Introduction About DUTANDRO TABLET

DUTANDRO TABLET contains Dutasteride which belongs to the group of medicines called 5-Alpha reductase inhibitors. It is used to manage 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.

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

Before taking DUTANDRO TABLET 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 DUTANDRO TABLET as it may cause serious harm to the growing fetus.

Men taking DUTANDRO TABLET should use condom to manage seminal exposure of DUTANDRO TABLET to their partners who are in childbearing age group.

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

The most common side effects of taking DUTANDRO TABLET 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 DUTANDRO TABLET

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

• benign prostatic hyperplasia (enlarged prostate)

How DUTANDRO TABLET Works

DUTANDRO TABLET 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.

How to use DUTANDRO TABLET

Take DUTANDRO TABLET as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. DUTANDRO TABLET 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 DUTANDRO TABLET without consulting your doctor.

Side Effects Of DUTANDRO TABLET

How To Manage Side Effects

Dizziness Or Drowsiness

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

Consult your doctor

DUTANDRO TABLET 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 DUTANDRO TABLET, as it may cause serious abnormalities in the growing baby. Contact your doctor for advice if a pregnant woman gets accidentally exposed to DUTANDRO TABLET.

Breastfeeding

Consult your doctor

DUTANDRO TABLET is not intended for use in women.

Driving and Using Machines

Use with Caution

DUTANDRO TABLET is unlikely to affect your ability for driving or handling heavy tools or machines.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking DUTANDRO TABLET as it may make you dizzier.

Kidney

Use with Caution

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

Liver

Consult your doctor

DUTANDRO TABLET 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

Contraindicated

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

Use In Pediatrics

Contraindicated

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

Use In Geriatrics

Use with Caution

DUTANDRO TABLET 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 DUTANDRO TABLET, inform your doctor if you are taking any of the following medicines such as:

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

Overdosage:

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

Synopsis

More Information

• Keep DUTANDRO TABLET out of reach of children
• Store DUTANDRO TABLET at room temperature

FAQs About DUTANDRO TABLET

Q: What is the use of DUTANDRO TABLET?

A: DUTANDRO TABLET is used to manage 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.

Q: Can DUTANDRO TABLET helps to urinate easily?

A: DUTANDRO TABLET 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.

Q: Can DUTANDRO TABLET help to dissolve kidney stones?

A: No. DUTANDRO TABLET is only used to manage benign prostatic hyperplasia. It cannot dissolve kidney stones. However, consult your doctor before taking it.

Q: Can the use of DUTANDRO TABLET reduce hair fall?

A: DUTANDRO TABLET is intended to manage benign prostatic hyperplasia. It is not recommended for use in reducing hair fall. However, consult your doctor before taking it.

Q: Can the use of DUTANDRO TABLET affect my sexual life?

A: DUTANDRO TABLET 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.

Q: Can the use of DUTANDRO TABLET cause prostate cancer?

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

Q: I wish to father a child. Can I use DUTANDRO TABLET?

A: Before taking DUTANDRO TABLET, 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 DUTANDRO TABLET should use condom during sexual intercourse to manage seminal exposure of DUTANDRO TABLET to their partners. They must also avoid donating their blood while on therapy with DUTANDRO TABLET and until at least 6 months after stopping the therapy to manage the exposure of dutasteride to a pregnant female transfusion recipient.

Q: Can DUTANDRO TABLET cause infertility?

A: DUTANDRO TABLET 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 DUTANDRO TABLET only for the stipulated duration mentioned by your doctor to avoid the risk of side effects.

Q: Can the use of DUTANDRO TABLET make me feel dizzy?

A: DUTANDRO TABLET 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.

Q: Who should not take DUTANDRO TABLET?

A: Do not take DUTANDRO TABLET 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 DUTANDRO TABLET as it may cause serious harm to the growing fetus. Before taking DUTANDRO TABLET inform your doctor if you any liver or kidney problems.

Q: What is the best time to take DUTANDRO TABLET?

A: Take DUTANDRO TABLET 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.

Q: What are the side effects of DUTANDRO TABLET?

A: The most common side effects of taking DUTANDRO TABLET 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.

Q: How long will it take for DUTANDRO TABLET to show the results?

A: It may take around 4 weeks for DUTANDRO TABLET 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.

Q: What to do if I forgot to take a dose of DUTANDRO TABLET?

A: If you have missed a dose of DUTANDRO TABLET, 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 DUTANDRO TABLET to compensate the missed ones.

Q: Can I stop taking DUTANDRO TABLET once my symptoms subside?

A: Do not stop taking DUTANDRO TABLET 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