Descriptions:

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.

Proper Use:
Drug information provided by: Merative, Micromedex®

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.

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.

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.

However, if it is almost time for your next dose, check with your doctor to see if you can double your dose.

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:
Drug information provided by: Merative, Micromedex®

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 and other tests for the heart may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant or planning to become pregnant. Tell your doctor right away if you think you might be pregnant at any time while you are using this medicine. If you are pregnant, make sure your doctor knows if you also have high blood pressure. You and your doctor should discuss whether you should continue to take this medicine during pregnancy.

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 increase your risk of having serious heart, kidney, lung, or stomach problems. Check with your doctor right away if you have chest pain or tightness, extreme tiredness, lower back or side pain, lump or tenderness in the stomach, persistent cough, troubled breathing, or swelling in your hands, ankles, lower legs, or feet.

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 behavior. Talk with your doctor if you start having problems with gambling or increased sex drive 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:
Drug information provided by: Merative, Micromedex®

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 and pains
• muscle 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.