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INTRODUCTION

DUTAS CAPSULE contains Dutasteride which belongs to the group of medicines called 5-Alpha reductase inhibitors. It is used to treat the signs and symptoms of benign prostatic hyperplasia (BPH) among adult men.

BPH (also known enlarged prostate) is a non-cancerous growth of the prostate gland caused due to increased production of a stress hormone called dihydrotestosterone (DHT) in aging men. Symptoms of BPH includes urinary problems such as difficulty in passing urine, urinary incontinence (unintentional passing of urine), frequent urination at night, sexual dysfunction, or painful ejaculation.

DUTAS CAPSULE is highly used in combination with other medicines (such as tamsulosin or silodosin) to achieve better results. During treatment with DUTAS CAPSULE, your doctor will regularly monitor your serum PSA levels (prostate specific antigen) to rule out risk of unwanted side effects.

Before taking DUTAS CAPSULE inform your doctor if you any liver or kidney problems. Women who are pregnant or think they may be pregnant should not come in contact with DUTAS CAPSULE as it may cause serious harm to the growing fetus.

Men taking DUTAS CAPSULE should use condom to prevent seminal exposure of DUTAS CAPSULE to their partners who are in childbearing age group.

They must also avoid donating their blood while on therapy with DUTAS CAPSULE and until at least 6 months after stopping the therapy to prevent the exposure of dutasteride to a pregnant female transfusion recipient.

The most common side effects of taking DUTAS CAPSULE are low sex drive, impotence, difficulty in reaching orgasm, low sperm count and problems in ejaculation. Consult your doctor if any of these side effects trouble you.

USES OF DUTAS CAPSULE

It is used in adult men to treat the signs and symptoms of:

  • benign prostatic hyperplasia (enlarged prostate)

HOW DUTAS CAPSULE WORKS

DUTAS CAPSULE is a 5-alpha reductase inhibitor. It blocks the activity of certain enzymes (Type II 5α-reductase) in the body that is responsible for converting normal male hormones (testosterone) into stress hormones (dihydrotestosterone) which causes abnormal prostate enlargement. As a result, it shrinks the size of an enlarged prostate and reduces the signs and symptoms of BPH.

DIRECTIONS FOR USE

Take DUTAS CAPSULE as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. DUTAS CAPSULE can be taken with or without meals.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking DUTAS CAPSULE without consulting your doctor.

SIDE EFFECTS OF DUTAS CAPSULE

COMMON

  • impotence (difficulty in maintain erection)
  • decreased sex desire
  • difficulty in ejaculating sperms
  • low sperm count
  • breast enlargement in men (gynecomastia)
  • dizziness

UNCOMMON

  • shortness of breath, extreme tiredness and swelling in your ankles and legs
  • hair loss (usually from the body) or hair growth

RARE

Stop taking DUTAS CAPSULE and consult your doctor immediately if you experience any of the following side effects:

  • severe allergic reactions (such as skin rash with redness and lumps, swelling of the face, eyelids, lips, mouth, and tongue causing difficulty in breathing or swallowing)
  • signs of prostate cancer (difficulty in urinating, decreased force in the urine flow, blood in the urine, blood in the semen, pain in the bone, sudden weight loss and erectile dysfunction)
  • signs of breast cancer (breast enlargement with pain, lump formation in breasts, discharge from nipples)

HOW TO MANAGE SIDE EFFECTS

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

WARNING & PRECAUTIONS

PREGNANCY

DUTAS CAPSULE is not intended for use in women. Also, women who are pregnant or can become pregnant should not handle the broken/leaked medicine or be exposed to the semen of men taking DUTAS CAPSULE, as it may cause serious abnormalities in the growing baby. Contact your doctor for advice if a pregnant woman gets accidentally exposed to DUTAS CAPSULE.

BREASTFEEDING

DUTAS CAPSULE is not intended for use in women.

