Caverject Powder
- Generic Name: alprostadil sterile powder for injection
- Brand Name: Caverject Powder
Caverject Powder (Alprostadil Sterile Powder for Injection) side effects drug center
Caverject Powder Side Effects Center
What Is Caverject Powder?
Caverject (alprostadil) Powder is a prostaglandin that relaxes blood vessels and muscles in the penis, increasing blood flow into the penis, causing 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 Powder in erectile disorders. Caverject Powder may be available in generic form.
What Are Side Effects of Caverject Powder?
Common side effects of Caverject Powder include:
- pain in the penis urethra, or testicles
- headache
- dizziness
- back pain
- unusual discharge from your penis
- a rash on the skin of the penis
- itching
- warmth or numbness of the penis
- cough, stuffy nose, cold symptoms, or flu symptoms
Dosage for Caverject Powder
The dose of Caverject is individualized for each patient under supervision by a physician. Doses of greater than 60 micrograms are not recommended.
What Drugs, Substances, or Supplements Interact with Caverject Powder?
Caverject may interact with nitroglycerin, hydralazine, or blood thinners.
Caverject Powder During Pregnancy and Breastfeeding
Women should not use Caverject, therefore, it is unlikely to be prescribed during pregnancy or breastfeeding. Consult your doctor if you have questions. Men should use a condom to prevent transfer of this medication to a sexual partner if she is pregnant or could become pregnant.
Additional Information
Our Caverject (alprostadil) Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Caverject Powder Consumer Information
Get emergency medical help if you have 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 light-headed feeling, like you might pass out;
- bleeding after an injection;
- a painful erection that lasts 4 hours or longer;
- new or worsening pain in your penis; or
- redness, swelling, tenderness, lumps, unusual shape or curving of the erect penis.
Common side effects may include:
- mild pain in your penis, urethra, or testicles;
- redness of the penis; or
- warmth or burning in your urethra.
Your sex partner may have side effects such as burning, itching, or irritation of body areas that come into contact with your penis.
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.
Read the entire detailed patient monograph for Caverject Powder (Alprostadil Sterile Powder for Injection)
Caverject Powder Professional Information
SIDE EFFECTS
Local Adverse Reactions: The following local adverse reaction information was derived from con- trolled and uncontrolled studies, including an uncontrolled 18-month safety study.
Local Adverse Reactions Reported by ≥ 1% of Patients
Treated with CAVERJECT for up to 18 Months*
| Event | CAVERJECT N = 1861 |
Event | CAVERJECT N = 1861 |
| Penile pain | 37% | Penis disorder*** | 3% |
| Prolonged erection | 4% | Injection site ecchymosis | 2% |
| Penile fibrosis** | 3% | Penile rash | 1% |
| Injection site hematoma | 3% | Penile edema | 1% |
| * Except for penile pain (2%), no significant local adverse
reactions were reported by 294 patientswho 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. |
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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%. In the majority of cases, spontaneous detumescence occurred. To minimize the chances of prolonged erection or priapism, CAVERJECT should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION section). The patient must be instructed to immediately report to his physician or, if unavailable, to seek immediate medical assistance for any erection that persists for longer than 4 hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
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, irri tation, sensit ivity, phimosis, pruritus, erythema, venous leak, painful erect ion, and abnormal ejaculat ion.
Systemic Adverse Events: The following systemic adverse event information was derived from controlled and uncontrolled studies, including an uncontrolled 18-month safety study.
Systemic Adverse Events Reported by ≥ 1% of Patients Treated
with CAVERJECT for up to 18 Months*
| Body System/Reaction | CAVERJECT N = 1861 |
Body System/Reaction (continued) | CAVERJECT N = 1861 |
| Cardiovascular System | Urogenital System | ||
| Hypertension | 2% | Prostatic Disorder** | 2% |
| Central Nervous System | Miscellaneous | ||
| Headache | 2% | Localized pain*** | 2% |
| Dizziness | 1% | Trauma**** | 2% |
| Musculoskeletal System | |||
| Back pain | 1% | ||
| Respiratory System | |||
| Upper respiratory infection | 4% | ||
| Flu syndrome | 2% | ||
| Sinusitis | 2% | ||
| Nasal congestion | 1% | ||
| Cough | 1% | ||
| * No significant adverse events were reported
by 294 patients who received 1 to 3 injections ofplacebo. ** prostatitis, pain, hypertrophy, enlargement *** pain in various anatomical structures other than injection site **** injuries, fractures, abrasions, lacerations, dislocat ions |
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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 micrograms and above 30 micrograms of alprostadil, respectively, and appeared to be dose-dependent. However, these changes were usually clinically unimportant; only three patients discont inued the treatment because of symptomatic hypotension.
CAVERJECT had no clinically important effect on serum or urine laboratory tests.
Read the entire FDA prescribing information for Caverject Powder (Alprostadil Sterile Powder for Injection)
© Caverject Powder Patient Information is supplied by Cerner Multum, Inc. and Caverject Powder Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.