DUTAMAX Tablet 10's

Introduction About DUTAMAX TABLET

DUTAMAX 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.

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

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

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

They must also avoid donating their blood while on therapy with DUTAMAX 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 DUTAMAX 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 DUTAMAX TABLET

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

• benign prostatic hyperplasia (enlarged prostate)

How DUTAMAX TABLET Works

DUTAMAX 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 DUTAMAX TABLET

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

Side Effects Of DUTAMAX TABLET

How To Manage Side Effects

Warning & Precautions

Interactions

A. Drug-Drug interactions:

Before taking DUTAMAX 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 DUTAMAX TABLET, 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 DUTAMAX TABLET out of reach of children
• Store DUTAMAX TABLET at room temperature

FAQs About DUTAMAX TABLET

Q: What is the use of DUTAMAX TABLET?

A: DUTAMAX 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 DUTAMAX TABLET helps to urinate easily?

A: DUTAMAX 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 DUTAMAX TABLET help to dissolve kidney stones?

A: No. DUTAMAX 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 DUTAMAX TABLET reduce hair fall?

A: DUTAMAX 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 DUTAMAX TABLET affect my sexual life?

A: DUTAMAX 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 DUTAMAX TABLET cause prostate cancer?

A: DUTAMAX TABLET may increase the risk of prostate cancer over prolonged use. Therefore, take DUTAMAX TABLET only as advised by your physician. During management with DUTAMAX 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 DUTAMAX TABLET?

A: Before taking DUTAMAX 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 DUTAMAX TABLET should use condom during sexual intercourse to manage seminal exposure of DUTAMAX TABLET to their partners. They must also avoid donating their blood while on therapy with DUTAMAX 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 DUTAMAX TABLET cause infertility?

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

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

A: DUTAMAX 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 DUTAMAX TABLET?

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

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

A: Take DUTAMAX 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 DUTAMAX TABLET?

A: The most common side effects of taking DUTAMAX 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 DUTAMAX TABLET to show the results?

A: It may take around 4 weeks for DUTAMAX 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 DUTAMAX TABLET?

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

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

A: Do not stop taking DUTAMAX 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

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