The instruction for medical use
of Duodart® medicine
the Trade name
of Duodart®
the International unlicensed name
Is not present
the Dosage form
of the Structure Structure Capsule of a soft gelatin capsule
active agent - dutasterid 0.5 mg,
excipients: mono - and diglycerides of caprylic/capric acid, butyl hydroxytoluene (E 321),
structure of a cover of the capsule: gelatin, glycerin, the titan dioxide (E171), gland (III) oxide yellow (E172),
Structure of pellets from a tamsulozin a hydrochloride
a pellet Kernel
active agent - a tamsulozina a hydrochloride of 0.4 mg,
excipients: microcrystalline cellulose, copolymer of methacrylic acid – etakrilat (1:1) 30 of % dispersion, talc, triethyl citrate,
a pellet Cover:
Copolymer of methacrylic acid – etakrilat (1:1) 30 of % dispersion, talc, triethyl citrate,
the Solid capsule from a gipromelloza
the Carrageenan (E407), potassium chloride, the titan dioxide (E 171), gland (III) oxide red (E 172), dye yellow (E110), water cleaned, gipromelloza-2910, wax of karnaubskiya, starch corn,
Structure
Shellac, propylene glycol, gland (II, III) blackened black (SW-9010 or SW-9008) oxide black (E172), potassium hydroxide.
The description
Oblong solid capsules from a gipromelloza 00 of No. in size, with the brown body and an orange lid on which black ink put the GS 7CZ code.
Contents of capsules: one oblong the opaque soft gelatin capsule of opaque yellow color containing dutasterid, and pellets from white till almost white color, supporting a tamsulozin a hydrochloride.
Pharmacotherapeutic group
Drugs for treatment of a benign hypertrophy of a prostate. Alpha adrenoblockers. Tamsulozin and Dutasterid.
The ATX G04CA52 code
the Pharmacological
Pharmacokinetics Absorption Later properties of reception of one dose of a dutasterid of 0.5 mg the maximum concentration of drug in serum is reached during 1-3 h.
The absolute bioavailability is about 60% in relation to 2-hour intravenous infusion. The bioavailability of a dutasterid does not depend on meal.
Tamsulozina a hydrochloride is well soaked up in intestines and nearly 100% have bioavailability. Tamsulozina a hydrochloride is characterized by linear kinetics, both at single, and at the repeated mode of dosing. At the single mode of dosing the equilibrium concentration of a tamsulozin of a hydrochloride is reached by 5th day. Absorption of a tamsulozin of a hydrochloride slows down after meal. Identical level of absorption can be reached in case the patient accepts a tamsulozin a hydrochloride daily, in 30 minutes after the same meal.
Distribution
Pharmacokinetic data of single and repeated receptions of a dutasterid testifies to the large volume of its distribution (from 300 to 500 l). Dutasterid possesses high extent of linking with proteins of plasma (& gt, 99.5%).
At daily reception the concentration of a dutasterid in serum reaches 65% of stationary level in 1 month and about 90% of this level in 3 months. Stationary concentration of a dutasterid in serum (Css) equal to about 40 ng/ml are reached in 6 months of daily reception of 0.5 mg of this drug. In sperm, as well as in serum, stationary concentration of a dutasterid are reached in 6 months too. In 52 weeks of treatment of concentration of a dutasterid in sperm averaged 3.4 ng/ml (from 0.4 to 14 ng/ml). From serum about 11.5% of a dutasterid get to sperm.
Tamsulozina a hydrochloride mostly contacts proteins of blood plasma (from 94% to 99%), mainly with alfa-1 an acid glycoprotein with a wide range of concentration (from 20 to 600 ng/ml). The visible average equilibrium volume of distribution at 10 healthy adult men at intravenous appointment was
16 l.
Metabolism
of In vitro dutasterid is metabolized by CYP-3A4 enzyme of a system of R-450 cytochrome to two small monohydroxylated metabolites, at the same time it is not affected by enzymes of this CYP1A2, CY2A6, CYP2E1, CYP2S8, CYP2S9, CYP2S19, CYP2V6 and CYP2D6 system.
After achievement of stationary concentration of a dutasterid in serum by means of a mass and spectrometer method find invariable dutasterid, 3 main metabolites (4’ hydroksidutasterid, 1.2 - digidrodutasterid and 6 – hydroksidutasterid) and 2 small metabolites (6.4 '-digidroksidutasterid and 15-hydroksidutasterid).
Tamsulozina a hydrochloride is mainly metabolized in a liver by means of enzymes of a system of P450 cytochrome, and less than 10% of a dose are excreted by kidneys in an invariable look. The pharmacokinetic profile of metabolites at the person was not studied, but results of in vitro show that CYP3A4 and CYP2D6 are involved in metabolism of a tamsulozin, just as, thus, the accompanying use of the drugs inhibiting metabolism of these enzymes can lead other CYP isotypes to increase in level of a tamsulozin. Metabolites of a tamsulozin of a hydrochloride are exposed to conjugation with glucuronides or sulfates before excretion by kidneys.
Linearity/nonlinearity
Pharmacokinetics of a dutasterid can be described as process of absorption of the first order and two parallel processes of elimination, one saturated (i.e. depending on concentration) and one – not saturable
(i.e. not depending on concentration). At low concentration in serum (less than 3 ng/ml) dutasterid it is quickly removed by means of both processes of elimination. After single dose dutasterid it eliminirutsya quickly from an organism and has the short elimination half-life equal to 3 - 9 days.
At concentration in serum higher than 3 ng/ml the clearance of a dutasterid happens more slowly (0.35 - 0.58 l/h), mainly by means of linear not saturable process of elimination to final elimination half-life of 3 - 5 weeks. At therapeutic concentration, against the background of daily administration of drug of Duodart®, slower clearance of a dutasterid prevails, the general clearance carries the linear and not depending on concentration character.
Removal
Dutasterid is exposed to intensive metabolism. After single dose in drug before achievement of steady state at the person from 1.0 to 15.4% (on average 5.4%) the accepted dose it is excreted through intestines in not changed look. The rest of a dose is excreted in the form of 4 main metabolites, components of 39, 21, 7 and 7% respectively, and 6 small metabolites (less than 5% fall to the share of each of which).
Through kidneys at the person trace quantities of not changed dutasterid (less than 0.1% of a dose) are excreted.
At reception of therapeutic doses of a dutasterid its final elimination half-life makes 3 – 5 weeks.
Dutasterid is found in serum (in concentration higher than 0.1 ng/ml) up to 4 – 6 months after the termination of its reception.
