Sildura 4/0.5mg Combi Kit 10'S

Introduction About SILDURA 4/0.5MG COMBI KIT

SILDURA 4/0.5MG COMBI KIT is a combination of Dutasteride and Silodosin, which belong to the group of medicines called 5-Alpha reductase inhibitors and Alpha-1 blockers, respectively. SILDURA 4/0.5MG COMBI KIT is used to manage signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms and reduce 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 that helps improve the flow of urination by relaxing the smooth muscles of the 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 SILDURA 4/0.5MG COMBI KIT, 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 managed with SILDURA 4/0.5MG COMBI KIT should not donate blood for at least 6 months after their last dose, in order to manage the exposure of the medicine to pregnant women via blood transfusion.

Avoid consumption of alcohol while taking SILDURA 4/0.5MG COMBI KIT, as it may lower your blood pressure. It is not recommended for use in children or adolescents less than 18 years of age. The most common side effects of taking SILDURA 4/0.5MG COMBI KIT are orgasm with reduced or no semen, trouble getting or keeping an erection (impotence), a decrease in sex drive (libido), ejaculation problems (enlarged or painful breasts), dizziness, and low blood pressure while standing up from a sitting or lying position. Contact your doctor if any of the symptoms worsen.

Uses Of SILDURA 4/0.5MG COMBI KIT

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

How SILDURA 4/0.5MG COMBI KIT Works

SILDURA 4/0.5MG COMBI KIT 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, SILDURA 4/0.5MG COMBI KIT helps in the shrinkage of an enlarged prostate, making it easier for the urine to pass through and providing relief from symptomatic BPH.

How to use SILDURA 4/0.5MG COMBI KIT

Take SILDURA 4/0.5MG COMBI KIT as advised by your physician. Swallow SILDURA 4/0.5MG COMBI KIT with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age and the severity of the condition.

Side Effects Of SILDURA 4/0.5MG COMBI KIT

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 to manage diarrhea. Consult your doctor if the symptoms have not improved.

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 alcohol, as it can aggravate your dizziness. Consult your doctor if the symptoms have not improved.

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 symptoms get worse.

Nausea And Vomiting

Try to take SILDURA 4/0.5MG COMBI KIT with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptoms have not improved.

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 symptoms have not improved.

Warning & Precautions

Pregnancy

Contraindicated

SILDURA 4/0.5MG COMBI KIT 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

SILDURA 4/0.5MG COMBI KIT 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 SILDURA 4/0.5MG COMBI KIT.

Alcohol

Contraindicated

Consumption of alcohol is not recommended while taking SILDURA 4/0.5MG COMBI KIT, as it may lower your blood pressure.

Kidney

Consult your doctor

SILDURA 4/0.5MG COMBI KIT 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 SILDURA 4/0.5MG COMBI KIT.

Liver

Consult your doctor

SILDURA 4/0.5MG COMBI KIT 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 SILDURA 4/0.5MG COMBI KIT.

Allergy

Contraindicated

Do not take SILDURA 4/0.5MG COMBI KIT if you are allergic (hypersensitive) to Silodosin or Dutasteride or other 5 alpha-reductase inhibitors such as finasteride.

Use In Pediatrics

Contraindicated

SILDURA 4/0.5MG COMBI KIT 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

SILDURA 4/0.5MG COMBI KIT should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking SILDURA 4/0.5MG COMBI KIT.

Interactions

A. Drug-Drug interactions:

Before taking SILDURA 4/0.5MG COMBI KIT inform to your doctor, if you are taking any of these medicines:

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

Overdosage:

If you or anyone else accidentally take too much of SILDURA 4/0.5MG COMBI KIT, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of SILDURA 4/0.5MG COMBI KIT include low blood pressure.

Synopsis

More Information

• Keep SILDURA 4/0.5MG COMBI KIT out of reach of children
• Store at room temperature

FAQs About SILDURA 4/0.5MG COMBI KIT

Q: Can SILDURA 4/0.5MG COMBI KIT cause infertility?

A: SILDURA 4/0.5MG COMBI KIT 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 SILDURA 4/0.5MG COMBI KIT make me feel dizzy?

A: Yes. SILDURA 4/0.5MG COMBI KIT 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 consuming 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 do I do if I forget to take SILDURA 4/0.5MG COMBI KIT?

A: You should take SILDURA 4/0.5MG COMBI KIT 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 make up for your missed dose.

Q: Is SILDURA 4/0.5MG COMBI KIT safe to use with children?

A: SILDURA 4/0.5MG COMBI KIT is not recommended for use in children and adolescents (below 18 years). If your child experiences any symptoms of difficulty urinating, consult the child’s doctor immediately.

Q: Can I take SILDURA 4/0.5MG COMBI KIT with blood pressure medicine?

A: No, before taking SILDURA 4/0.5MG COMBI KIT, inform your doctor about your previous medication history. This medicine can interact with blood pressure medicines (e.g., prazosin, furosemide), resulting in a severe decrease in blood pressure that 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. N. Sai Swaroop - Pharm.D

Reviewed For Accuracy By Dr. Pushpraj Singh - MBBS

Last updated on 31 Oct 2023 | 06:05 PM(IST)