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Dutasteride And Tamsulosin Hydrochloride is a brand name for Dutasteride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Dutasteride and tamsulosin hydrochloride capsules are a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations…
Verbatim from this product's FDA label. Tap a section to expand.
4 mg tamsulosin hydrochloride) taken once daily approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Contact with the contents of the dutasteride and tamsulosin hydrochloride capsule may result in irritation of the oropharyngeal mucosa.
Take one capsule daily approximately 30 minutes after the same meal each day. ( 2 ) Swallow capsule whole. ( 2 )
6 ADVERSE REACTIONS The most common adverse reactions, reported in ≥1% of subjects treated with coadministered dutasteride and tamsulosin are ejaculation disorders, impotence, decreased libido, dizziness, and breast disorders. gov/medwatch.
1 Clinical Trials Experience The clinical efficacy and safety of coadministered dutasteride and tamsulosin, which are individual components of dutasteride and tamsulosin hydrochloride capsules, have been evaluated in a multicenter, randomized, double-blind, parallel group trial (the Combination with Alpha-Blocker Therapy, or CombAT, trial).
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The most common adverse reactions reported in subjects receiving coadministered dutasteride and tamsulosin were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness.
Ejaculation disorders occurred significantly more in subjects receiving coadministration therapy (11%) compared with those receiving dutasteride (2%) or tamsulosin (4%) as monotherapy. Trial withdrawal due to adverse reactions occurred in 6% of subjects receiving coadministered dutasteride and tamsulosin and in 4% of subjects receiving dutasteride or tamsulosin as monotherapy.
5%). 4 mg tamsulosin hydrochloride) administered once daily in a 4-year double-blind trial. Overall, 1,623 subjects received monotherapy with dutasteride; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received coadministration therapy.
The population was aged 49 to 88 years (mean age: 66 years) and 88% were white. Table 1 summarizes adverse reactions reported in at least 1% of subjects receiving coadministration therapy and at a higher incidence than subjects receiving either dutasteride or tamsulosin as monotherapy.
5 WARNINGS AND PRECAUTIONS Orthostatic hypotension and/or syncope can occur. Advise patients of symptoms related to postural hypotension and to avoid situations where injury could result if syncope occurs. 1 ) Do not use dutasteride and tamsulosin hydrochloride capsules with other alpha-adrenergic antagonists, as this may increase the risk of hypotension.
2 ) Dutasteride and tamsulosin hydrochloride capsules reduce serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride and tamsulosin hydrochloride capsules may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men.
, ketoconazole). , paroxetine) or moderate CYP2D6 inhibitors, a combination of both CYP3A4 and CYP2D6 inhibitors, or known poor metabolizers of CYP2D6. Concomitant use with known inhibitors can cause a marked increase in drug exposure.
3 ) Exercise caution with concomitant use of phosphodiesterase-5 (PDE-5) inhibitors, as this may increase the risk of hypotension. 2 ) Drugs that contain dutasteride, including dutasteride and tamsulosin hydrochloride capsules, may increase the risk of high-grade prostate cancer.
1 ) Prior to initiating treatment with dutasteride and tamsulosin hydrochloride capsules, consideration should be given to other urological conditions that may cause similar symptoms. 5 ) Females who are pregnant or may be pregnant should not handle dutasteride and tamsulosin hydrochloride capsules due to potential risk to a male fetus.
1 ) Advise patients about the possibility and seriousness of priapism. 7 ) Patients should not donate blood until 6 months after their last dose of dutasteride and tamsulosin hydrochloride capsules. 8 ) Intraoperative Floppy Iris Syndrome has been observed during cataract and glaucoma surgery after alpha-adrenergic antagonist exposure.
4 CONTRAINDICATIONS Dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in: Pregnancy. Dutasteride use is contraindicated in females who are pregnant. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia.
Therefore, dutasteride and tamsulosin hydrochloride capsules may cause fetal harm when administered to a pregnant female. 1 ) ] . 2 ) ] . Pregnancy. Dutasteride use is contraindicated in females who are pregnant. , serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any component of dutasteride and tamsulosin hydrochloride capsules.
( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Table 1. 4 mg once daily. b Includes anorgasmia, retrograde ejaculation, semen volume decreased, orgasmic sensation decreased, orgasm abnormal, ejaculation delayed, ejaculation disorder, ejaculation failure, and premature ejaculation.
c These sexual adverse reactions are associated with dutasteride treatment (including monotheraphy and combination with tamsulosin). These adverse reactions may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
d Includes erectile dysfunction and disturbance in sexual arousal. e Includes libido decreased, libido disorder, loss of libido, sexual dysfunction, and male sexual dysfunction. f Includes breast enlargement, gynecomastia, breast swelling, breast pain, breast tenderness, nipple pain, and nipple swelling.
6%). Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating dutasteride in men at risk for development of prostate cancer. 4% (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both trials had comorbidities associated with an increased risk of cardiac failure.
Therefore, the clinical significance of the numerical imbalances in cardiac failure is unknown. No causal relationship between dutasteride alone or coadministered with tamsulosin and cardiac failure has been established. No imbalance was observed in the incidence of overall cardiovascular adverse events in either trial.
Additional information regarding adverse reactions in placebo-controlled trials with dutasteride or tamsulosin monotherapy follows. 5 ng/mL to 10 ng/mL and a negative prostate biopsy within the previous 6 months. 5 mg daily doses of dutasteride (n = 4,105) for up to 4 years.
The mean age was 63 years and 91% were white. Subjects underwent protocol-mandated scheduled prostate biopsies at 2 and 4 years of treatment or had “for-cause biopsies” at non-scheduled times if clinically indicated. 4 ) ]. 1%). No clinical benefit has been demonstrated in patients with prostate cancer treated with dutasteride.
Reproductive and Breast Disorders In the 3 pivotal placebo-controlled BPH trials with dutasteride, each 4 years in duration, there was no evidence of increased sexual adverse reactions (impotence, decreased libido, and ejaculation disorder) or breast disorders with increased duration of treatment.
Among these 3 trials, there was 1 case of breast cancer in the dutasteride group and 1 case in the placebo group. No cases of breast cancer were reported in any treatment group in the 4-year CombAT trial or the 4-year REDUCE trial. The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.
4 mg tamsulosin hydrochloride and at an incidence higher than in subjects receiving placebo were: infection, asthenia, back pain, chest pain, somnolence, insomnia, rhinitis, pharyngitis, cough increased, sinusitis, and diarrhea. 4 mg tamsulosin hydrochloride versus 11% (54/493) of subjects receiving placebo.
1 ) ] . 2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of the individual components of dutasteride and tamsulosin hydrochloride capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to drug exposure.
Dutasteride Immune System Disorders:
Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema.
Neoplasms:
Male breast cancer.
Psychiatric Disorders:
Depressed mood.
Reproductive System and Breast Disorders :
Testicular pain and testicular swelling.
Tamsulosin Immune System Disorders:
Hypersensitivity reactions, including rash, urticaria, pruritus, angioedema, and respiratory problems have been reported with positive rechallenge in some cases.
Cardiac Disorders:
Palpitations, dyspnea, atrial fibrillation, arrhythmia, and tachycardia.
Skin Disorders:
Skin desquamation, including Stevens-Johnson syndrome, erythema multiforme, dermatitis exfoliative.
Gastrointestinal Disorders:
Constipation, vomiting, dry mouth.
Reproductive System and Breast Disorders:
Priapism.
Respiratory:
Epistaxis.
Vascular Disorders:
Hypotension.
Ophthalmologic Disorders:
Blurred vision, visual impairment. 9 ) ] . gov/medwatch.
Advise patients considering cataract or glaucoma surgery to tell their ophthalmologist that they take or have taken dutasteride and tamsulosin hydrochloride capsules. 9 ) Exercise caution with concomitant use of warfarin. 1 Orthostatic Hypotension As with other alpha-adrenergic antagonists, orthostatic hypotension (postural hypotension, dizziness, and vertigo) may occur in patients treated with tamsulosin-containing products, including dutasteride and tamsulosin hydrochloride capsules, and can result in syncope.
1 ) ] . 3 )]. 3 ) ] . 3 ) ] . Other Alpha-adrenergic Antagonists Tamsulosin-containing products, including dutasteride and tamsulosin hydrochloride capsules, should not be coadministered with other alpha-adrenergic antagonists because of the increased risk of symptomatic hypotension.
