INTRODUCTION

SILOSALT 8D TABLET is a combination of Silodosin and Dutasteride which belongs to the group of medicines called Alpha-1 blockers and 5-Alpha reductase inhibitors respectively. SILOSALT 8D TABLET is used to treat signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms and reduces the risk of acute urinary retention (complete blockage of urine flow) or the need for BPH-related surgery. Benign prostatic hyperplasia (BPH) is a condition when an enlarged prostate gland causes uncomfortable urinary symptoms, such as blocking the flow of urine out of the bladder.

Silodosin is an alpha-1 blocker which helps to improve the flow of urination by relaxing the smooth muscles of bladder and prostrate. Dutasteride is a 5-alpha reductase inhibitor that reduces the production of a stress hormone called dihydrotestosterone which is responsible for causing prostate enlargement by inhibiting the activity of an intracellular enzyme called 5-alpha reductase. Collectively they shrink the size of an enlarged prostate and improve the flow of urine as well as the symptoms of BPH in men.

Before taking SILOSALT 8D TABLET inform your doctor if you have low blood pressure, or liver, kidney, or heart disease as a precaution. Women who are pregnant or can become pregnant should not handle the leaked medicine as it may cause serious harm to the baby. Men being treated with SILOSALT 8D TABLET should not donate blood for at least 6 months after their last dose, in order to prevent the exposure of the medicine to pregnant women via blood transfusion.

Avoid consumption of alcohol while taking SILOSALT 8D TABLET, as it may lower your blood pressure. It is not recommended for use in children and adolescents less than 18 years of age. The most common side effects of taking SILOSALT 8D TABLET are orgasm with reduced or no semen, trouble getting or keeping an erection (impotence), decrease in sex drive (libido), ejaculation problems enlarged or painful breasts, dizziness, low blood pressure while standing up from sitting or lying position. Contact your doctor if any of the symptoms worsen.

USES OF SILOSALT 8D TABLET

• To treat signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate

HOW SILOSALT 8D TABLET WORKS

SILOSALT 8D TABLET effectively reduces the symptoms of BPH, where silodosin acts by relaxing the muscles surrounding the bladder and prostate by inhibiting the alpha-1 adrenergic receptors of the lower urinary tract and dutasteride works by inhibiting the activity of an enzyme called 5-alpha reductase, which is responsible for the conversion of testosterone into dihydrotestosterone (a stress hormone that causes BPH). As a result, SILOSALT 8D TABLET help in shrinkage of an enlarged prostate, making it easier for the urine to pass through and provide relief from symptomatic BPH.  

DIRECTIONS FOR USE

Take SILOSALT 8D TABLET as advised by your physician. Swallow SILOSALT 8D TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age and severity of the condition.

SIDE EFFECTS OF SILOSALT 8D TABLET

HOW TO MANAGE SIDE EFFECTS

Diarrhea

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

Dry Mouth

Try to drink plenty of cold water. Sip on cold unsweetened drinks and use lip balm if your lips are dry. Try to brush your teeth twice a day and use mouthwash. Consult your doctor if the symptom gets worse.

Nausea And Vomiting

Try to take SILOSALT 8D TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.

Skin Rash Or Itching

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

PREGNANCY

Contraindicated

SILOSALT 8D TABLET is not recommended for use in women, only used in adult men. Women who are pregnant or can become pregnant should not handle the leaked medicine as it may cause serious harm to the baby. The contact area should be washed immediately with soap and water.

BREASTFEEDING

Contraindicated

SILOSALT 8D TABLET is not recommended for use in women, only used in adult men.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or handle any machines if you experience low blood pressure when standing up from sitting or lying position (with or without symptoms such as dizziness). Consult your doctor before taking SILOSALT 8D TABLET.

ALCOHOL

Contraindicated

Consumption of alcohol is not recommended while taking SILOSALT 8D TABLET, as it may lower your blood pressure.

KIDNEY

Consult your doctor

SILOSALT 8D TABLET is not recommended for use in patients with severe kidney impairment and it should be used with caution in patients with moderate kidney impairment. Consult your doctor before taking SILOSALT 8D TABLET.

LIVER

Consult your doctor

SILOSALT 8D TABLET is not recommended for use in patients with severe liver impairment and it should be used with caution in patients with liver problems. Consult your doctor before taking SILOSALT 8D TABLET.

