Duodart medicine 0.5mg/0.4mg GSK Treatment of benign prostatic hypertrophy (30 tablets)
Dosage form Box of 30 tablets
Specifications Dutasteride, tamsulosin
Ingredient Catalent
Ingredient
| Composition information | Content |
| Dutasteride | 0.5mg |
| Tamsulosin | 0.4mg |
Uses
Indications
Duodart drugs are indicated in the following cases:
Pharmacokological energy
duodart is a combination of two drugs with a supplementary mechanism to improve symptoms in BPH patients: Dutasteride, a dual inhibitor 5 α-Reductase (5 Ari) and Tamsulosin Hydrochloride, a receptor resistant alpha1a-adrenergic.
There is no expected difference in Duodart's pharmacological force, a fixed dosage combination compared to Dutasteride and Tamsulosin Hydrochloride, combined with separate drugs.
dutasteride
dutasteride is a dual inhibitor of 5 alpha-Reductase. Dutasteride inhibits isoenzyme 5 alpha-Reductase for both type 1 and type 2 are enzymes responsible for converting testosterone into 5 alpha-dihydrotestosterone (DHT). DHT is Androgen that plays the main role in the increase in prostate tissue.
dutasteride reduces the DHT level, reduces the prostate volume, improves the symptoms of lower urinary tract and the flow of urine and reduces the risk of urinary and surgery related to BPH.
When daily dutasteride use, the maximum effect reduces DHT depends on the dose and is observed for 1-2 weeks of taking the drug. After 1 week and 2 weeks of using dutasteride at a dose of 0.5 mg per day, the median of DHT concentration in serum decreases about 85% and 90%.
Patients with dutasteride daily 0.5 mg, the decrease of DHT is 94% at 1 year and 93% at 2 years, the gain of serum testosterone is 19% at both 1 and 2 years. This is a predicted consequence of the 5 alpha-Reductase inhibitor effect and does not cause any unwanted effects.
tamsulosin
tamsulosin inhibits receptor α1 adrenergic in the smooth prostate and bladder muscle. Approximately 75% of the receptor α1 in the prostate is the type α1a.
tamsulosin increases the maximum urine flow by reducing prostate and urethra smooth muscle tension, thus reducing blockage. Tamsulosin also improves complexes of stimulating symptoms and obstruction in which the unstable bladder's instability and the smooth muscle tension of the lower urinary tract plays an important role. Alpha-1 adrenergic blockers can lower blood pressure by reducing peripheral resistance.
pharmacokinetics
biological equivalent is proven between dutasteride - tamsulosin and simultaneous use of dutasteride and tamsulosin capsules.
Single -dose equivalent research is conducted in both hunger and full states. Observed a 30% cmax reduction for Tamsulosin component in a combination of dutasteride - tamsulosin in a state of hunger compared to the state of hunger. Food does not affect the AUC of Tamsulosin.
dutasteride
absorption:
dutasteride soft gelatin capsules are used orally with solution. After taking the single dose of 0.5 mg, the peak concentration of the dutasteride serum is achieved within 1 to 3 hours.
Absolute bioavailability in humans is about 60% compared to 2 hours of intravenous infusion. Dutasteride's bioavailability is not affected by food.
Distribution:
Dynamic data after single dose and reminders show that Dutasteride has a large distribution (300 to 500 l). Dutasteride is highly linked to plasma proteins (> 99.5%).
After daily dosage, dutasteride concentration in serum reaches 65% stable concentration after 1 month and about 90% after 3 months. Stable concentration in serum (CSS) is about 40 nanogram/ml achieved after 6 months of taking the drug at a dose of 0.5 mg once a day. Similar to serum, the dutasteride concentration in semen achieves a stable state after 6 months. After 52 weeks of treatment, the average dutasteride concentration in semen is 3.4 nanogram/ml (between 0.4 to 14 Nanogram/ml). Dutasteride from dispersed serum into semen average is 11.5%.
Biological Change:
On In vitro, Dutasteride is metabolized by the isoenzyme CYP3A4 of Cytochrome P450 in humans into 2 auxiliary metabolites in the form of monohydroxylate, but is not metabolized by CYP1A2, CYP2E6, CYP2E1, CYP2C8, CYP2C9, CYP2C19, CYP2B6 or CYP2D6 or CYP2D6.
