Sonirid Duo (Sonirid duo)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTamsulosin + Finasteride [set]Tamsulosin + Finasteride [set]
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  • Sonirid Duo
    capsulespills inwards 
    GEDEON RICHTER, OJSC     Hungary
    • Dosage form: & nbsptablets and capsules set
    Composition:

    Composition per 1 tablet:

    active ingredient: finasteride, 5 mg;

    Excipients:

    Core tablet: magnesium stearate 0.7500 mg; talc 4.5000 mg; sodium carboxymethyl starch (type A) 7.5000 mg; pregelatinized starch 15,0000 mg; cellulose microcrystalline 15,0000 mg; lactose monohydrate 102.2500 mg.

    Sheath: titanium dioxide C.I.77891 EEC 171 0.1881 mg; lactose monohydrate 0.3809 mg; macrogol-6000 0.6214 mg; giprolose 1.9048 mg; hypromellose 1.9048 mg.

    Tamsulosin Ingredients per 1 capsule:

    active ingredient: tamsulosin hydrochloride, 0.4 mg;

    Excipients:

    calcium stearate 0,800 mg; triethyl citrate 1,100 mg; talc 2,500 mg; methacrylic acid and ethyl acrylate copolymer (1: 1) 43.800 mg, containing also polysorbate-80 1,000 mg, sodium lauryl sulfate 0.300 mg; cellulose microcrystalline 281,400 mg.

    Composition of hard gelatin capsule

    Cap: dye iron oxide yellow C.I. 77492 E172 0.2000%, titanium dioxide C.I. 77891 E171 0.33333%, iron oxide dye black C.I. 77499 E172 0.5300%, iron oxide dye red C.I. 77491 E172 0.9300%, gelatin up to 100,000%.

    Housing: dye iron oxide red C.I. 77491 E172 0.010%, iron dye oxide black C.I. 77499 E172 0.0100 %, dye iron oxide yellow C.I. 77492 E172 0.1714%, titanium dioxide C.I. 77891 E171 3,000%, gelatin up to 100,000%.

    Description:

    Tamsulosin

    Hard gelatin capsules size # 2; lid: opaque, brown

    colors; body: opaque, brownish-yellow color.

    The contents of the capsule are pellets of white or almost white.

    Finasteride

    Tablets, film-coated, white or almost white in color, shape

    triangle with rounded ends, slightly biconvex, almost odorless, with

    engraving “RG” on one side.

    Pharmacotherapeutic group:Tamsulosin: alpha1-adrenoblocker Finasteride: 5-alpha reductase inhibitor.
    ATX: & nbsp

    G.04.C.A.02   Tamsulosin

    G.04.C.B.01   Finasteride

    Pharmacodynamics:

    The drug Sonirid Duo is designed to treat and control the symptoms of benign prostatic hyperplasia (BPH), if necessary, combined treatment with tamsulosin and finasteride to:

    - Achieve regression of the size of the prostate, improve urination and reduce symptoms from the lower urinary tract caused by BPH;

    - slowing the clinical progression of the disease and reducing the incidence of acute urinary retention and the need for surgical treatment,including transurethral resection of the prostate (TURP) and prostatectomy; Sonirid Duo can be used only with an increase in the prostate gland (the volume of the prostate is more than 40 cm3). With this increase in prostate combined treatment alleviates the symptoms of BPH and slowing clinical progression of the disease more effectively than finasteride monotherapy blocker or alpha-1-adrenoreceptors.

    - The drug can be used only to treat men.

