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INTRODUCTION

ALFUZZ D is a combination of Alfuzosin and Dutasteride which belongs to the group of medicines called Alpha-1 adrenergic blockers and 5-Alpha reductase inhibitors respectively. ALFUZZ D is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men with an enlarged prostate. Benign Prostatic Hyperplasia (also known as enlarged prostate) is a non-cancerous growth of prostate gland, which is predominantly caused by excessive production of a stress hormone called dihydrotestosterone (DHT) in men. Symptoms of BPH includes urinary problems such as difficulty in passing urine, urinary incontinence (unintentional passing of urine), frequent urination at night and sexual dysfunction or painful ejaculation.

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. Alfuzosin is a long-acting alpha-1 adrenergic blocker that relaxes the smooth muscles surrounding the bladder and prostate by selectively inhibiting the alpha-1 receptors of the lower urinary tract, thus making it easier for the urine to pass through. 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 ALFUZZ D inform your doctor if you have hypotension, or liver, kidney, or heart disease as a precaution. During treatment with ALFUZZ D, your doctor will regularly monitor your serum prostate-specific antigen (PSA) levels to rule out risk of prostate cancer. Women who are pregnant or think they may be pregnant should not handle the leaked medicine or be exposed to the semen of men taking ALFUZZ D, as it could cause serious abnormalities in the growing fetus. Usage of condom during sexual intercourse is recommended among fertile men to avoid conception. Men being treated with ALFUZZ 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. The most common side effects of taking ALFUZZ D are dizziness, fainting, weakness, and decreased sex drive or breast enlargement in men. Contact your doctor if any of the symptoms worsen.

USES OF ALFUZZ D

  • treat signs and symptoms of Benign Prostatic Hyperplasia (BPH) in adult men

HOW ALFUZZ D WORKS

ALFUZZ D effectively reduces the symptoms of BPH, where dutasteride acts 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) and alfuzosin acts by relaxing the muscles surrounding the bladder and prostate by inhibiting the alpha-1 adrenergic receptors of the lower urinary tract. As a result, ALFUZZ 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 ALFUZZ D as advised by your physician. Swallow the medicine as a whole and do not crush or chew the medicine. Try to take ALFUZZ D at the same time each day immediately after meals. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.

SIDE EFFECTS OF ALFUZZ D

COMMON

  • dizziness or fainting
  • headache, nausea, stomach pain
  • general weakness or tiredness
  • sexual impotence (unable to achieve or maintain an erection), decreased sex drive and difficulty with ejaculation
  • gynecomastia (breast enlargement or tenderness in men)

UNCOMMON

  • postural hypotension (feeling dizzy, lightheaded, or faint while standing up)
  • rapid heartbeat
  • drowsiness
  • diarrhea, dry mouth
  • skin rash with itching
  • signs of heart failure (shortness of breath, extreme tiredness and swelling in ankles)
  • hot flushes
  • fluid retention (may cause swollen arms or legs)
  • stuffy or runny nose, itching or sneezing
  • vision problems
  • hair loss (usually from the body) or hair growth

RARE

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

  • priapism (persistent painful penile erection unrelated to sexual activity)
  • chest pain
  • severe allergic reactions (such as skin rash with redness and lumps, swelling of face, eyelids, lips, mouth, and tongue causing difficulty in breathing or swallowing)

HOW TO MANAGE SIDE EFFECTS

Nausea:

Try to take ALFUZZ 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.

Diarrhoea:

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.

Headache:  

Rest and relax. Drink lot of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume too much of alcohol. 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.

WARNING & PRECAUTIONS

PREGNANCY

Women who are pregnant or can become pregnant should not handle the leaked medicine or be exposed to the semen of men taking ALFUZZ D, as it could cause serious abnormalities in the growing fetus. Usage of condom during sexual intercourse is therefore recommended in such population as a precaution. Contact your doctor for advice if a pregnant woman gets accidentally exposed to ALFUZZ D.

BREASTFEEDING

ALFUZZ D is not indicated to use in breast-feeding women, as it is indicated to use only in men.

DRIVING AND USING MACHINES

Do not drive or operate any heavy tools or machines if you experience dizziness, drowsiness, sleepiness, weakness or headache after taking ALFUZZ D.

ALCOHOL

Avoid consumption of alcohol while taking ALFUZZ D, as it could make you feel dizzier or weaker.

KIDNEY

ALFUZZ D should be taken with caution in patients with severe kidney impairment. Consult your doctor before taking ALFUZZ D.

LIVER

ALFUZZ D is not recommended for use in patients with moderate to severe liver impairment and it should be used with caution in patients with mild liver impairment. Consult your doctor before taking ALFUZZ D.

ALLERGY

Talk to your doctor if you are allergic to Alfuzosin or Dutasteride.

HEART DISEASE

ALFUZZ D should be taken with caution in patients with heart disease (Ex. angina, prolong QT interval). Consult your doctor before taking ALFUZZ D.

OTHERS

ALFUZZ D is not recommended for use if you:

  • have prostate cancer

Before taking ALFUZZ D, inform your physician if you:

  • have orthostatic hypotension (feeling dizzy or faint while standing up)
  • have an upcoming cataract surgery
  • are going to have blood test for PSA (Prostate Specific Antigen)

Use in pediatrics:

ALFUZZ D is not recommended for use in children and adolescents (below 18 years). Kindly consult your doctor before taking ALFUZZ D.