Tamsulozin the hydrochloride and its metabolites are mainly removed by kidneys, at the same time about 10% of drug are allocated in an invariable view with urine. Elimination half-life of a tamsulozin of a hydrochloride makes 5 – 7 hours.
Elderly men
studied Pharmacokinetics and a pharmacodynamics at 36 healthy men aged from 24 up to 87 years after reception of one dose (5 mg) of a dutasterid. Between different age groups there were no significant distinctions in such pharmacokinetic parameters of a dutasterid as AUC (the area under a pharmacokinetic curve) and Cmax (maximum concentration). Also significant differences in elimination half-life of a dutasterid between an age group of 50 - 69 years and an age group were not revealed 70 years which includes most of men with the benign hyperplasia of a prostate (BHP) are more senior.
Between age groups there were no significant differences in extent of decrease in the DGT levels. These results show lack of need to reduce a dose of a dutasterid at elderly patients.
Indicators of AUC and elimination half-life of a tamsulozin can be extended at elderly patients in comparison with young healthy men. The clearance in general does not depend on binding of a tamsulozin with alfa-1 an acid glycoprotein, but decreases with age, leading to increase in AUC approximately for 40% at patients of 55-75 years in comparison with patients of 20-32 years.
A renal failure
Influence of a renal failure on pharmacokinetics of a dutasterid was not studied, but as less than 0.1% of a dutasterid are found in urine after administration of drug in a dose of 0.5 mg, patients have no need for dose adjustment of a dutasterid with a renal failure.
Influence of a tamsulazin was studied at patients with easy and average degree of a renal failure - such patients have no need for dose adjustment of a tamsulozin. There are no data on use of a tamsulozin for patients with an end-stage of renal pathology.
A liver failure
Influence of a dutasterid on patients with a liver failure was not studied, however owing to his mainly hepatic metabolism, increase in exposure of a dutasterid at such patients is expected.
Dose adjustment of a tamsulozin is not required from patients with average degree of a liver failure. There are no data on use of a tamsulozin for patients with heavy degree of pathology of a liver.
A pharmacodynamics
of Duodart® - the combined drug of a dutasterid and tamsulozin with the complementary mechanism of action.
Dutasterid – dual inhibitor of 5a-reductase. It suppresses activity of isoenzymes of 5a-reductase of the 1st and 2nd types which are responsible for transformation of testosterone into 5a-dihydrotestosterone. Dihydrotestosterone (DGT) is the main androgen responsible for a hyperplasia of ferruterous fabric of a prostate. Dutasterid reduces the DGT level, reduces the prostate sizes, reduces disease symptoms, leads to urination improvement, reduction of risk of emergence of a sharp ischuria and the need for surgical treatment.
Influence on concentration of dihydrotestosterone (DGT) and testosterone
the Maximum influence of a dutasterid on decrease in concentration of DGT is dose-dependent and is observed in 1 – 2 weeks after an initiation of treatment. In 1 – 2 weeks of reception of a dutasterid in a dose of 0.5 mg a day the median values of concentration of DGT in serum decrease by
85 – 90% respectively.
At patients with the benign hyperplasia of a prostate (BHP) at reception of a dutasterid in a dose of 0.5 mg a day the average rates of decrease in the DGT level were 94% within the first year and 93% - within the second year of therapy, average values of testosterone in serum increased by 19% during first and second of treatment. This effect is caused by decrease in level 5 an alpha of reductase and does not lead to development of any known side reactions.
Tamsulozina a hydrochloride – a blocker postsynaptic α1a-адренорецепторов, being in smooth muscles of a prostate, a neck of a bladder and a prostatic part of an urethra. Blockade α1a-адренорецепторов leads to decrease in a tone of smooth muscles of a prostate, a neck of a bladder and a prostatic part of an urethra and improvement of outflow of urine. At the same time both obstructive symptoms, and the irritativny symptoms caused by the raised tone of smooth muscles and detruzorny hyperactivity at DGPZh decrease.
Indications
- treatment and prevention of progressing of a benign hyperplasia of a prostate (reduction of its sizes, reduction of symptoms of a disease, urination improvement, reduction of risk of emergence of a sharp ischuria and the need for surgical treatment)
the Route of administration and doses
Adult men (including elderly)
1 capsule (0.5 mg / 0.4 mg) inside, once a day, 30 minutes later after the same meal, washing down with water. Capsules should be accepted entirely, without opening and without chewing as the contact of contents of the capsule from a mucous oral cavity can cause the inflammatory phenomena from mucous.
Patients with renal failures
are not present data on use of the drug Duodart® for patients with renal failures Now. This cohort of patients has no need for dose adjustment.
Patients with abnormal liver functions
are not present data on use of the drug Duodart® for patients with abnormal liver functions Now.
To apply with care at patients with easy and average degree of a liver failure. The drug Duodart® is contraindicated to patients with heavy degree of a liver failure.
Side effects
the Undesirable phenomena caused by use of a tamsulozin of a hydrochloride in a combination with dutasteridy:
Very seldom (& lt, 1/10,000)
- impotence, decrease in a libido, disturbance of an ejaculation, a gynecomastia, morbidity of chest glands, dizziness
of Disorder of the sexual sphere are connected with use of a component of a dutasterid and can remain after therapy cancellation.
The undesirable phenomena caused by use of a dutasterid as monotherapy
Seldom (≥1/10,000 and & lt, 1/1,000)
- an alopecia (mainly a hair loss on a body), a hypertrichosis
Very seldom (& lt, 1/10,000)
- a depression
- pain and hypostasis in the field of testicles
the Undesirable phenomena caused by use of a tamsulozin of a hydrochloride as monotherapy
Often (≥1/100 and & lt, 1/10): dizziness, disturbance of an ejaculation
Infrequently (≥1/1,000 and & lt, 1/100): cardiopalmus, constipation, diarrhea, vomiting, asthenia, rhinitis, rash, itching, urticaria, postural hypotension
Seldom (≥1/10,000 and & lt, 1/1,000): loss of consciousness, Quincke's disease
Very seldom (& lt, 1/10,000): the priapism,
Stephens-Johnson Postmarketingovye's syndrome of a research
the Intraoperative syndrome of an atonichny iris (IFIS, a type of a syndrome of a small pupil) was observed at operations for a cataract at some patients receiving α1-адреноблокаторы including a tamsulozin a hydrochloride.
Cases of development of fibrillation of auricles, arrhythmias, tachycardias and asthmas against the background of reception of a tamsulozin were revealed. Frequency of side reactions and connection with reception of a tamsulozin is not established.
