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INTRODUCTION AFDURA 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. AFDURA is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in a...
AFDURA 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. AFDURA 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 AFDURA inform your doctor if you have hypotension, or liver, kidney, or heart disease as a precaution. During treatment with AFDURA, 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 AFDURA, 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 AFDURA 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 AFDURA are dizziness, fainting, weakness, and decreased sex drive or breast enlargement in men. Contact your doctor if any of the symptoms worsen.
AFDURA 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, AFDURA help in shrinkage of an enlarged prostate, making it easier for the urine to pass through and provide relief from symptomatic BPH.
Take AFDURA as advised by your physician. Swallow the medicine as a whole and do not crush or chew the medicine. Try to take AFDURA 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.
Stop taking AFDURA and contact your doctor immediately if you experience any of the following side effects:
Nausea:
Try to take AFDURA 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.
Women who are pregnant or can become pregnant should not handle the leaked medicine or be exposed to the semen of men taking AFDURA, 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 AFDURA.
AFDURA is not indicated to use in breast-feeding women, as it is indicated to use only in men.
Do not drive or operate any heavy tools or machines if you experience dizziness, drowsiness, sleepiness, weakness or headache after taking AFDURA.
Avoid consumption of alcohol while taking AFDURA, as it could make you feel dizzier or weaker.
AFDURA should be taken with caution in patients with severe kidney impairment. Consult your doctor before taking AFDURA.
AFDURA 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 AFDURA.
Do not take AFDURA if you are allergic to Alfuzosin or Dutasteride.
AFDURA should be taken with caution in patients with heart disease (Ex. angina, prolong QT interval). Consult your doctor before taking AFDURA.
AFDURA is not recommended for use if you:
Before taking AFDURA, inform your physician if you:
Use in pediatrics:
AFDURA is not recommended for use in children and adolescents (below 18 years). Kindly consult your doctor before taking AFDURA.
Use in geriatrics:
AFDURA should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking AFDURA.
A. Drug-Drug interactions:
Before taking AFDURA inform to your doctor, if you are taking any of these medicines:
Overdosage:
If you or anyone else accidentally take too much of AFDURA, 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).
| Drug | : |
Alfuzosin, Dutasteride |
| Pharmacological Category | : |
Alpha-1 adrenergic blockers, 5-Alpha reductase inhibitors |
| Therapeutic Indication | : |
Benign Prostatic Hyperplasia |
| Dosage Forms | : |
Tablet, Capsule |
Can the use of AFDURA cause long-lasting painful penile erection?
Yes. AFDURA can rarely cause a serious condition called priapism (persistent painful penile erection unrelated to sexual activity). Stop taking AFDURA 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 AFDURA cause prostate cancer?
Yes. AFDURA 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 AFDURA by male individuals affects pregnancy?
Before taking AFDURA, 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 AFDURA 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 AFDURA cause infertility?
Yes. AFDURA 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 AFDURA make me feel dizzy?
Yes. AFDURA 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 AFDURA?
You should take AFDURA 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 AFDURA safe to use in children?
AFDURA is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking AFDURA. If your child experiences any symptoms of difficulty in urination consult child’s doctor immediately.
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