    Pharmacodynamics

    Pharmaco dynamics of tamsulosin

    Tamsulosin selectively and competitively blocks postsynaptic alpha-1 adrenergic receptors located in the smooth muscle of the prostate, bladder neck and prostatic urethra (alpha 1 subtype A), and alpha-1 adrenergic receptors are mainly in the bladder body (subtype alpha- ID). This leads to a decrease in the tone of the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra and improve detrusor function. This reduces the symptoms of obstruction and irritation associated with benign prostatic hyperplasia.As a rule, the therapeutic effect develops 2 weeks after the beginning of taking the drug, although in a number of patients the decrease in the severity of symptoms is noted after taking the first dose. The ability of tamsulosin to affect alpha-1A-adrenergic receptors is 20 times greater than its ability to interact with alpha-1B-adrenergic receptors, which are located in the smooth muscle of the vessels. Due to this high selectivity, the drug does not cause any clinically significant decrease in systemic blood pressure (BP) in both patients with arterial hypertension and in patients with normal initial BP.

    Finasteride is a synthetic 4-azasteroid, a specific inhibitor of the intracellular enzyme of 5-alpha-reductase II type. The latter turns testosterone in a more active androgen - 5-alpha-dihydrotestosterone (DHT). The normal function and growth of the prostate gland, including its hypertrophied tissue, depends on the conversion of testosterone to DHT. Finasteride does not affect androgen receptors. Prostate cells proliferation and apoptosis in healthy volunteers
    balanced due to the interaction of factors that inhibit and stimulate growth. Although etiological factors, at the molecular level causing prostatic hyperplasia, are not yet known, it is likely that DHT plays the role in this process. Specific inhibitors of 5-alpha-reductase II type reduce the concentration of DHT in the prostate and promote regression of prostatic hyperplasia. According to clinical studies, treatment with finasteride rapidly reduces the concentration of DHT in the plasma by 70%, which leads to a decrease in the volume of the prostate gland. With constant admission, statistically significant effects are recorded after 3 months (a decrease in gland volume by approximately 20%) and 7 months, (a decrease in the severity of symptoms associated with prostatic hyperplasia).

    In the human body there are 2 types of 5-alpha-reductase: I and II. Their distribution in tissues varies: in the prostate, testicles and their appendages, the glans penis, scrotum, seminal vesicles, liver and in the chest, isoenzyme type II occurs; I type occurs mainly in the skin of the head, back and chest, sebaceous glands, in the liver, adrenal glands and kidneys. Finasteride oppresses in the first place isoenzyme type II, responsible for most of the DHT in the blood. A single dose of finasteride quickly and significantly changes the concentration of DHT in plasma. A single dose of 5 mg finasteride reduces the concentration of DHT in plasma by 75%, which reaches its minimum by 24 hours, then returns to the initial level within 7 days. With multiple reception finasteride keeps efficiency. Finasteride reduces the concentration of DHT in the prostate itself by <15% and provides a corresponding increase in testosterone levels in the prostate. Compared with surgical or chemical castration, treatment with finasteride is accompanied by a significantly greater decrease in the level of DHT in the prostate.

    Prostate-specific antigen (PSA) is a sensitive and specific androgen-dependent marker of prostate carcinoma. In most cases, after several months of treatment with finasteride, there is a rapid decrease in PSA concentration, and then setting it at low values.

    After 1 year of taking finasteride in a dose of 5 mg, the average PSA concentration is reduced by 50%.

    Finasteride does not show an affinity for androgen receptors and does not have a different hormonal effect.Following the discovery of 5-alpha-reductase and the description of the 5-alpha-reductase deficiency syndrome II type (hermaphroditism of the male type), the role of androgens in benign prostatic hyperplasia was again revised. The development of the prostate depends on DHT, strong androgen. When 5-alpha-reductase deficiency is present against a background of normal or high testosterone levels, prostate atrophy is observed in adulthood. DHT activates androgen receptors, forming after the addition of dimers to them, which, when linked to DNA, directly or indirectly contribute to the proliferation of cells by changing the expression of genes responsible for proliferation and apoptosis. In the intact prostate, the processes of apoptosis and proliferation are in balance. Despite the fact that the factors provoking prostate hyperplasia at the molecular level are unknown, the role of DHT in this is very likely. Specific inhibitors of 5-alpha-reductase type II can reduce the concentration of DHT in the prostate and promote the reverse development of hyperplastic prostate. There was a significant mortality in mice and rats of both sexes when fed with a first single dose of finasteride equal to 1500 mg / m2 (500 mg / kg), and the second - 2360 mg / m2 (400 mg / kg for females) and 5900 mg / m2 (1000 mg / kg for males). Small doses of the drug, fed to pregnant rats, caused malformations of the genitalia in male offspring.