Contraindications
- the known hypersensitivity to a tamsulozin, a dutasterid, other inhibitors 5 an alpha of reductase or to any other ingredient of drug
- the woman
- children and teenagers up to 18 years
- heavy degree of a liver failure
- attacks of orthostatic hypotension in the anamnesis
- the planned operation for a cataract
Medicinal interactions
was not conducted researches on studying intermedicinal interaction for a combination of a dutasterid from a tamsulozin by a hydrochloride. The data given below reflect information which is available about separate components.
Dutasterid
Dutasterid is metabolized by an isoenzyme of CYP3A4 of a fermental system of R-450 cytochrome. In the presence of CYP3A4 inhibitors of concentration of a dutasterid can increase in blood.
At simultaneous use of a dutasterid with CYP3A4 inhibitors verapamil and diltiazem note decrease in clearance of a dutasterid by 37% and 44% respectively. At the same time, amlodipin, other blocker of calcium channels, does not reduce clearance of a dutasterid.
Reduction of clearance of a dutasterid and the subsequent increase in its concentration in blood at simultaneous use of this drug and CYP3A4 inhibitors is not significant owing to the wide range of safety limits of this drug therefore there is no need to reduce its dose.
In vitro dutasterid is not metabolized by the following isoenzymes of a system of R-450 cytochrome of the person: CYP1A2, CY2A6, CYP2E1, CYP2S8, CYP2S9, CYP2S19, CYP2V6 and CYP2D6.
Dutasterid does not inhibit in vitro the enzymes of a system of R-450 cytochrome of the person participating in metabolism of medicines.
Dutasterid does not force out warfarin, atsenokomorol, fenprokomon, diazepam and Phenytoinum from sites of their linking with proteins of plasma, and these drugs, in turn, do not force out dutasterid.
Influence on pharmacokinetics and a pharmacodynamics combined use of a dutasterid in combination with tamsuloziny, terazoziny, warfarin, digoxin and holisteraminy was not observed any.
At use of a dutasterid along with hypolipidemic drugs, APF inhibitors, beta-blockers, blockers of calcium channels, corticosteroids, diuretics, non-steroidal anti-inflammatory drugs, phosphodiesterase inhibitors like V and hinolonovy antibiotics of any significant medicinal interactions it is not noted.
Tamsulozina a hydrochloride
Is available theoretical risk of strengthening of hypotensive effect at use of a tamsulozin of a hydrochloride together with the drugs capable to reduce arterial blood pressure, including anesthetics, α1-блокаторы and PDE5 inhibitors. It is not necessary to use the drug Duodart® in a combination with others α1-блокаторами.
Combined use of a tamsulozin and ketokonazol (strong CYP3A4 inhibitor) brings at increase in indicators of Cmax and AUC of a tamsulozin of a hydrochloride up to 2.2 and 2.8 respectively. Joint purpose of a tamsulozin and paroksetin (strong CYP2D6 inhibitor) brings at increase in indicators of Cmax and AUC of a tamsulozin of a hydrochloride up to 1.3 and 1.6 respectively. Combined use of CYP2D6 and CYP3A4 inhibitors with tamsuloziny was not studied, but at this combination the significant increase in exposure of a tamsulozin is supposed.
Simultaneous use of a tamsulozin of a hydrochloride (0.4 mg) and Cimetidinum (to 400 mg there are each six hours) within six days led to reduction of clearance (for 26%) and to increase in AUC of a tamsulozin of a hydrochloride (for 44%). It is required to be careful at combined use of the drug Duodart® and Cimetidinum.
Exhaustive researches of intermedicinal interaction between a tamsulozin a hydrochloride and warfarin were not conducted. It is necessary to be careful at simultaneous use of warfarin and a tamsulozin of a hydrochloride.
In three researches in which a tamsulozina the hydrochloride (0.4 mg within seven days, then 0.8 mg during the next seven days) was accepted together with atenolol, enalapril or nifedipine within three months the interaction was not revealed, therefore, there is no need for dose adjustment when using these drugs together with the drug Duodart®.
Simultaneous use of a tamsulozin of a hydrochloride (0.4 mg/day within two days, then 0.8 mg/day within 5 – 8 days) and single intravenous administration of theophylline (5 mg/kg) did not lead to change of pharmacokinetics of theophylline, therefore, correction of a dose is not required.
Simultaneous use of a tamsulozin of a hydrochloride (0.8 mg/day) and a single intravenous dose of furosemide (20 mg) led from 11 to 12% of Cmax to decrease and AUC of a tamsulozin of a hydrochloride, however, is expected that these changes are clinically insignificant and dose adjustment will not be required.
The combined use of a dutasterid and tamsulozin of a hydrochloride
In two 4 years' clinical trials the frequency of development of heart failure (the composite term of the celebrated events, generally heart failure and stagnant heart failure) was higher at the patients receiving a combination of a dutasterid and α1-блокатора, mainly, a tamsulozina of a hydrochloride than at the patients who were not receiving the combined treatment. In two 4 years' clinical trials the frequency of development of heart failure remained low (≤ 1%) and varied between researches. But in general divergences of indicators of frequency of side effects from a cardiovascular system were not noted. Causal relationships between treatment dutasteridy (one or in a combination with α1-блокатором) and heart failure were not established.
The special
instructions Dutasterid it is absorbed through skin therefore women and children have to avoid contact with the damaged capsules. In case of contact with the damaged capsules it is necessary to wash the respective site of skin with water with soap at once.
Combined use of a tamsulozin and strong CYP3A4 inhibitors (ketokonazol), CYP2D6 (paroksetin) and also their weaker inhibitors leads to increase in exposure of a tamsulozin. Thus, use of a tamsulozin in a combination with strong CYP3A4 inhibitors is not recommended, the combination of CYP2D6 inhibitors and a tamsulozina has to be appointed with care.
As elimination half-life of a dutasterid makes 3-5 weeks and is metabolized mainly in a liver, the drug Duodart® should be used with care at patients with presence of diseases of a liver.
Combination therapy tamsuloziny a hydrochloride and development of heart failure
In two 4 years' clinical trials the frequency of development of heart failure (the composite term of the celebrated events, generally heart failure and stagnant heart failure) was higher at the patients receiving a combination of a dutasterid and α1-блокатора, mainly, a tamsulozina of a hydrochloride than at the patients who were not receiving the combined treatment. In two 4 years' clinical trials the frequency of development of heart failure remained low (≤ 1%) and varied between researches. But in general divergences of indicators of frequency of side effects from a cardiovascular system were not noted. Causal relationships between treatment dutasteridy (one or in a combination with α1-блокатором) and heart failure were not established.
