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CAVERJECT® IMPULSE (alprostadil)
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CAVERJECT® IMPULSE Quick Finder
Highlights
Indications and Usage
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1 INDICATIONS AND USAGE
1.1 Erectile Dysfunction
CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
- •
- Alprostadil is available in different strengths and presentations. Determine the...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Caverject Impulse (alprostadil) for injection contains sterile, freeze-dried alprostadil for reconstitution and sterile bacteriostatic water in a prefilled dual chamber glass cartridge. It is...
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Contraindications
4 CONTRAINDICATIONS
CAVERJECT IMPULSE is contraindicated:
- •
- in men who have a known hypersensitivity to the drug [see Adverse Reactions (6.1)]
- •...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Prolonged Erection and Priapism
Prolonged erection, defined as erection lasting between 4 to 6 hours in duration, occurred in 4% of 1,...
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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...
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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...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
CAVERJECT IMPULSE is not indicated for use in females.
8.2...
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Overdosage
10 OVERDOSAGE
Overdosage was not observed in clinical trials with CAVERJECT IMPULSE. If intracavernous overdose of CAVERJECT IMPULSE occurs, the patient should be under medical supervision until any systemic effects have...
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Description
11 DESCRIPTION
CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries. This...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Long-term carcinogenicity studies...
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Clinical Studies
14 CLINICAL STUDIES
The efficacy of CAVERJECT IMPULSE was based upon clinical studies of CAVERJECT.
The efficacy of CAVERJECT was investigated in men with a diagnosis of erectile dysfunction due to psychogenic,...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
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...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
...
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Instructions For Use
INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
CAVERJECT [KAV-er-jeckt]®
(alprostadil)
for injection, for intracavernosal use
Before you use CAVERJECT, your doctor must train you in how to...
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Other
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com
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