection lasting ≥ 6 hours)
- Multiple myeloma - may increase risk of priapism (painful erection lasting ≥ 6 hours)
- Leukemia - may increase risk of priapism (painful erection lasting 6 hours)
- Penile deformities - use caution in patients with angulation, cavernosal fibrosis, or Peyronie's disease
- Vision loss - in rare cases, PDE-5Is have been associated with a condition known as non-arteritic anterior ischemic optic neuropathy (NAION) which can cause sudden, permanent vision loss (incidence 2.5 - 11.8 cases per 100,000 males ≥ 50 years old)
- Hearing loss - PDE-5Is have been associated with rare cases of sudden hearing loss
- Bleeding disorders - PDE-5Is may inhibit platelet aggregation and worsen bleeding disorders
- Kidney disease
- CrCl ≥ 30 - 50 ml/min: starting dose is 5 mg once daily, maximum dose is 10 mg every 48 hours
- CrCL < 30 ml/min: maximum dose is 5 mg every 72 hours
- CrCl ≥ 30 - 50 ml/min: starting dose is 2.5 mg once daily, increase to 5 mg if tolerated
- CrCL < 30 ml/min: DO NOT USE
- Liver disease
- Child Pugh A or B: - maximum dose is 10 mg a day
- Child Pugh C: DO NOT USE
- Child Pugh A or B: - has not been studied. Use caution
- Child Pugh C: DO NOT USE
-
As-needed dosing
-
As-needed dosing
Vardenafil | Levitra® | Staxyn®
Dosage forms
Levitra® - Tablet
- 2.5 mg
- 5 mg
- 10 mg
- 20 mg
Staxyn® - Orally disintegrating tablet
- 10 mg
- Comes in blister card with 4 tablets
Dosing - Levitra
Erectile dysfunction
- Starting: 10 mg taken 60 minutes before intercourse
- Maintenance: 5 - 20 mg before intercourse
- Elderly (≥ 65 years): Consider starting dose of 5 mg
- May take without regard to food
- Do not take more than once a day
Dosing - Staxyn
Erectile dysfunction
- Dosing: 10 mg taken 60 minutes before intercourse
- May take without regard to food
- Do not exceed one tablet per day
- Place tablet under the tongue where it will disintegrate. Do not take with liquid.
- Take immediately upon removal from blister
- Staxyn is not interchangeable with Levitra because it provides higher systemic exposure
Generic / Price
- Levitra (10 tablets) - YES/$$-$$$ (10 tablets)
- Staxyn (4 tablets) - YES/$
Pharmacokinetics
Levitra
- Tmax: 60 minutes
- Half-life: 4 - 5 hours
Staxyn
- Tmax: 90 minutes
- Half-life: 4 - 6 hours
Mechanism of action
- Inhibits PDE-5 which leads to an increase in intracellular cGMP. cGMP decreases calcium concentrations which causes smooth muscle relaxation.
- See ED drug mechanism of action
FDA-approved indications
- Erectile dysfunctionSide effects
- NOTE: Side effect data is combined data from trials using all different doses of Levitra. Only side effects that occurred at an incidence of ≥ 2% and ≥ 2% more than placebo are presented.
Side effect | Vardenafil | Placebo |
---|---|---|
Headache | 15% | 4% |
Flushing | 11% | 1% |
Nasal congestion | 9% | 3% |
Upset stomach | 4% | 1% |
Sinusitis | 3% | 1% |
Drug interactions
- Nitrates - DO NOT COMBINE. May cause dangerously low blood pressure. A suitable time interval following dosing of vardenafil for the safe administration of nitrates or nitric oxide donors has not been determined.
- Riociguat (Adempas®) - DO NOT COMBINE. May cause severe hypotension.
- Alpha blockers - taking vardenafil with an alpha blocker may cause dangerously low blood pressure, resulting in fainting and lightheadedness. When initiating vardenafil in patients on stable doses of alpha blockers, start with 5 mg. Use caution when increasing the dose of either medication.
- CYP3A4 inhibitors - vardenafil is a CYP3A4 sensitive substrate, and CYP3A4 inhibitors increase its exposure. Use caution when combining and reduce the vardenafil dose as needed. Staxyn, which only comes in a 10 mg dose, should not be used with moderate or strong CYP3A4 inhibitors.
