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Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Caverject Dual Chamber 20 micrograms

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Alprostadil may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Alprostadil
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Caverject Dual Chamber contains alprostadil which is similar to the natural substance in your body called prostaglandin E1. It widens blood vessels, increasing blood flow to your penis making it easier for you to have an erection. Caverject Dual Chamber is used for "erectile dysfunction" including weak erections or impotence. Your doctor may also use it to help find the exact cause of your erectile dysfunction along with other tests.

2.

What you need to know before you take it

e Caverject Dual Chamber

Do not use Caverject Dual Chamber:

  • if you are allergic to alprostadil or any of the other ingredients of this medicine (listed in section 6).
  • if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of the blood), multiple myeloma (bone cancer) or any other problem which increases risk of getting "priapism". This is when your erection lasts for longer than 6 hours.
  • if you have an implant in your penis.

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  • if you have a condition (such as severe heart disease) in which sexual activity should be avoided.
  • if you have a penis which is scarred, bent or kinked, or Peyronie's disease.
  • if you have a tight foreskin. Caverject Dual Chamber must not be given to children (see 'Caverject Dual Chamber contains benzyl alcohol and sodium').

Warnings and precautions If you experience an erection that lasts for longer than 4 hours, seek medical advice immediately as treatment should be started within 6 hours. If you cannot contact your doctor go to the hospital emergency department. Talk to your doctor or pharmacist before using Caverject Dual Chamber:

  • if you have a lung, chest or heart disorder (in these cases you also should engage in sexual activity with caution)
  • if you have a history of mental illness or addiction
  • if you have had a mini-stroke (transient ischaemic attack)
  • if you have one or more cardiovascular risk factors (these might include high blood pressure, tobacco use, raised blood glucose, raised blood cholesterol, overweight and obesity)
  • if you have one or more risk factors for stroke (these might include high blood pressure, raised blood cholesterol, coronary artery disease, heart arrhythmia, diabetes) Sexually transmitted diseases Caverject Dual Chamber will not protect you or your partner from sexually transmitted diseases like AIDS, herpes or gonorrhoea. The injection of Caverject Dual Chamber can start a small amount of bleeding where the needle enters. This could increase the risk of transmission of such diseases. Condoms can protect against sexually transmitted diseases. If you need advice about contraception or "safe sex" speak to your doctor or contact your local Family Planning Clinic. Other medicines and Caverject Dual Chamber Tell your doctor if you are taking any of the following medicines before you start using Caverject Dual Chamber: • • • • •

Antihypertensives (used for treating high blood pressure) Sympathomimetics (used for respiratory and heart disease) Vasodilative agents (drugs that widen blood vessels) Anticoagulants (blood-thinning agents) Other treatments for erectile dysfunction (e.g. sildenafil or papaverine)

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Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Pregnancy and breast-feeding Caverject Dual Chamber can be used by couples wishing to conceive and with a partner who is pregnant or breast-feeding. It will not protect your partner from pregnancy, so you should use a reliable contraceptive if appropriate. Driving and using machines Caverject Dual Chamber should not affect your ability to drive or use machines. Caverject Dual Chamber contains benzyl alcohol and sodium This medicine contains benzyl alcohol 8.9 mg/ml. Benzyl alcohol may cause allergic reactions. Using large amounts of Caverject Dual Chamber may cause a build-up of benzyl alcohol in your body resulting in an increased amount of acid in your blood (called metabolic acidosis). Patients with liver or kidney disease need to be especially cautious and discuss with their doctor. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called "gasping syndrome") in young children. Caverject Dual Chamber is not for use in children.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

3.

How to take it

Caverject Dual Chamber

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. A doctor will show you how to do the injection for at least the first time. Do not try to do it yourself until you have learnt the correct way or if you can't remember what to do, see your doctor again. These instructions are a reminder only. How much Caverject Dual Chamber should you inject? Different people need different amounts of Caverject Dual Chamber to treat erectile dysfunction. Your doctor will advise on the right dose for you and monitor you regularly to check how it is working. The starting dose in the clinic is 1.25-2.5 micrograms, although doses lower than 2.5 micrograms cannot be delivered with Caverject Dual Chamber. In this case, Caverject Page 3 of 10