In human serum, after the doses to achieve a stable state, evaluated by the method of spectrum detected Dutasteride in the form of unchanged, 3 main metabolites (4’-hydroxydutasteride, 1.2-dihydrodutasteride and 6-hydroxidedasteride) and 2 auxiliary substances (6.4’-dihydroxydutasteride and 15-Hydroxydutasteride). 5 metabolites of dutasteride in human serum are also detected in rat serum, but it is still not known for the stereoscopic chemistry of the hydroxyl group mounted at 6 and 15 positions in the metabolites in humans and rats.
Era:
dutasteride is widely metabolized. After taking Dutasteride 0.5 mg/day to achieve a stable state in humans, 1.0% to 15.4% (average 5.4%) The oral dose is excreted in the feces as Dutasteride. The rest of the dose is excreted in the feces in the form of 4 main metabolites with a ratio of 39%, 21%, 7% and 7% for each substance related to drugs and 6 auxiliary metabolites (less than 5% per substance).
Only a very small dutasteride (less than 0.1% of the dose) is found in urine.
With the treatment concentration, the last duration of dutasteride is 3 to 5 weeks.
still detects dutasteride concentration (larger than 0.1 nanogram/ml) up to 4-6 months after stopping treatment.
With low concentrations in serum (less than 3 nanograms/ml), Dutasteride is quickly eliminated by both concentration and concentration depends on concentration. Single doses of 5 mg or lower show that evidence of rapid excretion and short selling time from 3 to 9 days.
In serum concentration, greater than 3 nanograms/ml, Dutasteride is eliminated slowly (0.35 to 0.58 l/h) mainly by linear elimination, unsaturated with the last 3 to 5 weeks of sale. At treatment concentration, after using the dose repeats 0.5 mg/day, slower clearance is dominant and the whole body clearance is linear and does not depend on concentration.
tamsulosin
absorption:
tamsulosin hydrochloride is absorbed from the intestine and has almost complete bioavailability.
tamsulosin hydrochloride shows linear dynamics after single and multi -dose use, tamsulosin reaches a stable concentration on the 5th day when taking a dose once a day. The absorption speed of Tamsulosin Hydrochloride is reduced by new food. It is possible to achieve regular absorption by giving the patient tamsulosin hydrochloride about 30 minutes after a meal every day.
Distribution:
The average appointed distribution volume in the stable state of Tamsulosin Hydrochloride after using venous tract for 10 healthy adult men is 16L, this number suggests distribution in extracellular fluids in the body.
tamsulosin hydrochloride binds with a lot of plasma proteins (94% to 99%), mainly with Alpha-1 Glycoprotein (AAG), with linear connection in a wide range of concentrations (20 to 600 nanograms/ml).
Biological Change:
There is no biological transformation from Tamsulosin Hydrochloride [isomer R (-)] into isomorphic s (+) in humans. Tamsulosin Hydrochloride is widely metabolized by enzymes of Cytochrom P450 in the liver and less than 10% of the dose is excreted into urine in a constant form. However, pharmacokinetic properties of metabolites in humans have not been set up. In vitro results show that CYP3A4 and CYP2D6 are related to the metabolism of Tamsulosin as well as the small participation of other CYP isoenzymes. The inhibition of liver metabolic enzymes in the liver can lead to an increase in exposure to tamsulosin (see warning and interaction). The metabolites of Tamsulosin Hydrochloride undergo a widespread combination with glucuronide or sulfate before excretion through the kidney.
Era:
Tamsulosin's excreted sale time is 5 to 7 hours. Approximately 10% is excreted in the form of unchanged urine.