Influence on identification of the prostates specific antigens (PSA) and
a prostate cancer
At patients with DGPZh it is necessary to conduct a manual rectal research and other methods of a research of a prostate prior to the Duodart® drug treatment and to periodically repeat these researches in the course of treatment for an exception of development of a prostate cancer.
Definition of concentration of the DOG in serum is an important component of process of the screening directed to detection of a prostate cancer.
After 6-month therapy dutasterid reduces the PSA serumal levels at patients with a benign hyperplasia of a prostate approximately by 50%.
To the patients taking the drug Duodart® the new basic level of the DOG after 6 months of therapy has to be defined.
Any stable increase in the DOG level concerning the smallest value at the Duodart® drug treatment can demonstrate development of a prostate cancer (in particular, a prostate cancer with high degree of a differentiation on Gleason's scale) or non-compliance with the mode of therapy by the drug Duodart® and has to be exposed to careful assessment even if these DOG levels remain within normal values with the patients who are not accepting inhibitors 5α-reduktazy.
Level of the general DOG returns to a reference value within 6 months after cancellation of a dutasterid.
The ratio of content of a free DOG to the general remains to constants even against the background of therapy dutasteridy. At expression of this ratio in shares for detection of a prostate cancer from the men receiving dutasterid the correction of this size is not required.
Risk of developing a breast cancer
In clinical trials during treatment of DGPZh 2 cases of development of a breast cancer in the patients applying dutasterid were revealed. The first case developed in 10 weeks after the beginning of therapy, the second – in 11 months, 1 case of a breast cancer at the patient from group of placebo was also revealed. The ratio between long-term reception of a dutasterid and risk of developing a breast cancer is unknown.
The prostate cancer
In clinical trial for 4 years at 1517 from more than 8000 men with preliminary negative takes of a biopsy and the level of DOG OF 2.5-10 ng/ml, was diagnosed a prostate cancer. Higher frequency of development of cancer in patients from group of a dutasterid (n=29, 0.9%) in comparison with the group receiving placebo was observed (n=19, 0.6%). It was not established interactions between reception of a dutasterid and degree of a prostate cancer. The men accepting dutasterid have to be examined regularly on risk of developing of a prostate cancer, including carrying out the DOG of the test.
Hypotonia
As well as at use of any α1-блокаторов, at use of a tamsulozin of a hydrochloride can arise the orthostatic hypotonia in rare instances leading to faints.
The patients beginning the Duodart® drug treatment have to be warned about need to sit down or lay down at the first symptoms of orthostatic hypotonia (dizziness) until dizziness does not pass.
In order to avoid development of symptomatic hypotonia it is necessary to be careful at joint appointment α1-блокаторов and PDE5 inhibitors as these drugs belong to group of vasodilators and can lead to lowering of blood pressure.
The Floppi-iris-sindrom
the Intraoperative syndrome of an atonichny iris (IFIS, a type of a syndrome of a small pupil) was observed at operations for a cataract at some patients receiving α1-блокаторы including a tamsulozin a hydrochloride. The syndrome of an atonichny iris can lead to increase in quantity of complications at operations.
At peredoperatsionny inspection the oftalmokhirurga should be specified whether the patient accepts a combination of a dulasterid from a tamsulozin a hydrochloride for a possibility of a preparation for surgery, and acceptance of adequate measures at emergence of an atony of an iris intraoperatsionno.
Cancellation of a tamsulozin of a hydrochloride in 1 – 2 weeks prior to operation for a cataract is considered favorable, but the advantage and a span of drug withdrawal before operation for a cataract are not established.
The abnormal liver function
is not present data on use of the drug Duodart® for patients with abnormal liver functions Now. As dutasterid is exposed to intensive metabolism, and its elimination half-life makes 3 – 5 weeks, it is necessary to be careful at the Duodart® drug treatment of patients with abnormal liver functions.
Pregnancy and the period of a lactation
the Drug Duodart® is contraindicated for use for women.
There are no data on discharge of a dutasterid or tamsulozin with breast milk.
Use of a dutasterid was not studied at women since preclinical data assume that suppression of the DGT level in circulation can break forming of external genitalias at male fruits if mother during pregnancy received dutasterid.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
was not conducted the researches studying influence on driving of the car and work with mechanisms.
It is necessary to inform patients on possibility of the symptoms connected with orthostatic hypotension such as dizziness. It is necessary to be careful at control of vehicles or potentially dangerous mechanisms.
Overdose
there Are no overdoses given relatively at reception of a combination of a dutasterid from a tamsulozin a hydrochloride. The data given below reflect information which is available about separate components.
Dutasterid
Simptomy: at use of a dutasterid in a dose up to 40 mg/day (is 80 times higher than a therapeutic dose) within 7 days of the undesirable phenomena it was not noted. In clinical trials when assigning 5 mg a day within 6 months of side reactions besides listed for a therapeutic dose (0.5 mg a day) it was not noted.
Treatment: there is no specific antidote of a dutasterid therefore at suspicion on overdose it is enough to carry out the symptomatic and supporting treatment.
Tamsulozina
Simptomy's hydrochloride: at overdose of a tamsulozin a hydrochloride development of acute hypotension is possible.
Treatment: symptomatic therapy. Arterial blood pressure can be redeemed at acceptance by the person of horizontal situation. In the absence of effect it is possible to apply the means increasing the volume of the circulating blood and if it is necessary, vasoconstrictors. It is necessary to control function of kidneys. It is improbable that dialysis will be effective as a tamsulozina the hydrochloride is connected with proteins of plasma for 94 – 99%.
The form of release and packing
On 30, 90 capsules place in the bottle from polyethylene of high density of white color corked by the screwing-up cover with plastic laying, with control of the first opening and the device against opening of a bottle by children. The bottle is supplied with a membrane from aluminum foil.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
Storage conditions
At a temperature not above 30 °C.
To store out of children's reach!
2 years
not to use a period of storage after an expiration date.
