Alprostadil topical and urethral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Cream and urethral stick containing alprostadil
Drugs List
Therapeutic Indications
Uses
Adjunct to other diagnostic tests in the diagnosis of erectile dysfunction
Treatment of erectile dysfunction of primarily organic aetiology
Dosage
Adults
Treatment of erectile dysfunction
Urethral stick
The recommended starting dose is 500 micrograms.
Dosage may be increased stepwise to 1000 micrograms or decreased to 250 micrograms under medical supervision until the patient achieves a satisfactory response.
No more than 2 doses are recommended in any 24 hour period with a maximum of 7 doses in 1 week.
The onset of effect is within 5 to 10 minutes after administration and lasts approximately 30 to 60 minutes.
Cream
The recommended starting dose is 300 micrograms, especially in patients with serious erectile dysfunction, co-morbidity or failure to PDE-5 inhibitors.
Patients who do not tolerate the 300 microgram dose due to local side effects can be transferred to the lower 200 microgram dose.
No more than 1 dose is recommended in any 24 hour period with a maximum of 2 to 3 doses in 1 week.
The onset of effect is within 5 to 30 minutes after administration and lasts approximately 1 to 2 hours.
Adjunct to other tests in the diagnosis and management of erectile dysfunction
Urethral stick
A 500 microgram dose has a comparable effect on penile arterial dilation and peak systolic velocity flow to 10 micrograms of alprostadil given by intracavernosal injection.
The erection should have subsided by the time the patient leaves the clinic.
The cream is not licensed for this indication.
Elderly
(See Dosage; Adult)
Administration
Urethral stick: to be inserted into the urethra.
It is important for the patient to urinate before administration as a moist urethra makes administration easier and is essential to dissolve the drug.
Cream: to be applied topically to the tip of the penis.
Contraindications
Children under 18 years
Patients in whom sexual activity is inadvisable
Predisposition to priapism
Predisposition to venous thromboembolism
Acute urethritis
Anatomical deformation of penis
Balanitis
Cavernosal fibrosis
Chronic urethritis
Leukaemia
Multiple myeloma
Peyronie's disease
Polycythaemia
Recent myocardial infarction
Severe hypospadia
Sickle cell disease
Sickle cell trait
Thrombocythaemia
Urethral stricture
Precautions and Warnings
Females of childbearing potential
Cardiovascular disorder
Cerebrovascular disorder
Coagulopathy
Advise hypotension/syncope may affect ability to drive/operate machinery
Not all formulations are licensed for all uses
Not for use with other agents for erectile dysfunction
Treat medical causes of erectile dysfunction before therapy
Treatment for priapism should not be delayed more than 6 hours
Review effectiveness of treatment & frequency of use in self administration
Advise patient to report any erection lasting more than 4 hours
Reduce dose or discontinue treatment if priapism develops
Discontinue if cavernal fibrosis develops
Discontinue if penile angulation develops
Discontinue if Peyronie's disease develops
Male: Use of condoms advised if partner pregnant or may become pregnant
Male: Use of condom required to prevent local irritation to partner
Pregnancy and Lactation
Pregnancy
Alprostadil is not indicated in females.
Small amounts of alprostadil may be added to the naturally occurring prostaglandin E1 (PGE1) in the semen.
Reproductive toxicity has been demonstrated in some animal studies.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Alprostadil is not indicated in females.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Balanitis
Decrease in blood pressure
Dizziness
Dysuria
Ejaculation disorders
Epididymal cysts
Erectile dysfunction
Erythema at application site
Fibrotic changes in corpora cavernosa
Genital pain
Genital pruritus
Haematoma
Headache
Hyperaesthesia
Hyperhidrosis
Hypoaesthesia
Hypotension
Increased frequency of micturition
Increased heart rate
Leg pain
Leg vein swelling
Muscle spasm
Nausea
Numbness
Pain during erection
Pelvic pain
Penile angulation
Penile oedema
Perineal pain
Peripheral vascular disorders
Peyronie's disease
Phimosis
Pollakiuria
Priapism (erection lasting 6 hours or longer)
Prolonged erection (lasting 4-6 hours)
Pruritus
Rash
Scrotal disorders
Scrotal oedema
Serum creatinine increased
Syncope
Testicular pain
Testicular swelling
Urethral bleeding
Urethral burning
Urethral pain
Urethral stricture
Urethritis
Urinary tract infections
Urticaria
Vasodilatation
Vein disorder
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: May 2014
Reference Sources
Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on [May 1, 2014]].
Summary of Product Characteristics: Muse 250 microgram urethral Stick. Meda Pharmaceuticals. Revised December 2013.
Summary of Product Characteristics: Muse 500 microgram urethral Stick. Meda Pharmaceuticals. Revised December 2013.
Summary of Product Characteristics: Muse 1000 microgram urethral Stick. Meda Pharmaceuticals. Revised December 2013.
Summary of Product Characteristics: Vitaros 3 mg/g cream. Takeda UK Ltd. Revised October 2013.
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