Powder for Injection will be used. Most men find that a dose of 5-20 micrograms works for them, however, some men may require a higher dose. To minimise the risk of prolonged painful erection, your doctor will select the lowest effective dose. You should never use more than 40 micrograms. If Caverject Dual Chamber is being used to find the reason for your erectile dysfunction, the dose will be 5-20 micrograms. If the dose that has been prescribed for you does not work well enough, tell your doctor. Do not change your dose unless your doctor tells you to. If you forget how much to use, read the label on the pack or speak to your doctor. How do you use Caverject Dual Chamber? These instructions are intended as a reminder only; you should follow your doctor's advice where it differs from this leaflet. If you are using Caverject Dual Chamber for the first time and you have previously used Caverject Powder for Injection, your doctor should have given you advice about using Caverject Dual Chamber. You and your partner You may like your partner to be involved in preparing and/or giving the injection. If so, you should speak to your doctor about training for your partner.

The Caverject Dual Chamber device

Preparing the injection Wash your hands. Dry them with a clean towel. If your partner wishes to be involved in preparing or giving the injection, they should wash their hands too. 1. Remove one of the injection devices and needles from the box. Peel the foil cover from the needle.

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2. Attach the needle to the device by pushing the needle on to the tip of the device. Turn clockwise until it is firmly in place. The injection needle is enclosed in 2 protective caps. Pull off the outer protective cap of the needle. 3. Hold the device with the needle pointing upwards. The plunger rod should be in the extended position.

4. Turn the plunger rod clockwise until it stops. This mixes the powder and diluent. Gently shake to make sure that the solution is evenly mixed and the powder has dissolved. Do not use if it remains cloudy or contains particles.

5. Hold the device with the needle upwards. Carefully remove the inner protective cap from the needle. Make sure that the needle is not bent. If it is, do not use it and throw it away. Do not attempt to straighten it out.

6. To remove any large bubbles from the solution, flick the cartridge with your finger until the bubbles disappear. Then, keeping the device upright, make sure that the plunger rod is fully turned to the stop by screwing it to the right (clockwise) then immediately press the plunger rod as far as it will go. A few drops will appear at the needle point. It is normal for there to be small bubbles at the side of the glass cartridge. 7. Turn the end of the plunger rod slowly clockwise to select your dose. There are four dosage options. Each option is one of four quarterly parts of a full dose delivered by the device. Your doctor will have told you what this should be. The number appearing in the window indicates the dose of the injection. If you make a mistake, continue to turn the plunger rod clockwise until you reach the correct dose.

You can prepare your injection up to 24 hours before using it, providing it is kept at room temperature.

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How do you do the injection? • Get undressed and make yourself comfortable. Take some time to relax yourself and your partner. If your doctor has recommended you use an alcohol cleansing pad, open one now. • Make sure that the needle is not bent. A bent and re-straightened needle is predisposed to breakage. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalisation and surgical removal. If the needle is bent, do not use it and throw it away. Do not attempt to straighten it out. Attach a new, unused sterile needle to the syringe.

  • Take hold of the penis from the front, with the first two fingers underneath close to the testicles and the thumb on top. Gently squeeze the penis between your thumb and finger so that the injection site bulges out. If there is a foreskin on the penis, make sure it is stretched. The injection will go into the part of the penis shown as the shaded area in diagram A.
  • Using the alcohol swab, wipe over the area and let it dry. Check or if necessary adjust so that the right dose is in the dose window.
  • Keeping a firm grip on the penis and taking the syringe in your free hand, push the needle straight through the skin all the way into the bulgy part avoiding veins or other obvious blood vessels. The angle is shown in diagrams B and C. Push the plunger firmly and if the solution does not come out fairly easily, move the needle slightly and try again. Do not force the Caverject Dual Chamber liquid from the syringe. • •

Pull the needle out. Massage the penis to help the alprostadil spread through it. Do not keep any mixture in the cartridge to use for a second injection. When you have finished with the needle, throw it away carefully as recommended by your doctor, so no-one will see it, use it, or prick themselves on it.

How often can you use Caverject Dual Chamber? Do not use Caverject Dual Chamber more than once in 24 hours or more than three times in a week. Change the exact place and side of the penis that you inject Caverject Dual Chamber each time you use it.