- CYP3A4 inducers - vardenafil is a CYP3A4 sensitive substrate, and CYP3A4 inducers decrease its exposure, possibly reducing its effectiveness
- P-glycoprotein substrates - in vitro data suggests vardenafil may inhibit p-glycoprotein. In a drug interaction study with digoxin, a p-glycoprotein substrate, vardenafil did not increase digoxin exposure; however, its effects on other substrates are unknown.
- Ritonavir - vardenafil dose should not exceed 2.5 mg every 72 hours when taken with ritonavir
- Atazanavir - vardenafil dose should not exceed 2.5 mg every 24 hours when taken with atazanavir
- Cobicistat - vardenafil dose should not exceed 2.5 mg every 72 hours when taken with cobicistat
- CYP2C9 inhibitors and inducers - vardenafil is a minor substrate of CYP2C9. CYP2C9 inhibitors and inducers may affect vardenafil exposure.
- Ketoconazole - vardenafil dose should not exceed 5 mg every 24 hours when taken with ketoconazole 200 mg once daily. Vardenafil dose should not exceed 2.5 mg every 24 hours when taken with ketoconazole 400 mg once daily.
- Itraconazole - vardenafil dose should not exceed 5 mg every 24 hours when taken with itraconazole 200 mg once daily. Vardenafil dose should not exceed 2.5 mg every 24 hours when taken with itraconazole 400 mg once daily.
- Indinavir - vardenafil dose should not exceed 2.5 mg every 24 hours when taken with indinavir
- Saquinavir - vardenafil dose should not exceed 2.5 mg every 24 hours when taken with saquinavir
- Clarithromycin - vardenafil dose should not exceed 2.5 mg every 24 hours when taken with clarithromycin
- Erythromycin - vardenafil dose should not exceed 5 mg every 24 hours when taken with erythromycin
- Blood pressure medications - vardenafil lowers blood pressure (average maximum decrease after 20 mg dose: SBP -7 mmHg, DBP -8 mmHg) This may potentiate the effects of blood pressure agents.
- Drugs that prolong the QT interval - vardenafil may prolong the QT interval. Avoid concomitant use with medications that are known to prolong the QT interval. (examples include quinidine, procainamide, amiodarone, and sotalol)
- Alcohol - alcohol lowers blood pressure. Vardenafil may potentiate this effect.
- Alprostadil - combination has not been studied. Concomitant use is not recommended.
Contraindications / Precautions
- Cardiovascular disease - patients with significant cardiovascular disease may be at increased risk of cardiac events during sexual activity. The BP lowering-effect of PDE-5Is may increase this risk.
- Hypotension (low blood pressure) - vardenafil lowers blood pressure (average maximum decrease after 20 mg dose: SBP -7 mmHg, DBP -8 mmHg). Susceptible patients may experience symptoms of hypotension.
- Prolonged erection - if an erection lasts longer than 4 hours, patients should seek medical help
- Sickle cell disease - may increase risk of priapism (painful erection lasting ≥ 6 hours)
- Multiple myeloma - may increase risk of priapism (painful erection lasting ≥ 6 hours)
- Leukemia - may increase risk of priapism (painful erection lasting 6 hours)
- Penile deformities - use caution in patients with angulation, cavernosal fibrosis, or Peyronie's disease
- Vision loss - in rare cases, PDE-5Is have been associated with a condition known as non-arteritic anterior ischemic optic neuropathy (NAION) which can cause sudden, permanent vision loss (incidence 2.5 - 11.8 cases per 100,000 males ≥ 50 years old)
- Prolonged QT syndrome - vardenafil may prolong the QT interval. Avoid use in patients with prolonged QT syndrome.
- Hearing loss - PDE-5Is have been associated with rare cases of sudden hearing loss
- Bleeding disorders - PDE-5Is may inhibit platelet aggregation and worsen bleeding disorders
- Kidney disease - no dose adjustment necessary. Avoid use in hemodialysis.
