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DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE is a brand name for Dutasteride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. For information on effects of treatment and patient populations studied in clinical trials please see section 5.1. 2
Verbatim from this product's MHRA label. Tap a section to expand.
4mg) once daily. Where appropriate, Dutasteride/Tamsulosin Hydrochloride may be used to substitute concomitant dutasteride and tamsulosin hydrochloride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to Dutasteride/Tamsulosin Hydrochloride may be considered.
Renal impairment The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. 2). 2). 3). 3). Method of administration For oral use. Patients should be instructed to swallow the capsules whole, approximately 30 minutes after the same meal each day.
The capsules should not be chewed or opened. Contact with the contents of the dutasteride capsule contained within the hard-shell capsule may result in irritation of the oropharyngeal mucosa.
4mg once daily for four years as co-administration or as monotherapy. 2). Information on the adverse event profiles of the individual components (dutasteride and tamsulosin) is also provided. Note that not all the adverse events reported with the individual components have been reported with dutasteride and tamsulosin and these are included for information for the prescriber.
Data from the 4 year CombAT study have shown that the incidence of any investigator-judged drug- related adverse event during the first, second, third and fourth years of treatment respectively was 22%, 6%, 4% and 2% for dutasteride + tamsulosin co-administration therapy, 15%, 6%, 3% and 2% for dutasteride monotherapy and 13%, 5%, 2% and 2% for tamsulosin monotherapy.
The higher incidence of adverse events in the co-administration therapy group in the first year of treatment was due to a higher incidence of reproductive disorders, specifically ejaculation disorders, observed in this group. The investigator-judged drug-related adverse events have been reported with an incidence of greater than or equal to 1% during the first year of treatment in the CombAT Study, BPH monotherapy 8 clinical studies and REDUCE study are shown in the table below.
In addition the undesirable effects for tamsulosin below are based on information available in the public domain. The frequencies of adverse events may increase when the combination therapy is used.
The frequency of adverse reactions identified from clinical trials:
Common; ≥1/100 to <1/10, Uncommon; ≥1/1000 to <1/100, Rare; ≥1/10,000 to <1/1000, Very rare; <1/10,000. Within each SOC grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Adverse Reaction Dutasteride + Tamsulosina Dutasteride Tamsulosinc Syncope - - Rare Dizziness Common - Common Nervous System Disorders Headache - - Uncommon Cardiac Failure (Composite term1) Uncommon Uncommond - Cardiac Disorders Palpitations - - Uncommon Vascular Disorders Orthostatic Hypotension - - Uncommon Respiratory, Thoracic and Mediastinal Disorders Rhinitis - - Uncommon Constipation - - Uncommon Diarrhoea - - Uncommon Nausea - - Uncommon Gastrointestinal Disorders Vomiting - - Uncommon Angioedema - - Rare Stevens-Johnson Syndrome - - Very Rare Urticaria - - Uncommon Rash - - Uncommon Skin and Subcutaneous Disorders Pruritus - - Uncommon Priapism - - Very Rare Impotence3 Common Commonb - Altered (decreased) libido3 Common Commonb - Ejaculation disorders3 ^ Common Commonb Common Reproductive System and Breast Disorders Breast Disorders2 Common Commonb - General Disorders and Administration Site Disorders Asthenia - - Uncommon a.
3 Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies.
5 to 10 ng/ml and a negative prostate biopsy 6 months before study enrolment) compared to placebo. 6%). The relationship between dutasteride and Gleason 8 - 10 prostate cancers is not clear. 1). Prostate specific antigen (PSA) Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer.
Dutasteride/Tamsulosin Hydrochloride causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving Dutasteride/Tamsulosin Hydrochloride should have a new PSA baseline established after 6 months of treatment with Dutasteride/Tamsulosin Hydrochloride.
It is recommended to monitor PSA values regularly thereafter. 1). In the interpretation of a PSA value for a patient taking dutasteride, previous PSA values should be sought for comparison. Treatment with Dutasteride/Tamsulosin Hydrochloride does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established.
Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Dutasteride/Tamsulosin Hydrochloride. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Dutasteride/Tamsulosin Hydrochloride therapy, no adjustment to its value appears necessary.
Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Dutasteride/Tamsulosin Hydrochloride and periodically thereafter.
6). 1. • patients with a history of orthostatic hypotension. • patients with severe hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dutasteride in United Kingdom.
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Dutasteride + tamsulosin: from CombAT study - the frequencies of these adverse events decrease over time of treatment, from year 1 to year 4. b. Dutasteride: from BPH monotherapy clinical studies. c. Tamsulosin: from EU Core Safety Profile for tamsulosin.
d. 1). 1. Cardiac failure composite term comprised of cardiac failure congestive, cardiac failure, left ventricular failure, cardiac failure acute, cardiogenic shock, left ventricular failure acute, right ventricular failure, right ventricular failure acute, ventricular failure, cardiopulmonary failure, congestive cardiomyopathy.
2. Includes breast tenderness and breast enlargement. 3. These sexual adverse events are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse events may persist after treatment discontinuation.
The role of dutasteride in this persistence is not known. ^. Includes semen volume decreased. 1). Whether the effect of dutasteride to reduce prostate volume, or study related factors, impacted the results of this study has not been established.
4). Post marketing Data Adverse events from world-wide post-marketing experience are identified from spontaneous post- marketing reports; therefore the true incidence is not known.
Dutasteride Immune system disorders Not known:
Allergic reactions, including rash, pruritus, urticaria, localised oedema, and angioedema.
Psychiatric disorders Not known:
Depression Skin and subcutaneous tissue disorders Uncommon: Alopecia (primarily body hair loss), hypertrichosis. 4). In addition atrial fibrillation, arrhythmia, tachycardia, dyspnoea, epistaxis, vision blurred, visual impairment, erythema multiforme, dermatitis exfoliative, ejaculation disorder, retrograde ejaculation, ejaculation failure and dry mouth have been reported in association with tamsulosin use.
The frequency of events and the role of tamsulosin in their causation cannot be reliably determined. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at […]
Cardiovascular adverse events In two 4-year clinical studies, the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure and congestive cardiac failure) was marginally higher among subjects taking the combination of dutasteride and an alpha1- adrenoceptor antagonist, primarily tamsulosin, than it was among subjects not taking the combination.
1). Breast neoplasia There have been rare reports of male breast cancer reported in men taking dutasteride in 4 clinical trials and during the post-marketing period. 1). Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge.
Mood alteration and depression Mood alteration including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with another oral 5-alpha reductase inhibitor. Patients should be advised to seek medical advice if any of these symptoms occur.
Renal impairment The treatment of patients with severe renal impairment (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied.
Hypotension Orthostatic:
As with other alpha1- adrenoceptor antagonists, a reduction in blood pressure can occur during treatment with tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Dutasteride/Tamsulosin Hydrochloride should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved.
In order to minimise the potential for developing postural hypotension the patient should be haemodynamically stable on an alpha1- adrenoceptor antagonist prior to initiating use of PDE5 inhibitors. g. sildenafil, tadalafil, vardenafil).
Alpha1- adrenoceptor antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. 5). Intraoperative Floppy Iris Syndrome Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin.
IFIS may increase the risk of eye complications during and after the operation. The initiation of therapy with Dutasteride/Tamsulosin Hydrochloride in patients for whom cataract surgery is scheduled is therefore not recommended. During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether […]