What the medication is used for:
DUTASTERIDE is used alone (monotherapy) in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates.
Use in hair loss
DUTASTERIDE is not approved by Health Canada for use in hair loss. Due to its clinical effectiveness, DUTASTERIDE is widely used ‘off label’ for hair loss.
When it should not be used:
- Women and children should never take DUTASTERIDE.
- Do not take DUTASTERIDE if you are allergic to dutasteride or other alpha-reductase inhibitors or any of the other ingredients of DUTASTERIDE.
What the medicinal ingredient is:
Dutasteride
WARNINGS AND PRECAUTIONS:
Serious Warnings and Precautions
- DUTASTERIDE is for use by men only
- Women who are pregnant, or who may become pregnant, should not handle DUTASTERIDE as it may pass through the skin. 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 you use DUTASTERIDE, talk to your doctor or pharmacist if:
- You have or have had liver problems.
- You have or have had prostate cancer or urinary tract disease.
What are the special precautions about DUTASTERIDE?
- Do not donate blood while taking DUTASTERIDE and for at least 6 months after you have stopped taking DUTASTERIDEin 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.
Checking for prostate cancer
A man can have BPH and prostate cancer at the same time. Prior to treatment with DUTASTERIDE, you should have a thorough urological evaluation to determine the severity of your 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 you to have a Prostate Specific Antigen (PSA) test which is used for screening prostate cancer, you should tell your doctor that you are taking DUTASTERIDE.
DUTASTERIDE can lower the PSA test result. A low PSA level may give you a false sense of security about your risk for prostate cancer. Your doctor is aware of this effect and can still use PSA to see if you might have prostate cancer.
Increases in your PSA levels while on treatment with DUTASTERIDE (even if the PSA levels are in the normal range) should be evaluated by your doctor.
INTERACTIONS WITH THIS MEDICATION:
Interactions with other medicines
Some medicines can react with DUTASTERIDE and may make it more likely that you will 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 your doctor knows if you are taking any of these, or other medicines. Your dose of DUTASTERIDE may need to be reduced. Remember to include all medicines, herbal remedies or dietary supplements, such as vitamins, iron or calcium, which you have bought yourself without a prescription.
Do not eat grapefruit or drink grapefruit juice while taking DUTASTERIDE. This drink is known to increase the blood levels of some drugs in the body.
PROPER USE OF THIS MEDICATION:
Always take DUTASTERIDE exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Usual dose:
Monotherapy: One DUTASTERIDE 0.5 mg capsule once a day.
Combination therapy: One 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 your mouth or throat sore.
- The capsules can be taken with or without food.
Do not share your medication with others.
Overdose
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.
Missed Dose:
If you miss a dose, you can just take the next scheduled dose. Don’t take any extra capsules to make up for doses you forgot to take.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM:
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
If breasts swelling or tenderness becomes troublesome, or if you notice breast lumps or nipple discharge, you should talk to your 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.