CAVERJECT IMPULSE- alprostadil injection, powder, lyophilized, for solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

ALPROSTADIL (UNII: F5TD010360) (ALPROSTADIL - UNII:F5TD010360)

Dostupné z:

U.S. Pharmaceuticals

INN (Medzinárodný Name):

ALPROSTADIL

Zloženie:

ALPROSTADIL 10 ug in 0.5 mL

Spôsob podávania:

INTRACAVERNOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

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:

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

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