Kaverdzhekt - prostaglandin E1 drug used for erectile dysfunction.
Release form and composition
Kaverdzhekta dosage form is a lyophilisate, from which a solution is prepared for intracavernous administration (in vials, 1 pc each in a plastic box complete with a solvent in a syringe, 2 needles and 2 napkins).
The active ingredient of the drug is alprostadil, in one vial it may contain 10 or 20 mg.
Indications for use
- Erectile dysfunction of psychogenic, vascular, neurogenic and mixed etiology;
- Diagnosis of erectile dysfunction (in addition to diagnostic tests).
Strong contraindications to the use of Kaverdzhekta are:
- Anatomical deformities of the penis (Peyronie's disease, angulation, or cavernous fibrosis);
- The presence of a penile implant;
- Diseases that can cause the development of priapism (including leukemia, myeloma, sickle cell anemia);
- Urethral stricture;
- Venereal diseases;
- Age up to 18 years and over 75 years.
- Known hypersensitivity to alprostadil;
Also, the drug is not prescribed to men who have sex is not recommended or contraindicated.
Patients diagnosed with the following should be under constant observation during the treatment period:
- Venous thrombosis or predisposition to it;
- Increased blood viscosity;
- Coronary heart disease;
- Chronic heart failure;
- Lung disease.
Dosing and Administration
The first injections are carried out in the doctor's office. Self-administration of the drug is possible only after detailed instruction and mastering the technique of self-injection.
A solution is prepared from the lyophilisate for intracavernous administration. To do this, use only the supplied solvent or injectable water with 0.9% benzyl alcohol. After dilution, the volume of the resulting solution is 1.13 ml. Depending on the dose of Kaverdzhekt, 1 ml of solution contains 10.5 or 20.5 μg of alprostadil, of which 10 or 20 μg, respectively, are injected into the body after injection (0.5 μg is lost due to adsorption on the walls of the vial and syringe). The solution is introduced into the dorsolateral part of the proximal third of the penis with a needle of 27-30 G 13 mm long and 13 mm long.
The dose required for each patient is selected by careful titration taking into account the erectile response. The optimal is the dose that causes an erection lasting for a long time for intercourse, but not more than 60 minutes. If there is no reaction to the injected dose, the next one can be entered in approximately 1 hour, if there is a response, in a day. The patient must be under the supervision of a physician until complete detumescence occurs (cessation of erection and reduction of penis size).
Recommended dosing regimens:
- For erectile dysfunction of neurogenic etiology: the initial dose is 1.25 mcg, the second injection is 2.5 mcg, the third one is 5 mcg, and further until the optimum dose is reached, the incremental increase is 5 mcg;
- For erectile dysfunction of psychogenic, vascular or mixed etiology: the initial dose is 2.5 μg, the second injection is 5 μg with a partial response to the first injection and 7.5 μg in the absence of a response, then until the optimum dose is reached, the incremental increase is 5 -10 µg.
Maintenance dose is 5-20 mcg. Not recommended doses of more than 60 mg.
As an additional tool in the diagnosis of erectile disorders, Kaverdzhekt is administered once in a dose that causes a normal erection.
Self-administration at home should be started with the dose prescribed by the doctor. If necessary, change it is necessary to consult with a doctor. The recommended frequency of administration is no more than 3 times a week. Only one dose can be administered per day. An erection usually occurs 5–20 minutes after the injection.
Rules for self-injection:
- Wash hands with soap and water;
- Remove the protective plastic cap from the bottle;
- Using one of the included napkins to wipe the rubber stopper of the vial;
- Unpack a large needle marked 22G11 / 2 (do not remove the protective cap!) And connect it with a syringe;
- Carefully remove the cap;
- Holding the syringe with the needle up, bring the plunger to the “1 ml” mark to remove excess solvent;
- Pierce the rubber stopper of the vial with a needle approximately in the center and add solvent to it;
- Gently hold the vial with the syringe as one, lightly stir the powder in a circular motion until completely dissolved;
- Turn the bottle upside down;
- After making sure that the needle tip is located below the level of the liquid, slowly draw the solution into the syringe to the desired mark;
- Lightly tap on the syringe to remove bubbles;
- Remove the needle from the bottle and put on a protective cap;
- Open the package with the second needle of size 27G1 / 2, but do not get it yet;
- Remove the needle with a protective cap from a large syringe and set it aside;
- Holding the syringe in one hand, take the smaller needle from the opened package and connect it with the syringe without removing the cap;
- Take a comfortable position - sitting, reclining or standing;
- The thumb and index finger to take the head of the penis. Pull the penis and firmly take his hands so that he does not slip out during the procedure. Men who have not been circumcised should be given foreskin to determine the exact location of the injection;
- Carefully handle the injection site with a second napkin and set it aside;
- Take the syringe with your thumb and forefinger, with a confident movement at an angle of 90º, insert the needle;
- Slowly press on the piston with your thumb or index finger until the entire solution is injected;
- Remove the needle;
- Hold the penis on both sides, press the napkin to the injection site and hold it for about 3 minutes or until blood stops;
- Collect all used materials and discard them.
Injections should be done only in the places indicated by the doctor, trying to avoid falling into the veins. Repeated administration of the drug should be carried out alternately on one and the other side of the penis, choosing a new point on the corresponding side.
The most common local side effect of Kaverdzhekta observed in approximately 37% of patients is pain in the penis. In 4% of cases, an excessively long erection occurs (up to 4-6 hours), in 3% - a hematoma, in 2% - ecchymosis at the injection site. The last two reactions are mainly related to improper administration techniques. In 3-4% of patients fibrous nodules are formed, penile fibrosis develops, including angulation, and Peyronie's disease.
Very rarely (less than in 1% of cases) the following local reactions are possible: priapism (erection for more than 6 hours), hemorrhage, inflammation, itching and swelling at the injection site, balanitis, sensation of heat in the penis or numbness, irritation, hyperesthesia of the skin, bleeding from the urethra, erythema, phimosis, fungal infection, painful erection, impaired ejaculation, venous discharge of blood from the cavernous bodies.
Relatively frequent systemic reactions: increased blood pressure, headache, dizziness, flu-like syndrome, pain syndrome, cough, nasal congestion, upper respiratory tract infections, sinusitis, prostatitis.
Very rarely (less than 1% of cases) there are: thickening and / or swelling of the testicles, swelling or redness of the scrotum, feeling of warmth in the testicles, pain in the testicles and / or scrotum, spermatocele, hematuria, increased or impaired urination, imperative urination , pelvic pain, vasodilation, tachycardia, peripheral vascular disorders, lowering blood pressure, supraventricular extrasystole, hypoesthesia, vasovaginal reactions, muscle weakness, rash, pruritus, itching, hyperhidrosis, dry mouth, nausea, spasms of gastrointestinal muscles, exacerbation, hyperhidrosis, dry mouth, nausea, spasms of gastrointestinal muscles, hysterogyrosis, dry mouth, nausea, cramps nya creatinine in serum, dilation of the pupils.
An increase in pulse rate and a decrease in blood pressure were observed when Kaverdzhekt was administered in doses of more than 20–30 μg, so these symptoms are presumably dose-dependent, but have no clinical significance. There is evidence that only three patients were forced to discontinue treatment due to symptomatic hypotension.
Overdose symptoms: pain in the penis, prolonged erection and / or priapism. Possible irreversible deterioration of erectile function. If an erection lasts less than 6 hours, only medical observation is necessary, since spontaneous detumescence occurs quite often. If an erection persists for longer than 6 hours, an intracavernous injection of an alpha adrenergic mimic (epinephrine, ethylephrine, ephedrine, phenylephrine) is made, or aspiration of blood from the cavernous bodies is performed. In some cases, surgical treatment may be required.
Before starting Kaverdzhekta need to diagnose the causes of erectile dysfunction.
Patients conducting self-treatment should always come to the doctor’s office, especially at the beginning, since dose adjustment may be required. In the future, it is recommended to visit the doctor every 3 months to assess the safety and efficacy of therapy, and if necessary, adjust the dose.
With intracavernous administration, slight bleeding may develop. The risk increases in patients undergoing treatment with anticoagulants such as heparin or warfarin.
A prolonged erection in men receiving MAO inhibitors or alpha adrenergic mimetics can lead to a hypertensive crisis.
Kaverdzhekt can not be mixed and / or simultaneously administered with other drugs, including those intended for the treatment of erectile disorders.
Terms and conditions of storage
Store in original packaging out of the reach of children at a temperature up to 25 ºС. Do not freeze or cool!
Shelf life - 2 years.