Lower urinary tract symptoms (LUTS), suggestive of prostate gland enlargement is a common condition prevalent in elderly men. It is not a life-threatening disorder but can interfere with daily activities. It also disrupts the health-related quality of life specific to urinary symptoms such as urinary frequency, urinary urgency, nocturia and sensation of incomplete bladder emptying.
Also, the number of benign prostate hyperplasia (BPH) patients are increasing in developed countries in accordance with the ageing of the population. The prevalence of BPH increases after the age of 40 years, with incidence rates of 8%-60% at age 90 years, as per the study published in Asian Journal of Urology.
Although the exact cause of BPH is not fully understood, smooth muscle tension in the prostate stroma, urethra and bladder neck are thought to be a significant component of LUTS secondary to BPH. The smooth muscle tension is regulated by specific receptors termed as alpha-1-adrenergic receptors. Therefore, alpha 1 adrenergic receptors were shown to have integral roles in the development of BPH.
Treatment options of BPH include lifestyle modifications, use of herbal preparations, prescription medications and surgical procedures in critical cases. Medical management of BPH is the first therapeutic option in patients with symptomatic BPH. The goal of medical management involves improvement of short term symptoms, reducing adverse effects of treatment, and preventing complications along with preserving the quality of life.
ALPHA BLOCKERS USE IN MANAGEMENT OF BPH
The potential role of alpha 1 adrenergic receptors in the aetiology of BPH, promotes the use of selective Alpha-adrenoreceptor antagonists (alpha 1A-blockers) as the first-line treatment agents for patients with BPH.
α1-Adrenergic receptor antagonists are recommended by 80% of physicians to treat patients with BPH presenting with LUTS.
Alpha-blockers improve symptoms and increase the urinary flow rate by relaxing prostatic and bladder neck smooth muscles through sympathetic activity blockade. These agents also improve the bladder outlet obstruction and can rapidly relieve LUTS.
The commonly prescribed alpha-blockers include doxazosin, terazosin, prazosin, alfuzosin, and tamsulosin. Among these agents, tamsulosin hydrochloride is the most preferred and widely used medicine in clinical practice due to its favourable efficacy, safety and tolerability profile
CLINICAL USE OF TAMSULOSIN HYDROCHLORIDE
Tamsulosin has been approved by the FDA for the treatment of the signs and symptoms of BPH. It was the first drug developed specifically to treat only LUTS due to BPH. It exhibits a higher degree of specificity for alpha-adrenergic receptors including α1A-adrenergic receptors and α1B receptors. Because of its higher specificity and prostate selectivity, tamsulosin improves urinary symptoms with fewer side effects.
Mechanism of Action
Pharmacologic and molecular studies have reported the efficacy and tolerability of tamsulosin in patients with symptomatic BPH. It usually acts by reducing muscle contraction in the prostate and urethra. This facilitates the flow of urine through the urethra and aids urination.
Recent studies have also reported the use of tamsulosin in the recovery of sexual function. It shows inhibitory effects such as reduced ejaculatory volume and delayed ejaculation. The inhibitory effect on ejaculation could be beneficial to patients with premature ejaculation (PE).
Dosage And Administration
- Benign prostatic hyperplasia (BPH) and Lower urinary tract symptoms (LUTS)
The recommended dose of Tamsulosin hydrochloride in BPH and LUTS patients is 0.4 mg orally, once daily. It is usually administered ~30 minutes after the same meal each day. The dose might be increased after 2-4 weeks to 0.8 mg once daily in patients who fail to respond. If therapy is interrupted for several days, restart with 0.4 mg once daily.
- Bladder outlet obstruction symptoms (unlabeled use)
Tamsulosin hydrochloride is also recommended in patients with bladder outlet obstruction symptoms at a dose of 0.4 mg PO, once daily.
- Ureteral stones, expulsion (unlabeled use)
Tamsulosin hydrochloride is also recommended in patients with ureteral stones at a dose of 0.4 mg PO, once daily. The use of the drug should be discontinued after successful expulsion (average time to expulsion was 1-2 weeks).
Possible Adverse Reactions
Like all medicines, tamsulosin hydrochloride also causes some side effects and adverse reactions. The side effects caused by tamsulosin hydrochloride are listed below according to the frequency:
- Common side effects (affecting 1 in 10 people)
Dizziness, Weakness, Difficulties with ejaculation and Cloudy urine following sexual activity
- Uncommon side effects (affecting 1 in 100 people)
Headache, Palpitations, Light Headedness, Fainting (orthostatic hypertension), Rhinitis, Constipation, Diarrhea, Nausea, Vomiting, Rashes, Itching and Feeling of Weakness
- Rare side effects (affecting 1 in 1000 people)
Short term loss of consciousness and Angioedema
- Very rare side effects (affecting 1 in 10,000 people)
Painful unwanted erection that requires medical attention and Stevens-Johnson Syndrome
Discontinue use of medicine, and seek medical assistance in the occurrence of:
- Hypersensitivity reaction followed by a painful red or purplish rash and flu-like symptoms (Stevens-Johnson Syndrome)
- Serious allergic reaction which causes swelling of face or throat (Angioedema)
The use of tamsulosin hydrochloride is contraindicated in patients with known hypersensitivity to the active ingredient. It is not indicated for use in children and women.
Warning and Precautions
- Alpha-blockers often present a reduction in blood pressure, therefore it may occur in individual cases during treatment with Tamsulosin and also result in syncope (fainting due to low blood pressure). At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared.
- It should be used with caution in patients with severe renal impairment.
- It is not recommended before cataract or glaucoma surgery.
- It should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype and should be used with caution in combination with strong and moderate inhibitors of CYP3A4.
You must have known the potential benefits of tamsulosin hydrochloride in the management of BPH and LUTS associated with prostate enlargement, by now.
The recommended dose of tamsulosin hydrochloride is highly effective, in monotherapy as well as in combination with dutasteride. However, the combination of dutasteride and tamsulosin is associated with significant improvement in symptoms as compared to tamsulosin or dutasteride as monotherapy. Therefore, it is logical to use the two medications into one tablet.
The combination of dutasteride and tamsulosin is easily available as DR EASY D at Dr Best Pharmaceuticals Pvt Ltd.
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