    Pharmacokinetics:

    Tamsulosin

    Suction: Tamsulosin absorbed in the small intestine, bioavailability on an empty stomach is almost 100%. When taking tamsulosin with food, its absorption decreases. To achieve the same level of absorption, the drug should be taken daily at the dose specified in the instructions after breakfast. When taking one capsule of the prolonged action of 0.4 mg after meals, the maximum concentration (Cmax) of the drug in plasma is reached after about 6 hours. With multiple intake, the equilibrium concentration is reached by day 5, when the maximum concentration of the drug in the plasma is approximately 2-3 times higher than in a single dose. Although these indicators were evaluated in elderly patients, it is assumed that they are similar in young patients. With a single and multiple intake, individual fluctuations in the concentration of the drug in the plasma can occur.

    Distribution: Approximately 99% of tamsulosin binds to plasma proteins; the volume of distribution is small (about 0.2 l / kg).

    Metabolism: Tamsulosin is metabolized slowly, the effect of "first passage" is insignificant. Tamsulosin slowly biotransformiruetsya in the liver with the formation of pharmacologically active metabolites that retain high selectivity to alpha-adrenergic receptors. Most of the active substance is present in the blood in unchanged form. In rats, a slight microsomal induction induced by tamsulosin was detected. None of the metabolites shows more activity than tamsulosin.

    Excretion: Tamsulosin and its metabolites are mainly excreted by the kidneys, approximately 9% of the accepted dose of the drug - in unchanged form. The half-life of the drug from the plasma was 10 hours with a single capsule intake of 0.4 mg, after repeated intake of -13 hours, the final half-life is 22 hours. With kidney diseases, dose correction is not required.

    Finasteride

    Suction: Quickly absorbed from the gastrointestinal tract, after 2 hours reaches a maximum concentration in the plasma, equal to 37 ng / ml. Absorption in the gastrointestinal tract is completed 6-8 hours after admission. Eating does not affect the absorption of finasteride.The bioavailability of finasteride upon ingestion is approximately 80%.

    Distribution: 90% of circulating finasteride is bound to plasma proteins and does not have a damaging effect in kidney diseases. Finasteride penetrates the blood-brain barrier and in a small amount is distributed in the seminal fluid of patients. The volume of distribution is 76 ± 14 liters.

    Metabolism: Finasteride It is actively metabolized in the liver by oxidative biotransformation. Two of the 5 metabolites of finasteride have a weak activity and account for 20% of the total inhibition of 5-alpha-reductase.

    Excretion: The average half-life of finasteride is 6 hours (4-12 hours), in men over 70 years - 8 hours (6-15 hours). When using labeled finasteride, approximately 39% (32-49%) of the administered dose was excreted by the kidneys in the form of metabolites. Unchanged finasteride almost not detected in urine. Approximately 57% (51-64%) of the total dose is excreted through the intestine. In patients with impaired renal function (creatinine clearance> 9 ml / min), there was no difference in the excretion of finasteride. The concentration of finasteride in sperm ranges from undetectable (<1 ng / ml) to 21 ng / ml.

    A long, 3-7-month dose of 5 mg / day reduces the concentration of DHT in blood serum by 70%.

    Pharmacokinetics in selected patient groups: In elderly patients finasteride is shown a little slower, but it has no clinical significance and does not require a dose adjustment. This also applies to patients with renal insufficiency, since a decrease in renal excretion of metabolites is compensated by an increase in the excretion of the drug through the intestine. The pharmacokinetics of finasteride in patients with hepatic insufficiency have not been studied. Because the finasteride actively metabolized in the liver, with liver disease requires additional control.

