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Caverject Impulse

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Caverject Impulse

Caverject Impulse Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Caverject Impulse (alprostadil dual chamber system for injection) is used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. This drug 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 this medication in erectile disorders. It works by helping the blood flow into the penis to achieve and maintain an erection. Common side effects include mild/moderate pain, irritation, or slight bleeding at the injection site.

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

Local Adverse Reactions

The following local adverse reaction information was derived from controlled and uncontrolled studies of CAVERJECT Sterile Powder, including an uncontrolled 18-month safety study.

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

Event CAVERJECT
N = 1861
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%
* Except for penile pain (2%), no significant local adverse reactions were reported by 294 patients who received 1 to 3 injections of placebo.
** See General PRECAUTIONS.
*** Includes numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, penile skin tear, strange feeling of penis, discoloration of penile head, itch at tip of penis.

Penile Pain

Penile pain after intracavernosal administration of CAVERJECT was reported at least once by 37% of patients in clinical studies of up to 18 months in duration. 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. The frequency of penile pain was 2% in 294 patients who received 1 to 3 injections of placebo.

Prolonged Erection/Priapism

In clinical trials, prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as erection that lasted 6 hours or longer. The frequency of prolonged erection after intracavernosal administration of CAVERJECT was 4%, while the frequency of priapism was 0.4% (see WARNINGS).

Hematoma/Ecchymosis

The frequency of hematoma and ecchymosis was 3% and 2%, respectively. In most cases, hematoma/ecchymosis was judged to be a complication of a faulty injection technique. Accordingly, proper instruction of the patient in self-injection is of importance to minimize the potential of hematoma/ecchymosis (see DOSAGE AND ADMINISTRATION).

The following local adverse reactions were reported by fewer than 1% of patients after injection of CAVERJECT: balanitis, injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection, and abnormal ejaculation.

Systemic Adverse Events

The following systemic adverse event information was derived from controlled and uncontrolled studies of CAVERJECT Sterile Powder, including an uncontrolled 18-month safety study.

Systemic Adverse Events Reported by ≥ 1% of Patients Treated with CAVERJECT Sterile Powder for up to 18 Months*

Body System/Reaction CAVERJECT
N = 1861
Cardiovascular System
  Hypertension 2%
Central Nervous System
  Headache 2%
  Dizziness 1%
Musculoskeletal System
  Back pain 1%
Respiratory System
  Upper respiratory infection 4%
  Flu syndrome 2%
  Sinusitis 2%
  Nasal congestion 1%
  Cough 1%
Urogenital System
  Prostatic Disorder** 2%
Miscellaneous
  Localized pain*** 2%
  Trauma**** 2%
* No significant adverse events were reported by 294 patients who received 1 to 3 injections of placebo.
** Prostatitis, pain, hypertrophy, enlargement
*** Pain in various anatomical structures other than injection site
**** Injuries, fractures, abrasions, lacerations, dislocations

The following systemic events, which were reported for < 1% of patients in clinical studies, were judged by investigators to be possibly related to use of CAVERJECT: testicular pain, scrotal disorder, scrotal edema, hematuria, testicular disorder, impaired urination, urinary frequency, urinary urgency, pelvic pain, hypotension, vasodilation, peripheral vascular disorder, supraventricular extrasystoles, vasovagal reactions, hypesthesia, non-generalized weakness, diaphoresis, rash, non-application site pruritus, skin neoplasm, nausea, dry mouth, increased serum creatinine, leg cramps, and mydriasis.

Hemodynamic changes, manifested as decreases in blood pressure and increases in pulse rate, were observed during clinical studies, principally at doses above 20 mcg and above 30 mcg of alprostadil, respectively, and appeared to be dose-dependent. However, these changes were usually clinically unimportant; only three patients discontinued the treatment because of symptomatic hypotension.

CAVERJECT had no clinically important effect on serum or urine laboratory tests.

The safety of CAVERJECT IMPULSE was evaluated in a study that compared the formulation of alprostadil for injection contained in CAVERJECT IMPULSE with the formulation contained in CAVERJECT Sterile Powder. The doses used by the 87 patients in this crossover study were the same for both formulations. The number and type of events reported for CAVERJECT IMPULSE were consistent between formulations in this study and in other controlled and uncontrolled studies with CAVERJECT Sterile Powder.

Post-Marketing Surveillance

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) »

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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.



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