Dostinex (Oral)

Cabergoline is used to treat various medical issues caused by too much of the hormone prolactin. It can be used for certain menstrual issues, fertility problems in both men and women, and pituitary prolactinomas (tumors of the pituitary gland).

It works by preventing the brain from producing and releasing the prolactin hormone from the pituitary gland. Cabergoline is typically stopped when prolactin levels are normal for 6 months. It may be given again if symptoms of excess prolactin return.

This medicine is available only with your doctor's prescription.

It is important for your doctor to monitor your progress during regular visits while you are taking this medicine to ensure it is working properly. You may need blood and other tests for your heart to check for unwanted effects.

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

This medicine may cause some people to feel drowsy, dizzy, or less alert than usual. Be aware of how this medicine affects you before driving, operating machinery, or doing other tasks that require you to be alert.

Dizziness, lightheadedness, or fainting may occur, especially when you stand up from a lying or sitting position. Getting up slowly may help.

Contact your doctor right away if you experience symptoms of fainting, hallucinations (seeing, hearing, or feeling things that are not there), lightheadedness, stuffy nose, or a racing heartbeat.

This medicine may increase your risk of serious heart, kidney, lung, or stomach problems. Seek immediate medical attention if you have chest pain or tightness, extreme tiredness, lower back or side pain, a lump or tenderness in the stomach, a persistent cough, difficulty breathing, or swelling in your hands, ankles, lower legs, or feet.

Also inform your doctor if you have a persistent cough along with chest discomfort or trouble breathing while using this medicine. This could be a sign of a serious lung condition called pulmonary fibrosis.

Some people who have taken this medicine experienced unusual changes in their behavior. Talk to your doctor if you notice problems with gambling or an increased sex drive while using this medicine.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. If you're using non-prescription products, be sure to read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of cabergoline in children. Its safety and effectiveness have not been confirmed for this group.

Geriatric

Studies done so far have not found any specific problems related to older adults that would limit the use of cabergoline. However, older patients are more likely to have age-related issues with the liver, kidneys, or heart, which may require careful monitoring and possible dose adjustments for those taking cabergoline.

Breast Feeding

Research shows that this medication may change how milk is produced or its composition. If you do not have an alternative medication prescribed, you should keep an eye on your baby for any side effects and ensure they are getting enough milk.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together, even if there may be interactions. If you are prescribed this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen for their possible importance and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you are taking.

• Sulpiride

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both medicines.

• Haloperidol
• Itraconazole
• Metoclopramide
• Olanzapine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with some types of food because interactions may happen. Drinking alcohol or using tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Fibrotic disorders (scar-like tissues in the heart, lungs, or stomach), history of or
• Heart problems (like heart valve disease), history of or
• Uncontrolled hypertension (high blood pressure)—Should not be used in patients with these conditions.

• Heart disease or
• Lung disease or other breathing problems—Use with caution. This may worsen these conditions.

• Controlled high blood pressure or
• History of high blood pressure during pregnancy—Cabergoline usually lowers blood pressure but may sometimes raise it and worsen these conditions.

• Liver disease—Use with caution. You may need a lower dose of this medicine.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, 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 a 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 happen 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 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.

In the U.S.

• Dostinex

Available Dosage Forms:

• Tablet

Therapeutic Class: Prolactin Secretion Inhibitor

Pharmacologic Class: Dopamine Agonist

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.