Prescription status
According to the prescription
the Owner of the registration certificate
of GlaxoSmithKline GmbH & Co. KG, Germany
(Theresienhohe 11, 80339, Munchen)
Catalent Germany Schorndorf GmbH Producer, Germany
(Steinbeisstrasse 2, Schorndorf, D-73614)
the Packer
of Catalent Germany Schorndorf GmbH, Germany
(Steinbeisstrasse 2, Schorndorf, D-73614)
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Predstavitelstvo GlaksoSmitKlyayn Export Ltd in Kazakhstane050059, Almaty, Furmanov St., 273 Phone number: +7 727 258 28 92, +7 727 259 09 96 Fax number: + 7 727 258 28 90 E-mail address:
To Develop kaz.med@gsk.com
of Duodart® medicine
the Trade name
of Duodart®
the International unlicensed name
Is not present
the Dosage form
of the Structure Structure Capsule of a soft gelatin capsule
active agent - dutasterid 0.5 mg,
excipients: mono - and diglycerides of caprylic/capric acid, butyl hydroxytoluene (E 321),
structure of a cover of the capsule: gelatin, glycerin, the titan dioxide (E171), gland (III) oxide yellow (E172),
Structure of pellets from a tamsulozin a hydrochloride
a pellet Kernel
active agent - a tamsulozina a hydrochloride of 0.4 mg,
excipients: microcrystalline cellulose, copolymer of methacrylic acid – etakrilat (1:1) 30 of % dispersion, talc, triethyl citrate,
a pellet Cover:
Copolymer of methacrylic acid – etakrilat (1:1) 30 of % dispersion, talc, triethyl citrate,
the Solid capsule from a gipromelloza
the Carrageenan (E407), potassium chloride, the titan dioxide (E 171), gland (III) oxide red (E 172), dye yellow (E110), water cleaned, gipromelloza-2910, wax of karnaubskiya, starch corn,
Structure
Shellac, propylene glycol, gland (II, III) blackened black (SW-9010 or SW-9008) oxide black (E172), potassium hydroxide.
The description
Oblong solid capsules from a gipromelloza 00 of No. in size, with the brown body and an orange lid on which black ink put the GS 7CZ code.
Contents of capsules: one oblong the opaque soft gelatin capsule of opaque yellow color containing dutasterid, and pellets from white till almost white color, supporting a tamsulozin a hydrochloride.
Pharmacotherapeutic group
Drugs for treatment of a benign hypertrophy of a prostate. Alpha adrenoblockers. Tamsulozin and Dutasterid.
The ATX G04CA52 code
the Pharmacological
Pharmacokinetics Absorption Later properties of reception of one dose of a dutasterid of 0.5 mg the maximum concentration of drug in serum is reached during 1-3 h.
The absolute bioavailability is about 60% in relation to 2-hour intravenous infusion. The bioavailability of a dutasterid does not depend on meal.
Tamsulozina a hydrochloride is well soaked up in intestines and nearly 100% have bioavailability. Tamsulozina a hydrochloride is characterized by linear kinetics, both at single, and at the repeated mode of dosing. At the single mode of dosing the equilibrium concentration of a tamsulozin of a hydrochloride is reached by 5th day. Absorption of a tamsulozin of a hydrochloride slows down after meal. Identical level of absorption can be reached in case the patient accepts a tamsulozin a hydrochloride daily, in 30 minutes after the same meal.
Distribution
Pharmacokinetic data of single and repeated receptions of a dutasterid testifies to the large volume of its distribution (from 300 to 500 l). Dutasterid possesses high extent of linking with proteins of plasma (& gt, 99.5%).
At daily reception the concentration of a dutasterid in serum reaches 65% of stationary level in 1 month and about 90% of this level in 3 months. Stationary concentration of a dutasterid in serum (Css) equal to about 40 ng/ml are reached in 6 months of daily reception of 0.5 mg of this drug. In sperm, as well as in serum, stationary concentration of a dutasterid are reached in 6 months too. In 52 weeks of treatment of concentration of a dutasterid in sperm averaged 3.4 ng/ml (from 0.4 to 14 ng/ml). From serum about 11.5% of a dutasterid get to sperm.
Tamsulozina a hydrochloride mostly contacts proteins of blood plasma (from 94% to 99%), mainly with alfa-1 an acid glycoprotein with a wide range of concentration (from 20 to 600 ng/ml). The visible average equilibrium volume of distribution at 10 healthy adult men at intravenous appointment was
16 l.
Metabolism
of In vitro dutasterid is metabolized by CYP-3A4 enzyme of a system of R-450 cytochrome to two small monohydroxylated metabolites, at the same time it is not affected by enzymes of this CYP1A2, CY2A6, CYP2E1, CYP2S8, CYP2S9, CYP2S19, CYP2V6 and CYP2D6 system.
After achievement of stationary concentration of a dutasterid in serum by means of a mass and spectrometer method find invariable dutasterid, 3 main metabolites (4’ hydroksidutasterid, 1.2 - digidrodutasterid and 6 – hydroksidutasterid) and 2 small metabolites (6.4 '-digidroksidutasterid and 15-hydroksidutasterid).
Tamsulozina a hydrochloride is mainly metabolized in a liver by means of enzymes of a system of P450 cytochrome, and less than 10% of a dose are excreted by kidneys in an invariable look. The pharmacokinetic profile of metabolites at the person was not studied, but results of in vitro show that CYP3A4 and CYP2D6 are involved in metabolism of a tamsulozin, just as, thus, the accompanying use of the drugs inhibiting metabolism of these enzymes can lead other CYP isotypes to increase in level of a tamsulozin. Metabolites of a tamsulozin of a hydrochloride are exposed to conjugation with glucuronides or sulfates before excretion by kidneys.
Linearity/nonlinearity
Pharmacokinetics of a dutasterid can be described as process of absorption of the first order and two parallel processes of elimination, one saturated (i.e. depending on concentration) and one – not saturable
(i.e. not depending on concentration). At low concentration in serum (less than 3 ng/ml) dutasterid it is quickly removed by means of both processes of elimination. After single dose dutasterid it eliminirutsya quickly from an organism and has the short elimination half-life equal to 3 - 9 days.
At concentration in serum higher than 3 ng/ml the clearance of a dutasterid happens more slowly (0.35 - 0.58 l/h), mainly by means of linear not saturable process of elimination to final elimination half-life of 3 - 5 weeks. At therapeutic concentration, against the background of daily administration of drug of Duodart®, slower clearance of a dutasterid prevails, the general clearance carries the linear and not depending on concentration character.
Removal
Dutasterid is exposed to intensive metabolism. After single dose in drug before achievement of steady state at the person from 1.0 to 15.4% (on average 5.4%) the accepted dose it is excreted through intestines in not changed look. The rest of a dose is excreted in the form of 4 main metabolites, components of 39, 21, 7 and 7% respectively, and 6 small metabolites (less than 5% fall to the share of each of which).
Through kidneys at the person trace quantities of not changed dutasterid (less than 0.1% of a dose) are excreted.
At reception of therapeutic doses of a dutasterid its final elimination half-life makes 3 – 5 weeks.
Dutasterid is found in serum (in concentration higher than 0.1 ng/ml) up to 4 – 6 months after the termination of its reception.
