Alprostadil injectable and transurethral

Name: Alprostadil injectable and transurethral

What should I discuss with my healthcare provider before using alprostadil?

You should not use alprostadil if you are allergic to it, or if you have:

  • sickle cell anemia or the sickle cell anemia trait;

  • leukemia;

  • a tumor of the bone marrow (multiple myeloma);

  • a curved or deformed penis;

  • penile fibrosis or Peyronie's disease;

  • if you have a penile implant; or

  • if you have been told you should not have sexual intercourse for health reasons.

To make sure alprostadil is safe for you, tell your doctor if you have:

  • a history of blood clots;

  • heart disease, high or low blood pressure; or

  • a bleeding or blood-clotting disorder.

Use a condom to prevent transfer of this medicine to your sexual partner if she is pregnant or could become pregnant.

Caverject, Caverject Impulse, Edex, or Muse should not be used by women or by anyone under 18 years old.

What happens if I miss a dose?

Since alprostadil is used as needed, you will not be on a dosing schedule.

For Healthcare Professionals

Applies to alprostadil: compounding powder, injectable kit, injectable powder for injection, injectable solution, transurethral suppository

General

The most common side effects were penile pain, local bleeding, fever, urethral pain, urethral burning, apnea, and flushing.[Ref]

Genitourinary

Very common (10% or more): Penile pain (up to 36%), urethral pain (13%), urethral burning (12%)
Common (1% to 10%): Prolonged erection greater than 4 hours, penile angulation, penile fibrosis, cavernous body fibrosis, Peyronie's disease, penis disorder, prostate disorder, testicular pain, urethral bleeding/spotting and other minor urethral abrasions, vaginal burning/itching
Uncommon (0.1% to 1%): Priapism, scrotal erythema, dysuria, hematuria, pollakiuria, micturition urgency, urethral hemorrhage, balanitis, phimosis, ejaculation disorder, scrotal disorder, scrotal pain, testicular swelling, testicular edema, scrotal edema, spermatocele, testicular disorder, testicular mass, penile hemosiderin deposits, swelling of the preputium or the glans, perineal pain, painful erection
Rare (less than 0.1%): Urinary tract infection
Frequency not reported: Anuria, abnormal ejaculation, penile deviations, penile warmth, urinary frequency/urinary urgency/impaired urination[Ref]

Cardiovascular

Very common (10% or more): Flushing (10.1%)
Common (1% to 10%): Bradycardia, hypotension, tachycardia, cardiac arrest, edema, hematoma, hypertension, myocardial infarction, abnormal ECG
Uncommon (0.1% to 1%): Vascular fragility, supraventricular extrasystoles, vein disorder, vasodilatation, peripheral vascular disorder, peripheral edema, swelling of the leg veins
Frequency not reported: Congestive heart failure, hyperemia, second degree heart block, shock, spasm of the right ventricle infundibulum, supraventricular tachycardia, ventricular fibrillation, rapid pulse, pneumopericardium, ventricular hypertrophy, tachyphylaxis, ductus arteriosus histological changes, venous leak, cardiac arrhythmias, postural hypotension, changes in blood pressure, vagal shock, vasovagal reactions, myocardial ischemia[Ref]

Local

Very common (10% or more): Local bleeding (15%)
Common (1% to 10%): Injection site hematoma, injection site burning, sensation of tension in the penis, injection site pain
Uncommon (0.1% to 1%): Injection site hemorrhage, injection site edema, injection site inflammation, injection site mass, injection site pruritus, injection site swelling and reddening, injection site irritation, injection site anesthesia, injection site warmth
Frequency not reported: Localized pain[Ref]

Respiratory

Very common (10% or more): Apnea (12%)
Common (1% to 10%): Upper respiratory tract infection, sinusitis, rhinitis
Frequency not reported: Bradypnea, bronchial wheezing, hypercapnia, respiratory depression, respiratory distress, tachypnea, hypoplastic lungs, pneumothorax[Ref]