Use in geriatrics:

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

INTERACTIONS

A. Drug-Drug interactions:

Before taking ALFUZZ D inform to your doctor, if you are taking any of these medicines:

  • medicines used to treat fungal infection (Ex. ketoconazole or itraconazole)
  • medicines used to treat high blood pressure and other heart problems (such as nitroglycerin, verapamil, atenolol or diltiazem)
  • antibiotics (used to treat bacterial infections) such as troleandomycin and ciprofloxacin
  • other alpha blockers (used to treat enlarged prostate or high blood pressure) such as prazosin, doxazosin, terazosin
  • medicines used to treat erectile dysfunction (Ex vardenafil, sildenafil and tadalafil)
  • warfarin (used to prevent formation of blood clots in the body)
  • ritonavir (used to treat HIV infections)
  • cimetidine (used to treat stomach ulcers)

Overdosage:

If you or anyone else accidentally take too much of ALFUZZ D, contact your doctor immediately or go to a hospital straight away. Symptoms of overdosage include severe hypotension (decrease in blood pressure causing severe dizziness and fainting).

SYNOPSIS

Drug :  

Alfuzosin, Dutasteride

Pharmacological Category :  

Alpha-1 adrenergic blockers, 5-Alpha reductase inhibitors

Therapeutic Indication :  

Benign Prostatic Hyperplasia

Dosage Forms :  

Tablet, Capsule

MORE INFORMATION

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

FAQs ABOUT ALFUZZ D

Can the use of ALFUZZ D cause long-lasting painful penile erection?

Yes. ALFUZZ D can rarely cause a serious condition called priapism (persistent painful penile erection unrelated to sexual activity). Stop taking ALFUZZ D and contact your doctor immediately if you experience persistent painful erections of the penis that is unrelated to sexual activity, because this condition can lead to permanent erectile dysfunction if not treated properly.

Can the use of ALFUZZ D cause prostate cancer?

Yes. ALFUZZ D can increase the risk of high-grade prostate cancer in men, and so your doctor would regularly monitor your serum prostate specific antigen (PSA) levels. Current clinical findings show that men taking dutasteride develops a serious form of prostate cancer more often than men who are not relied on dutasteride therapy. However, the mechanism behind the incidence of prostate cancer is not clear.

Use of ALFUZZ D by male individuals affects pregnancy?

Before taking ALFUZZ D, inform your doctor if you are planning to have a baby, because this medicine can be found in the semen of men taking it. Both pregnant women and women of child-bearing potential must not be exposed to ALFUZZ D either through direct handling or through semen, because it could cause serious abnormalities to the growing fetus. Usage of condom during sexual intercourse is recommended among fertile men to avoid conception.

Can ALFUZZ D cause infertility?

Yes. ALFUZZ 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 ALFUZZ D make me feel dizzy?

Yes. ALFUZZ 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 ALFUZZ D?

You should take ALFUZZ D immediately when you remember. If it is time for your next dose skip the dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.

Is ALFUZZ D safe to use in children?

ALFUZZ D is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking ALFUZZ D. If your child experiences any symptoms of difficulty in urination consult child’s doctor immediately.

REFERENCES

1. KD. Tripathi. Antiadrenergic Drugs (Adrenergic Receptor Antagonists) and Drugs for Glaucoma and Androgens and Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Seventh edition. 2013. Page – 142-144 & 303.

2. B Ventimiglia, S Consoli, M Serrao, A Tsirgiotis. [Efficacy of dutasteride, alfuzosin or both on Quality of Life in patients with prostatic hyperplasia and BOO.A two-year spontaneous, observational, self-controlled study]. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April-June 2008. [Accessed on 12th November 2021] https://pubmed.ncbi.nlm.nih.gov/21086358/

3. Mostafa Elhilali, Mark Emberton, Haim Matzkin, R Jeroen A van Moorselaar, Rudolf Hartung, Niels Harving, Antonio Alcaraz, Guy Vallancien, ALF-ONE Study Group. Long-term efficacy and safety of alfuzosin 10 mg once daily: a 2-year experience in 'real-life' practice. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. March 2006. [Accessed on 12th November 2021] https://pubmed.ncbi.nlm.nih.gov/16469018/

4. Zhongbao Zhou, Shiqiang Song, Zhenli Gao, Jitao Wu, Jiajia Ma, and Yuanshan Cui. The efficacy and safety of dutasteride compared with finasteride in treating men with androgenetic alopecia: a systematic review and meta-analysis. NCBI; PMC US National Library of Medicine, National Institute of Health. February 2019. [Accessed on 12th November 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6388756/

5. R Jeroen A van Moorselaar, Rudolf Hartung, Mark Emberton, Niels Harving, Haim Matzkin, Mostafa Elhilali, Antonio Alcaraz, Guy Vallancien, ALF-ONE Study Group. Alfuzosin 10 mg once daily improves sexual function in men with lower urinary tract symptoms and concomitant sexual dysfunction. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. March 2005. [Accessed on 12th November 2021] https://pubmed.ncbi.nlm.nih.gov/15705088/

6. Sanofi Winthrop Industrie. Electronic Medicines Compendium (EMC). [Revised in September 2020] [Accessed on 12th November 2021] https://www.medicines.org.uk/emc/files/pil.1475.pdf

7. APL Swift Services (Malta) Limited or Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in August 2019] [Accessed on 12th November 2021] https://www.medicines.org.uk/emc/files/pil.9277.pdf

8. Cipla Ltd. ALFUSIN D Tablets (Alfuzosin hydrochloride + Dutasteride). Ciplamed.com. [Revised in December 2013] [Accessed on 12th November 2021] https://www.ciplamed.com/content/alfusin-d-tablets

PRODUCT DETAILS

    Country Of Origin
    India
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