Tamsulozin the hydrochloride and its metabolites are mainly removed by kidneys, at the same time about 10% of drug are allocated in an invariable view with urine. Elimination half-life of a tamsulozin of a hydrochloride makes 5 – 7 hours.
Elderly men
studied Pharmacokinetics and a pharmacodynamics at 36 healthy men aged from 24 up to 87 years after reception of one dose (5 mg) of a dutasterid. Between different age groups there were no significant distinctions in such pharmacokinetic parameters of a dutasterid as AUC (the area under a pharmacokinetic curve) and Cmax (maximum concentration). Also significant differences in elimination half-life of a dutasterid between an age group of 50 - 69 years and an age group were not revealed 70 years which includes most of men with the benign hyperplasia of a prostate (BHP) are more senior.
Between age groups there were no significant differences in extent of decrease in the DGT levels. These results show lack of need to reduce a dose of a dutasterid at elderly patients.
Indicators of AUC and elimination half-life of a tamsulozin can be extended at elderly patients in comparison with young healthy men. The clearance in general does not depend on binding of a tamsulozin with alfa-1 an acid glycoprotein, but decreases with age, leading to increase in AUC approximately for 40% at patients of 55-75 years in comparison with patients of 20-32 years.
A renal failure
Influence of a renal failure on pharmacokinetics of a dutasterid was not studied, but as less than 0.1% of a dutasterid are found in urine after administration of drug in a dose of 0.5 mg, patients have no need for dose adjustment of a dutasterid with a renal failure.
Influence of a tamsulazin was studied at patients with easy and average degree of a renal failure - such patients have no need for dose adjustment of a tamsulozin. There are no data on use of a tamsulozin for patients with an end-stage of renal pathology.
A liver failure
Influence of a dutasterid on patients with a liver failure was not studied, however owing to his mainly hepatic metabolism, increase in exposure of a dutasterid at such patients is expected.
Dose adjustment of a tamsulozin is not required from patients with average degree of a liver failure. There are no data on use of a tamsulozin for patients with heavy degree of pathology of a liver.
A pharmacodynamics
of Duodart® - the combined drug of a dutasterid and tamsulozin with the complementary mechanism of action.
Dutasterid – dual inhibitor of 5a-reductase. It suppresses activity of isoenzymes of 5a-reductase of the 1st and 2nd types which are responsible for transformation of testosterone into 5a-dihydrotestosterone. Dihydrotestosterone (DGT) is the main androgen responsible for a hyperplasia of ferruterous fabric of a prostate. Dutasterid reduces the DGT level, reduces the prostate sizes, reduces disease symptoms, leads to urination improvement, reduction of risk of emergence of a sharp ischuria and the need for surgical treatment.
Influence on concentration of dihydrotestosterone (DGT) and testosterone
the Maximum influence of a dutasterid on decrease in concentration of DGT is dose-dependent and is observed in 1 – 2 weeks after an initiation of treatment. In 1 – 2 weeks of reception of a dutasterid in a dose of 0.5 mg a day the median values of concentration of DGT in serum decrease by
85 – 90% respectively.
At patients with the benign hyperplasia of a prostate (BHP) at reception of a dutasterid in a dose of 0.5 mg a day the average rates of decrease in the DGT level were 94% within the first year and 93% - within the second year of therapy, average values of testosterone in serum increased by 19% during first and second of treatment. This effect is caused by decrease in level 5 an alpha of reductase and does not lead to development of any known side reactions.
Tamsulozina a hydrochloride – a blocker postsynaptic α1a-адренорецепторов, being in smooth muscles of a prostate, a neck of a bladder and a prostatic part of an urethra. Blockade α1a-адренорецепторов leads to decrease in a tone of smooth muscles of a prostate, a neck of a bladder and a prostatic part of an urethra and improvement of outflow of urine. At the same time both obstructive symptoms, and the irritativny symptoms caused by the raised tone of smooth muscles and detruzorny hyperactivity at DGPZh decrease.
Indications
- treatment and prevention of progressing of a benign hyperplasia of a prostate (reduction of its sizes, reduction of symptoms of a disease, urination improvement, reduction of risk of emergence of a sharp ischuria and the need for surgical treatment)
the Route of administration and doses
Adult men (including elderly)
1 capsule (0.5 mg / 0.4 mg) inside, once a day, 30 minutes later after the same meal, washing down with water. Capsules should be accepted entirely, without opening and without chewing as the contact of contents of the capsule from a mucous oral cavity can cause the inflammatory phenomena from mucous.
Patients with renal failures
are not present data on use of the drug Duodart® for patients with renal failures Now. This cohort of patients has no need for dose adjustment.
Patients with abnormal liver functions
are not present data on use of the drug Duodart® for patients with abnormal liver functions Now.
To apply with care at patients with easy and average degree of a liver failure. The drug Duodart® is contraindicated to patients with heavy degree of a liver failure.
Side effects
the Undesirable phenomena caused by use of a tamsulozin of a hydrochloride in a combination with dutasteridy:
Very seldom (& lt, 1/10,000)
- impotence, decrease in a libido, disturbance of an ejaculation, a gynecomastia, morbidity of chest glands, dizziness
of Disorder of the sexual sphere are connected with use of a component of a dutasterid and can remain after therapy cancellation.
The undesirable phenomena caused by use of a dutasterid as monotherapy
Seldom (≥1/10,000 and & lt, 1/1,000)
- an alopecia (mainly a hair loss on a body), a hypertrichosis
Very seldom (& lt, 1/10,000)
- a depression
- pain and hypostasis in the field of testicles
the Undesirable phenomena caused by use of a tamsulozin of a hydrochloride as monotherapy
Often (≥1/100 and & lt, 1/10): dizziness, disturbance of an ejaculation
Infrequently (≥1/1,000 and & lt, 1/100): cardiopalmus, constipation, diarrhea, vomiting, asthenia, rhinitis, rash, itching, urticaria, postural hypotension
Seldom (≥1/10,000 and & lt, 1/1,000): loss of consciousness, Quincke's disease
Very seldom (& lt, 1/10,000): the priapism,
Stephens-Johnson Postmarketingovye's syndrome of a research
the Intraoperative syndrome of an atonichny iris (IFIS, a type of a syndrome of a small pupil) was observed at operations for a cataract at some patients receiving α1-адреноблокаторы including a tamsulozin a hydrochloride.
Cases of development of fibrillation of auricles, arrhythmias, tachycardias and asthmas against the background of reception of a tamsulozin were revealed. Frequency of side reactions and connection with reception of a tamsulozin is not established.