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Your erection after injecting Caverject Dual Chamber It will take a little while for your erection to come on after the injection. With the right dose of Caverject Dual Chamber, your erection should be strong enough for you and your partner to enjoy lovemaking. Usually, your erection should not last longer than an hour. If you would like it to last longer, talk to your doctor. If your erection lasts longer than four hours, you should seek medical advice immediately (see section on Take special care with Caverject Dual Chamber). If you use more Caverject Dual Chamber than you should Tell your doctor straight away as you may need treatment; particularly if you experience an erection that lasts for longer than four hours. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if your erection goes on for longer than 4 hours. If you cannot contact your doctor, go to a hospital casualty department immediately as treatment should be started within 6 hours. Other side effects may include the following Very common side effects (may affect more than 1 in 10 people) •

Pain in the penis

Common side effects (may affect up to 1 in 10 people) • • • • •

Penis can become bruised, scarred, bent or kinked, particularly after long term use. Tell your doctor if this happens as you may need to stop Caverject Dual Chamber Prolonged erections Other problems with your penis Swelling and skin discolouration or bruising at site of injection. You may find this happening the first time you use Caverject Dual Chamber but should occur less often with practice Muscle spasms.

Uncommon side effects (may affect up to 1 in 100 people)

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• • • •

• • •

•

The area injected becomes irritated, inflamed or swollen and may itch or bleed, or feel numb, warm, tender or painful The testes or scrotum could become red, swollen or painful, or develop lumps called spermatocele, which are cysts containing sperm. The penis could feel numb You may get uncomfortable, painful or prolonged erections or none at all, your ejaculation may change or your foreskin could feel tight or swollen, as well as the head of your penis The desire to pass urine more urgently or frequently than normal or you may have pain or difficulty in urinating. Some blood may appear in the urine or at the end of the penis specially if Caverject Dual Chamber is injected by mistake into the tube which carries urine out through the penis (urethra) Pelvic pain, weakness, sweating, feeling sick or swollen legs or arms, having a common cold or dry mouth. You may get a yeast infection (thrush) Changes in blood pressure and heart rhythm, faintness, shallow breathing and collapse could occur because of the injection itself Skin itching, redness of the skin at site of injection, rash or skin growth, increased sweating, eye sensitivity to bright light or excessive dilation of the pupil (blown pupil), impaired or enhanced sense of touch, leg cramps, cold hands and feet, venous problems including bleeding (bleeding from vein(s)) If you have a blood test you may have raised levels of creatinine (a substance found in your muscles).

Not known (frequency cannot be estimated from available data) • •

Insufficient blood flow to the heart muscle via the coronary arteries Stroke

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible

Possible side effects

not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store it

Caverject Dual Chamber

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the pack after 'EXP'. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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You can prepare your injection up to 24 hours before using it, providing it is kept below or at 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Caverject Dual Chamber contains The active ingredient in Caverject Dual Chamber is alprostadil. Depending on the strength you have been given, the front compartment of each cartridge delivers a maximum of 10 or 20 micrograms of alprostadil in 0.5 ml. The other ingredients are lactose monohydrate, alfadex, sodium citrate, hydrochloric acid and sodium hydroxide. The diluent in the rear compartment is Bacteriostatic Water for Injection and contains 0.9% w/v benzyl alcohol and water for injections. The cleaning swabs are soaked in isopropyl alcohol. What Caverject Dual Chamber looks like and contents of the pack This product is a dual chamber glass cartridge assembled as a single unit in a disposable delivery device. The cartridge contains a powder in the front compartment and diluent in the rear compartment. There are sufficient components in each box to enable two or ten separate injections of Caverject Dual Chamber. Not all pack sizes may be marketed. In the Caverject Dual Chamber box you will find: 1. Two or ten single use injection devices each containing a Caverject Dual Chamber cartridge 2. Two or ten 29G needles 3. Alcohol cleaning swabs Marketing Authorisation Holder Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK. Manufacturer

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Caverject Dual Chamber is made by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium. The needle is made by Becton Dickinson Consumer Products, Dublin, Ireland. This leaflet was last revised in 04/2024. Ref: CJDC 16_0

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Frequently asked questions about Caverject Dual Chamber 20 micrograms

What is the active substance in Caverject Dual Chamber 20 micrograms?

