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INTRODUCTION

PROSTAGARD D is a combination of Silodosin and Dutasteride which belongs to the group of medicines called Alpha-1 blockers and 5-Alpha reductase inhibitors respectively. PROSTAGARD D 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 PROSTAGARD D 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 PROSTAGARD D 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 PROSTAGARD D, 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 PROSTAGARD D 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 PROSTAGARD D

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

HOW PROSTAGARD D WORKS

PROSTAGARD D 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, PROSTAGARD D 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 PROSTAGARD D as advised by your physician. Swallow PROSTAGARD D 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 PROSTAGARD D

COMMON

  • 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
  • diarrhea
  • nasal congestion
  • low blood pressure while standing up from sitting or lying position

UNCOMMON

  • increased heart rate
  • nausea, dry mouth
  • skin rash, itching, drug eruption
  • low blood pressure
  • hair loss or hair growth

RARE

  • fainting or loss of consciousness
  • fast or irregular heartbeat (irregular heartbeat)

Stop taking PROSTAGARD D and contact your doctor immediately if you experience any of the following side effects:

  • signs of allergic reactions (such as swelling of the eyelids, face or throat, difficulty in breathing, feeling faint, itchy skin or hives, arms, or legs)
  • serious skin reactions such as skin peeling

HOW TO MANAGE SIDE EFFECTS

Nausea:

Try to take PROSTAGARD D 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.

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:

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.

Skin rash:

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.

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.

WARNING & PRECAUTIONS

PREGNANCY

PROSTAGARD D 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

PROSTAGARD D is not recommended for use in women, only used in adult men.

DRIVING AND USING MACHINES

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 PROSTAGARD D.

ALCOHOL

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

KIDNEY

PROSTAGARD D 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 PROSTAGARD D.

LIVER

PROSTAGARD D 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 PROSTAGARD D.

ALLERGY

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

OTHERS

Before taking PROSTAGARD D, inform your physician if you:

  • have low blood pressure
  • planned for cataract surgery or other procedures involving the eyes

Use in pediatrics:

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

Use in geriatrics:

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

INTERACTIONS

A. Drug-Drug interactions:

Before taking PROSTAGARD D 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 PROSTAGARD D, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of PROSTAGARD D include low blood pressure.

SYNOPSIS

Drug :   Silodosin and Dutasteride
Pharmacological Category :   Alpha-blockers and 5-alpha-reductase inhibitor
Therapeutic Indication :   Benign prostatic hyperplasia
Dosage Forms :   Tablet, Capsule

MORE INFORMATION

  • Keep PROSTAGARD D out of reach of children
  • Store at room temperature

FAQs ABOUT PROSTAGARD D

Can PROSTAGARD D cause infertility?

PROSTAGARD D 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.

Can the use of PROSTAGARD D make me feel dizzy?

Yes. PROSTAGARD D 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.

What to do If I forget to take PROSTAGARD D?

You should take PROSTAGARD D 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.

Is PROSTAGARD D safe to use in children?

PROSTAGARD D 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.

Can I take PROSTAGARD D with blood pressure medicine?

No, before taking PROSTAGARD D 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

VIDEOS

Dutasteride+Silodosin CAPSULE - Drug Information

Dutasteride+Silodosin CAPSULE : Therapeutic Uses, Warning and Precautions, Interactions, Directions for Use, Side Effects and Storage

PRODUCT DETAILS

    Net Qty
    1 N
    Shelf Life
    24 months
    Item Weight
    17.5 g
    Ingredient
    SILODOSIN 8MG+DUTASTERIDE 0.5MG
    Hsn Code
    30049099
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The contents of this website are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Do not disregard professional medical advice or delay in seeking it because of something you have read on this website.

Prostagard D 8mg Capsule 10'S

Prostagard D 8mg Capsule 10'S Mkt: Aristo Pharmaceuticals Pvt Ltd

M.R.P.: Rs.217.50
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