Caverject (alprostadil)

The initial dose of alprostadil in patients with caverjet dysfunction of neurogenic origin secondary to spinal cord injury is 1. To minimize the risk, select the lowest effective dose. Any alprostadil entering the systemic circulation from the corpus cavernosum will be rapidly metabolised. Side effects in more detail. Find out more here. Alprostadil would not be expected to have an influence on the ability to drive or operate machines. Following intracavernosal injection of 20 micrograms alprostadil, mean plasma concentrations of alprostadil increased 22 fold from the baseline endogenous levels approximately 5 minutes post-injection. Single pack containing a 5 ml clear, colourless, glass vial of Caverject 20 micrograms powder with a bromobutyl rubber stopper and an aluminium overseal with caverjet flip-off cap. Sodium For the full list of excipients, caverjet, see section 6. Renal and urinary disorders. The dose of Caverject should be individualised for each patient by careful titration under supervision by a physician. Caverjet dose that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse. The adverse drug reactions are listed in order of decreasing medical seriousness within each frequency category and system organ class. Patients on anticoagulants such as warfarin caverjet heparin may have increased propensity for bleeding after the intracavernosal injection. Penile fibrosis, including angulation, cavernosal fibrosis, fibrotic nodules and Peyronie's disease may occur following the intracavernosal administration of alprostadil. A half inch, 27 to 30 gauge needle is generally recommended. Caverject is not indicated for paediatric use see section 4. No significant binding to erythrocytes or white blood cells was observed, caverjet. The pharmacotoxic signs of alprostadil are similar in all animal species and include depression, soft stools or diarrhoea and rapid breathing. Alprostadil may enhance the effects of antihypertensives, vasodilative agents, anticoagulants and platelet aggregation inhibitors, caverjet. Use Caverject alprostadil injection as ordered by your doctor. Should an ensuing erection persist for more than one hour detumescent therapy please refer to Section 4. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state. High doses of alprostadil 0. Such agents should not be used in combination with alprostadil due to the potential for inducing prolonged erections.

Overdosage was not observed in clinical trials with alprostadil. The lowest effective dose should be used. The most frequent adverse reaction after intracavernosal injection of alprostadil is penile pain. Alprostadil did not affect rat spermatogenesis at doses times greater than the proposed human intrapenile dose. Treatment The initial dose of alprostadil in patients with erectile dysfunction of neurogenic origin secondary to spinal cord injury is 1. Subsequent incremental increases of micrograms should be given until an optimal dose is achieved. The frequency of priapism defined as an erection caverjet lasts 6 hours or longer was 0. No relevant information additional to that already contained in this SPC. Careful patient instruction in proper handling and injection techniques may caverjet the potential for needle breakage. Duplex ultrasonography was used to measure the peak systolic velocity and diameter of the cavernosal arteries at the end of the titration phase and after 4, 8, and 12 months of the home phase. Alprostadil should not be used in patients who have a known hypersensitivity to alprostadil or to any of the excipients listed in section 6. Company contact details Pfizer Limited. Qualitative and quantitative composition 3. In patients infected with blood-borne diseases, this could increase caverjet transmission of such diseases to caverjet partner. The effects of combinations of alprostadil with other treatments for erectile dysfunction e. Haemorrhage, Injection site haemorrhage, Inflammation, caverjet, Injection site inflammation, caverjet, 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. These patients when using alprostadil should engage in sexual activity with caution. Powder for solution for injection A white to off-white powder.

Uses of Caverject:

Sixty-three men entered the caverjet phase; 49 of them filled out the diaries and 42 completed the study. Inject the 1 ml of diluent into the vial, and shake to dissolve the powder entirely. The first injections of alprostadil must be done by medically trained personnel. Single pack containing a 5 ml clear, colourless, glass vial caverjet Caverject 20 caverjet powder with a bromobutyl rubber stopper and an aluminium overseal with polypropylene flip-off cap. The most frequent adverse effect following an intracavernous injection was pain in caverjet penis. The majority of patients achieve a satisfactory response with doses in the range of 5 to 20 micrograms. Packs also each contain a syringe of solvent, a sterile 22G and a 30G needle plus a preinjection swab. The metabolites caverjet excreted primarily by the kidney and excretion is essentially complete within 24 hours. They should remove the needle from the syringe, caverjet, caverjet it, and attach a new, unused sterile needle to the syringe. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe. Subsequent incremental increases of micrograms should be given until an optimal dose is achieved. If the duration is longer, caverjet, the dose should be reduced. The minimum amount of benzyl alcohol at which toxicity may occur is not known. The pharmacokinetics of alprostadil is therefore unchanged in Caverject Dual Chamber in comparison with Caverject Powder for Injection. In the majority of the cases, penile pain was rated mild or moderate in intensity. Alprostadil is present in various mammalian tissues and fluids. Last updated on eMC: No relevant information additional to that already contained in this SPC. Excipients with known effect: Caverject Dual Chamber may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. Patients on anticoagulants such as warfarin or heparin may have increased propensity for bleeding after the intracavernosal injection, caverjet. Each 1ml of reconstituted solution contains 8. High doses of alprostadil 0. In the majority of cases, spontaneous detumescence occurred. Treatment with Caverject Dual Chamber should be discontinued in patients who develop penile caverjet, cavernosal fibrosis, or Peyronie's disease.

Marketing authorisation number s 9. The potential for abuse of alprostadil should be considered in patients with a history of caverjet disorder or addiction. Alprostadil should not be used in men for whom sexual activity is inadvisable or contraindicated. The solution should be clear. The Journal of Urology ; Shelf life of the medicinal product as packaged for sale 36 months. Sexual stimulation and intercourse can lead to cardiac and pulmonary events in patients with coronary heart disease, congestive heart failure or pulmonary disease. To bookmark a medicine you must sign up and log in. Use of intracavernosal alprostadil offers no protection from the transmission of sexually transmitted diseases. Fit the 22 gauge needle to the syringe. Invert the device twice in order to make sure the solution is evenly mixed. Reconstituted solutions are intended for single use only, they should be used immediately and not stored. Carefully remove the inner protective cap from the needle. The intracavernosal injection must be done under sterile conditions. Sexual stimulation and intercourse can lead to cardiac and pulmonary events in patients with coronary heart disease, congestive heart failure or pulmonary disease. Use immediately after reconstitution. Sodium For the full list of excipients, see section 6. Nephrology Family Medicine Urology. The usual maximum recommended frequency of injection is no more than once daily and no more than three times weekly. Generic Name and Formulations: Alprostadil may enhance the effects of antihypertensives, vasodilative agents, anticoagulants and platelet aggregation inhibitors. If still unsuccessful, intracavernous injection of alpha-adrenergic medication is recommended, caverjet. Alprostadil should be used with caverjet in patients with cardiovascular and cerebrovascular risk factors. Following intracavernosal injection of 20 micrograms alprostadil, mean plasma concentrations caverjet alprostadil increased 22 fold from the baseline endogenous levels approximately 5 minutes post-injection. Venous haemorrhage, Hypotension, Vasodilatation, Peripheral vascular disorder, Vein disorder.

Caverjet

Use immediately after reconstitution, caverjet. Sympathomimetics may reduce the effect of alprostadil. For patients with erectile dysfunction of neurogenic origin requiring doses less than 2. In some patients, injection of alprostadil can induce a small amount of bleeding at the site of injection. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state. Reconstituted solutions of alprostadil are intended for single use only, they should be used immediately and not stored. A vacuum device involves placing a cylinder-like device and attached pump over the penis. The adverse drug reactions are listed in order of decreasing medical seriousness within each frequency category and system organ class. Alprostadil should caverjet be used in patients who have a known hypersensitivity to alprostadil or to any of the excipients listed in section 6. This site uses cookies. Patients should be instructed to report to a physician any erection lasting for a prolonged time period, such as 4 hours or longer. Single pack containing a 5 ml clear, colourless, glass vial of Caverject 20 micrograms powder with a bromobutyl rubber stopper and an aluminium overseal with polypropylene flip-off cap Packs also each contain a syringe of solvent, a sterile 22G and caverjet 30G needle plus a preinjection swab. Individuals who use alprostadil should be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus HIV, caverjet. Although the pharmacokinetics of alprostadil have not been formally examined in patients with renal or hepatic insufficiency, alterations in renal or hepatic function would not be expected to have a major influence on the pharmacokinetics of alprostadil. Alprostadil is present in various mammalian tissues and caverjet. In the majority of the cases, caverjet, penile pain was rated mild or moderate in intensity. The package insert provides caverjet instructions on reconstitution, cleansing the injection site, and also how to perform the injection. Date of revision of the text. Marketing authorisation holder 8. Company contact details Pfizer Limited. Doses greater than 40 micrograms of alprostadil are not routinely justified. Marketing authorisation caverjet s 9. Peyronie's disease, Penis disorder, Erection increased.

Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalisation and surgical removal. Use of intracavernosal alprostadil offers no protection from caverjet transmission of sexually transmitted diseases. Reevaluate every 3 months. To reconstitute Caverject using the prefilled diluent syringe: Vasculogenic, psychogenic, or mixed etiology: Fit the 22 gauge needle to the syringe. If the duration is longer, the dose should caverjet reduced. The usual site of injection is along caverjet dorsolateral aspect of the proximal third of the penis. The Journal of Urology ; At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state. Fit the 22 gauge needle to the syringe. The dose of Caverject should be individualised for each patient by careful titration under supervision by a physician. The minimum amount of benzyl alcohol at which toxicity may occur is not known. The presence of benzyl alcohol caverjet the reconstitution vehicle caverjet the degree of binding to package surfaces. Caverject is administered by direct intracavernous injection. The lowest, effective dose should be used caverjet provides the patient with an erection that is satisfactory for sexual intercourse. No relevant information additional to that already contained in this SPC. Marketing authorisation number s 9. If necessary, the procedure may be repeated on the opposite side of the penis until a total of up to ml blood has been aspirated. As with all superfine needles, the possibility of needle breakage exists. Adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. Penile fibrosis, including angulation, caverjet, cavernosal fibrosis, caverjet, fibrotic nodules and Peyronie's disease may occur following the intracavernosal administration of alprostadil.

Dual chamber glass caverjet containing a white lyophilised powder and diluent for reconstitution. Its duration is dose dependent. Musculoskeletal and Connective Tissue Disorders. Penile fibrosis, including angulation, caverjet, cavernosal fibrosis, fibrotic nodules and Peyronie's disease may occur following the intracavernosal administration of alprostadil. Powder for solution for injection A white to off-white powder. Extreme caution is required in patients with coronary heart disease, uncontrolled hypertension, cerebral ischaemia, and in subjects taking monoamine oxidase inhibitors. Marketing authorisation number s 9. Name of the medicinal product 2. They should remove the needle from the syringe, discard it, and attach a new, caverjet, unused sterile needle to the syringe. Should an ensuing erection persist for more than one hour detumescent therapy please refer to Section 4. To view the changes to a medicine you must sign up and log in. The adverse drug reactions are listed in order of decreasing medical seriousness within each frequency category and system organ class. This information is intended for use by health professionals. The usual maximum recommended frequency of injection is no caverjet than once daily and no more than three times weekly. Haemorrhage, Injection site haemorrhage, Inflammation, Injection site inflammation, Injection site warmth, Injection site oedema, Injection site swelling, Injection site caverjet, Injection site irritation, Asthenia, Injection site anaesthesia, Oedema, Oedema peripheral, Injection site pruritus. Therefore, a more consistent product delivery is produced when Bacteriostatic Water for Injection containing benzyl alcohol is used. Alprostadil did not affect rat spermatogenesis at doses times greater than the proposed human caverjet dose. In the majority of the cases, penile pain was rated mild or moderate in intensity. Marketing authorisation holder 8. Peyronie's disease, Penis disorder, Erection increased. General disorders and administration site conditions. General Disorders and Administration Site Conditions.

If the duration is longer, the dose should be reduced. The pharmacologic effect of alprostadil in the treatment of erectile dysfunction is presumed to be mediated by inhibition of alpha 1 -adrenergic activity in penile tissue and by its relaxing effect on cavernosal smooth muscle. Reconstituted solutions of alprostadil are intended for single use only, they should be used immediately and not stored. Initial therapy should be by penile aspiration. Shelf life of the medicinal product as packaged for sale 36 months. Reconstituted solutions are intended for single use only, they should be used immediately and not stored. Adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. Adjust volume to the required dose for injection. Treatment with alprostadil should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie's disease. The initial dose of alprostadil in patients with erectile dysfunction of neurogenic origin secondary to spinal cord injury is 1. The maximum dose of phenylephrine should be 1 mg, or adrenaline micrograms 5 ml of the solution. The solution should be clear. Marketing authorisation number s 9. To reconstitute Caverject using the prefilled diluent syringe: Show table of contents Hide table of contents 1. After proper training and instruction, alprostadil may be injected at home. Packs also each contain a syringe of solvent, a sterile 22G and a 30G needle plus a preinjection swab. 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. In some patients, injection of alprostadil can induce a small amount of bleeding at the site of injection. Sign Up Log In Cancel.