The active substance in Caverject Dual Chamber 20 micrograms is alprostadil.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Caverject Dual Chamber 20 micrograms, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Caverject Dual Chamber 20 micrograms without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Alprostadil (12 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Caverject Dual Chamber is indicated for the symptomatic treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic, or mixed aetiology.

Caverject Dual Chamber may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Caverject is not indicated for paediatric use (see section 4.4 Benzyl alcohol).

4.2. Posology and method of administration

Posology

No formal studies with Caverject have been performed in patients younger than 18 years and older than 75 years.

Method of administration

Caverject Dual Chamber should be administered by direct intracavernosal injection using the 1/2-inch 29 gauge needle provided. The usual site of injection is along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided. Both the side of the penis and the site of injection must be altered between injections.

The initial injections of Caverject Dual Chamber must be administered by medically trained personnel and after proper training, alprostadil may be injected at home. It is recommended that patients are regularly monitored (e.g. every 3 months) particularly in the initial stages of self-injection therapy when dose adjustments may be needed.

The dose of Caverject Dual Chamber should be individualised for each patient by careful titration under a physician's supervision. The lowest effective dose should be used that provides the patient with an erection that is satisfactory for sexual intercourse. It is recommended that the dose administered produces a duration of the erection not exceeding one hour. If the duration is longer, the dose should be reduced. The majority of patients achieve a satisfactory response with doses in the range of 5 to 20 micrograms.

The delivery device is designed to deliver a single dose which can be set at 25% increments of the nominal dose. Doses greater than 40 micrograms of alprostadil are not routinely justified. The following doses can be given using Caverject Dual Chamber:

Presentation

Dose Available

Caverject Dual Chamber 20 micrograms

5, 10, 15, 20 micrograms

Treatment

The initial dose of alprostadil for erectile dysfunction of vasculogenic, psychogenic, or mixed aetiology is 2.5 micrograms. The second dose should be 5 micrograms if there is a partial response, and 7.5 micrograms if there is no response. Subsequent incremental increases of 5 to 10 micrograms should be given until an optimal dose is identified. If there is no response to the administered dose, then the next higher dose may be given within one hour. If there is a response, there should be a one day interval before the next dose is given.

For patients with erectile dysfunction of neurogenic origin requiring doses less than 2.5 micrograms, it should be considered to dose titrate with Caverject Powder for Injection. Starting with a dose of 1.25 micrograms, if this produces no response, the second dose should be 2.5 micrograms. Apart from the starting dose, it is possible to dose titrate with either Caverject Dual Chamber or Caverject Powder for Injection with similar increments to the treatment of non-neurogenic erectile dysfunction.

The maximum recommended frequency of injection is no more than once daily and no more than three times weekly.

Adjunct to aetiologic diagnosis

Patients without evidence of neurological dysfunction: 10 to 20 micrograms alprostadil to be injected into the corpus cavernosum and massaged through the penis. Over 80% of patients may be expected to respond to a single 20 micrograms dose of alprostadil.

Patients with evidence of neurological dysfunction: These patients can be expected to respond to lower doses of alprostadil. In patients with erectile dysfunction caused by neurologic disease/trauma, the dose for diagnostic testing must not exceed 10 micrograms and an initial dose of 5 micrograms is likely to be appropriate.

Should an ensuing erection persist for more than one hour, detumescent therapy should be employed prior to the patient leaving the clinic to prevent a risk of priapism (see section 4.9). At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state.

In case of lack of erectile response during the titration phase, patients should be monitored for systemic adverse effects.

4.3. Contraindications

Caverject Dual Chamber must not be used in patients who have:

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Conditions that might predispose them to priapism, such as sickle cell anaemia or trait, multiple myeloma, or leukaemia.

• Anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease.

• Penile implants.

Caverject Dual Chamber must not be used in men for whom sexual activity is contraindicated (e.g. patients suffering from severe heart disease).

4.4. Special warnings and precautions for use

Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with alprostadil.

Prolonged erection and/or priapism may occur following intracavernosal administration of alprostadil.To minimise the risk, select the lowest effective dose. Patients should be instructed to immediately report to a physician any erection lasting for a prolonged time period, such as 4 hours or longer. Treatment of priapism should not be delayed more than 6 hours. Treatment of priapism should be according to established medical practice (see section 4.9).

