Sonirid Duo
Sonirid Duo: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Sonirid Duo
ATX code: G04CA02; G04CB01
Active ingredient: tamsulosin (Tamsulosinum) + finasteride (Finasteridum)
Producer: Gedeon Richter (Hungary), Gedeon Richter Romania A. O. (Gedeon Richter Romania) (Romania)
Description and photo updated: 30.11.2018
Prices in pharmacies: from 949 rubles.
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Sonirid Duo is a combined drug that affects the metabolism in the prostate gland and corrects urodynamics.
Release form and composition
The drug is available in the form of a set of tablets and capsules (10 pcs. In blisters, of which 5 capsules and 5 tablets, 6 blisters in a cardboard box and instructions for use of Sonirid Duo):
- film-coated tablets: almost white or white, triangular in shape with rounded ends, slightly biconvex, engraved with "GR" on one side, practically odorless;
- capsules with modified release: gelatinous, size No. 2, with a hard opaque shell, consisting of a brown cap and a yellow-brown body, inside the capsules there are almost white or white pellets.
1 tablet contains:
- active substance: finasteride - 5 mg;
- auxiliary components: lactose monohydrate, sodium carboxymethyl starch (type A), magnesium stearate, MCC (microcrystalline cellulose), pregelatinized starch, talc;
- shell composition: lactose monohydrate, titanium dioxide (EEC171), macrogol 6000, hypromellose, hyprolose.
1 capsule contains:
- active substance: tamsulosin hydrochloride - 0.4 mg;
- auxiliary components: triethyl citrate, calcium stearate, copolymer (1: 1) of ethyl acrylate and methacrylic acid (also contains sodium lauryl sulfate, polysorbate 80), microcrystalline cellulose, talc;
- shell composition (cap and body): gelatin, titanium dioxide (E171), iron dye yellow oxide (E172), iron dye red oxide (E172), iron dye black oxide (E172).
Pharmacological properties
Pharmacodynamics
Sonirid Duo is a drug intended only for the treatment of men. It consists of two active substances: tamsulosin (an alpha 1 -adrenergic blocker) and finasteride (a 5-alpha reductase inhibitor). This combination provides symptom control and treatment for benign prostatic hyperplasia (BPH). The combined use is indicated only with an increase in the volume of the prostate gland of more than 40 cm 3, when monotherapy with a 5-reductase inhibitor or an alpha 1- adrenergic blocker does not sufficiently alleviate the symptoms of BPH and does not cause the desired slowdown in the clinical progression of the disease.
The purpose of the combined treatment is to reduce the size of the prostate gland and treat symptoms of the lower urinary tract associated with BPH, improve urination, slow the clinical progression of the disease, reduce the incidence of acute urinary retention, and prevent the need for surgery, including prostatectomy or transurethral resection of the prostate.
The mechanism of action of Sonirid Duo is due to the pharmacodynamic properties of the active ingredients.
Tamsulosin
Tamsulosin is part of the capsule is an alpha 1 adrenoblokatorom directional influencing the alpha 1 adrenergic receptors subtype alpha 1A and alpha 1D. A decrease in the tone of smooth muscles of the prostate gland, bladder neck, and prostatic urethra is the result of selective and competitive blocking of postsynaptic alpha 1 -adrenergic receptors in them. In addition, blocking alpha 1 -adrenergic receptors (alpha 1D subtype) located primarily in the body of the bladder contributes to the functional improvement of the detrusor.
The clinical effect of the drug is manifested by a decrease in symptoms of irritation and obstruction caused by benign prostatic hyperplasia. The therapeutic effect usually develops within 14 days after the start of taking the capsules, in some patients there is a decrease in the severity of the symptoms of the disease after taking the first dose.
The selective ability of tamsulosin allows avoiding a clinically significant decrease in systemic blood pressure (BP) in patients with normal baseline blood pressure and arterial hypertension. Its interaction with alpha 1B- adrenergic receptors of vascular smooth muscles is 20 times lower than the ability to act on alpha 1A- adrenergic receptors.
Finasteride
Finasteride is contained in tablets, is a synthetic 4-azasteroid, a specific inhibitor of the intracellular enzyme 5-alpha reductase type II. It promotes the conversion of testosterone to 5-alpha-dihydrotestosterone (DHT). The significant activity of this androgen is responsible for the normal function and growth of the prostate gland, including its hypertrophied tissues. Finasteride does not act on androgen receptors. It is assumed that at the molecular level, DHT exerts an influence on the etiological factors causing prostatic hyperplasia. Specific inhibitors of 5-alpha-reductase type II, lowering the concentration of DHT in the prostate gland, contribute to the regression of prostatic hyperplasia. The results of clinical studies confirm a rapid decrease in plasma DHT concentration by 70%,which causes a decrease in the volume of the prostate gland. Taking the pills regularly for 90 days leads to a decrease in the volume of the prostate gland by about 20%. After 210 days of therapy, there is a decrease in the severity of symptoms associated with BPH.