Phosphodiesterase-5 (PDE-5) Inhibitors Caution is advised when alpha-adrenergic-antagonist-containing products, including dutasteride and tamsulosin hydrochloride capsules, are coadministered with PDE-5 inhibitors. Alpha-adrenergic antagonists and PDE-5 inhibitors are both vasodilators that can lower blood pressure.
Concomitant use of these 2 drug classes can potentially cause symptomatic hypotension. 3 ) ] . 3 Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection Coadministration of dutasteride with tamsulosin resulted in similar changes to serum PSA as with dutasteride monotherapy.
In clinical trials, dutasteride reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. This decrease was predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals.
Dutasteride‑containing treatment, including dutasteride and tamsulosin hydrochloride capsules, may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men treated with a dutasteride-containing product, including dutasteride and tamsulosin hydrochloride capsules, a new baseline PSA should be established at least 3 months after starting treatment and PSA monitored periodically thereafter.
Any confirmed increase from the lowest PSA value while on a dutasteride-containing treatment, including dutasteride and tamsulosin hydrochloride capsules, may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5-alpha-reductase inhibitor.
Noncompliance with dutasteride and tamsulosin hydrochloride capsules may also affect PSA test results. To interpret an isolated PSA value in a man treated with dutasteride and tamsulosin hydrochloride capsules, for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men.
The free-to-total PSA ratio (percent free 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 receiving dutasteride and tamsulosin hydrochloride capsules, no adjustment to its value appears necessary.
1 ) ] . 1%). 5-alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5-alpha-reductase inhibitors to reduce prostate volume or trial‑related factors impacted the results of these trials has not been established.
5 Evaluation for Other Urological Diseases Prior to initiating treatment with dutasteride and tamsulosin hydrochloride capsules, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist.
6 Transdermal Exposure of Dutasteride and Tamsulosin Hydrochloride in Pregnant Females -Risk to Male Fetus Dutasteride and tamsulosin hydrochloride capsules should not be handled by females who are pregnant or may be pregnant. Dutasteride can be absorbed through the skin and could result in unintended fetal exposure and potential risk to a male fetus.
1 ) ] . 2 ) ] . 7 Priapism Priapism (persistent painful penile erection unrelated to sexual activity) has been associated (probably less than 1 in 50,000) with the use of alpha-adrenergic antagonists, including tamsulosin, which is a component of dutasteride and tamsulosin hydrochloride capsules.
Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition. 8 Blood Donation Men being treated with a dutasteride-containing product, including dutasteride and tamsulosin hydrochloride capsules, should not donate blood until at least 6 months have passed following their last dose.
The purpose of this deferred period is to prevent administration of dutasteride to a pregnant female transfusion recipient. 9 Intraoperative Floppy Iris Syndrome Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract and glaucoma surgery in some patients on or previously treated with alpha-adrenergic-antagonists, including tamsulosin, which is a component of dutasteride and tamsulosin hydrochloride capsules.
Most reports were in patients taking the alpha-adrenergic-antagonist when IFIS occurred, but in some cases, the alpha-adrenergic antagonist had been stopped prior to surgery. In most of these cases, the alpha-adrenergic antagonist had been stopped recently prior to surgery (2 to 14 days), but in a few cases, IFIS was reported after the patients had been off the alpha-adrenergic antagonist for a longer period (5 weeks to 9 months).
IFIS is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions.
The patient’s ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. IFIS may increase the risk of eye complications during and after the operation.
The benefit of stopping alpha-adrenergic antagonist therapy prior to cataract or glaucoma surgery has not been established. The initiation of therapy with tamsulosin in patients for whom cataract or glaucoma surgery is scheduled is not recommended.
10 Sulfa Allergy In patients with sulfa allergy, allergic reaction to tamsulosin has been rarely reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted when administering tamsulosin-containing products, including dutasteride and tamsulosin hydrochloride capsules.
5 mg/day on semen characteristics were evaluated in healthy men throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, compared with placebo, dutasteride treatment resulted in mean reduction in total sperm count, semen volume, and sperm motility; the effects on total sperm count were not reversible after 24 weeks of follow-up.
Sperm concentration and sperm morphology were unaffected and mean values for all semen parameters remained within the normal range at all timepoints. The clinical significance of the effect of dutasteride on semen characteristics for an individual patient’s fertility is not known.
3 ) ] . Tamsulosin The effects of tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated.