Description
Note: Women of childbearing potential should not use or handle dutasteride capsules. Dutasteride can cause birth defects in male fetuses.
Dutasteride is used alone or in combination with tamsulosin (Flomax®) to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems with urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely.
Dutasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate to grow. As a result, the size of the prostate is decreased. The effect of dutasteride lasts only as long as the medicine is taken. If it is stopped, the prostate begins to grow again.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Dutasteride is not indicated for use in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dutasteride in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Ceritinib
- Itraconazole
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cimetidine
- Ciprofloxacin
- Diltiazem
- Ketoconazole
- Ritonavir
- Verapamil
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
You may take this medicine with or without food.
Swallow the capsule whole. Do not crush, chew, or open it. The contents of the capsule may irritate your lips, mouth, or throat.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For benign prostatic hyperplasia:
- Adults—0.5 milligram (mg) once a day.
- Children—Use is not recommended.
- For benign prostatic hyperplasia:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check you at regular visits to make sure that this medicine is working properly and to check for any unwanted effects that may be caused by this medicine.
Women and children should not use this medicine. Pregnant women or women who may become pregnant should not handle or touch the capsules. Dutasteride can be absorbed through the skin and can cause birth defects in male fetuses. If a pregnant woman does come in contact with this medicine, the affected area should be washed right away with soap and water, especially if the capsule is broken.
Men who have taken this medicine should not donate blood until 6 months have passed since the last dose. Dutasteride can remain in your blood for a long time and be passed on to a pregnant woman who receives a blood transfusion.
This medicine may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.
This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.
This medicine does not usually affect normal sexual abilities for most men. You may notice that you ejaculate less fluid when you have sex.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Rare
- Chest pain or discomfort
- dilated neck veins
- extreme fatigue
- irregular breathing
- irregular heartbeat
- swelling of the face, fingers, feet, or lower legs
- trouble breathing
- weight gain
Incidence not known
- Blistering, flaking, or peeling of the skin
- cough
- difficulty with swallowing
- dizziness
- fast heartbeat
- hives or welts, itching skin, rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- tightness in the chest
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Abnormal ejaculation
- decreased interest in sexual intercourse
- decreased sexual performance or desire
- impotence
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- pain, soreness, swelling, or discharge from the breast or breasts
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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