    Indications:

    Treatment and control of symptoms of benign prostatic hyperplasia (BPH).

    Contraindications:

    - hypersensitivity to active ingredients or excipients;

    - presence of postural hypotension in the anamnesis;

    - hepatic failure of severe degree;

    - impaired renal function (plasma creatinine concentration> 2 mg / dL);

    - intolerance to galactose, lactase deficiency or glucose-galactose malabsorption;

    - women and children.

    Carefully:

    if there is a risk of developing obstructive uropathy;

    - liver disease;

    - when planning surgical cataract treatment.

    Pregnancy and lactation:

    Sonirid Duo can not be used by women. Pregnant women and women of childbearing age should avoid contact with crushed or lost integrity tablets of finasteride, and contact with the semen fluid of the male taking finasteride (use a condom).

    Dosing and Administration:

    The drug Sonirid Duo contains tamsulosin 0.4 mg in modified release capsules and finasteride 5 mg in film-coated tablets. The drugs are for daily use. The daily dose of Sonirid Duo contains one capsule with a modified release of tamsulosin 0.4 mg and one film-coated tablet finasteride 5 mg.

    Tamsulosin 0.4 mg, modified-release capsules, should be taken at the same time of day, after eating. Capsules should be swallowed whole, do not break and do not chew, as this can disrupt the sustained release of the active substance.

    For a full therapeutic effect, a long-term use of Sonirid Duo is necessary. If unwanted reactions appear, you can transfer the patient to monotherapy with finasteride; However, it is recommended to return to a combined regimen with an increase in the severity of BPH symptoms.

    Side effects:

    Side effects are defined as frequent> 1/100 to <1/10; infrequent (> 1/1000 to <1/100); rare (> 1/10000 to <1/1000); very rare (<1/10000).

    Undesirable reactions with monotherapy with tamsulosin Impaired nervous system:

    Frequent: dizziness;

    Infrequent: headache;

    Rare: faint.

    Disorders from the cardiovascular system:

    Infrequent: postural hypotension, tachycardia.

    Violations from hand respiratory system, chest and mediastinal organs: Infrequent: rhinitis;

    Violations from hand gastrointestinal tract:

    Infrequent: constipation, diarrhea, nausea, vomiting.

    Violations from side of the skin and subcutaneous fat:

    Infrequent: a rash, itching, hives;

    Rare: angioedema.

    On the part of the reproductive system:

    Infrequent: retrograde ejaculation;

    Rare: priapism.

    Undesirable monotherapy reactions with finasteride From the immune system Infrequent: hypersensitivity.

    Co hand organ of vision Infrequent: clouding of the lens.

    From the gastrointestinal tract Frequent: pain in the abdomen.

    Co hand skin and subcutaneous fat cellulose

    Infrequent: rash.

    On the part of the reproductive system and milk glands:

    Frequent: erectile dysfunction, impaired ejaculation, decreased ejaculate volume, decreased libido;

    Infrequent: soreness of the mammary glands, enlargement of the mammary glands, pain in the testicles.

    During post-marketing surveillance, the following additional unwanted reactions are described (there is no data on the frequency of adverse reactions):

    hypersensitivity reactions, including itching, hives, swollen lips and face. Unwanted reactions of combined treatment

    In patients receiving combined treatment (finasteride and alpha-1-adrenoblocker), the same undesirable reactions occur at the same frequency as with monotherapy with finasteride and alpha-1-adrenoblocker. Nevertheless, the following exceptions were identified: erectile dysfunction and ejaculation disorders were detected more often with combined treatment,whereas progression of the disease (including increased symptoms of BPH or the need for surgical treatment) was noted more often with monotherapy.

    Overdose:

    There are no cases of simultaneous overdose of finasteride and tamsulosin.

