Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ALPROSTADIL (UNII: F5TD010360) (ALPROSTADIL - UNII:F5TD010360)
U.S. Pharmaceuticals
ALPROSTADIL
ALPROSTADIL 10 ug in 0.5 mL
INTRACAVERNOUS
PRESCRIPTION DRUG
CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction. CAVERJECT IMPULSE is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. CAVERJECT IMPULSE should not be used: - 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. CAVERJECT IMPULSE is not indicated for use in females. CAVERJECT IMPULSE is not indicated for use in females. CAVERJECT IMPULSE is not indicated for use in pediatric patients [see Warnings and Precautions (5.8)] . A total of 341 subjects included in clinical studies were 65 and older. No o
CAVERJECT IMPULSE is supplied as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge, which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for reconstitution in the rear chamber. The syringes contain either 12.8 or 25.6 mcg of alprostadil to allow delivery of a maximum of 10 or 20 mcg/0.5mL. Store the unreconstituted product at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. When reconstituted and used as directed, the deliverable amount for the 10 mcg strength is 10 mcg/0.5 mL or an increment of 10 mcg/0.5 mL: 2.5 mcg/0.125 mL, 5 mcg/0.25 mL, or 7.5 mcg/0.375 mL of alprostadil. The deliverable amount for the 20 microgram strength is 20 mcg/0.5 mL or an increment of 20 mcg/0.5 mL: 5 mcg/ 0.125 mL, 10 mcg/0.250 mL, or 15 mcg/0.375 mL of alprostadil. The reconstituted solution should be used within 24 hours when stored between 36–77°F (2°C to 25°C). Do not freeze. CAVERJECT IMPULSE is supplied in a carton containing 2 blister trays. Each blister tray contains one dual chamber syringe system, one needle and 2 alcohol swabs. It is available in the following strengths:
New Drug Application
CAVERJECT IMPULSE- ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION U.S. PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CAVERJECT IMPULSE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CAVERJECT IMPULSE. CAVERJECT IMPULSE (ALPROSTADIL) FOR INJECTION, FOR INTRACAVERNOSAL USE INITIAL U.S. APPROVAL: 1981 RECENT MAJOR CHANGES Warnings and Precautions, Needle Breakage (5.7) 05/2016 Warnings and Precautions, Benzyl Alcohol (5.8) 10/2016 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). DOSAGE AND ADMINISTRATION Determine the most suitable dose and formulation of CAVERJECT to use (2.1) Administer first intracavernosal injections in the physician's office and titrate the dose for each patient to the lowest effective dose (2.1) Dosage for erectile dysfunction (2.2): Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate dosing with 2.5 mcg 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 erectile dysfunction for patient home use in the physician'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 physician's office every 3 months to assess the efficacy and safety of the therapy (2.2) 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 (2.3) To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT IMPULSE intracavernosally and monitor patients for the occurrence of an erection (2.4) Follow procedure for CAVERJECT Lesen Sie das vollständige Dokument