caverjet

Name of the medicinal product 2. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe. Careful patient instruction in proper handling and injection techniques may minimise the potential for needle breakage. Peripheral levels of the major circulating metabolite, oxo,dihydro-PGE 1 , increase to reach a peak 30 minutes after injection and return to pre-dose levels by 60 minutes after injection. Symptomatic treatment of any systemic symptoms would be appropriate. Priapism a painful erection for more than 6 hours occurred in 0. Reproductive System and Breast Disorders. The second dose should be 5 micrograms if there is a partial response, and 7. No significant binding to erythrocytes or white blood cells was observed. Continue typing to refine. For the treatment of erectile dysfunction, alprostadil is administered by injection into the corpora cavernosa. Treatment of erectile dysfunction. To email a medicine you must sign up and log in. Peripheral levels of the major circulating metabolite, oxo,dihydro-PGE 1 , increase to reach a peak 30 minutes after injection and return to pre-dose levels by 60 minutes after injection. The effects of combinations of alprostadil with other treatments for erectile dysfunction e. For the estimated 10 to 20 million American men who suffer from impotence, Caverject provides an alternative to devices previously approved by FDA. The initial injections of Caverject Caverjet Chamber must be administered by medically trained personnel and after proper training, alprostadil may be injected at home. High doses of alprostadil 0. Should an ensuing erection persist for more than one hour detumescent therapy please refer to Section 4. Patients should be instructed to report immediately to a physician, or if unavailable to seek immediate medical assistance for any erection lasting for a prolonged time period, caverjet, such as 4 hours. To view the changes to a medicine you must sign up and log in. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:. Hypotension; avoid in those with known cavernosa venous leakage.

Caverject is indicated for the treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed aetiology. There is no evidence of tissue retention of alprostadil or its metabolites following intravenous administration. Qualitative and quantitative composition 3. Caverject is not indicated for paediatric use see section 4. Penile fibrotic conditions eg, anatomical deformation, angulation, cavernosal fibrosis, Peyronie's disease. Sign Up Log In Cancel. Although the pharmacokinetics of alprostadil have not been formally examined in patients with renal or hepatic insufficiency, alterations in renal or hepatic function would not be expected to have a major influence on the pharmacokinetics of alprostadil. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalisation and surgical removal. The remainder of the dose is excreted in the faeces. Adjust volume to the required dose for injection. Starting with a dose of 1. General Disorders and Administration Site Conditions. Patients should be instructed to report immediately to a physician, or if unavailable to seek immediate medical assistance for any erection lasting for a prolonged time period, such as 4 hours. The following doses can be given using Caverject Dual Chamber:. The majority of patients achieve a satisfactory response with doses in the range of 5 to 20 micrograms. The frequency of priapism defined as an erection that lasts 6 hours or longer was 0. Caverject uses a superfine needle for administration. Caverject is indicated for the treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed aetiology. Blood pressure and pulse should be continuously monitored during the procedure. Painful erection is more likely to occur in patients with anatomical deformations of the penis, such as angulation, phimosis, cavernosal fibrosis, caverjet, Peyronie's disease or plaques. Following intracavernous injection of 20 micrograms of alprostadil, mean peripheral caverrjet of alprostadil at 30 and 60 minutes after injection are not significantly greater than baseline levels of endogenous PGE 1. The pharmacologic effect of alprostadil in the treatment of erectile dysfunction is presumed to be mediated by inhibition caverjet alpha 1 -adrenergic activity in penile tissue and by its relaxing effect on cavernosal smooth muscle. Alprostadil should be used with caution in patients with cardiovascular and cerebrovascular risk factors. Find out more here. Although the usual contra-indication to intrapenile administration of a vasoconstrictor does not apply in the treatment of priapism, caution is advised when this option is exercised.