- Liver disease
- Child Pugh B: use starting dose of 5 mg. Maximum dose is 10 mg.
- Child Pugh C: DO NOT USE
- Child Pugh A: okay to use
- Child Pugh B/C: DO NOT USE
-
Levitra
- ALPROSTADIL
Alprostadil (Muse®)
Dosage forms
Urethral suppository
- 125 mcg
- 250 mcg
- 500 mcg
- 1000 mcg
- Comes in carton with 6 suppositories
Dosing
Erectile dysfunction
- Starting: 125 - 250 mcg inserted 5 - 10 minutes before intercourse
- Maintenance: 125 - 1000 mcg before intercourse
- The duration of effect is 30 - 60 minutes
- Maximum use is 2 suppositories in 24 hours
Generic / Price
- NO/$$$$Other
General
- Patient should urinate immediately prior to use
- Suppository dissolves in small amount of urine left in penis
- Suppository is inserted into the urethra with included device
- Store in refrigerator
- May be kept at room temperature for up to 14 days
- Do not expose to temperatures above 86°F
Initiating therapy
- The manufacturer recommends that Muse® dose titration be performed under physician supervision to insure proper technique and monitor for hypotension
Mechanism of action
- Alprostadil stimulates PGE1 receptors which leads to an increase in intracellular cGMP. cGMP decreases calcium concentrations which causes smooth muscle relaxation.
- See ED drug mechanism of action
FDA-approved indications
- Erectile dysfunctionSide effects
- NOTE: Side effect data is combined data from trials using all different doses. Only side effects that occurred at an incidence of ≥ 2% and ≥ 2% more than placebo are presented.
Side effect | Alprostadil | Placebo |
---|---|---|
Penile pain | 32% | 3% |
Urethral burning | 12% | 4% |
Female partner vaginal itching/burning | 5.8% | 0.8% |
Urethral bleeding | 5% | 1% |
Testicular pain | 5% | 1% |
Flu symptoms | 4% | 2% |
Other
|
Drug interactions
- Following Muse® administration, blood levels of alprostadil are low to undetectable; therefore, systemic drug-drug interactions are unlikely
Contraindications / Precautions
- Penile abnormalities - DO NOT USE in patients with urethral stricture, balanitis (inflammation/infection of the glans of the penis), severe hypospadias and curvature, and in patients with acute or chronic urethritis.
- Sickle cell disease - DO NOT USE. May increase risk of priapism (painful erection lasting ≥ 6 hours)
- Multiple myeloma - DO NOT USE. May increase risk of priapism (painful erection lasting ≥ 6 hours)
- Leukemia - DO NOT USE. May increase risk of priapism (painful erection lasting 6 hours)
- Thrombocythemia - DO NOT USE. May increase risk of priapism (painful erection lasting 6 hours)
- Polycythemia - DO NOT USE. May increase risk of priapism (painful erection lasting 6 hours)
- Pregnant partner - only use with condom barrier
- Cardiovascular disease - patients with significant cardiovascular disease may be at increased risk of cardiac events during sexual activity. The hypotensive effects of alprostadil may increase this risk.
- Hypotension (low blood pressure) - in trials, 3% of patients experienced symptomatic hypotension after using Muse®
- Prolonged erection - if an erection lasts longer than 4 hours, patients should seek medical help
- Pulmonary disease - alprostadil is metabolized in the lungs. Significant pulmonary disease may increase the risk of systemic effects.
- Kidney disease - manufacturer makes no recommendation
- Liver disease - manufacturer makes no recommendation
Alprostadil | Caverject® | Caverject Impulse® | Edex®
Dosage forms
Caverject® vial
- 5 mcg
- 10 mcg
- 20 mcg
- 40 mcg
- Comes in carton with 6 vials
Caverject® impulse
- 10 mcg
- 20 mcg
- Single dose disposable syringe
- One carton contains 2 syringes
Edex® cartridge
- 10 mcg
- 20 mcg
- 40 mcg
- Each cartridge contains one dose
- Cartridge is loaded into Edex® injection device
- Comes in carton with 2 or 6 cartridges
Dosing
Erectile dysfunction
- Starting: Dose should be titrated under physician supervision. See Caverject® PI for titration recommendations. In one study, the average dose at the end of the titration phase was 17.8 mcg
- Maintenance: in studies, the average effective dose was around 20 mcg
- Maximum: doses above 60 mcg are not recommended
- Do not use more than 3 times a week
- Allow at least 24 hours between each dose
Generic / Price
- (all 3 brands) NO/$$$$Other
Caverject vial
- Vial must be reconstituted with sterile water
- Reconstituted solution should be used within 24 hours. Do not refrigerate solution.
