Caverject Impulse 10 ug/.5mL
Alprostadil · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Pharmacia & Upjohn Company LLC
Caverject Impulse is a injection, powder, lyophilized, for solution containing alprostadil at 10 ug/.5mL, taken intracavernous. Manufactured by Pharmacia & Upjohn Company LLC.
Key Facts
- Brand Name
- Caverject Impulse
- Generic Name
- Alprostadil
- NDC Code (Product)
0009-5181- Manufacturer
- Pharmacia & Upjohn Company LLC
- Strength
- 10 ug/.5mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVERNOUS
- Marketing Status
- Application #
- NDA021212
- Drug Class
- Prostaglandin Analog [EPC]; Prostaglandin E1 Agonist [EPC]
- Marketing Start
- 06/11/2002
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated • For the treatment of erectile dysfunction ( 1.1 ) • As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction ( 1.2 ). 1.1 Erectile Dysfunction CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction. 1.2 Diagnostic Test CAVERJECT IMPULSE is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Determine the most suitable dose and presentation of CAVERJECT to use. Use a new syringe for each dose of CAVERJECT ( 2.1 ). • Administer first intracavernosal injections in the health care provider’s office and titrate the dose for each patient to the lowest effective dose ( 2.1 ). • Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of at-home use ( 2.1 ). • Recommended dosage for erectile dysfunction ( 2.2 ): o Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate dosing with 2.5 mcg o Erectile dysfunction of pure neurogenic etiology (spinal cord injury): Initiate dosing with 1.25 mcg • Follow dose titration procedures for each type of erectile dysfunction and determine the maintenance dosage for patient home use in the health care provider’s office ( 2.2 ). • The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose ( 2.2 ). • While on self-injection treatment, the patient should visit the prescribing health care provider’s office every 3 months to assess the efficacy and safety of the therapy ( 2.…
Contraindications
4 CONTRAINDICATIONS CAVERJECT IMPULSE is contraindicated: • in men who have a known hypersensitivity to the drug [see Adverse Reactions (6.1) ] • in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see Warnings and Precautions (5.1) ] • for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease [see Warnings and Precautions (5.2) ] • in men with penile implants. • Known hypersensitivity to the drug ( 4 ). • Men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia ( 4 ). • Treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease ( 4 ). • Men with penile implants ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied [see Warnings and Precautions (5.6) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Prolonged Erection and Priapism [see Warnings and Precautions (5.1) ] • Penile Fibrosis [see Warnings and Precautions (5.2) ] Most common (≥10%) adverse reactions: penile pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (1-800-438-1985 and www.pfizer.com ) or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . 6.1 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. 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%), r…
Frequently Asked Questions
What is Caverject Impulse used for?
Caverject Impulse contains Alprostadil. It is a injection, powder, lyophilized, for solution taken intracavernous. Consult your doctor for specific uses.
Is Caverject Impulse a controlled substance?
Caverject Impulse is not classified as a controlled substance by the DEA.
What is the generic name for Caverject Impulse?
The generic name for Caverject Impulse is Alprostadil. There are 8 other brand versions of Alprostadil.
What is the NDC code for Caverject Impulse 10 ug/.5mL?
The NDC (National Drug Code) for Caverject Impulse 10 ug/.5mL is 0009-5181, listed by Pharmacia & Upjohn Company LLC.