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Prescribing Information
CAVERJECT IMPULSE® Dual Chamber System alprostadil for injection
How Supplied
Return to the CAVERJECT IMPULSE Product Center

Comp
(not actual size)

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 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [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 and 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 at or below 25°C (77°F).

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:

10 mcg
NDC 0009-5181-01
20 mcg
NDC 0009-5182-01

CAVERJECT is also available as follows:

CAVERJECT Sterile Powder (alprostadil for injection) packaged in vials,
6 vials per carton

10 mcg
NDC 0009-3778-05
20 mcg
NDC 0009-3701-05
40 mcg
NDC 0009-7686-04

CAVERJECT Sterile Powder (alprostadil for injection) vials with diluent syringe,
6 syringe systems per carton

5 mcg
NDC 0009-7212-03
10 mcg
NDC 0009-3778-08
20 mcg
NDC 0009-3701-01

CAVERJECT Injection ([alprostadil injection] aqueous), 5 ampoules per carton

10 mcg (10 mcg/mL)
NDC 0009-7655-02
20 mcg (20 mcg/mL)
NDC 0009-7654-02
40 mcg (40 mcg/2mL)
NDC 0009-7650-02

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(not actual size)

Rx only

MADE IN SWEDEN

Manufactured for:
Pharmacia & Upjohn Company
A subsidiary of Pharmacia Corporation
Kalamazoo, MI 49001, USA

By:
Pharmacia AB
Stockholm, Sweden


CAVERJECT IMPULSE Safety Information
 

Important Safety Information

CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

The most common side effect of CAVERJECT IMPULSE was penile pain, reported by 37% of patients in clinical studies. Only 3% discontinued CAVERJECT IMPULSE for this reason.

CAVERJECT IMPULSE should not be used in men hypersensitive to alprostadil, men with conditions that may predispose them to priapism, men with anatomical deformities of the penis, men with penile implants, or men for whom sexual activity is not advisable or is contraindicated. Penile fibrosis, including Peyronie's disease, was reported in clinical trials with CAVERJECT IMPULSE.

Patients should be instructed to report any erection lasting 4 hours or longer. Treatment of priapism should not be delayed more than 6 hours.

Each patient should be titrated to the lowest effective dose.

The product information in this site is intended only for residents of the United States.

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