Contraindications
- the known hypersensitivity to a tamsulozin, a dutasterid, other inhibitors 5 an alpha of reductase or to any other ingredient of drug
- the woman
- children and teenagers up to 18 years
- heavy degree of a liver failure
- attacks of orthostatic hypotension in the anamnesis
- the planned operation for a cataract
Medicinal interactions
was not conducted researches on studying intermedicinal interaction for a combination of a dutasterid from a tamsulozin by a hydrochloride. The data given below reflect information which is available about separate components.
Dutasterid
Dutasterid is metabolized by an isoenzyme of CYP3A4 of a fermental system of R-450 cytochrome. In the presence of CYP3A4 inhibitors of concentration of a dutasterid can increase in blood.
At simultaneous use of a dutasterid with CYP3A4 inhibitors verapamil and diltiazem note decrease in clearance of a dutasterid by 37% and 44% respectively. At the same time, amlodipin, other blocker of calcium channels, does not reduce clearance of a dutasterid.
Reduction of clearance of a dutasterid and the subsequent increase in its concentration in blood at simultaneous use of this drug and CYP3A4 inhibitors is not significant owing to the wide range of safety limits of this drug therefore there is no need to reduce its dose.
In vitro dutasterid is not metabolized by the following isoenzymes of a system of R-450 cytochrome of the person: CYP1A2, CY2A6, CYP2E1, CYP2S8, CYP2S9, CYP2S19, CYP2V6 and CYP2D6.
Dutasterid does not inhibit in vitro the enzymes of a system of R-450 cytochrome of the person participating in metabolism of medicines.
Dutasterid does not force out warfarin, atsenokomorol, fenprokomon, diazepam and Phenytoinum from sites of their linking with proteins of plasma, and these drugs, in turn, do not force out dutasterid.
Influence on pharmacokinetics and a pharmacodynamics combined use of a dutasterid in combination with tamsuloziny, terazoziny, warfarin, digoxin and holisteraminy was not observed any.
At use of a dutasterid along with hypolipidemic drugs, APF inhibitors, beta-blockers, blockers of calcium channels, corticosteroids, diuretics, non-steroidal anti-inflammatory drugs, phosphodiesterase inhibitors like V and hinolonovy antibiotics of any significant medicinal interactions it is not noted.
Tamsulozina a hydrochloride
Is available theoretical risk of strengthening of hypotensive effect at use of a tamsulozin of a hydrochloride together with the drugs capable to reduce arterial blood pressure, including anesthetics, α1-блокаторы and PDE5 inhibitors. It is not necessary to use the drug Duodart® in a combination with others α1-блокаторами.
Combined use of a tamsulozin and ketokonazol (strong CYP3A4 inhibitor) brings at increase in indicators of Cmax and AUC of a tamsulozin of a hydrochloride up to 2.2 and 2.8 respectively. Joint purpose of a tamsulozin and paroksetin (strong CYP2D6 inhibitor) brings at increase in indicators of Cmax and AUC of a tamsulozin of a hydrochloride up to 1.3 and 1.6 respectively. Combined use of CYP2D6 and CYP3A4 inhibitors with tamsuloziny was not studied, but at this combination the significant increase in exposure of a tamsulozin is supposed.
Simultaneous use of a tamsulozin of a hydrochloride (0.4 mg) and Cimetidinum (to 400 mg there are each six hours) within six days led to reduction of clearance (for 26%) and to increase in AUC of a tamsulozin of a hydrochloride (for 44%). It is required to be careful at combined use of the drug Duodart® and Cimetidinum.
Exhaustive researches of intermedicinal interaction between a tamsulozin a hydrochloride and warfarin were not conducted. It is necessary to be careful at simultaneous use of warfarin and a tamsulozin of a hydrochloride.
In three researches in which a tamsulozina the hydrochloride (0.4 mg within seven days, then 0.8 mg during the next seven days) was accepted together with atenolol, enalapril or nifedipine within three months the interaction was not revealed, therefore, there is no need for dose adjustment when using these drugs together with the drug Duodart®.
Simultaneous use of a tamsulozin of a hydrochloride (0.4 mg/day within two days, then 0.8 mg/day within 5 – 8 days) and single intravenous administration of theophylline (5 mg/kg) did not lead to change of pharmacokinetics of theophylline, therefore, correction of a dose is not required.
Simultaneous use of a tamsulozin of a hydrochloride (0.8 mg/day) and a single intravenous dose of furosemide (20 mg) led from 11 to 12% of Cmax to decrease and AUC of a tamsulozin of a hydrochloride, however, is expected that these changes are clinically insignificant and dose adjustment will not be required.
The combined use of a dutasterid and tamsulozin of a hydrochloride
In two 4 years' clinical trials the frequency of development of heart failure (the composite term of the celebrated events, generally heart failure and stagnant heart failure) was higher at the patients receiving a combination of a dutasterid and α1-блокатора, mainly, a tamsulozina of a hydrochloride than at the patients who were not receiving the combined treatment. In two 4 years' clinical trials the frequency of development of heart failure remained low (≤ 1%) and varied between researches. But in general divergences of indicators of frequency of side effects from a cardiovascular system were not noted. Causal relationships between treatment dutasteridy (one or in a combination with α1-блокатором) and heart failure were not established.
The special
instructions Dutasterid it is absorbed through skin therefore women and children have to avoid contact with the damaged capsules. In case of contact with the damaged capsules it is necessary to wash the respective site of skin with water with soap at once.
Combined use of a tamsulozin and strong CYP3A4 inhibitors (ketokonazol), CYP2D6 (paroksetin) and also their weaker inhibitors leads to increase in exposure of a tamsulozin. Thus, use of a tamsulozin in a combination with strong CYP3A4 inhibitors is not recommended, the combination of CYP2D6 inhibitors and a tamsulozina has to be appointed with care.
As elimination half-life of a dutasterid makes 3-5 weeks and is metabolized mainly in a liver, the drug Duodart® should be used with care at patients with presence of diseases of a liver.
Combination therapy tamsuloziny a hydrochloride and development of heart failure
In two 4 years' clinical trials the frequency of development of heart failure (the composite term of the celebrated events, generally heart failure and stagnant heart failure) was higher at the patients receiving a combination of a dutasterid and α1-блокатора, mainly, a tamsulozina of a hydrochloride than at the patients who were not receiving the combined treatment. In two 4 years' clinical trials the frequency of development of heart failure remained low (≤ 1%) and varied between researches. But in general divergences of indicators of frequency of side effects from a cardiovascular system were not noted. Causal relationships between treatment dutasteridy (one or in a combination with α1-блокатором) and heart failure were not established.