Painful erection is more likely to occur in patients with anatomical deformations of the penis, such as angulation, phimosis, cavernosal fibrosis, Peyronie's disease or plaques. Penile fibrosis, including angulation, cavernosal fibrosis, fibrotic nodules and Peyronie's disease may occur following the intracavernosal administration of Caverject Dual Chamber. The occurrence of fibrosis may increase with increased duration of use. Regular follow-up of patients, with careful examination of the penis, is strongly recommended to detect signs of penile fibrosis or Peyronie's disease. Treatment with Caverject Dual Chamber should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie's disease.

Patients on anticoagulants such as warfarin or heparin may have increased propensity for bleeding after the intracavernosal injection. In some patients, injection of Caverject Dual Chamber can induce a small amount of bleeding at the site of injection. In patients infected with blood-borne diseases, this could increase the transmission of such diseases to their partner.

Caverject should be used with caution in patients with cardiovascular and cerebrovascular risk factors.

Caverject should be used with care in patients who have experienced transient ischaemic attacks or those with unstable cardiovascular disorders.

Sexual stimulation and intercourse can lead to cardiac and pulmonary events in patients with coronary heart disease, congestive heart failure or pulmonary disease. Caverject should be used with care in these patients and they should engage in sexual activity with caution.

Caverject Dual Chamber is not intended for co-administration with any other agent for the treatment of erectile dysfunction (see section 4.5).

The potential for abuse of Caverject should be considered in patients with a history of psychiatric disorder or addiction.

Reconstituted solutions of Caverject Dual Chamber are intended for single use only. The injection delivery system/syringe and any remaining solution should be properly discarded.

Caverject Dual Chamber uses a superfine needle for administration. As with all superfine needles, the possibility of needle breakage exists.

Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalisation and surgical removal.

Careful patient instruction in proper handling and injection techniques may minimise the potential for needle breakage.

The patient should be instructed that, if the needle is bent, it must not be used; they should also not attempt to straighten a bent needle. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.

Benzyl alcohol

Caverject Dual Chamber contains benzyl alcohol, which may cause hypersensitivity reactions.

The combined daily metabolic load of benzyl alcohol from all sources should be considered, especially in patients with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

This medicine is only indicated for intracavernosal injection. Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events and death in paediatric patients including neonates (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth weight infants may be more likely to develop toxicity. Caverject Dual Chamber is not indicated for paediatric use.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

Sympathomimetics may reduce the effect of alprostadil. Alprostadil may enhance the effects of antihypertensives, vasodilative agents, anticoagulants and platelet aggregation inhibitors.

The effects of combinations of alprostadil with other treatments for erectile dysfunction (e.g. sildenafil) or other medicinal products inducing erection (e.g. papaverine) have not been formally studied. Such medicinal products should not be used in combination with Caverject due to the potential for inducing prolonged erections.

4.6. Fertility, pregnancy and lactation

Not applicable.

4.7. Effects on ability to drive and use machines

Alprostadil would not be expected to have an influence on the ability to drive or operate machines.

4.8. Undesirable effects

Summary of the safety profile

The most frequent adverse effect following an intracavernous injection was pain in the penis. Thirty percent of patients reported pain at least once. Pain was associated with 11% of the injections administered. In most cases pain was assessed as mild or moderate. Three per cent of patients discontinued treatment because of pain.

Penile fibrosis, including angulation, fibrotic nodules, and Peyronie's disease, was reported in 3% of clinical trial patients overall. In one self-injection study in which the duration of use was up to 18 months, the incidence of penile fibrosis was higher, approximately 8%.

Haematoma and ecchymosis at the injection site, which is related with the injection technique rather than the effect of alprostadil, was reported by 3% and 2% of patients, respectively.

Prolonged erection (an erection for 4 to 6 hours) developed in 4% of patients. Priapism (a painful erection for more than 6 hours) occurred in 0.4%. In most cases it disappeared spontaneously.

Tabulated list of adverse reactions

Adverse drug reactions reported during clinical trials and post marketing experience are presented in the table below, frequencies are very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); not known (cannot be estimated from the available data). The adverse drug reactions are listed in order of decreasing medical seriousness within each frequency category and system organ class.