DRIVING AND USING MACHINES

DUTAS CAPSULE is unlikely to affect your ability for driving or handling heavy tools or machines.

ALCOHOL

Avoid consumption of alcohol while taking DUTAS CAPSULE as it may make you dizzier.

KIDNEY

DUTAS CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.

LIVER

DUTAS CAPSULE is not recommended for use in patients with severe liver diseases. It should be used with caution in patients with any other liver problems. Therefore, consult your doctor before taking it.

ALLERGY

Do not take DUTAS CAPSULE if you are allergic to dutasteride or to any other 5-alpha reductase inhibitors (such as finasteride).

OTHERS

DUTAS CAPSULE is not recommended for use if you:

  • have prostate cancer
  • wish to donate blood

Before taking DUTAS CAPSULE, inform your physician if you:

  • are going to have blood test for PSA (Prostate Specific Antigen)

Use in paediatrics:

DUTAS CAPSULE is not recommended for use in children and adolescents (below 18 years). Therefore, consult your doctor before taking it.

Use in geriatrics:

DUTAS CAPSULE should be used with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking DUTAS CAPSULE, inform your doctor if you are taking any of the following medicines such as:

  • medicines used to treat heart problems (Ex. verapamil or diltiazem)
  • medicines used to treat HIV infection (Ex. ritonavir or indinavir)
  • medicines used to treat fungal infections (Ex. itraconazole or ketoconazole)
  • nefazodone (a medicine used to treat depression)
  • other medicines used in the treatment of enlarged prostate such as alpha blockers (Ex. prazosin, terazosin and doxazosin)

Overdosage:

If you or anyone else accidentally took more DUTAS CAPSULE, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

Drug :   Dutasteride
Pharmacological Category :   5-Alpha reductase inhibitors
Therapeutic Indication :   Benign prostatic hyperplasia        
Dosage Forms :   Tablet, Capsule, Softgels

MORE INFORMATION

  • Keep DUTAS CAPSULE out of reach of children
  • Store DUTAS CAPSULE at room temperature

FAQs ABOUT DUTAS CAPSULE

What is the use of DUTAS CAPSULE?

DUTAS CAPSULE is used to treat the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men. It helps in the shrinkage of an enlarged prostate and reduce the unpleasant symptoms associated with BPH.

Can DUTAS CAPSULE helps to urinate easily?

DUTAS CAPSULE shrinks the size of an abnormally enlarged prostate which obstructs urine flow in patients with BPH. As a result, it improves urine flow and reduces pain or discomfort while passing urine.

Can DUTAS CAPSULE help to dissolve kidney stones?

No. DUTAS CAPSULE is only used to treat benign prostatic hyperplasia. It cannot dissolve kidney stones. However, consult your doctor before taking it.

Can the use of DUTAS CAPSULE reduce hair fall?

DUTAS CAPSULE is intended to treat benign prostatic hyperplasia. It is not recommended for use in reducing hair fall. However, consult your doctor before taking it.

Can the use of DUTAS CAPSULE affect my sexual life?

DUTAS CAPSULE may cause problems in sperm release (ejaculation) or decrease in sex drive. These side effects are usually temporary and disappears once therapy has been stopped. However, consult your doctor if they trouble you.

Can the use of DUTAS CAPSULE cause prostate cancer?

DUTAS CAPSULE may increase the risk of prostate cancer over prolonged use. Therefore, take DUTAS CAPSULE only as advised by your physician. During treatment with DUTAS CAPSULE, your doctor will regularly monitor your serum PSA levels (prostate specific antigen) to rule out risk of unwanted side effects.

I wish to father a child. Can I use DUTAS CAPSULE?