Influence on identification of the prostates specific antigens (PSA) and
a prostate cancer
At patients with DGPZh it is necessary to conduct a manual rectal research and other methods of a research of a prostate prior to the Duodart® drug treatment and to periodically repeat these researches in the course of treatment for an exception of development of a prostate cancer.
Definition of concentration of the DOG in serum is an important component of process of the screening directed to detection of a prostate cancer.
After 6-month therapy dutasterid reduces the PSA serumal levels at patients with a benign hyperplasia of a prostate approximately by 50%.
To the patients taking the drug Duodart® the new basic level of the DOG after 6 months of therapy has to be defined.
Any stable increase in the DOG level concerning the smallest value at the Duodart® drug treatment can demonstrate development of a prostate cancer (in particular, a prostate cancer with high degree of a differentiation on Gleason's scale) or non-compliance with the mode of therapy by the drug Duodart® and has to be exposed to careful assessment even if these DOG levels remain within normal values with the patients who are not accepting inhibitors 5α-reduktazy.
Level of the general DOG returns to a reference value within 6 months after cancellation of a dutasterid.
The ratio of content of a free DOG to the general remains to constants even against the background of therapy dutasteridy. At expression of this ratio in shares for detection of a prostate cancer from the men receiving dutasterid the correction of this size is not required.
Risk of developing a breast cancer
In clinical trials during treatment of DGPZh 2 cases of development of a breast cancer in the patients applying dutasterid were revealed. The first case developed in 10 weeks after the beginning of therapy, the second – in 11 months, 1 case of a breast cancer at the patient from group of placebo was also revealed. The ratio between long-term reception of a dutasterid and risk of developing a breast cancer is unknown.
The prostate cancer
In clinical trial for 4 years at 1517 from more than 8000 men with preliminary negative takes of a biopsy and the level of DOG OF 2.5-10 ng/ml, was diagnosed a prostate cancer. Higher frequency of development of cancer in patients from group of a dutasterid (n=29, 0.9%) in comparison with the group receiving placebo was observed (n=19, 0.6%). It was not established interactions between reception of a dutasterid and degree of a prostate cancer. The men accepting dutasterid have to be examined regularly on risk of developing of a prostate cancer, including carrying out the DOG of the test.
Hypotonia
As well as at use of any α1-блокаторов, at use of a tamsulozin of a hydrochloride can arise the orthostatic hypotonia in rare instances leading to faints.
The patients beginning the Duodart® drug treatment have to be warned about need to sit down or lay down at the first symptoms of orthostatic hypotonia (dizziness) until dizziness does not pass.
In order to avoid development of symptomatic hypotonia it is necessary to be careful at joint appointment α1-блокаторов and PDE5 inhibitors as these drugs belong to group of vasodilators and can lead to lowering of blood pressure.
The Floppi-iris-sindrom
the Intraoperative syndrome of an atonichny iris (IFIS, a type of a syndrome of a small pupil) was observed at operations for a cataract at some patients receiving α1-блокаторы including a tamsulozin a hydrochloride. The syndrome of an atonichny iris can lead to increase in quantity of complications at operations.
At peredoperatsionny inspection the oftalmokhirurga should be specified whether the patient accepts a combination of a dulasterid from a tamsulozin a hydrochloride for a possibility of a preparation for surgery, and acceptance of adequate measures at emergence of an atony of an iris intraoperatsionno.
Cancellation of a tamsulozin of a hydrochloride in 1 – 2 weeks prior to operation for a cataract is considered favorable, but the advantage and a span of drug withdrawal before operation for a cataract are not established.
The abnormal liver function
is not present data on use of the drug Duodart® for patients with abnormal liver functions Now. As dutasterid is exposed to intensive metabolism, and its elimination half-life makes 3 – 5 weeks, it is necessary to be careful at the Duodart® drug treatment of patients with abnormal liver functions.
Pregnancy and the period of a lactation
the Drug Duodart® is contraindicated for use for women.
There are no data on discharge of a dutasterid or tamsulozin with breast milk.
Use of a dutasterid was not studied at women since preclinical data assume that suppression of the DGT level in circulation can break forming of external genitalias at male fruits if mother during pregnancy received dutasterid.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
was not conducted the researches studying influence on driving of the car and work with mechanisms.
It is necessary to inform patients on possibility of the symptoms connected with orthostatic hypotension such as dizziness. It is necessary to be careful at control of vehicles or potentially dangerous mechanisms.
Overdose
there Are no overdoses given relatively at reception of a combination of a dutasterid from a tamsulozin a hydrochloride. The data given below reflect information which is available about separate components.
Dutasterid
Simptomy: at use of a dutasterid in a dose up to 40 mg/day (is 80 times higher than a therapeutic dose) within 7 days of the undesirable phenomena it was not noted. In clinical trials when assigning 5 mg a day within 6 months of side reactions besides listed for a therapeutic dose (0.5 mg a day) it was not noted.
Treatment: there is no specific antidote of a dutasterid therefore at suspicion on overdose it is enough to carry out the symptomatic and supporting treatment.
Tamsulozina
Simptomy's hydrochloride: at overdose of a tamsulozin a hydrochloride development of acute hypotension is possible.
Treatment: symptomatic therapy. Arterial blood pressure can be redeemed at acceptance by the person of horizontal situation. In the absence of effect it is possible to apply the means increasing the volume of the circulating blood and if it is necessary, vasoconstrictors. It is necessary to control function of kidneys. It is improbable that dialysis will be effective as a tamsulozina the hydrochloride is connected with proteins of plasma for 94 – 99%.
The form of release and packing
On 30, 90 capsules place in the bottle from polyethylene of high density of white color corked by the screwing-up cover with plastic laying, with control of the first opening and the device against opening of a bottle by children. The bottle is supplied with a membrane from aluminum foil.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
Storage conditions
At a temperature not above 30 °C.
To store out of children's reach!
2 years
not to use a period of storage after an expiration date.
Prescription status
According to the prescription
the Owner of the registration certificate
of GlaxoSmithKline GmbH & Co. KG, Germany
(Theresienhohe 11, 80339, Munchen)
Catalent Germany Schorndorf GmbH Producer, Germany
(Steinbeisstrasse 2, Schorndorf, D-73614)
the Packer
of Catalent Germany Schorndorf GmbH, Germany
(Steinbeisstrasse 2, Schorndorf, D-73614)
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Predstavitelstvo GlaksoSmitKlyayn Export Ltd in Kazakhstane050059, Almaty, Furmanov St., 273 Phone number: +7 727 258 28 92, +7 727 259 09 96 Fax number: + 7 727 258 28 90 E-mail address:
To Develop kaz.med@gsk.com
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