Description
Note: Women of childbearing potential should not use or handle this medicine. Dutasteride can cause birth defects in male fetuses.
Dutasteride and tamsulosin combination is used 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. When the prostate gland gets larger, certain muscles in the gland 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 gland to grow. Dutasteride will cause the size of the prostate to decrease, but the effect lasts only as long as the medicine is taken. If it is stopped, the prostate begins to grow again.
Tamsulosin helps relax the muscles in the prostate gland and the opening of the bladder. This may help increase the flow of urine or decrease symptoms.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
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 and tamsulosin combination 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 and tamsulosin combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Boceprevir
- Mavorixafor
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Alfuzosin
- Avacopan
- Bunazosin
- Carbamazepine
- Celecoxib
- Ceritinib
- Clarithromycin
- Cobicistat
- Conivaptan
- Dapiprazole
- Desvenlafaxine
- Doxazosin
- Escitalopram
- Fedratinib
- Idelalisib
- Iloperidone
- Indinavir
- Itraconazole
- Ketoconazole
- Lopinavir
- Mavacamten
- Melphalan
- Moxisylyte
- Nefazodone
- Nelfinavir
- Omaveloxolone
- Paroxetine
- Phenobarbital
- Phenoxybenzamine
- Phentolamine
- Posaconazole
- Prazosin
- Primidone
- Ritonavir
- Saquinavir
- Sertraline
- Sildenafil
- Silodosin
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.
- Acebutolol
- Alprenolol
- Atenolol
- Avanafil
- Betaxolol
- Bevantolol
- Bisoprolol
- Bucindolol
- Carteolol
- Carvedilol
- Celiprolol
- Cimetidine
- Ciprofloxacin
- Dilevalol
- Diltiazem
- Esmolol
- Ketoconazole
- Labetalol
- Levobunolol
- Mepindolol
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Oxprenolol
- Penbutolol
- Pindolol
- Propranolol
- Ritonavir
- Sotalol
- Talinolol
- Tertatolol
- Timolol
- 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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:
- Allergy to sulfa drugs (eg, sulfamethoxazole, sulfasalazine, sulfasoxazole, Azulfidine®, Bactrim®, or Septra®)—Increased allergic reaction in patients with this condition.
- Hypotension (low blood pressure) or
- Postural hypotension (low blood pressure when arising), history of or
- Priapism (painful or prolonged erection of the penis)—Use with caution. May make these conditions worse.
- 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.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Take the capsule at least 30 minutes after the same meal each day. Swallow the capsule whole. Do not chew or open it.
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—One capsule once a day. Each capsule contains 0.5 milligram (mg) dutasteride and 0.4 mg tamsulosin.
- 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 your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
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.
Because this medicine may cause some people to become dizzy or feel faint, make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
Dizziness, lightheadedness, or fainting may occur after you take this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help with this problem. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.
If you plan to have cataract surgery, tell your eye doctor (ophthalmologist) that you are taking this medicine or that you used this medicine in the previous 9 months. A serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in some patients who were taking this medicine or who had recently taken this medicine when they had cataract surgery.
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 will not prevent prostate cancer but may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.
You should seek medical attention right away if you experience a prolonged erection while using this medicine. This is an extremely rare unwanted effect that must be treated right away to prevent permanent erectile damage (impotence).
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 does not usually affect normal sexual abilities for most men. You may notice that you ejaculate less fluid when you have sex.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
More common
- Chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
Less common
- Chest pain
- cough or hoarseness
- fever
- lower back or side pain
- painful or difficult urination
Incidence not known
- Blistering, flaking, or peeling of the skin
- blurred vision
- difficulty with breathing
- fast, irregular, pounding, or racing heartbeat or pulse
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- pain or swelling of the treated skin
- painful or prolonged erection of the penis
- sweating
- trouble breathing
- 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:
More common
- Change or problem with discharge of semen
- decreased interest in sexual intercourse
- dizziness
- enlarged and painful breasts
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
Less common
- Back pain
- body aches or pain
- congestion
- diarrhea
- dryness or soreness of the throat
- headache
- increased cough
- lack or loss of strength
- pain or tenderness around the eyes and cheekbones
- runny nose
- sleepiness or unusual drowsiness
- sleeplessness
- sneezing
- stuffy nose
- tender, swollen glands in the neck
- tightness of the chest
- trouble sleeping
- trouble with swallowing
- unable to sleep
- voice changes
Incidence not known
- Bloody nose
- constipation
- hives or welts, itching, skin rash
- joint or muscle pain
- red irritated eyes
- red skin lesion, often with a purple center
- redness of the skin
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- vomiting
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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