Duodart® [Tamsulosin, Dutasteride]
Catalent Germani Schorndorf GmbH
885 Items
2019-09-19
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Clinical Pharmacology
A drug for the treatment of benign prostatic hyperplasia. Alpha blockers.
After taking a single dose of dutasteride, the maximum concentration of the drug in serum is reached within 1-3 hours.
Absolute bioavailability is about 60% relative to a 2-hour intravenous infusion. Bioavailability of dutasteride does not depend on food intake.
Tamsulosin hydrochloride is well absorbed in the intestine and has almost 100% bioavailability. Tamsulosin hydrochloride is characterized by linear kinetics, both in single and multiple dosage regimens. With a single dosing regimen, the equilibrium concentration of tamsulosin hydrochloride is reached by the 5th day. The absorption of tamsulosin hydrochloride slows down after a meal. The same level of absorption can be achieved if the patient takes tamsulosin hydrochloride daily, 30 minutes after the same meal.
Indications
- treatment and prevention of progression of benign prostatic hyperplasia (reducing its size, reducing symptoms of the disease, improving urination, reducing the risk of acute urinary retention and the need for surgical treatment)
Composition
Dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg are contained in one capsule.
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Dosage and Administration
Tulosin is taken orally after eating. 400 mcg (1 capsule) per day. Capsules are taken after the first meal, drinking plenty of water. The capsule should not be crushed and chewed.
Adverse reactions
The most common side effects (1–10%) - dizziness, drowsiness or insomnia.
Rare (0.1–1%) - headache, reduced visual acuity, rhinitis, nausea, vomiting, diarrhea or constipation, retrograde ejaculation, asthenia, decreased libido, back pain.
Extremely rare (0.01–0.1%) - orthostatic hypotension, tachycardia, increased heartbeat, chest pain, fainting, hypersensitivity reactions (skin rash, itching, urticaria, angioedema).
Contraindications
Hypersensitivity to tamsulosin hydrochloride or any other component of the drug Tulosin.
Carefully: chronic renal failure (a decrease in Cl creatinine below 10 ml / min); arterial hypotension (including orthostatic); severe liver failure.
Drug interactions
The simultaneous use of cimetidine increases the level of tamsulosin in the blood plasma; Furosemide reduces its plasma levels. However, in both cases, these levels remain within therapeutically active levels, and the dosage should not be changed.
Diclofenac and indirect anticoagulants slightly increase the rate of elimination of tamsulosin.
The simultaneous use of tamsulosin with other α1-adrenergic blockers and other drugs that reduce blood pressure, can lead to a pronounced increase in the hypotensive effect.
No interaction was detected with simultaneous use of tamsulosin with atenolol, enalapril, nifedipine or theophylline.
Plasma tamsulosin concentration did not change in the presence of diazepam, trichloromethiazide, amitriptyline, diclofenac, glibenclamide, simvastatin or warfarin.
Tamsulosin also did not change the concentration of diazepam, propranolol, trichloromethiazide and chlormadinone.
Special instructions
Tamsulosin should be used with caution in patients with a predisposition to orthostatic hypotension, because, like in the case of taking other alpha1- blockers in some patients during the course of treatment can decrease blood pressure, which sometimes can lead to fainting. When the first signs of orthostatic hypotension (dizziness or weakness) appear, the patient should be seated or laid before the symptoms disappear.
Before starting drug therapy, the patient should be examined in order to exclude the presence of other diseases that can cause the same symptoms as BPH. Before treatment, and regularly during therapy, a digital rectal examination should be performed and, if required, a prostate-specific antigen (PSA) determination.
In patients with severe renal insufficiency (Cl creatinine less than 10 ml / min), the drug should be used with caution, because this group of patients has not been investigated.
Influence on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.
Overdosage
Symptoms: theoretically, the occurrence of acute hypotension.
Treatment: The patient should be placed in order to restore blood pressure and normalize heart rate. Cardiotropic therapy is performed. Renal function and general maintenance therapy should be monitored.
- Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial
- THE EFFECTS OF DUTASTERIDE OR TAMSULOSIN ALONE AND IN COMBINATION ON STORAGE AND VOIDING SYMPTOMS IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS) AND BENIGN PROSTATIC HYPERPLASIA (BPH): 4-YEAR DATA FROM THE COMBINATION OF AVODART AND TAMSULOSIN (CombAT) STUDY
- The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study
- Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study
- Simultaneous Determination of Tamsulosin and Dutasteride in Human Plasma by LC–MS–MS
- Corrigendum to: “The Influence of Baseline Parameters on Changes in IPSS with Dutasteride, Tamsulosin, and Combination Therapy: Two-Year Data from the Combination of Avodart® and Tamsulosin (CombAT) Study” [Eur Urol Suppl 2008;7:171 (Abstract no. 403)]
- The Influence of Baseline Parameters on Changes in International Prostate Symptom Score with Dutasteride, Tamsulosin, and Combination Therapy among Men with Symptomatic Benign Prostatic Hyperplasia and an Enlarged Prostate: 2-Year Data from the CombAT Study
- The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study
- Corrigendum to “The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study” [Eur Urol 2010;57:123–31]
- Effect of Dutasteride on Prostate Biopsy Rates and the Diagnosis of Prostate Cancer in Men with Lower Urinary Tract Symptoms and Enlarged Prostates in the Combination of Avodart and Tamsulosin Trial
- IPSS and Qmax responders with dutasteride plus tamsulosin: 4-year results from the CombAT study
- Effect of dutasteride on the detection of prostate cancer in men with benign prostatic hyperplasia in the Combination of Avodart and Tamsulosin (CombAT) trial
- Effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: Four-year results from the CombAT study
- The effects of dutasteride, tamsulosin, and the combination on storage and voiding symptoms in men with moderate-to-severe BPH: 4-year results from the CombAT study
- Comparison of the response to treatment between Asian and Caucasian men with benign prostatic hyperplasia: Long-term results from the combination of dutasteride and tamsulosin study
- Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart® and Tamsulosin) trial rationale and study design
- UP-03.24: The safety and efficacy evaluation of Tamsulosin and Dutasteride and combination therapy in patients with benign prostatic hypertrophy (BPH): a single-blind parallel, randomized, comparative, prospective, phase III trial
- POD-06.02: The effects of dutasteride, tamsulosin, and combination therapy on lower urinary tract symptoms and Qmax in men with BPH and prostatic enlargement: Two-year results from the Combination of Avodart® and Tamsulosin (CombAT) study
- MP-20.28: Dutasteride provides greater improvement in symptoms and Qmax than tamsulosin in men with moderate-to-severe symptoms of BPH and prostate enlargement: Two-year results from the Combination of Avodart® and Tamsulosin (CombAT) study
- MP-20.16: Safety and tolerability of dutasteride, tamsulosin and a combination of dutasteride and tamsulosin: Two-year results from the Combination of Avodart® and Tamsulosin (CombAT) study
- POD-10.11: Long-term Efficacy of Combination Therapy with the Dual 5-α Reductase Inhibitor Dutasteride and the α-Blocker Tamsulosin in the Treatment of Benign Prostatic Hyperplasia: 4-year Results from the Randomized, Double-blind, CombAT Trial
- MP-06.17: Efficacy and safety of dutasteride, tamsulosin and the combination in Asian men: 4-year results from the randomised, double-blind, CombAT trial
- Effect of Discontinuation of Tamsulosin in Korean Men with Benign Prostatic Hyperplasia Taking Tamsulosin and Dutasteride: An Open-Label, Prospective, Randomized Pilot Study
- Re: Clinical Outcomes After Combined Therapy With Dutasteride Plus Tamsulosin or Either Monotherapy in Men With Benign Prostatic Hyperplasia (BPH) by Baseline Characteristics: 4-Year Results From the Randomized, Double-Blind Combination of Avodart and Tamsulosin (CombAT) Trial
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