The inhibitory effect of finasteride is primarily directed at the isoenzyme 5-alpha-reductase type II, which is distributed in the human body in the tissues of the liver, chest, prostate, in the testes and their appendages, scrotum, glans penis, seminal vesicles. Type II isoenzyme is responsible for a significant proportion of DHT in the blood.
A single intake of finasteride at a dose of 5 mg causes a decrease in plasma DHT levels by 75% during the day. The achieved minimum concentration of DHT returns to the initial level within 7 days. Repeated intake of pills does not cause a decrease in the effectiveness of the drug.
Directly in the prostate gland, finasteride provides a corresponding increase in testosterone levels and reduces the concentration of DHT by 15%, which is significantly higher than the level achieved as a result of surgical or chemical castration.
After several months of using finasteride, most patients experience a rapid decrease in concentration and the subsequent establishment of low values of prostate-specific antigen (PSA), which is a sensitive specific androgen-dependent marker of prostate carcinoma. Regular therapy with finasteride at a dose of 5 mg for 12 months on average reduces the PSA concentration by 50%.
The hormonal effects of finasteride have not been established, including proximity to androgen receptors. In adult men, against the background of normal or high testosterone levels, 5-alpha reductase deficiency causes prostate atrophy. By activating androgen receptors, DHT binds to them, forming dimers. By binding to DNA, dimers promote cell proliferation by altering the expression of genes responsible for proliferation and apoptosis. In a healthy prostate gland, the processes of apoptosis and proliferation are balanced.
Specific type II 5-alpha reductase inhibitors, by reducing the concentration of DHT in the prostate gland, promote the regression of the hyperplastic prostate gland.
Pharmacokinetics
After oral administration, tamsulosin is absorbed in the small intestine. Its fasting bioavailability is about 100%, the simultaneous consumption of food reduces absorption. Daily intake of capsules in a therapeutic dose after breakfast ensures that the same level of drug absorption is achieved. The maximum concentration (Cmax) of tamsulosin in plasma when taking one capsule after a meal is reached after 6 hours. After repeated administration, Cmax in plasma is 2–3 times higher than after a single dose. In older men, the equilibrium concentration (Css) of tamsulosin in plasma is achieved after four days of treatment. It is assumed that this rate is similar in younger patients. Individual fluctuations in the concentration of the drug are possible with single and multiple doses.
Absorption of finasteride from the gastrointestinal tract (GIT) is rapid. Its Cmax in plasma already 2 hours after taking the tablet inside is 37 ng / ml. Absorption in the gastrointestinal tract lasts 6-8 hours, food intake does not affect absorption. The bioavailability of finasteride is about 80%.
Plasma protein binding of tamsulosin is about 99%; finasteride - 90%.
Vd (volume of distribution) of tamsulosin - approximately 0.2 l / kg; finasteride - from 62 to 90 liters.
Finasteride crosses the blood-brain barrier, a small amount of the substance enters the seminal fluid. Its concentration in semen can reach 21 ng / ml.
As a result of the slow metabolism of tamsulosin in the liver, active metabolites are formed, which retain high selectivity for alpha 1A- adrenergic receptors, but are inferior in activity to tamsulosin. A large amount of the active substance is present in the blood unchanged.
Finasteride is actively metabolized in the liver by oxidation. Of the 5 formed metabolites, two metabolites have weak activity, accounting for only 20% of the total inhibition of 5-alpha reductase.
Excretion of tamsulosin and its metabolites is carried out mainly through the kidneys. About 9% of the dose taken is excreted unchanged. The half-life (T 1/2) from plasma with a single dose of one capsule is 10 hours, multiple doses - 13 hours, the final T 1/2 is 22 hours.
Finasteride is excreted in the form of metabolites through the kidneys about 39%, through the intestines 51-64% of the total administered dose. The T 1/2 of finasteride varies in the range from 4 to 12 hours; in men over 70 years of age, it averages 8 hours.
In case of kidney disease, dose adjustment of Sonirid Duo is not required.
In elderly patients, no dose adjustment of finasteride is required.
The pharmacokinetic parameters of finasteride in liver failure have not been studied.
Indications for use
The use of Sonirid Duo is indicated for the treatment and control of symptoms of benign prostatic hyperplasia.
Contraindications
Absolute:
- a history of postural hypotension;
- severe liver failure;
- impaired renal function (plasma creatinine level is more than 2 mg / dl);
- galactose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency;
- belonging to the female sex;
- age up to 18 years;
- hypersensitivity to the components of the drug.