Caverject impulse
- Store reconstituted and unreconstituted product at room temperature
- Reconstituted solution should be used within 24 hours. Do not refrigerate solution.
- 10mcg syringe can deliver 7.5, 5, and 2.5 mcg partial doses
- 20 mcg syringe can deliver 15, 10, and 5 mcg partial doses
Edex
- Store cartridges at room temperature
- Use reconstituted product immediately
- Syringe can be adjusted to deliver partial doses
Injection technique
- Solution is injected into the corpus cavernosum from the side of the penis
- Patients should alternate sides of the penis with each injection
- A 27 - 29 ga half-inch needle is typically used
Mechanism of action
- Alprostadil stimulates PGE1 receptors which leads to an increase in intracellular cGMP. cGMP decreases calcium concentrations which causes smooth muscle relaxation.
- See ED drug mechanism of action
FDA-approved indications
- Erectile dysfunctionSide effects
- NOTE: No significant local adverse reactions were reported for placebo. Side effect data is combined data from trials using all different doses.
- Penile pain - 37%
- Prolonged erection - 4%
- Penile fibrosis - 3% (up to 7.8% in some studies)
- Injection site hematoma - 3%
- Other penile complaints (numbness, sensitivity) - 3%
- Injection site bruising - 2%
- Penile rash - 1%
- Penile edema - 1%
Drug interactions
- Following Caverject administration, blood levels of alprostadil are low to undetectable; therefore, systemic drug-drug interactions are unlikely
Contraindications / Precautions
- Penile abnormalities - DO NOT USE in patients with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease
- Sickle cell disease or sickle cell trait - DO NOT USE. May increase the risk of priapism.
- Multiple myeloma - DO NOT USE. May increase the risk of priapism.
- Leukemia - DO NOT USE. May increase the risk of priapism.
- Penile implants - DO NOT USE
- Prolonged erection - in studies, prolonged erections lasting 4 - 6 hours occurred in 4% of men treated with Caverject for up to 18 months. Patients should seek immediate medical attention for erections lasting longer than 4 hours.
- Penile fibrosis - in one 18-month study, penile fibrosis occurred in 7.8% of Caverject-treated men. Monitor for signs of fibrosis (e.g. angulation, cavernosal fibrosis) and discontinue Caverject if they occur.
- Hypotension - systemic absorption of alprostadil can cause hypotension. Do not use in patients with known cavernosal venous leakage.
- Combination with other vasoactive penile injections - Caverject should not be used in combination with other vasoactive penile injections because the risk of priapism and hypotension may be increased
- Injection site bleeding - patients receiving antithrombotic therapy (e.g. antiplatelet drugs, anticoagulants) may have injection site bleeding. If bleeding occurs, compression should be applied.
- Cardiovascular disease - patients with significant cardiovascular disease may be at increased risk of cardiac events during sexual activity. Use caution in susceptible patients.
- Needle breakage - cases of Caverject needles breaking off inside the penis have been reported, sometimes requiring surgery for removal. Patients should follow the injection instructions carefully to help prevent these occurrences.
- Benzyl alcohol - reconstituted Caverject contains benzyl alcohol which can be toxic to infants. Do not give to pediatric patients.
- Kidney disease - has not been studied
- Liver disease - has not been studied
- PRICE ($) INFO
Pricing legend
- $ = 0 - $50
- $$ = $51 - $100
- $$$ = $101 - $150
- $$$$ = > $151
- Pricing based on one month of therapy at standard dosing in an adult
- Pricing based on information from GoodRX.com®
- Pricing may vary by region and availability
- BIBLIOGRAPHY
- 1 - Manufacturer's Package Insert for each drug listed