Silodosin
What is Silodosin?[edit | edit source]
- Silodosin (Rapaflo) an alpha-1 adrenergic receptor antagonist used for the symptomatic treatment of benign prostatic hyperplasia (BPH).
What are the uses of this medicine?[edit | edit source]
- Silodosin (Rapaflo) is used for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Limitations of use:
- RAPAFLO is not indicated for the treatment of hypertension.
How does this medicine work?[edit | edit source]
- Silodosin is a selective antagonist of post-synaptic alpha-1 adrenoreceptors, which are located in the human prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.
- Blockade of these alpha-1 adrenoreceptors can cause smooth muscle in these tissues to relax, resulting in an improvement in urine flow and a reduction in BPH symptoms.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients with:
- severe renal impairment.
- severe hepatic impairment.
- Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir).
What drug interactions can this medicine cause?[edit | edit source]
- Concomitant administration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and RAPAFLO is contraindicated.
- RAPAFLO is not recommended in patients taking strong P-gp inhibitors such as cyclosporine.
- RAPAFLO should not be used in combination with other alpha-blockers.
- Concomitant administration of RAPAFLO and digoxin did not significantly alter the steady state pharmacokinetics of digoxin. No dose adjustment is required.
- Concomitant use of PDE5 inhibitors with alpha-blockers including Rapaflo can potentially cause symptomatic hypotension.
Is this medicine FDA approved?[edit | edit source]
* The United States Food and Drug Administration and Health Canada approved silodosin under the brand name Rapaflo on 9 October 2008 and 11 January 2011, respectively.
How should this medicine be used?[edit | edit source]
Recommended dosage:
- 8 mg capsules taken orally once daily with a meal.
- 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment.
Administration:
- Patients should be instructed to take RAPAFLO once daily with a meal.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Capsules: 8 mg and 4 mg
This medicine is available in fallowing brand namesː
- RAPAFLO
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- retrograde ejaculation
- dizziness
- diarrhea
- orthostatic hypotension
- headache
- nasopharyngitis
- nasal congestion
What special precautions should I follow?[edit | edit source]
- Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning RAPAFLO treatment. Patients should be cautioned about driving, operating machinery, or performing hazardous tasks when initiating therapy.
- In patients with moderate renal impairment, RAPAFLO dose should be reduced to 4 mg once daily. Exercise caution and monitor such patients for adverse events. RAPAFLO is contraindicated in patients with severe renal impairment.
- RAPAFLO should not be used in combination with other alpha-blockers.
- Carcinoma of the prostate and BPH cause many of the same symptoms. These two diseases frequently co-exist. Examine patients thought to have BPH prior to starting therapy with RAPAFLO to rule out the presence of carcinoma of the prostate.
- Inform patients planning cataract surgery to notify their ophthalmologist that they are taking RAPAFLO because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS).
- RAPAFLO has not been tested in patients with severe hepatic impairment, and therefore, should not be prescribed to such patients.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include:
Management of overdosage:
- Restoration of blood pressure and normalization of heart rate may be accomplished by maintaining the patient in the supine position.
- If this measure is inadequate, administration of intravenous fluid should be considered.
- If necessary, vasopressors could be used, and renal function should be monitored and supported as needed.
- Dialysis is unlikely to be of significant benefit since silodosin is highly (97%) protein bound.
Can this medicine be used in pregnancy?[edit | edit source]
- Pregnancy Category B.
- RAPAFLO is not indicated for use in women.
Can this medicine be used in children?[edit | edit source]
- RAPAFLO is not indicated for use in pediatric patients.
- Safety and effectiveness in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient:
- SILODOSIN
Inactive ingredients:
- none
Who manufactures and distributes this medicine?[edit | edit source]
Manufactured by: Watson Laboratories, Inc. Corona, CA USA
Distributed by:
- Watson Pharma, Inc.
- Parsippany, NJ USA
What should I know about storage and disposal of this medication?[edit | edit source]
- Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
- Protect from light and moisture.
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