With caution, Sonirid Duo should be prescribed to men with liver disease, liver failure, significantly reduced urine flow and / or a large volume of residual urine (the risk of developing obstructive uropathy), in old age, in case of planning surgery for cataracts.
Sonirid Duo, instructions for use: method and dosage
Sonirid Duo tablets and capsules are intended for oral administration.
Modified-release capsules (tamsulosin) are taken after meals, swallowing whole (the integrity of the shell must not be violated), always at the same time of day.
Recommended dosage: 1 tablet and 1 capsule once a day, daily for a long period.
In cases of adverse reactions, the patient can be transferred to monotherapy with finasteride. The patient can return to combination therapy when the severity of BPH symptoms increases.
Side effects
With tamsulosin monotherapy, the following adverse reactions may develop:
- from the nervous system: often - dizziness; infrequently - headache; rarely - fainting;
- from the respiratory system: infrequently - rhinitis;
- on the part of the cardiovascular system: infrequently - tachycardia, postural hypotension;
- from the genitals and breast: infrequently - retrograde ejaculation; very rarely - priapism;
- from the digestive system: infrequently - diarrhea, constipation, nausea, vomiting;
- dermatological reactions: infrequently - itchy skin, rash, urticaria; rarely - angioedema.
With monotherapy with finasteride, the following adverse reactions may develop:
- from the nervous system: often - decreased libido; the frequency has not been established - depression, decreased libido, which does not recover after stopping treatment;
- from the immune system: the frequency has not been established - hypersensitivity reactions, including pruritus, urticaria, angioedema (swelling of the lips, face, tongue, larynx);
- on the part of the organ of vision: infrequently - clouding of the lens;
- from the digestive system: often - abdominal pain; frequency not established - increased activity of hepatic transaminases;
- dermatological reactions: infrequently - skin rash;
- on the part of the cardiovascular system: frequency not established - palpitations;
- from the reproductive system and mammary glands: often - a decrease in ejaculate volume, erectile dysfunction; infrequently - violation of ejaculation, pain and / or enlargement of the mammary glands; frequency not established - testicular tenderness, sexual dysfunction, transient decrease in semen quality and / or infertility.
Against the background of combined treatment (finasteride and tamsulosin), adverse reactions and the frequency of their occurrence are similar, with some exceptions. Patients were more likely to have erectile dysfunction and ejaculation disorder with combination therapy, and disease progression (including increased BPH symptoms, the need for surgery) with monotherapy.
Overdose
Symptoms: an acute overdose of tamsulosin is theoretically capable of leading to arterial hypotension, which can result in cardiovascular disorders.
Treatment: in order to reduce the absorption of tamsulosin, it is advisable to immediately induce vomiting, and gastric lavage. Prescribe activated charcoal, sodium sulfate or other osmotic laxative. The patient should take a horizontal position. To restore blood pressure and heart rate, it is possible to use plasma-substituting and vasopressor drugs, depending on the patient's condition. It is necessary to monitor kidney function. Dialysis is ineffective.
Simultaneous administration of a high dose of finasteride does not cause clinically significant adverse reactions, therefore, specific treatment for overdose is not required.
special instructions
With finasteride treatment, there is a rapid decrease in PSA concentration, which in most men is observed during the first month of therapy and stabilizes at this level. When assessing the PSA indicator, it is necessary to take into account that its new (post-therapeutic) baseline level corresponds to approximately half of the pre-therapeutic indicator. Therefore, in the case of using finasteride for six months or more, the PSA should be doubled, comparing it with the normal values in patients not taking finasteride. This correction will preserve the PSA specificity and sensitivity, providing the possibility of diagnosing prostate cancer.
The appointment of Sonirid Duo can be made after a complete examination of the patient to exclude other diseases, the symptoms of which are similar to BPH. Before starting treatment, it is necessary to conduct a digital rectal examination, and, if necessary, determine the PSA. The examination is carried out regularly during the entire period of therapy.
When diagnosing prostate cancer in men with BPH taking finasteride, it should be borne in mind that PSA values within the normal range do not exclude the presence of prostate cancer.
If the monitoring of the PSA concentration indicator against the background of the use of finasteride shows a tendency to a constant increase, a thorough examination of the patient is required. In this case, the possibility of violation of the recommended dosage regimen cannot be excluded.
During treatment with finasteride, the free PSA value and the ratio of free PSA to total remain unchanged. For the diagnosis of prostate cancer, no correction is required when determining the proportion of free PSA.
With a large volume of residual urine and / or severe difficulty in urinating, the patient is examined for obstructive uropathy.
When using tamsulosin, a man should take precautions about a possible decrease in blood pressure. To avoid fainting when dizziness or weakness occurs, he needs to sit down or lie down until symptoms disappear completely.
