Apo-Dutasteride

Dutasteride.

Each capsule contains 0.5 mg of dutasteride.
Excipients/Inactive Ingredients: butylated hydroxytoluene, gelatin, glycerine, mono- and di-glycerides of caprilic/capric acids, purified water, titanium dioxide and yellow ferric oxide, and red printing ink containing iron red oxide as the colourant.

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). APO-DUTASTERIDE belongs to a group of medicines called 5 alpha-reductase enzyme inhibitors.
APO-DUTASTERIDE lowers DHT production in the body, leading to a shrinkage of the enlarged prostate in most men, which leads to improvements in BPH symptoms and improved urinary flow, reduced risk of acute urinary retention (or where patient suddenly cannot urinate at all), and reduced risk of the need for BPH related surgery.
APO-DUTASTERIDE is also used with another medicine called tamsulosin, an alpha blocker, which acts by relaxing smooth muscle in the prostate and bladder neck at the site of obstruction, resulting in improvements in BPH symptoms and improved urinary flow.
Symptoms of BPH may be seen to improve after 3 months of treatment with APO-DUTASTERIDE, however, it may take up to 6 months to know if treatment with APO-DUTASTERIDE will be beneficial.

APO-DUTASTERIDE is used alone (monotherapy) in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates.
APO-DUTASTERIDE is also used in combination with the alpha blocker, tamsulosin, in the treatment of moderate to severe symptomatic BPH in men with enlarged prostates.
Combination therapy was also shown to be better than tamsulosin, but not APO-DUTASTERIDE at reducing the risk of acute urinary retention (or where patient suddenly cannot urinate at all) and/or the need for BPH related surgery.
APO-DUTASTERIDE is not approved for use in the prevention of prostate cancer.

Always take APO-DUTASTERIDE exactly as advised by the doctor.
Check with the doctor or pharmacist if not sure.
Usual dose: Monotherapy: One APO-DUTASTERIDE 0.5 mg capsule once a day.
Combination therapy: One APO-DUTASTERIDE 0.5 mg capsule once a day with one tamsulosin 0.4 mg once a day.
Swallow the capsule whole. DO NOT chew or open the capsules. Contact with the contents of the capsules may make the mouth or throat sore.
The capsules can be taken with or without food.
Do not share the medication with others.
Missed Dose: If the patient misses a dose, he can just take the next scheduled dose.
Don't take any extra capsules to make up for doses that were forgotten to be taken.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Women and children should never take APO-DUTASTERIDE.
Do not take APO-DUTASTERIDE if allergic to dutasteride or other alpha-reductase inhibitors or any of the other ingredients of APO-DUTASTERIDE.

APO-DUTASTERIDE is for use by men only.
Use in Pregnancy: Women who are pregnant, or who may become pregnant, should not handle APO-DUTASTERIDE as it may pass through the skin. APO-DUTASTERIDE may affect the normal development of the external genital organs in a male baby.

Heart failure (the heart does not pump blood as well as it should) was reported more often in patients taking dutasteride and an alpha-blocker, tamsulosin, in clinical studies than in patients taking dutasteride. It is not known if taking dutasteride and an alpha-blocker caused heart failure.
BEFORE the patient uses APO-DUTASTERIDE, talk to the doctor or pharmacist if: The patient has or has had liver problems; The patient has or has had prostate cancer or urinary tract disease.
Special precautions about APO-DUTASTERIDE: Do not donate blood while taking APO-DUTASTERIDE and for at least 6 months after taking APO-DUTASTERIDE has been stopped in order to prevent giving dutasteride to a pregnant woman through blood transfusion.
In a clinical study of men aged 50 to 75 years with a recent negative biopsy for prostate cancer and an increased prostate specific antigen (PSA) blood test, men taking dutasteride had a serious form of prostate cancer more often than men who did not take dutasteride.
The patient must see the doctor regularly: While taking APO-DUTASTERIDE, the patient must have regular checkups, including digital rectal examination and PSA examination. Follow the doctor's advice about when to have these checkups.
Checking for prostate cancer: A man can have BPH and prostate cancer at the same time. Prior to treatment with APO-DUTASTERIDE, the patient should have a thorough urological evaluation to determine the severity of the condition, and to rule out the need for immediate surgery or the possibility of prostate cancer.
About Prostate Specific Antigen (PSA): If a doctor asks the patient to have a Prostate Specific Antigen (PSA) test which is used for screening prostate cancer, the patient should tell the doctor that he is taking APO-DUTASTERIDE.
APO-DUTASTERIDE can lower the PSA test result. A low PSA level may give a false sense of security about the risk for prostate cancer. The doctor is aware of this effect and can still use PSA to see if the patient might have prostate cancer.
Increases in the PSA levels while on treatment with APO-DUTASTERIDE (even if the PSA levels are in the normal range) should be evaluated by the doctor.

The most common side effects of Dutasteride capsules, taken alone or in combination with tamsulosin, are not being able to achieve or maintain an erection *(impotence), decrease in libido* (decreased desire to have sex or a reduced sex drive), changes or problems with ejaculations* (including a decrease in amount of semen released during sex) and breast swelling or tenderness.
If breasts swelling or tenderness becomes troublesome, or if the patient notices breast lumps or nipple discharge, the patient should talk to the doctor about these changes. Additionally, some people may experience dizziness when taking Dutasteride capsules with tamsulosin.
Rare side effects (may affect up to 1 in 1,000 people) of hair loss (usually from the body) or abnormal hair growth have been reported.
Very rare side effects (1 in 10,000 people) of allergic reactions depressed mood, and pain and swelling in the testicles have been reported.
Breast cancer has been reported in patients taking Dutasteride capsules however, the relationship between long-term use of Dutasteride capsules and breast cancer is not known.
*In a small number of people some of these events may continue after taking Dutasteride capsules is stopped.
Serious side effects, how often they happen and what to do about them: See table.

Click on icon to see table/diagram/image

If these side effects and any other side effects not mentioned in this monograph are noticed, tell the doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking Dutasteride capsules, contact the doctor or pharmacist.

Some medicines can react with APO-DUTASTERIDE and may make it more likely to have side effects. Some of these medicines may include: Verapamil or diltiazem (for high blood pressure); Ritonavir (for HIV); Ketaconazole (for fungal infections); Ciprofloxacin or troleandomycin (for bacterial infections); Cimetidine (for heart burn); Certain herbal medicines such as St. John's Wort or Milk Thistle.
Make sure the doctor knows if any of these, or other medicines, is being taken. The dose of APO-DUTASTERIDE may need to be reduced. Remember to include all medicines, herbal remedies or dietary supplements, such as vitamins, iron or calcium, which have been bought without a prescription.
Do not eat grapefruit or drink grapefruit juice while taking APO-DUTASTERIDE. This drink is known to increase the blood levels of some drugs in the body.

Store APO-DUTASTERIDE capsules at room temperature 15°C - 30°C (59°F-86°F).
Return any cracked or leaking capsules to the pharmacist for replacement.
Return any unused capsules to a pharmacist.

Drugs for Bladder & Prostate Disorders

G04CB02 - dutasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.

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