System Organ Class

Very common

≥1/10

Common

≥1/100 to <1/10

Uncommon

≥1/1,000 to <1/100

Not known (cannot be estimated from the available data)

Infections and infestations

Fungal infection, Common cold

Nervous system disorders

Presyncope, Hypoaesthesia, Hyperaesthesia

Cerebrovascular accident

Eye disorders

Mydriasis

Cardiac disorders

Supraventricular extrasystoles

Myocardial ischaemia

Vascular disorders

Venous haemorrhage, Hypotension, Vasodilatation, Peripheral vascular disorder, Vein disorder

Gastrointestinal disorders

Nausea, Dry mouth

Skin and subcutaneous tissue disorders

Rash, Hyperhidrosis, Pruritus, Erythema

Musculoskeletal and connective tissue disorders

Muscle spasms

Renal and urinary disorders

Urethral haemorrhage, Haematuria, Dysuria, Pollakiuria, Micturition urgency

Reproductive system and breast disorders

Penile pain

Peyronie's disease, Penis disorders (including penile fibrosis, angulation and fibrotic nodules), Erection increased

Priapism, Pelvic pain, Testicular mass, Spermatocele, Testicular swelling, Testicular oedema, Testicular disorder, Scrotal pain, Scrotal erythema, Scrotal oedema, Testicular pain, Scrotal disorder, Painful erection, Balanitis, Phimosis, Erectile dysfunction, Ejaculation disorder

General disorders and administration site conditions

Injection site haematoma, Ecchymosis

Haemorrhage, Injection site haemorrhage, Inflammation, Injection site inflammation, Injection site warmth, Injection site oedema, Injection site swelling, Injection site pain, Injection site irritation, Asthenia, Injection site anaesthesia, Oedema, Oedema peripheral, Injection site pruritus

Investigations

Blood creatinine increased, Blood pressure decreased, Heart rate increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Overdosage was not observed in clinical trials with alprostadil. If intracavernous overdose of Caverject Dual Chamber occurs, the patient should be placed under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Symptomatic treatment of any systemic symptoms would be appropriate.

The treatment of priapism (prolonged erection) should not be delayed more than 6 hours. Initial therapy should be by penile aspiration. Using aseptic technique, insert a 19 to 21 gauge butterfly needle into the corpus cavernosum and aspirate 20 to 50 ml of blood. This may detumesce the penis. If necessary, the procedure may be repeated on the opposite side of the penis until a total of up to 100 ml blood has been aspirated. If still unsuccessful, intracavernous injection of alpha-adrenergic medication is recommended. Although the usual contraindication to intrapenile administration of a vasoconstrictor does not apply in the treatment of priapism, caution is advised when this option is exercised. Blood pressure and pulse should be continuously monitored during the procedure. Extreme caution is required in patients with coronary heart disease, uncontrolled hypertension, cerebral ischaemia, and in patients taking monoamine oxidase inhibitors. In the latter case, facilities should be available to manage a hypertensive crisis. A 200 microgram/ml solution of phenylephrine should be prepared, and 0.5 to 1.0 ml of the solution injected every 5 to 10 minutes. Alternatively, a 20 microgram/ml solution of epinephrine should be used. If necessary, this may be followed by further aspiration of blood through the same butterfly needle. The maximum dose of phenylephrine should be 1 mg, or epinephrine 100 micrograms (5 ml of the solution). As an alternative metaraminol may be used, but it should be noted that fatal hypertensive crises have been reported. If this still fails to resolve the priapism, urgent surgical referral for further management, which may include a shunt procedure is required.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

  • ALPROSTADIL ROMPHARM 20 micrograme prescriptionALPROSTADILUM · injection / infusion
  • NEUPEDIX 500 micrograme prescriptionALPROSTADILUM · injection / infusion
  • VASAPROSTAN 20 µg/ml prescriptionALPROSTADILUM · injection / infusion
  • PRIDAX 20µg prescriptionALPROSTADILUM · injection / infusion
  • VITAROS 2 mg/g prescriptionALPROSTADILUM · skin / topical
  • VITAROS 3 mg/g prescriptionALPROSTADILUM · skin / topical

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

  • Prostin VRAlprostadilum · injection / infusion
  • Prostavasin 60Alprostadilum · injection / infusion

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Caverject Dual Chamber 20 micrograms. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

📋 Official guidance mentioning this medicine

→ Erectile dysfunction: Alprostadil cream (NICE · 2014)
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