In the case of planning surgical treatment for cataracts, the patient should inform the ophthalmologist and surgeon about taking tamsulosin at the present time or earlier. Usually, to reduce the risk of developing intraoperative atonic iris syndrome (ATS) and complications, the doctor recommends stopping tamsulosin taking 7-14 days before surgery.
If, during treatment, the duration of an erection is more than 4 hours, the patient needs immediate medical attention. Lack of timely therapy for priapism can damage the tissues of the penis and lead to irreversible loss of potency.
When using finasteride in patients with lactose intolerance, it should be borne in mind that in one tablet the content of lactose monohydrate is 102.6 mg.
Due to the existing risk of developing breast cancer, men should be informed about the need to see a doctor immediately if any changes in breast tissue are detected, including the appearance of lumps, pain, nipple discharge or gynecomastia.
Influence on the ability to drive vehicles and complex mechanisms
When treating Sonirid Duo, patients should be prepared for the possible development of such undesirable phenomena as drowsiness, blurred vision, dizziness and fainting. Therefore, care is required, and if you feel unwell, temporary abstinence from driving or working with complex mechanisms.
Application during pregnancy and lactation
You can not use Sonirid Duo to treat women.
During pregnancy and women of reproductive age, it is recommended to avoid contact with tablets with compromised film coat integrity or seminal fluid of men taking finasteride. For sexual intercourse during the treatment of a sexual partner with finasteride and for at least two months after stopping therapy, it is recommended to use barrier (mechanical) contraception. The period of complete elimination of finasteride from the semen of a man after the termination of its use has not been established.
Pediatric use
The use of Sonirid Duo in pediatrics is contraindicated.
With impaired renal function
It is contraindicated to prescribe Sonirid Duo in case of impaired renal function with a plasma creatinine concentration above 2 mg / dL.
For violations of liver function
The appointment of Sonirid Duo to patients with severe hepatic insufficiency is contraindicated.
With caution, complex therapy should be used for liver diseases.
Use in the elderly
In elderly patients, finasteride is excreted somewhat more slowly, but this has no clinical significance on therapy. Therefore, in old age, the Sonirid Duo dose adjustment is not required.
Drug interactions
The results of studies of hepatic microsomal fractions in vitro indicate the absence of pharmacokinetic interaction of tamsulosin with finasteride, amitriptyline, salbutamol, glibenclamide during their metabolism in the liver.
There was no clinically significant interaction of finasteride with the simultaneous use of the following drugs: alpha 1- adrenergic blockers, beta-blockers, slow calcium channel blockers, diuretics, blockers of histamine H 2 -receptors, warfarin, angiotensin-converting enzyme inhibitors, theophylline, paracetalysteric acid anti-inflammatory drugs, nitrates, benzodiazepines, quinolones, anticonvulsants, HMG-CoA reductase inhibitors (3-hydroxy-3-methylglutaryl coenzyme A reductase).
With the simultaneous use of tamsulosin:
- cimetidine, furosemide: against the background of the use of cimetidine, an increase in the level of tamsulosin in plasma is observed within the normal range, furosemide is a decrease within the normal range, therefore, it is not required to adjust the dose of tamsulosin;
- atenolol, enalapril, nifedipine, theophylline: no interaction with these agents was found;
- simvastatin, warfarin, diazepam, propranolol, chlormadinone, trichloromethiazide, amitriptyline, diclofenac, glibenclamide: in vitro these agents do not affect the content of the free fraction of tamsulosin in human plasma;
- diazepam, propranolol, trichloromethiazide, chlormadinone: concomitant therapy with these agents does not affect the content of their free fraction;
- diclofenac, warfarin: taking diclofenac or warfarin can increase the rate of elimination of tamsulosin;
- other alpha 1 -adrenergic blockers, agents for general anesthesia: it is expected to increase the hypotensive effect of these and other similar drugs.
Analogs
The analogues of Sonirid Duo are Alfinal, Kardura, Focusin Combi, Prostalamin, Dalfaz Retard, Omnik, Finast, Tamsulon, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at 15-30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Sonirid Duo
Reviews of Sonirid Duo are few and far between. Pointing to the positive effect of therapy, patients note that undesirable reactions such as decreased libido, abnormal ejaculation, and impotence often develop. These side effects often cause discontinuation of the combination treatment.
Price for Sonirid Duo in pharmacies
The price of Sonirid Duo for a package containing 30 tablets and 30 capsules can range from 1059 rubles.
Sonirid Duo: prices in online pharmacies
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Drug name Price Pharmacy |
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Sonirid Duo in 1 bl. 5 tabl.p.p. 5mg (finasteride) + 5 capsules with mod. 0.4 mg (tamsulosin) tablets and capsules set of 60 pcs. 949 RUB Buy |
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Sonirid DUO set of tablets and capsules 5mg + 0.4mg 60 pcs. 976 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
