Description
Cabergoline is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas (tumors of the pituitary gland).
It works by stopping the brain from making and releasing the prolactin hormone from the pituitary gland. Cabergoline use is usually stopped when prolactin levels are normal for 6 months. It may be given again if symptoms of too much prolactin occur again.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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
Appropriate studies have not been performed on the relationship of age to the effects of cabergoline 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 cabergoline in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving cabergoline.
Breastfeeding
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
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.
- Sulpiride
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.
- Haloperidol
- Itraconazole
- Metoclopramide
- Olanzapine
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:
- Fibrotic disorders (scar-like tissues in the heart, lungs, or stomach), history of or
- Heart problems (eg, heart valve disease), history of or
- Hypertension (high blood pressure), uncontrolled—Should not be used in patients with these conditions.
- Heart disease or
- Lung disease or other breathing problems—Use with caution. May make these conditions worse.
- High blood pressure, controlled or
- High blood pressure of pregnancy, or history of—Cabergoline usually decreases blood pressure but at times it may increase blood pressure and worsen these conditions.
- Liver disease—Use with caution. You may need a lower dose of this medicine.
- Postpartum lactation—Should not be used to prevent or suppress breast milk production after giving birth.
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. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
You may take this medicine with or without food.
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 (tablets):
- For disorders of high prolactin levels or pituitary tumors:
- Adults—At first, 0.25 milligram (mg) 2 times a week. Your doctor may increase your dose every 4 weeks as needed, according to body prolactin levels, up to 1 mg two times a week.
- Children—Use and dose must be determined by the doctor.
- For disorders of high prolactin levels or pituitary tumors:
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 important that your doctor check your progress at regular visits while you are taking this medicine to make sure that this medicine is working properly. Blood tests for the heart may be needed to check for unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant. Your doctor will ask you to do tests if you think you are pregnant.
This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help.
Check with your doctor right away if you have symptoms of fainting, hallucinations (seeing, hearing, or feeling things that are not there), lightheadedness, stuffy nose, or racing heartbeat.
This medicine may cause heart valve problems and fibrosis (scarring) in the heart, chest, lungs, or stomach area. Check with your doctor right away if you have chest pain, lumps or tenderness in the stomach, persistent cough, swelling in the arms or legs, or trouble breathing.
Also tell your doctor if you have persistent cough along with chest discomfort or troubled breathing while you are using this medicine. This could be symptoms of a serious lung disorder called pulmonary fibrosis.
Some people who have used this medicine had unusual changes in their mood or behavior. Talk with your doctor right away if you start having unusual urges, including gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.
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:
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- general feeling of discomfort or illness
- rapid weight gain
- swelling around the eyes
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Chest pain or tightness
- continuing loss of appetite
- continuing or severe abdominal or stomach pain
- continuing or severe nausea and vomiting
- cough
- decreased ability to exercise
- fever
- increased frequency of urination
- loss of appetite
- lower abdominal or stomach pain
- lower back pain
- nausea
- trouble breathing
- vomiting
- weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Fainting
- seeing, hearing, or feeling things that are not there
- stuffy nose
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
- Difficulty having a bowel movement (stool)
- dizziness
- excess air or gas in the stomach or intestines
- full feeling
- headache
- lack or loss of strength
- passing gas
Less common
- Abdominal or stomach pain
- acid or sour stomach
- anxiety
- belching
- blemishes on the skin
- breast pain
- burning, itching, or stinging of the skin
- changes in vision
- cramps
- depression
- diarrhea
- difficulty with moving
- dry mouth or toothache
- feeling of constant movement of self or surroundings
- feeling of warmth
- gas
- heartburn
- heavy bleeding
- indigestion
- itching skin
- joint pain
- muscle aches, pains, or stiffness
- pimples
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- sensation of spinning
- shivering
- sleepiness or unusual drowsiness
- sneezing
- sore throat
- stomach discomfort or upset
- sudden sweating
- trouble sleeping
- weight loss
Rare
- Bloody nose
- difficulty in concentrating
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
Incidence not known
- Attack, assault, or force
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- hair loss or thinning of the hair
- pathological gambling
- severe mood or mental changes
- unusual behavior
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.
DRG-20062485