Before taking DUTAS CAPSULE, inform your doctor if you are planning to have a baby, because it can be found in the semen of men taking it. Both pregnant women and women of child-bearing potential must not be exposed to this medicine either through direct handling or through semen, because it may harm to the unborn baby. Men taking DUTAS CAPSULE should use condom during sexual intercourse to prevent seminal exposure of DUTAS CAPSULE to their partners. They must also avoid donating their blood while on therapy with DUTAS CAPSULE and until at least 6 months after stopping the therapy to prevent the exposure of dutasteride to a pregnant female transfusion recipient.

Can DUTAS CAPSULE cause infertility?

DUTAS CAPSULE does not make you infertile. However, it can reduce sex drive or can cause few problems in ejaculation. These side effects are usually temporary and disappears once therapy is stopped. However, consult your doctor if they trouble you. Also, take DUTAS CAPSULE only for the stipulated duration mentioned by your doctor to avoid the risk of side effects.

Can the use of DUTAS CAPSULE make me feel dizzy?

DUTAS CAPSULE may make you feel dizzy or faint especially while changing position. Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Who should not take DUTAS CAPSULE?

Do not take DUTAS CAPSULE if you have prostate cancer. It is not recommended for use in children and adolescents aged below 18 years. It should be used with caution in elderly patients. Women who are pregnant or think they may be pregnant should not come in contact with DUTAS CAPSULE as it may cause serious harm to the growing fetus. Before taking DUTAS CAPSULE inform your doctor if you any liver or kidney problems.

What is the best time to take DUTAS CAPSULE?

Take DUTAS CAPSULE regularly at the same time each day. It can be taken in the morning or at night with or without meals as instructed by your doctor.

What are the side effects of DUTAS CAPSULE?

The most common side effects of taking DUTAS CAPSULE are low sex drive, impotence, difficulty in reaching orgasm, low sperm count and problems in ejaculation. Consult your doctor if any of these side effects trouble you.

How long will it take for DUTAS CAPSULE to show the results?

It may take around 4 weeks for DUTAS CAPSULE to show results. However, this period may vary from patient-to-patient depending upon their disease condition. Therefore, continue to take this medicine as advised by your doctor.

What to do if I forgot to take a dose of DUTAS CAPSULE?

If you have missed a dose of DUTAS CAPSULE, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose and take the next one regularly. Do not take a double dose of DUTAS CAPSULE to compensate the missed ones.

Can I stop taking DUTAS CAPSULE once my symptoms subside?

Do not stop taking DUTAS CAPSULE without consulting your doctor. Make sure to take this medicine for the stipulated duration recommended by your doctor to achieve maximum results.

REFERENCES

1. KD Tripathi. Hormones and related drugs: Androgens and Drugs for Erectile Dysfunction. Essentials of Medical Pharmacology. 7th edition. 2013. Page - 303.

2. Roehrborn CG, Marks LS, Fenter T, Freedman S, Tuttle J, Gittleman M, Morrill B, Wolford ET. Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia. Urology. April 2004. [Accessed on 6th December 2022] https://www.goldjournal.net/article/S0090-4295(04)00068-8/fulltext

3. Cyndea Pharma S.L.Galenicum Health S.L. Accord Healthcare Limited. Pharmadox Healthcare Ltd. Electronic Medicines Compendium (EMC). [Revised in October 2019] [Accessed on 6th December 2022] https://www.medicines.org.uk/emc/files/pil.8917.pdf

4. GlaxoSmithKline Pharmaceuticals Inc. U.S. Food & Drug Administration. [Revised in June 2011] [Accessed on 6th December 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf

USEFUL DIAGNOSTIC TESTS

  • Prostate-specific antigen (PSA) blood test
  • Prostate magnetic resonance imaging (MRI)
  • Urine flow study
  • Digital rectal examination
  • Cystoscopy

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 06 Dec 2022 | 05:37 PM(IST)

PRODUCT DETAILS
    Net Qty
    1 N
    Shelf Life
    24
    Item Weight
    17.5 g
    Ingredient
    Dutasteride 0.5 mg
    Hsn Code
    30042099
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DISCLAIMER

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.

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