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DUTASTERIDE 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.
Verbatim from this product's MHRA label. Tap a section to expand.
1). 5 mg) taken orally once a day. The capsules should be swallowed whole and not chewed or opened as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. The capsules may be taken with or without food.
Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the elderly. Renal impairment The effect of renal impairment on dutasteride pharmacokinetics has not been studied.
2). 2). 3).
The adverse reactions frequency is defined using the following conventions: very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Dutasteride as Monotherapy Approximately 19% of the 2167 patients who received dutasteride in the 2 year Phase III placebo-controlled trials developed adverse reactions during the first year of treatment. The majority of events were mild to moderate and occurred in the reproductive system.
No change to the adverse event profile was apparent over a further 2 years in open-label extension studies. The following table shows adverse reactions from controlled clinical trials and post- marketing experience. The listed adverse events from clinical trials are investigator- judged drug-related events (with incidence more than or equal to 1%) reported with a higher incidence in patients treated with dutasteride compared with placebo during the first year of treatment.
3% Incidence estimated from post-marketing data Immune system disorders Allergic reactions including rash, pruritus, urticaria, localised oedema, and angioedema Not known Psychiatric disorders Depressed mood Not known Skin and subcutaneous tissue disorders Alopecia (primarily body hair loss), hypertrichosis Uncommon Reproductive system and breast disorders Testicular pain and swelling Not known * 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 unknown. 4mg (n=1611) once daily alone and in combination (n=1610) 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 combination therapy, 15%, 6%, 3% and 2% for dutasteride monotherapy and 13%, 5%, 2% and 2% for tamsulosin monotherapy.
2). Cardiac failure 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 higher among subjects taking the combination of dutasteride and an alpha blocker, primarily tamsulosin, than it was among subjects not taking the combination.
1). Effects on prostate specific antigen (PSA) and prostate cancer detection Digital rectal examination, as well as other evaluations for prostate cancer, must be performed on patients prior to initiating therapy with dutasteride and periodically thereafter.
Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer. Dutasteride causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving dutasteride should have a new PSA baseline established after 6 months of treatment.
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. 1). 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. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing dutasteride therapy, no adjustment to its value appears necessary.
Prostate cancer and high grade tumours Results of one clinical study (the REDUCE study) in men at increased risk of prostate cancer revealed a higher incidence of Gleason 8-10 prostate cancers in dutasteride treated men compared to placebo.
The relationship between dutasteride and high grade prostate cancer is not clear. 1). 6). If contact is made with leaking capsules, the contact area should be washed immediately with soap and water. Hepatic impairment Dutasteride was not studied in patients with liver disease.
1. 6). - patients with severe hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The higher incidence of adverse events in the combination therapy group in the first year of treatment was due to a higher incidence of reproductive disorders, specifically ejaculation disorders, observed in this group. 2% 0% a. 4 mg once daily.
b. 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.
c. 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 unknown.
d. Includes breast tenderness and breast enlargement. ^ 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). 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. uk/yellowcard.
2). 1) and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of dutasteride.