Urology

Duodart Dutasteride - tamsulosin hydrochloride. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule for oral use contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride. PHARMACEUTICAL PACKAGING Capsules: hard, oblong capsules with a brown body and orange cap with the initials GS 7CZ or GS TEV printed in black ink. Indications: Duodart treats and prevents the progression of benign prostatic hyperplasia (BPH, benign prostatic hyperplasia English) by the relief of symptoms, reducing the prostate size (volume), improved urinary flow rate and reducing the risk of acute urinary retention and the need for BPH -related surgery. 

Dosage and Administration: adult males (including elderly). The recommended dose Duodart through a capsule (0.5 mg / 0.4 mg) orally administered about 30 minutes after the same meal each day. Warnings and Precautions: If contact with capsules is presented spills, wash the exposed area with water and soap immediately. Tamsulosin hydrochloride should be used with caution in patients taking a moderate CYP3A4 inhibitor in combination with strong inhibitors both as moderate inhibitors of CYP2D6, or in patients known as poor metabolizers of CYP2D6. Not studied the effect of the presence of hepatic impairment on the pharmacokinetics of dutasteride, however; caution should be exercised when administering Duodart patients with liver disease. 

Combination therapy with tamsulosin and heart failure: The relative risk estimate for time to first cardiac failure event was 3.57 [95% CI 1.17, 10.8] for combination treatment compared to AVODART® monotherapy and 1.36 [95% CI 0.61, 3.07] compared to tamsulosin monotherapy. Effects on prostate-specific antigen (prostate specific antigen)  and the detection of prostate cáncer: In the REDUCE study, patients with a prior negative biopsy for prostate cancer and baseline PSA between 2.5 ng/mL and 10.0 ng/mL, AVODART® treatment caused a decrease in mean serum PSA by approximately 50% after six months of treatment with a large variability (standard deviation of 30%) among patients. 

The PSA suppression observed at six months was similar in men who did or who did not develop biopsy-detectable prostate cancer during the study. Prostate cancer and high-grade tumors : No causal relationship between dutasteride and high grade prostate cancer. Men taking DUODART® should be regularly evaluated for prostate cancer risk including PSA testing. Hypotension: Orthostatic hypotension may occur in patients treated with tamsulosin, caution is advised when alpha adrenergic blocking agents including tamsulosin co- administered with PDE5 inhibitors. Adverse Reactions: 

Co-administration of Dutasteride and Tamsulosin: The following have been reported adverse events related to the drug, according to the researcher (with greater or equal to 1 % cumulative incidence): erectile dysfunction, alteration (decrease) in libido, disorders ejaculation, breast disorders, dizziness. Dutasteride monotherapy: In addition to adverse events reported from clinical trial data, post- marketing adverse reactions : Very rare: allergic reactions including rash, pruritus, urticaria, localized edema and angioedema, depressed mood, testicular pain, testicular swelling. 

Rare: alopecia, hypertrichosis. Monotherapy with tamsulosin: GSK does not have the database up any product with tamsulosin as a single ingredient, so adverse reactions and frequency categories that are listed below are supported on information available to the public : Common (≥ 1/100 to <1/ 10): dizziness, abnormal ejaculation. Common  (≥ 1/1000 to <1/ 100): palpitations, constipation, diarrhea, vomiting, asthenia, rhinitis, rash, pruritus, urticaria, hypotension, postural orthostatic. Rare (≥ 1/10, 000 to <1/ 1000): syncope and angioedema. Very rare(< 1/10, 000) including isolated reports priapism, Stevens -Johnson syndrome. Contraindications: Duodart is contraindicated in patients with known hypersensitivity to dutasteride, other inhibitors of 5 alpha reductase, to tamsulosin hydrochloride or any component of the preparation. Using Duodart is contraindicated in women and children.GDS15/IPI12 JM, TTLast review: September 11th 2018.