Caverject lyophilisate for solution preparation 10mkg, No. 1

• Erectile dysfunction of neurogenic, vascular, psychogenic or mixed etiology;

• diagnosis of erectile dysfunction (as an additional tool to other diagnostic tests).

Intracavernous. In the absence of an erection of neurogenic etiology (spinal cord injury): the first injection is 1.25 mcg, the second - 2.5 mcg, the third - 5 mcg; the value of a step-by-step increase in the dose until the optimum is reached - 5 ?g.

With impotence of vascular, psychogenic and mixed etiology: the first injection - 2.5 ?g, the second (with a partial response) - 5 ?g or (in the absence of a partial response) 7.5 ?g; the value of the step-by-step increase in the dose until the optimal dose is reached is 5Ц10 ?g.

Lyophilisate for the preparation of a solution for intracavernous administration

1 fl.

alprostadil 10 mcg or 20 mcg

in vials of 10 or 20 ?g, complete with a syringe filled with solvent and two needles; in the box 1 set.

• Diseases predisposing to the occurrence of priapism (sickle cell anemia, myeloma, leukemia);

• anatomical deformities of the penis (penile angulation, cavernous fibrosis, Peyronie's disease);

• the presence of a penile implant;

• established hypersensitivity to the components of the drug.

  The drug is not used in men for whom sexual activity is contraindicated or not recommended.

  In persons under 18 years of age, the safety and efficacy of the drug has not been studied.

pharmachologic effect

The drug prostaglandin E1, used for erectile dysfunction. With intracavernous injection (into the penis), alprostadil inhibits the ? 1 -adrenoreceptors of the penile tissues, relaxes the muscles of the corpora cavernosa, increases blood flow and improves microcirculation. Alprostadil induces an erection by relaxing the trabecular smooth muscles of the cavernous bodies and dilating the cavernous arteries, which leads to the expansion of the lacunar spaces and the blockage of blood flow due to pressing the venules to the protein membrane (occlusion of the veins of the penis).

Alprostadil inhibits platelet aggregation.

The onset of action of the drug is 5-10 minutes after administration, the duration of action is 1-3 hours.

Side effect

Local reactions: pain and burning sensation in the penis; 4% of patients had a prolonged erection (duration 4-6 hours); in 3-4% of patients - fibrosis of the penis, including angulation of the penis, the formation of fibrous nodules and Peyronie's disease; in 3% of patients - hematoma at the injection site and in 2% of patients - ecchymosis at the injection site (these side effects are usually associated with the injection technique, and not with the action of alprostadil).

Less than 1% - priapism (duration of erection more than 6 hours; frequency is 0.4%; in most cases spontaneous relaxation of the penis was observed), balanitis, hemorrhages at the injection site, inflammation, itching and swelling at the injection site, bleeding from the urethra, feeling of warmth in the penis, numbness, fungal infection, irritation, skin hyperesthesia, phimosis, erythema, 'venous discharge' from the corpora cavernosa, painful erection, ejaculation disorder.

Systemic reactions: most often - increased blood pressure, dizziness, headache, back pain, upper respiratory tract infections, flu-like syndrome, sinusitis, nasal congestion, cough, prostatitis, pain syndrome.

Less than 1% - testicular pain, testicular edema, a feeling of warmth in the testicles, thickening of the testicles, redness of the scrotum, pain in the scrotum, spermatocele, scrotal edema, hematuria, urinary disturbance, increased urination, urge to urinate, pelvic pain, decrease BP, tachycardia, vasodilation, peripheral vascular disorders, supraventricular extrasystole, vasovagal reactions, hypoesthesia, muscle weakness, hyperhidrosis, rash, pruritus, nausea, dry mouth, increased serum creatinine levels, cramps, gastrocnemius cramps.

A decrease in blood pressure and an increase in heart rate were observed with the use of the drug in doses of more than 20 ?g and 30 ?g, respectively, and, apparently, were dose-dependent. However, these changes were of no clinical significance; only 3 patients discontinued treatment due to symptomatic hypotension.

special instructions

Before starting therapy with Caverject, a diagnosis of treatable causes of erectile dysfunction should be carried out.

It is necessary to carry out constant monitoring of the condition of the patient conducting self-treatment, especially in the initial period, when a dose change may be required. Every 3 months, the patient is recommended to visit a doctor to assess the effectiveness and safety of treatment and adjust the dose (if necessary).

It is known that after intracavernous administration of vasoactive drugs, including Caverject, priapism may develop. To reduce the risk of developing priapism, the lowest effective dose should be administered. The patient should immediately inform the doctor about all cases of erection lasting more than 4 hours. Treatment of priapism is carried out in accordance with established medical practice.

After intracavernous administration of the drug, fibrosis of the penis may develop, including angulation of the penis, the formation of fibrous nodules, and Peyronie's disease. The incidence of fibrosis may increase with the duration of drug use. To detect signs of penile fibrosis or Peyronie's disease, regular examination of patients with a careful 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 protective measures against sexually transmitted and hematogenous infections, including the human immunodeficiency virus (HIV).

Patients treated with anticoagulants such as warfarin or heparin have an increased tendency to bleed after intracavernous injection.

In patients receiving MAO inhibitors and alpha-adrenergic agonists, in the case of prolonged erection, a hypertensive crisis may develop.

In patients with coronary artery disease, chronic heart failure, or pulmonary disease, sexual stimulation and intercourse can exacerbate the disease.

The compliance of the used dosage form of alprostadil with specific indications for its use should be observed.

There was no clinically significant effect of Caverject on the results of laboratory tests of blood and urine.

The vial with the diluted preparation is intended for single use and discarded after use. The patient should be instructed on the rules for the disposal of the needle, syringe and vial.

Overdose

Symptoms: pain in the penis, prolonged erection and / or priapism, irreversible deterioration of erectile function.

Treatment: if the 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-adrenergic agonists (ephedrine, epinephrine, phenylephrine, ethylephrine) should be given, or blood aspiration from the corpora cavernosa should be performed, or surgical treatment should be performed. The patient should be under medical supervision until the disappearance of systemic phenomena and / or until the onset of complete detumescence of the penis.

Drug interactions

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.

Concomitant use with antihypertensive drugs, diuretics, hypoglycemic drugs (including insulin) or non-steroidal anti-inflammatory drugs does not have any effect on the safety or efficacy of Caverject.

The safety and efficacy of the combined use of 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 a more complete administration of the drug is provided.