    There is no clinical evidence of an overdose of tamsulosin. Theoretically, an acute overdose of tamsulosin can cause arterial hypotension, which can lead to cardiovascular disorders. To restore blood pressure and heart rhythm of the patient must be laid, if necessary, use plasma-substituting drugs and, depending on the patient's condition, vasopressor drugs. It is recommended to monitor kidney function. The dialysis is not shown due to the significant binding of tamsulosin to plasma proteins. To reduce the absorption of the drug, it is advisable to induce vomiting. Gastric lavage after taking a large amount of the drug should be carried out together with the appointment of activated charcoal and osmotic laxative (for example, sodium sulfate).

    Overdose of Finasteride: The use of a single dose of finasteride 400 mg and repeated intake in a dose of up to 80 mg / day for 3 months showed no undesirable reactions. In case of an overdose, no specific treatment is required.

    Interaction:

    In studies in vitro hepatic microsomal fractions (model of the metabolism of the preparation by the enzymatic system of cytochrome P450) determined that tamsulosin does not enter into pharmacokinetic interaction with finasteride during metabolism in the liver.

    Additional interaction of tamsulosin with other drugs and other interactions

    No interaction was found with simultaneous use of tamsulosin and atenolol, enalapril, nifedipine, or theophylline. Co-administration with cimetidine may cause an increase in tamsulosin concentration in the plasma, while furosemide causes its reduction. However, there is no need to change the dose of the drug, since the concentration of tamsulosin remains within the normal range. In vitro diazepam, propranolol, trichloromethiazide, chloromadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the content of the free tamsulosin fraction in human plasma. Also tamsulosin does not change the content of the free fraction of diazepam, propranolol, trichloromethiazide and chloromadinone. In studies in vitro hepatic microsomal fractions (model of the metabolism of the preparation by the enzymatic system cytochrome P450), no interaction with amitriptyline, salbutamol, glibenclamide and finasteride was observed at the level of hepatic metabolism. but diclofenac and warfarin can increase the rate of excretion of tamsulosin. Theoretically, there is a possibility that a joint application with tamsulosin can enhance the hypotensive effect of other drugs, such as general anesthetics or other alpha-1-blockers.

    Additional interaction of Finasteride with other drugs and other interactions

    There was no clinically significant interaction in the joint use of finasteride with the following drugs: warfarin, angiotensin-converting enzyme inhibitors, alpha-1-adrenergic blockers, theophylline, acetylsalicylic acid, paracetamol, Beta-blockers, diuretics, nitrates, calcium channel blockers slow, anticonvulsants, nonsteroidal antiinflammatory drugs (NSAIDs), benzodiazepines, quinolones, NG-blockers histamine receptors, inhibitors of H-W-hydroxy-methyl-glyutaril-coenzyme A reductase ( HMG-CoA).

    Special instructions:

    When evaluating indicator of prostate-specific antigen (PSA) should take into account the fact that the treatment with finasteride decreases PSA concentration. In most patients, the concentration of PSA decreases rapidly during the first month of treatment, and then stabilizes at a new baseline. This "post-therapeutic baseline" is approximately half the pre-therapeutic value. Thus, in typical cases, treatment with finasteride for six months or more, PSA doubling the figure must be compared with normal values ​​in patients not taking finasteride. There were no other differences in standard laboratory rates between patients receiving placebo or finasteride.

    Before beginning treatment with Sonirid Duo patient should be examined to exclude the presence of other diseases that manifest the same symptoms as BPH.Before the treatment and regularly during treatment, it is necessary to perform digital rectal examination and, if necessary, the determination of PSA.

    Patients with a large volume of residual urine and / or severe difficulty urinating should be examined for obstructive uropathy.

    Precautions for the use of tamsulosin:

    - As with the use of other alpha-1-adrenoreceptor blockers, arterial pressure may decrease during tamsulosin treatment, which in rare cases leads to fainting. At the first signs of postural hypotension (for example, dizziness, weakness), you should sit or lay the patient until the symptoms disappear completely.