Other

Very common (10% or more): Fever (14%)
Common (1% to 10%): Sepsis, influenza-like symptoms, pain, accidental injury
Uncommon (0.1% to 1%): Asthenia
Rare (less than 0.1%): Vertigo
Frequency not reported: Hypothermia, jitteriness, non-generalized weakness[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, leg pain, pelvic pain, muscle spasms
Uncommon (0.1% to 1%): Exostosis
Frequency not reported: Hyperextension of the neck, stiffness, cortical proliferation of the long bones, microcephaly, leg cramps[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, hypertriglyceridemia, hypercholesterolemia, hyperglycemia
Frequency not reported: Hypoglycemia, hyperkalemia[Ref]

Nervous system

Common (1% to 10%): Seizures, headache, dizziness
Uncommon (0.1% to 1%): Syncope, hypoesthesia, hyperesthesia, presyncope
Frequency not reported: Cerebral bleeding, lethargy, numbness, collapse, amnesia, cerebrovascular accident[Ref]

Dermatologic

Common (1% to 10%): Ecchymosis, erythema, skin disorder
Uncommon (0.1% to 1%): Rash, pruritus, hyperhidrosis
Rare (less than 0.1%): Urticaria
Frequency not reported: Diaphoresis, sensitivity, irritation, non-application site pruritus[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, inguinal hernia
Uncommon (0.1% to 1%): Obstruction gastric, gastric mucosal hypertrophy, nausea, dry mouth
Frequency not reported: Gastric regurgitation, peritonitis[Ref]

Immunologic

Common (1% to 10%): Infection
Uncommon (0.1% to 1%): Fungal infection, common cold
Rare (less than 0.1%): Anaphylactic/anaphylactoid reactions[Ref]

Hematologic

Common (1% to 10%): Disseminated intravascular coagulation
Uncommon (0.1% to 1%): Blood creatinine increased
Very rare (less than 0.01%): Thrombocytopenia
Frequency not reported: Anemia, bleeding, hypochromic anemia[Ref]

Ocular

Common (1% to 10%): Abnormal vision
Uncommon (0.1% to 1%): Mydriasis[Ref]

Hepatic

Frequency not reported: Hyperbilirubinemia, biliary atresia[Ref]

Renal

Frequency not reported: Polycystic kidneys, renal failure[Ref]

Psychiatric

Frequency not reported: Hyperirritability[Ref]

Some side effects of alprostadil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Pediatric Dose for Patent Ductus Arteriosus

Less than 12 Months:
Initial dose: 0.05 to 0.1 mcg/kg/min continuous IV infusion
Maintenance dose: 0.01 to 0.4 mcg/kg/min continuous IV infusion

Comments:
-The preferred route is continuous IV infusion into a large vein; may also be administered through an umbilical artery catheter placed at the ductal opening.
-Once a therapeutic response is achieved (increased partial oxygen pressure in patients with restricted pulmonary blood flow or increased systemic blood pressure and blood pH in patients with restricted systemic blood flow), reduce the infusion rate to the lowest dose that maintains the desired response.
-If response to initial dose is inadequate, dosage can be increased up to 0.4 mcg/kg/min. However, in general, higher infusion rates do not produce greater effects.

Use: Palliative, not definitive, therapy to temporarily maintain ductus arteriosus patency until corrective or palliative surgery can be performed in neonates with congenital heart defects who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, aortic arch interruption, aorta coarctation, or transposition of the great vessels with or without other defects.

Alprostadil Pregnancy Warnings

This drug is not indicated for use in women. AU TGA pregnancy category: Not formally assigned to a pregnancy category US FDA pregnancy category: C (suppositories) US FDA pregnancy category: Not formally assigned to a pregnancy category (non-suppository formulations) Comments: Male partners should use a condom during intercourse.

Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy. This drug is chemically identical to prostaglandin E1 (PGE1), which occurs naturally in seminal fluid. Use of this drug may add to the amount of PGE1 present in the seminal fluid. Male partners should use a condom during intercourse to avoid vaginal irritation and risk of preterm delivery. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Alprostadil Breastfeeding Warnings

This drug is not indicated for use in women. Excreted into human milk: Unknown Excreted into animal milk: Data not available

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