Product Overview

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Prostacel 500 mcg injection is a prescription medication formulated for the treatment of erectile dysfunction (ED) in adult men. Each vial contains a sterile solution of alprostadil at a strength of 500 micrograms per milliliter, packaged for single‑use administration. The product is supplied by Celon Laboratories Ltd, a globally recognized manufacturer with a track record of compliance with Good Manufacturing Practices (GMP). Pack size options include one, three, or six injectable vials, allowing patients and clinicians to select the most appropriate supply based on treatment plans. The injection is designed for intramuscular or intracavernosal delivery, providing a localized therapeutic effect with a rapid onset of action.

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What is Prostacel

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Prostacel is the brand name for a pharmaceutical formulation that contains alprostadil, a synthetic analog of prostaglandin E1. Alprostadil belongs to the class of prostaglandins that induce vasodilation by stimulating adenylate cyclase and increasing cyclic AMP within smooth muscle cells. This biochemical pathway leads to relaxation of arterial and trabecular smooth muscle in the penis, facilitating increased blood inflow and erection when sexual stimulation is present. The medication is classified in the therapeutic category of phosphodiesterase‑5 (PDE‑5) inhibitors only indirectly; rather, its mechanism is distinct and relies on direct vascular smooth muscle relaxation.

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Uses and Benefits

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The primary indication for Prostacel 500 mcg injection is the management of erectile dysfunction, a condition characterized by the inability to achieve or maintain a satisfactory erection for sexual activity. Clinical studies have demonstrated that intracavernosal administration of alprostadil yields a response rate of approximately 50‑60 % among men who have not responded to oral PDE‑5 inhibitors. Benefits include a rapid onset — often within five to ten minutes — and a short duration of effect that allows for on‑demand use. Because the drug is delivered locally, systemic exposure is minimal, reducing the likelihood of widespread side effects. Additionally, Prostacel can be used in patients who have contraindications to oral therapies, such as those taking nitrates or who have severe hepatic impairment.

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How It Works

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The pharmacodynamic action of alprostadil begins when the compound binds to prostanoid receptors (DP1, EP2, EP3, EP4) on endothelial and smooth muscle cells of the corpora cavernosa. This binding triggers a cascade that raises intracellular cyclic AMP, leading to phosphorylation of myosin light chains and subsequent relaxation of smooth muscle. The resulting vasodilation increases arterial inflow while limiting venous outflow, creating the hydraulic conditions necessary for erection. Because the drug acts directly on penile tissue, the systemic half‑life is short, typically less than two minutes, which contributes to its favorable safety profile when used as directed.

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Dosage Guidelines

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Administration of Prostacel must be performed by a qualified healthcare professional or under direct supervision after appropriate training. The recommended dose for most patients starts at 2.5 micrograms per injection, with gradual titration based on efficacy and tolerability, up to a maximum of 20 micrograms per dose. In clinical practice, the typical administered volume is 0.5 to 1 milliliter, delivered into the lateral aspect of the corpora cavernosa to avoid injury to the neurovascular bundles. Patients are instructed to limit use to no more than once daily and to refrain from consecutive daily injections to minimize the risk of fibrosis or priapism. Dosage adjustments are necessary in individuals with severe cardiovascular disease, hepatic impairment, or those concurrently using antiplatelet agents. It is essential that each vial be used only once and discarded after opening, and that proper aseptic technique be observed throughout the injection process.

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Side Effects

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Like all pharmacologic agents, Prostacel can be associated with adverse reactions. The most frequently reported side effects include mild to moderate penile pain, burning sensation, erythema, and transient swelling at the injection site. Systemic side effects are uncommon but may manifest as headache, dizziness, flushing, or nausea. Rarely, patients may experience prolonged erection lasting more than four hours (priapism), which requires immediate medical attention to prevent tissue damage. Allergic reactions, although infrequent, can present as rash, pruritus, or more severe hypersensitivity manifestations. Patients should be advised to report any persistent pain, discoloration, or signs of infection to their prescribing clinician promptly.

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Warnings and Precautions

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Prostacel is contraindicated in patients with known hypersensitivity to alprostadil or any component of the formulation. Caution is advised in individuals with a history of Peyronie’s disease, penile fibrosis, or recent penile surgery, as these conditions may increase the risk of complications. The medication should not be used in patients who are taking medications that lower blood pressure or those with unstable angina, recent myocardial infarction, or severe uncontrolled hypertension, unless a physician determines the benefit outweighs the risk. Proper storage conditions require refrigeration at 2‑8 °C; however, the vial may be kept at room temperature not exceeding 30 °C for a limited period before use. It is imperative that the injection be performed with a sterile, disposable needle and that the site be rotated to prevent tissue damage. Patients should be instructed to avoid sharing the medication and to keep it out of reach of children.

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Frequently Asked Questions

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1. What is the recommended starting dose of Prostacel for a new patient?
The typical initial dose is 2.5 micrograms per injection, administered intracavernously. Dose escalation is guided by clinical response and tolerability, with a maximum recommended dose of 20 micrograms per administration.

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2. How long does the effect of Prostacel last after injection?
The pharmacologic effect usually begins within five to ten minutes and may persist for up to one hour, providing a window for sexual activity. The duration can vary based on individual metabolism and the presence of other medications.

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3. Can Prostacel be used together with oral erectile dysfunction medications?
Combining alprostadil with PDE‑5 inhibitors such as sildenafil or tadalafil is generally not recommended without medical supervision, as the combined vasodilatory effect may increase the risk of hypotension or priapism.

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4. Are there any dietary restrictions when using Prostacel?
No specific dietary modifications are required. However, patients are advised to avoid excessive alcohol consumption, as alcohol can exacerbate the vasodilatory effects and increase the likelihood of side effects such as dizziness.

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5. Where can I find more detailed prescribing information and clinical data?
Comprehensive prescribing details are available on the official product label and can be cross‑referenced with authoritative sources such as the U.S. Food and Drug Administration, the MedlinePlus database, and peer‑reviewed articles indexed on PubMed.

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Additional Resources

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For further reading, consult resources such as the National Institutes of Health, the Wikipedia entry on Alprostadil, and the FDA Drugs Portal.

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