    - The intraoperative atonic iris syndrome (SAR, a variant of the small pupil syndrome) was observed during the operation for cataracts in some patients taking tamsulosin. Intraoperative ATS can increase the frequency of complications of surgery. It is not recommended to begin treatment with tamsulosin in patients who are scheduled for surgical cataract treatment. Discontinuing tamsulosin for 1-2 weeks before surgery usually reduces the risk, but the optimal timing for stopping it has not yet been established.To prevent the development of intraoperative syndrome of atonic iris, the surgeon and ophthalmologists in the preoperative period should find out whether the patient has taken tamsulosin earlier or continues its reception. This will allow to take appropriate measures during the planning and during the surgical intervention.

    Precautions when applying finasteride:

    - Data on the possibility of entering finasteride in the body with manual separation of the tablet or during sexual intercourse in contact with the semen of the male taking finasteride, are absent. In this regard, pregnant women and women of reproductive age are not recommended to share tablets by hands, to avoid contact with crushed or lost integrity tablets, and to avoid contact with the semen fluid of the male taking finasteride. Since the duration of the presence of finasteride in the seminal fluid of a man after discontinuation of the drug is unknown, it is necessary to observe such precautions within 2 months after the end of treatment.

    - The finasteride tablets contain lactose monohydrate.Patients with a rare hereditary intolerance to galactose, lactase deficiency, or impaired glucose-galactose absorption should not be taken. Patients with lactose intolerance should take into account that the preparation contains 102.6 mg of lactose monohydrate.

    Effect of Finasteride on the concentration of PSA and diagnosis of prostate cancer Before the start of treatment and periodically during treatment with finasteride, a digital rectal examination should be performed and, if necessary, the concentration of prostate-specific antigen (PSA) should be determined. There is a significant coincidence of the concentration of PSA in men with prostate cancer and without. Thus, in men with BPH, the value of PSA, which is within the normal range due to the use of finasteride, does not exclude the presence of prostate cancer.

    The use of finasteride reduces the concentration of serum PSA by approximately 50% in patients with BPH even in the presence of prostate cancer. Reduction of PSA concentration is noted in the whole range of its values ​​and can be different for different patients.When evaluating the PSA value, it should be borne in mind that a decrease in PSA in plasma in patients with BPH, finasteride, does not exclude the presence of prostate cancer. In patients receiving finasteride for 6 months or more, the value of PSA must be doubled for comparison with normal indicators in patients not taking finasteride. This adjustment allows to preserve the sensitivity and specificity of the PSA measurement and provides the possibility of diagnosing prostate cancer.

    With a constant increase in the concentration of PSA in men taking finasteride, a thorough examination should be carried out. In this case, it is impossible to exclude the possibility of violation of the dosing regimen specified in the instruction for the use of finasteride.

    Finasteride does not significantly reduce the proportion of free PSA and the ratio of free PSA to total; this index remains unchanged in the treatment with finasteride. When determining the proportion of free PSA for prostate cancer diagnosis, correction is not required.

    Effect on the ability to drive transp. cf.and fur:

    There are no similar effects of finasteride. Especially such effects of tamsulosin have not been studied. However, one should consider the possibility of drowsiness, visual impairment, dizziness, fainting in some patients, and therefore they should temporarily refrain from driving and working with mechanisms with an increased risk of injury.

    Form release / dosage:

    5 tablets coated with a film coat (finasteride) and 5 capsules with a modified release (tamsulosin) in a blister of PVC / PVDC / A1.

    For 6 blisters in a cardboard box together with instructions for medical use.

    Packaging:(5) - blister PVC / PVDC / | Al (6) / 5 tablets film-coated (finasteride) and 5 capsules with modified release (tamsulosin) in the blister of PVC / PVDC / Al. 6 blisters in a cardboard box. / - packs of cardboard
    Storage conditions:

    Store at temperatures between 15 and 30 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001488
    Date of registration:08.02.2012
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp30.08.2015
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