ALLERGY

Contraindicated

Do not take SILOSALT 8D TABLET if you are allergic (hypersensitive) to Silodosin or Dutasteride or other 5 alpha-reductase inhibitors such as finasteride.

USE IN PEDIATRICS

Contraindicated

SILOSALT 8D TABLET is not recommended for use in children and adolescents (below 18 years of age) due to lack of safety and effectiveness.

USE IN GERIATRICS

Use with Caution

SILOSALT 8D TABLET should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking SILOSALT 8D TABLET.

INTERACTIONS

A. Drug-Drug interactions:

Before taking SILOSALT 8D TABLET inform to your doctor, if you are taking any of these medicines:

• diltiazem, verapamil, and alpha-blockers such as doxazosin, prazosin (treats high blood pressure)
• ketoconazole, itraconazole (treats fungal infections)
• ritonavir (treats HIV infection)
• troleandomycin, ciprofloxacin, clarithromycin, erythromycin (treats bacterial infection)
• cyclosporine (used to prevent organ rejection after transplant)
• digoxin (treats heart problems)

Overdosage:

If you or anyone else accidentally take too much of SILOSALT 8D TABLET, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of SILOSALT 8D TABLET include low blood pressure.

SYNOPSIS

MORE INFORMATION

• Keep SILOSALT 8D TABLET out of reach of children
• Store at room temperature

FAQs ABOUT SILOSALT 8D TABLET

Q: Can SILOSALT 8D TABLET cause infertility?

A: SILOSALT 8D TABLET can cause sexual impotence, decreased sex drive or difficulty in ejaculation in men because it reduces the sperm count, semen volume and sperm movement. Consult your doctor if this bothers you.  

Q: Can the use of SILOSALT 8D TABLET make me feel dizzy?

A: Yes. SILOSALT 8D TABLET can cause dizziness in some people. Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Avoid consumption of alcohol as it can aggravate your dizziness. However, if you experience severe persistent dizziness and fainting while standing up, please contact your doctor. 

Q: What to do If I forget to take SILOSALT 8D TABLET?

A: You should take SILOSALT 8D TABLET immediately when you remember. If it is time for your next dose skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.  

Q: Is SILOSALT 8D TABLET safe to use in children?

A: SILOSALT 8D TABLET is not recommended for use in children and adolescents (below 18 years). If your child experiences any symptoms of difficulty in urination consult child’s doctor immediately.

Q: Can I take SILOSALT 8D TABLET with blood pressure medicine?

A: No, before taking SILOSALT 8D TABLET inform your doctor about your previous medication history. This medicine can interact with blood pressure medicines (e.g., prazosin, furosemide) resulting in severe decrease in blood pressure and may cause dizziness or fainting. 

REFERENCES

1. KD. Tripathi. Antiadrenergic Drugs and Drugs for Glaucoma & Androgens and Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Seventh edition. 2013. Page – 142-144 & 303.

2. Kazuhisa Hagiwara, Takuya Koie, Hiromichi Iwamura, Atsushi Imai, Shingo Hatakeyama, Takahiro Yoneyama, Yasuhiro Hashimoto and Chikara Ohyama. Efficacy and Safety of Silodosin and Dutasteride Combination Therapy in Acute Urinary Retention due to Benign Prostatic Hyperplasia: A Single-Arm Prospective Study. April 2016. [Accessed on 25th August 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4852328/

3. Iram Kahkashan, Shabnam Chawdhary, Vishal R. Tandon, Rahul Gupta. To compare the efficacy and safety of silodosin and dutasteride combination with alfuzosin and dutasteride combination in patients of benign prostatic hyperplasia: a randomized, open label study. International journal of basic & clinical pharmacology (IJBCP). 2019. [Accessed on 25th August 2021] https://www.ijbcp.com/index.php/ijbcp/article/view/3207

4. Cipla House. Swiss Garnier Genexiaa Sciences Pvt. Ltd. [Revised in February 2021] [Accessed on 25th August 2021] https://www.ciplamed.com/print-product-pdf/49744

5. APL Swift Services (Malta) Limited or Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in August 2019] [Accessed on 25th August 2021] https://www.medicines.org.uk/emc/files/pil.9277.pdf

6. Recordati S.p.A. European Medicines Agency (EMA). [Accessed on 25th August 2021] https://www.ema.europa.eu/en/documents/product-information/silodyx-epar-product-information_en.pdf

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 20 Mar 2023 | 08:51 AM(IST)