Caverject powder lyophilisate for injection 10mkg bottle with p-lem syringe N1
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Active ingredients
Alprostadil
Composition
The active substance alprostadil 10 μg, excipients: lactose, sodium citrate. The composition of the solvent: benzyl alcohol 9 mg, water for injection q.s. 1 ml., Dosage form: lyophilisate for preparation of solution for intracavernous administration.
Pharmacological effect
The drug is prostaglandin E1, used for erectile dysfunction. When intracavernous administration (to the penis), alprostadil inhibits α1 -adrenoreceptors of the tissues of the penis, relaxes the muscles of the cavernous bodies, increases blood flow and improves microcirculation. Alprostadil causes an erection by relaxing the trabecular smooth muscles of the cavernous bodies and dilating the cavernous arteries, which leads to the expansion of lacunary spaces and blocking the blood flow due to the pressure of the venules to the protein membrane (occlusion of the veins of the penis). Alprostadil inhibits platelet aggregation. The onset of action of the drug after 5-10 minutes after administration, the duration of action - 1-3 hours
Indications
Erectile dysfunction of a neurogenic, vascular, psychogenic or mixed etiology, diagnosis of erectile dysfunction in addition to other diagnostic tests.
Contraindications
Installed hypersensitivity to the components of the drug, diseases that may predispose to the occurrence of priapism, such as sickle cell anemia, myeloma, leukemia, anatomical deformities of the penis (angulation of the penis, cavernous fibrosis, Peyronie's disease), the presence of a penile implant, men contraindicated or not recommended sex life.
Dosage and administration
Direct intracavernous introduction. It is recommended to use a needle of 27 - 30 G in size, 13 mm long. The injection site is the dorsolateral part of the proximal third of the penis.
Side effects
Local (most often) pain and burning sensation in the penis, prolonged erection (duration 4-6 hours), penile fibrosis, hematoma and ecchymosis at the injection site. Fibrosis of the penis, including penile angulation, formation of fibrous nodules, and Peyronie's disease are noted in 3–8% of patients. The hematoma at the injection site (3% of patients) and ecchymosis at the injection site (2% of patients) are associated with the injection technique, rather than with alprostadil.The frequency of prolonged erection (4-6 hours) was 4%. Local (less than 1%) priapism (erection duration more than 6 hours), balanitis, hemorrhages at the injection site, inflammation, itching and swelling at the injection site, bleeding from the urethra, feeling heat in the penis, numbness, fungal infection, irritation, skin sensitivity (hyperesthesia), phimosis, pruritus, erythema, "venous discharge" from the cavernous bodies, painful erection, impaired ejaculation. Systemic effects (most often) increased blood pressure, dizziness, headache bo l in the back, upper respiratory tract infections, flu-like syndrome, sinusitis, nasal congestion, cough, prostatitis, pain not at the injection site. Systemic effects (less than 1%) pain in the testicles, swelling of the testicles, feeling of warmth in the testicles, thickening of the testicles, redness scrotum, pain in scrotum, spermatocele, scrotal edema, hematuria, urinary disturbance, increased urination, urgency to urinate, pain in the pelvic region, reduction of blood pressure, tachycardia, vasodilation, peripheral vascular disorders, heart rate, heart rate, vaginal reactions, hypesthesia, muscle weakness, hyperhidrosis, rash, itching not at the injection site, nausea, dry mouth, increased serum creatinine levels, cramps of the calf muscles, pupillary dilation.
Overdose
Symptoms: pain in the penis, prolonged erection and / or priapism, irreversible deterioration of erectile function. Treatment: if an erection lasts less than 6 hours, medical supervision is necessary, since spontaneous detumescence often occurs; if an erection persists for more than 6 hours, an intracavernous injection of alpha adrenomimetic agents (ephedrine, epinephrine, phenylephrine, ethylephrine) should be performed, or aspiration of blood from the cavernous bodies should be performed, or surgical treatment should be carried out. The patient should be under medical supervision until the disappearance of systemic phenomena and / or until the full detumescence of the penis.
Interaction with other drugs
Caverject is not intended for mixing or simultaneous administration with other drugs, as well as for joint use with other drugs for the treatment of erectile dysfunction. The possibility of pharmacokinetic interactions with other drugs has not been studied.Combined use with antihypertensive drugs, diuretics, hypoglycemic drugs (including insulin) or nonsteroidal anti-inflammatory drugs does not have any effect on the safety or efficacy of Caverject. The safety and efficacy of co-administration of the drug Caverject with other vasoactive drugs has not been studied. The presence of benzyl alcohol in the solvent reduces the degree of binding to the walls of the vial. In this regard, when using water for injection containing benzyl alcohol, a more stable solution is obtained and more complete administration of the drug is provided.
special instructions
Before starting treatment with Caverject, diagnostics of treatable causes of erectile dysfunction should be made. You should constantly monitor the condition of the patient, conducting self-treatment, especially in the initial period, when you may need to change the dose. Every 3 months, the patient is advised to visit a doctor to assess the efficacy and safety of treatment and dose adjustment (if necessary). It is known that after intracavernous administration of vasoactive drugs, including Caverject, priapism may develop. To reduce the risk of priapism, the smallest effective dose should be administered. The patient should immediately inform the doctor about all cases of erection lasting more than 4 hours. The treatment of priapism is carried out in accordance with the established medical practice. After intracavernous administration of the drug, penile fibrosis can develop, including penile angulation, formation of fibrous nodules, and Peyronie's disease. The incidence of fibrosis may increase with increasing duration of use of the drug. To identify signs of penile fibrosis or Peyronie's disease, regular examination of patients with a close examination of the penis is recommended. In patients with the development of penile angulation, cavernous fibrosis or Peyronie's disease, treatment with the drug should be discontinued. Since intracavernous administration may cause slight bleeding, patients using Caverject should be informed about measures to protect against sexually and hematogenous infections, including the human immunodeficiency virus (HIV). Patients receiving treatment with warfarin or heparin anticoagulants have an increased tendency to bleed after intracavernous injection.In patients receiving MAO inhibitors and alpha adrenomimetics, in the case of a prolonged erection, a hypertensive crisis may develop. In patients with coronary artery disease, chronic heart failure or pulmonary diseases, sexual stimulation and sexual intercourse can lead to an exacerbation of the disease. It is necessary to observe compliance of the used dosage form of alprostadil to specific indications for its use. No clinically significant effects of Caverject on the results of laboratory testing of blood and urine. The bottle with the diluted drug is intended for single use and is discarded after use. It is necessary to instruct the patient about the rules for the destruction of the needle, syringe and vial.