Elderly
dutasteride:
Dutasteride'spharmacokinetics and pharmacodynamics have been assessed over 36 healthy men aged 24 to 87 using a single -dose of 5 mg dutasteride. Exposure to dutasteride, expressed by AUC and CMAX values, is not different of statistical significance when comparing age groups. There is no statistically significant difference in the sale time in the group of 50 to 69 years older than the group of people over 70 years old, which is the common age of BPH. There is no observation that the difference in the effectiveness of the drug is measured by a decrease in DHT among age groups. The results showed no need to adjust the dutasteride dose by age.
tamsulosin:
Crossed research compares fully exposed exposure (AUC) and the sale time of Tamsulosin Hydrochloride shows that the pharmacokinetic tendency of Tamsulosin Hydrochloride can last a bit in elderly men compared to young, healthy men. Ergation is independent of Tamsulosin Hydrochloride associated with AAG, but decreases with age, causing the body exposure (AUC) to be 40% higher than the age group 55 to 75 compared to the age group 20 to 32 years old.
kidney failure
dutasteride:
The effect of kidney failure on dutasteride pharmacokinetics has not been studied. However, less than 0.1% of 0.5 mg dutasteride oral dose has been detected in a stable state in human urine, so there is no need to adjust the dose in patients with renal failure.
tamsulosin:
The pharmacy of Tamsulosin Hydrochloride is compared to 6 subjects of mild - medium renal failure (30 ≤ Clcr 90ml/min/1.73m2). While observing the change in the total plasma concentration of Tamsulosin Hydrochloride as a result of the cohesion with AAG was changed, the concentration of Tamsulosin Hydrochloride is not linked (active), as well as in fact, still relatively constant. Therefore, there is no need to adjust the dose of Tamsulosin hydrochloride capsule for patients with renal failure. However, there is no study in patients with end -stage renal failure (CLCRliver failure
dutasteride:
No effect of liver failure on dynamic pharmacokinetics of dutasteride (see the warning section). Because dutasteride is widely metabolized, exposed can be higher in patients with liver failure.
tamsulosin:
The pharmacokinetics of Tamsulosin Hydrochloride have been compared to 8 subjects of average liver failure (classification of Child - Pugh: level A and B) and 8 normal objects. While observing the change of total plasma concentrations of Tamsulosin Hydrochloride as a result of the cohesion with the AAG, the concentration of Tamsulosin Hydrochloride is not linked (active) negligible with moderate change (32%) of the actual clearance of Tamsulosin Hydrochloride. Therefore, there is no need to adjust the dose of Tamsulosin hydrochloride for patients with average liver failure. Tamsulosin Hydrochloride has not been studied in patients with severe liver failure.Before taking Duodart medicine 0.5mg/0.4mg GSK Treatment of benign prostatic hypertrophy (30 tablets)
How to use
Oral drugs.
Dosage
Adult men (including the elderly):
Duodart's recommended dose is a capsule (0.5mg/0.4mg) orally about 30 minutes after a meal every day. Should swallow the capsule, should not chew or open the cyst. Exposure to the substance contained in the dutasteride capsule in the hard shell can cause oral mucosa irritation.kidney failure:
Effects of kidney failure on pharmacokinetics of dutasteride-tamsulosin have not been studied. However, data is no need to adjust the dose in patients with renal failure.
Hepatic failure:
The effect of liver failure on pharmacokinetics of dutasteride-tamsulosin has not been studied. Contraindicated to use Duodart medicine for patients with severe liver failure.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? The following items reflect the information available for separate ingredients.
dutasteride
In volunteer studies, dosastide doses up to 40 mg/day (80 times the dose of treatment) for 7 days is not significant about safety. In clinical studies, when the patient is used by 5 mg daily for 6 months, there is no more unwanted effect other than unwanted effects that have been encountered at 0.5 mg treatment.
Because there is no specific antidote for dutasteride, in case of an overdose suspected, symptomatic treatment should be conducted and use appropriate support measures.
tamsulosin
In the case of acute hypotension occurs after the overdose of Tamsulosin Hydrochloride, cardiovascular support. The recovery of blood pressure and normalization of the heart rate can be achieved by letting the patient lie down. If this is not effective enough, use substances that increase the volume and if necessary, use vasoconstrictor medication and kidney function should be monitored and supported if necessary. Data from the laboratory shows that Tamsulosin Hydrochloride binds 94% to 99% to plasma proteins; Therefore, the separation does not seem useful in eliminating tamsulosin from the body.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Duodart medicine, you may experience unwanted effects (ADR).
dutasteride
Very rare ADR
Rare, ADR
tamsulosin
Popular (≥ 1/100,
Not popular (≥ 1/1000, Brush the chest drum, constipation, diarrhea, vomiting, weakness, rhinitis, rash, itching, urticaria, posture hypotension.
