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|Apo-Bromocriptine

BROMOCRIPTINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Parlodel
• Parlodel SnapTabs

In Canada—

• Alti-Bromocriptine
• Apo-Bromocriptine
• Parlodel

Generic name product may be available in the U.S. and Canada.

Category

• Antidyskinetic
• Antihyperprolactinemic
• Dopamine agonist
• Growth hormone suppressant, acromegaly
• Infertility therapy adjunct
• Lactation inhibitor
• Neuroleptic malignant syndrome therapy

Description

Bromocriptine (broe-moe-KRIP-teen) belongs to the group of medicines known as ergot alkaloids. Bromocriptine blocks release of a hormone called prolactin from the pituitary gland. Prolactin affects the menstrual cycle and milk production. Bromocriptine is used to treat certain menstrual problems or to stop milk production in some women or men who have abnormal milk leakage. It is also used to treat infertility in both men and women that occurs because the body made too much prolactin.

Bromocriptine is also used to treat some people who have Parkinson"s disease. It works by stimulating certain parts of the brain and nervous system that are involved in this disease.

Bromocriptine is also used to treat acromegaly (overproduction of growth hormone) and pituitary prolactinomas (tumors of the pituitary gland).

Bromocriptine may also be used for other conditions as determined by your doctor.

Bromocriptine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Capsules (U.S. and Canada)
• Tablets (U.S. and Canada)

Before Using This Medicine

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 bromocriptine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to bromocriptine or other ergot medicines such as ergotamine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Bromocriptine is not generally recommended for use during pregnancy. However, bromocriptine can be used during pregnancy in certain patients who are closely monitored by their doctor.

Breast-feeding—This medicine stops milk from being produced.

Children— This medicine has been tested in a limited number of teenagers 15 years of age and older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults. Appropriate studies have not been done in teenagers younger than 15 years of age, and there is no specific information comparing use of bromocriptine in these teenagers with use in other age groups.

Older adults—Confusion, hallucinations, or uncontrolled body movements may be more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of bromocriptine.

Other medicines—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 bromocriptine, it is especially important that your health care professional know if you are taking any of the following:

• Ergot alkaloids (dihydroergotamine [e.g., D.H.E. 45], ergoloid mesylates [e.g., Hydergine], ergonovine [e.g., Ergotrate], ergotamine [e.g., Gynergen], methylergonovine [e.g., Methergine], methysergide [e.g., Sansert])—Severe cases of high blood pressure have occurred with the use of bromocriptine. This may be made worse with the use of ergot alkaloids

• Erythromycin (e.g., E.E.S. or Erytab) or
• Risperidone (e.g., Risperdal) or
• Ritonavir (e.g., Norvir)—Use of these medications with bromocriptine may greatly increase the effects of bromocriptine

Other medical problems—The presence of other medical problems may affect the use of bromocriptine. Make sure you tell your doctor if you have any other medical problems, especially:

• High blood pressure (or history of) or
• Pregnancy-induced high blood pressure (history of)—Rarely, bromocriptine can make the high blood pressure worse

• Liver disease—Toxic effects of bromocriptine may occur in patients with liver disease because the body is not able to remove bromocriptine from the bloodstream as it normally would

• Mental problems (history of)—Bromocriptine may make certain mental problems worse

Proper Use of This Medicine

If bromocriptine upsets your stomach, it may be taken with meals or milk. Also, taking the dose at bedtime may help to lessen nausea if it occurs. If stomach upset continues, check with your doctor. Your doctor may recommend that you take the first doses vaginally.

Dosing—The dose of bromocriptine 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 bromocriptine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets 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 taking bromocriptine .

• For oral dosage forms (capsules and tablets):
  • For infertility, male hormone problem (male hypogonadism), starting the menstrual cycle (amenorrhea), or stopping abnormal milk secretion from nipples (galactorrhea):
    • Adults and teenagers 15 years of age or older—At first, 1.25 to 2.5 milligrams (mg) once a day taken at bedtime with a snack. Then your doctor may change your dose by 2.5 mg every three to seven days as needed. Doses greater than 5 mg a day are taken in divided doses with meals or at bedtime with a snack.
    • Teenagers less than 15 years of age and children—Use and dose must be determined by your doctor.
  • For lowering growth hormone (acromegaly):
    • Adults and teenagers 15 years of age or older—At first, 1.25 to 2.5 milligrams (mg) once a day taken at bedtime with a snack for three days. Then your doctor may change your dose by 1.25 or 2.5 mg every three to seven days as needed. Doses greater than 5 mg are divided into smaller doses and taken with meals or at bedtime with a snack.
    • Teenagers less than 15 years of age and children—Use and dose must be determined by your doctor.
  • For Parkinson"s disease:
    • Adults and teenagers 15 years of age or older—At first, 1.25 milligrams (mg) one or two times a day taken with meals or at bedtime with a snack. Then your doctor may change your dose over several weeks as needed.
    • Teenagers less than 15 years of age and children—Use and dose must be determined by your doctor.
  • For pituitary tumors:
    • Adults and teenagers 15 years of age or older—At first, 1.25 milligrams (mg) two or three times a day taken with meals. Then your doctor may change your dose over several weeks as needed.
    • Teenagers less than 15 years of age and children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine and remember it within 4 hours, take the missed dose when you remember it. However, if a longer time has passed, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is 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.

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 anything else that could be dangerous if you are dizzy or are not alert .

Dizziness is more likely to occur after the first dose of bromocriptine. Taking the first dose at bedtime or when you are able to lie down may lessen problems. It may also be helpful if you get up slowly from a lying or sitting position. Your doctor may also recommend that you take the first dose vaginally.

Bromocriptine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist . Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

It may take several weeks for bromocriptine to work. Do not stop taking this medicine or reduce the amount you are taking without first checking with your doctor.

Drinking alcohol while you are taking bromocriptine may cause you to have a certain reaction. Avoid alcoholic beverages until you have discussed this with your doctor . Some of the symptoms you may have if you drink any alcohol while you are taking this medicine are blurred vision, chest pain, confusion, fast or pounding heartbeat, flushing or redness of face, nausea, severe weakness, sweating, throbbing headache, or vomiting.

For females who are able to bear children and who are taking this medicine for menstrual or infertility problems, to stop milk production, or to treat acromegaly or pituitary tumors :

• It is best to use some type of birth control while you are taking bromocriptine. However, do not use oral contraceptives (“the Pill”) since they may prevent this medicine from working. For women using bromocriptine for infertility, tell your doctor when your normal menstrual cycle returns. If you wish to become pregnant, you and your doctor should decide on the best time for you to stop using birth control. Tell your doctor right away if you think you have become pregnant while taking this medicine. You and your doctor should discuss whether or not you should continue to take bromocriptine during pregnancy.
• Check with your doctor right away if you develop blurred vision, a sudden headache, or severe nausea and vomiting.

Side Effects of This Medicine

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.

Some serious side effects have occurred during the use of bromocriptine to stop milk flow after pregnancy or abortion. These side effects have included strokes, seizures (convulsions), and heart attacks. Some deaths have also occurred. You should discuss with your doctor the good that this medicine will do as well as the risks of using it.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

Some side effects may be more likely to occur in patients who are taking bromocriptine for Parkinson"s disease, acromegaly, or pituitary tumors since they may be taking larger doses.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, bromocriptine is used in certain patients with the following medical conditions:

• To stop milk production after an abortion or miscarriage or in women after a delivery who should not breast-feed for medical reasons
• Neuroleptic malignant syndrome

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 08/20/1997

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