May 25, 2016
Recommended Topic Related To:

Caverject Impulse

"For men with low testosterone, taking testosterone along with Viagra may not help their erections more than if they only took Viagra, a new study shows.

“There were lots of reasons to think that it would work," Boston University rese"...

A A A

Caverject Impulse




Caverject Impulse Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/17/2016

Caverject Impulse (alprostadil dual chamber system for injection) is a vasodilator that works by helping the blood flow into the penis to achieve and maintain an erection used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This medication guide addresses only the adult male use of Caverject Impulse in erectile disorders. Common side effects of Caverject Impulse include injection site reactions (mild/moderate pain, irritation, or slight bleeding), unusual discharge from your penis, mild pain in your penis/urethra/testicles, headache, dizziness, back pain, a rash on the skin of your penis, itching/warmth/numbness of your penis, cough, stuffy nose, cold symptoms, or flu symptoms.

The dose of Caverject is individualized by careful titration under supervision by the physician. Doses of greater than 60 mcg are not recommended. Caverject Impulse may interact with nitroglycerin, hydralazine, or blood thinners. Tell your doctor all medications and supplements you use. Caverject Impulse should not be used by women, therefore, it is unlikely to be used during pregnancy or while breastfeeding. Men should use a condom to prevent transfer of this medication to a sexual partner if she is pregnant or could become pregnant.

Our Caverject Impulse (alprostadil dual chamber system for injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Caverject Impulse in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alprostadil and call your doctor at once if you have a serious side effect such as:

  • feeling light-headed, fainting;
  • trouble urinating, blood in your urine;
  • bleeding, bruising, or swelling where you injected the medication;
  • a painful erection that lasts 4 hours or longer;
  • severe pain or irritation of your penis or urethra; or
  • redness, lumps, tenderness, unusual shape or curving of the erect penis.

Less serious side effects may include:

  • unusual discharge from your penis; or
  • mild pain in your penis, urethra, or testicles;
  • headache, dizziness;
  • back pain;
  • a rash on the skin of your penis;
  • itching, warmth, or numbness of your penis;
  • cough, stuffy nose, cold symptoms, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Your sexual partner may also have side effects such as burning, itching, or irritation of the body areas that come into contact with your penis.

Read the entire detailed patient monograph for Caverject Impulse (Alprostadil Dual Chamber System for Injection)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Caverject Impulse Overview - Patient Information: Side Effects

SIDE EFFECTS: Mild/moderate pain, irritation, or slight bleeding at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: redness/tenderness/swelling of the penis, lumps/unusual curving of the penis.

In the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Caverject Impulse (Alprostadil Dual Chamber System for Injection)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Caverject Impulse FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following are discussed in more detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

CAVERJECT IMPULSE was evaluated in 87 patients in an open-label crossover study of 6 weeks treatment duration that compared the formulation of alprostadil for injection contained in CAVERJECT IMPULSE with the formulation contained in CAVERJECT Sterile Powder. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penis disorder (4.6%), prolonged erection (1.1%), injection site erythema (1.1%), rash (1.1%), dizziness (1.1%), and hematospermia (1.1%). Penis disorder included penile pain, post-injection pain, and pain with erection.

CAVERJECT IMPULSE was also evaluated in 63 patients in a single-dose, double-blind, crossover study that compared CAVERJECT IMPULSE with CAVERJECT Sterile Powder. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penile pain (1.6%) and pruritis (1.6%).

In addition to the adverse reactions observed for CAVERJECT IMPULSE in these two studies, the following adverse reactions have been reported in clinical studies of CAVERJECT Sterile Powder:

Local Adverse Reactions

Local adverse reactions derived from 1861 patients in clinical studies of CAVERJECT Sterile Powder, including an 18-month, open-label study, are shown in Table 1.

Table 1: Local Adverse Reactions Reported by ≥ 1% of Patients Treated with CAVERJECT Sterile Powder for up to 18 Months

Penile pain 37%
Prolonged erection 4%
Penile fibrosis 3%
Injection site hematoma 3%
Penis disorder* 3%
Injection site ecchymosis 2%
Penile rash 1%
Penile edema 1%
* Penis disorder includes: numbness, irritation, sensitivity, pruritus, erythema, skin tear, discoloration, itching.

The following local adverse reactions were reported in < 1% of patients: injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, irritation, sensitivity, pruritus, erythema, painful erection, and abnormal ejaculation.

In these studies, no local adverse reactions were reported in the 294 patients who received placebo, except for penile pain (2%).

Penile Pain: In the majority of the cases, penile pain was rated mild or moderate in intensity. Three percent of patients discontinued treatment because of penile pain

Prolonged Erection/Priapism: Prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as an erection that lasted 6 hours or longer. In clinical studies, the frequency of prolonged erection after intracavernosal administration of CAVERJECT Sterile Powder was 4%, while the frequency of priapism was 0.4% [see WARNINGS AND PRECAUTIONS].

Penile Hematoma/Ecchymosis: In clinical studies the frequency of penile hematoma and ecchymosis was 3% and 2%, respectively.

Systemic Adverse Reactions: Systemic adverse reactions reported by ≥ 1% of subjects in clinical studies of CAVERJECT

Sterile Powder included: dizziness (1%).

The following systemic adverse reactions, were reported in < 1% of patients: testicular pain, scrotal edema, hematuria, pelvic pain, hypotension, vasodilation, vasovagal reaction, diaphoresis, rash, and non-application site pruritus. Three patients (0.2%) discontinued due to symptomatic hypotension. No systemic adverse reactions were reported in the 294 patients who received placebo.

Post-marketing Experience

The following additional adverse reactions have been reported: device malfunction/failure, drug ineffective and drug effect decreased.

Read the entire FDA prescribing information for Caverject Impulse (Alprostadil Dual Chamber System for Injection)

Caverject Impulse - User Reviews

Caverject Impulse User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Caverject Impulse sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.



Sex & Relationships

Get tips to boost your love life.