Rare (≥ 1/10000, fainting, angiography.
Experience after circulation: In addition, atrial fibrillation, arrhythmia, tachycardia, shortness of breath, nosebleeds, blurred vision, visional reduction, polymorphic erythema, scales and dry mouth have been reported related to the use of tamsulosin.
Instructions on how to handle ADR
When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Duodart drugs contraindicated in the following cases:
Precautions when using
Prostate cancer:
In a 4 -year study over 8,000 men aged 50 to 75, with the results of prostate cancer biopsy negative before and the initial PSA value in the range of 2.5NG/mL and 10.0NG/mL (Reduce research), 1,517 men were diagnosed with prostate cancer. The new incidence of prostate cancer has Gleason 8 - 10 in the group using Avodart (n = 29, 0.9%) higher than the placebo group (n = 19, 0.6%).
Do not increase the new incidence of prostate cancer with GLASON 5 - 6 or 7 - 10. It is not established a cause and effect relationship between Avodart and high -level prostate cancer. The clinical significance of this arithmetic difference is unclear. Men using Duodart should be evaluated regularly about the risk of prostate cancer including PSA test.
In an additional 2 -year monitoring study in the initial patients from the prevention of Avodart (Reduce), a new low rate of new prostate cancer was diagnosed in the Dutasteride group (N = 14, 1.2%) and the placebo group (N = 7, 0.7%), in which no new cases were identified with GLASON 8 - 10.
PSA-Prostate Specific Antigen:
Duodart reduces the average PSA in serum by about 50% after 6 months of treatment.
Patients using Duodart should reach a new basic PSA value, established after 6 months of treatment with Duodart. Recommendations to regularly monitor PSA values afterwards. Any PSA increase is confirmed from the lowest PSA level while using Duodart may be a sign of prostate cancer or of non-compliance with Duodart and should be carefully evaluated, even when these values are still within normal limits for men who do not use 5-kara. To evaluate PSA value in patients using Duodart, it is advisable to find previous PSA values to compare.
Serum PSA levels return to basic value within 6 months after stopping treatment.
The ratio between free PSA and total PSA is still constant even under the impact of Duodart. If clinical doctors want to use free PSA percentage as supportive measures to detect prostate cancer in men who are using Duodart therapy, this value does not need to be adjusted.
Should rectal examination with fingers as well as other reviews to detect prostate cancer in patients BPH (Benign Prostatic Hyperplasia: Prostate hypertrophy) before using Duodart and then should be checked periodically.
Cardiovascular adverse events:
In two 4 -year clinical studies, the new incidence of heart failure (a combination term of reported events, mainly includes heart failure and congestive heart failure) in patients using Duodart combination and an alpha blocker, mainly tamsulosin, higher than those who do not use coordinated therapy. In these two tests, the new incidence of heart failure is low (≤1%) and difference between studies. There is no observation of an imbalance in the new incidence of adverse cardiovascular events in general in both tests. No cause of causal relationship between Duodart (single therapy or in combination with an alpha blocker) and heart failure.
Breast cancer:
Rarely reports on breast cancer in men in patients using Duodart in clinical trials and during the stage after circulation. However, epidemiological studies have shown that there is no increase in the risk of developing breast cancer in men with the use of 5-kara. Doctors need to guide their patients to promptly report any changes in their mammary tissue such as tumors or nipples secretion.
Hypotension:
As well as other alpha-1 adrenergic blockers, vertical hypotension may occur in patients treated with tamsulosin, in some rare cases that can cause fainting.
Patients who start treatment with Duodart should be careful to sit or lie down when there are the first signs of hypotension (dizziness and dizziness) until the symptoms are out of symptoms.
Should be cautious when using alpha adrenergic blockers, including Tamsulosin with PDE5 inhibitors. Alpha adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Simultaneous use of these two groups of drugs has the potential to cause symptoms of hypotension.
Soft iris syndrome during surgery (Intraoperative Floppy Iris Syndrome - IFIS):
Observed soft iris syndrome during surgery (ifis, a variant of small pupils) during cataract surgery in some patients treated with Alpha-1 adrenergic blockers, including Tamsulosin. Ifis can lead to an increased risk of eye complications during and after surgery.
