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Caverject
Overview
What is Caverject?
CAVERJECT contains alprostadil a synthetic form of prostaglandin E (PGE) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.
Alprostadil is a white to off-white crystalline powder with a melting point between 115°C and 116° C. CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in sizes: 20 mcg and 40 mcg per vial. When reconstituted as directed with 1 mL of bacteriostatic water for injection preserved with benzyl alcohol 0.945% w/v, gives 1.13 mL of reconstituted solution. Each mL of CAVERJECT contains 20.5 mcg or 41.1 mcg of alprostadil depending on vial strength, 172 mg of lactose, 47 mcg of sodium citrate and 8.4 mg of benzyl alcohol. The deliverable amount of alprostadil is 20 mcg or 40 mcg per mL because approximately 0.5 mcg for the 20 mcg strength and 1.1 mcg for the 40 mcg strength is lost due to adsorption to the vial and syringe. During manufacture, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.
The structural formula of alprostadil is represented below:
What does Caverject look like?
What are the available doses of Caverject?
For injection: 20mcg and 40mcg lyophilized powder in single-dose vials for reconstitution ().
What should I talk to my health care provider before I take Caverject?
How should I use Caverject?
CAVERJECT is indicated for the treatment of erectile dysfunction.
Determine the most suitable dose and formulation of CAVERJECT to use. Use a new vial for each dose of CAVERJECT ().
Administer first intracavernosal injections in the physician's office and titrate the dose for each patient to the lowest effective dose ().
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 ().
Recommended dosage for erectile dysfunction ():
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 ().
The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose ().
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 ().
Follow the procedure for CAVERJECT syringe preparation ().
Follow procedure for CAVERJECT intracavernosal injection administration ().
To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection ().
What interacts with Caverject?
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What are the warnings of Caverject?
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What are the precautions of Caverject?
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What are the side effects of Caverject?
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What should I look out for while using Caverject?
CAVERJECT is contraindicated:
What might happen if I take too much Caverject?
Overdosage was not observed in clinical trials with CAVERJECT. If intracavernous overdose of CAVERJECT occurs, the patient should be under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Treatment of any systemic symptoms (e.g., hypotension) would be appropriate.
How should I store and handle Caverject?
Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.CAVERJECT is a lyophilized powder supplied in vials containing 23.2 or 46.4 mcg of alprostadil for intracavernosal administration. When reconstituted as directed with 1 milliliter of bacteriostatic water for injection preserved with benzyl alcohol 0.945% w/v, the delivered amount of alprostadil is 20 mcg or 40 mcg.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Alprostadil (PGE1) is a prostaglandin with a wide variety of pharmacological actions including vasodilation and inhibition of platelet aggregation. Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries by binding to its receptors and increasing intracellular cyclic adenosine monophosphate (cAMP) levels via modulation of adenylate cyclase. This leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism. Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum.
Studies in vitro have shown that alprostadil relaxed isolated preparations of human corpus cavernosum and spongiosum, as well as cavernous arterial segments contracted by either noradrenaline or PGF2α. In pigtail monkeys (), alprostadil increased cavernous arterial blood flow in a dose-dependent manner .
Non-Clinical Toxicology
CAVERJECT is contraindicated:Lidocaine Hydrochloride Injection, USP should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block. Concomitant use of beta-blocking agents or cimetidine may reduce hepatic blood flow and thereby reduce lidocaine clearance. The concomitant use of these two agents may cause an increased incidence of adverse reactions, including central nervous system adverse reactions such as seizure.
Lidocaine and tocainide are pharmacodynamically similar.
Prolonged erection defined as erection lasting between 4 to 6 hours in duration occurred in 4% of 1,861 patients treated up to 18 months in studies of CAVERJECT. The incidence of priapism (erections lasting more than 6 hours in duration) was 0.4%. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
To minimize the chances of prolonged erection or priapism, CAVERJECT should be titrated slowly to the lowest effective dose see In addition, do not use CAVERJECT in patients who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia .
The following are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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