In the process of evaluating the surgery, the cataract surgeon and the medical eye team should consider whether the patient can schedule a cataract surgery schedule or have been treated with Duodart or not to ensure that there are appropriate measures to treat ifi if this occurs during surgery.
Leak capsules:
dutasteride is absorbed through the skin, so women and children should avoid contact with leaked capsules. If contact with capsules leaked, wash the skin immediately with soap and water.
CYP3A4 and CYP2D6 inhibitors:
Because Tamsulosin may be exposed to exposure, it is not recommended to coordinate Tamsulosin Hydrochloride for patients who are using strong CYP3A4 inhibitors (such as ketoconazole) and should be used carefully in patients who are using medium CYP3A4 inhibitors (eg erythromycin), strong or medium or medical inhibitors. Combining both CYP3A4 and CYP2D6 inhibitors, or in patients known as poor metabolism CYP2D6.
Hepatic failure:
The effect of liver failure on dutastide pharmacokinetics has not been studied. Because dutasteride is widely metabolized and has a half -life of 3 to 5 weeks, cautious when using Dutasteride for patients with liver disease.
The ability to drive and operate machinery
There has been no study to assess the effect of Duodart on the ability to perform jobs that require judgment, motor skills or cognitive skills. However, it is advisable to notify the patient about the possibility of symptoms related to hypotension such as dizziness when using duodart.
Pregnancy
Contraindicated to use Duodart for women.
dutasteride
Do not conduct a Dutasteride research in women clinical data suggesting that the blockade of dihydrotestosterone levels can inhibit the development of an external genital organs in the son when the mother is exposed to Dutasteride.
tamsulosin
There is no evidence that tamsulosin hydrochloride for mice and female rabbits is pregnant at a higher dose than the treatment of harmful treatments.
Breastfeeding period
Do not know whether dutasteride or tamsulosin will excrete in breast milk.
Drug interaction
There is no study on drug interaction with Duodart. The following items reflect the information available for separate components.
dutasteride
In vitro metabolic studies show that dutasteride is metabolized by isoenzyme CYP3A4 of Cytochrome P450 in humans. Therefore, the dutasteride concentration in the blood may increase when the presence of CYP3A4 inhibitors.
The compounds have been tested for human interactions including Tamsulosin, Terazosin, Warfarin, Digoxin and Cholestyramine and do not observe the pharmacokinetic or pharmacoketic interactions of clinical significance.
Although the study has not been conducted specific interactions with other compounds, about 90% of the subjects in major phase III studies have taken Dutasteride simultaneously with other drugs. No observations of clinical significant adverse interactions in clinical trials when Dutasteride is simultaneously used with anti-lipid drugs, Angiotensin (ACE), Beta-adrenergic medications, calcium channel blockers, corticosteroids, diuretic drugs, non-steroid anti-inflammatory drugs (NSAIDs) Quinolone group.
tamsulosin
There is a risk in theory of increased hypotension effect when using Tamsulosin hydrochloride with drugs that can lower blood pressure, including anesthesia, PDE5 inhibitors and other alpha-1 adrenergic blockers. Duodart should not be used in combination with Alpha-1 Adrenergic blockers.
Simultaneously tamsulosin hydrochloride and ketoconazole, paroxetine will increase CMAX and AUC of Tamsulosin Hydrochloride. The influence of simultaneous use of both CYP3A4 and CYP2D6 inhibitors with Tamsulosin Hydrochloride has not been clinically evaluated, but has the ability to significantly increase exposure to Tamsulosin.
Simultaneously tamsulosin hydrochloride (0.4mg) and cimetidine (400mg every 6 hours in 6 days) reduces clearance (26%) and increases AUC (44%) of tamsulosin hydrochloride. Should be cautious when using duodart in combination with cimetidine.
There has been no research on drug interactions - drugs between Tamsulosin Hydrochloride and Warfarin. Results from limited studies on in vito and in vivo are not enough to conclude. Should be cautious when using Warfarin and tamsulosin hydrochloride.
There is no interaction when using Tamsulosin simultaneously with Atenolol, Enalapril or Nifedipine; Single dosage byophylline (5mg/kg); Single dose of intravenous furosemide (20mg); Therefore, there is no need to adjust the dose when using these drugs with Duodart.
Storage
Store no more than 30 ° C.
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