Cycloset

Generic Name: bromocriptine (Oral route)

broe-moe-KRIP-teen

Commonly used brand name(s)

In the U.S.

• Cycloset


• Parlodel

Available Dosage Forms:

• Tablet


• Capsule

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Dopamine Agonist

Uses For Cycloset

Bromocriptine 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 is also used together with proper diet and exercise to treat high blood sugar levels in patients with type 2 diabetes.

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

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

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.

Before Using Cycloset

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 bromocriptine in the pediatric population. Safety and efficacy have not been established.

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bromocriptine in the elderly.

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with 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 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 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.

• Isometheptene


• Phenylpropanolamine

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.

• Bromperidol


• Clarithromycin


• Cyclosporine


• Kava


• Thioridazine

Interactions with Food/Tobacco/Alcohol

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:

• Diabetic ketoacidosis (ketones in the blood) or


• Syncopal (fainting) migraine headaches or


• Type I diabetes—Should not be used in patients with these conditions.

• Fever or


• Infection or


• Surgery or


• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.

• High blood pressure, or history of or


• Pregnancy-induced high blood pressure, history of—Rarely, bromocriptine can make the high blood pressure worse.

• Hypotension (low blood pressure) or


• Mental problems (e.g., psychotic disorder)—May make these conditions 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.

Proper Use of bromocriptine

This section provides information on the proper use of a number of products that contain bromocriptine. It may not be specific to Cycloset. Please read with care.

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.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

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 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 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 younger 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 younger 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 younger than 15 years of age and children—Use and dose must be determined by your doctor.
    
    
  
  
  • For type 2 diabetes:
    
    • Adults—At first, 0.8 milligram (mg) once a day, taken within two hours after waking up in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 4.8 mg per day.
    
    
    • Children—Use and dose must be determined by your 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.

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 While Using Cycloset

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.

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, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased.

Too much bromocriptine can cause low blood sugar (hypoglycemia) when it is used under certain conditions. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly and call someone on your health care team right away when you need advice.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your sugar level and then call your doctor for instructions.

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 the 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.

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.

Cycloset 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.

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.

Check with your doctor immediately if any of the following side effects occur:

More common

• Dizziness or lightheadedness, especially when getting up from a lying or sitting position


• nausea

Less common—reported more often in patients with Parkinson's disease

• Confusion


• hallucinations (seeing, hearing, or feeling things that are not there)


• uncontrolled movements of the body, such as the face, tongue, arms, hands, head, and upper body

Rare—reported more often in patients taking large doses

• Abdominal or stomach pain (continuing or severe)


• increased frequency of urination


• loss of appetite (continuing)


• lower back pain


• runny nose (continuing)


• weakness

Rare

• Black, tarry stools


• bloody vomit


• chest pain (severe)


• convulsions (seizures)


• fainting


• fast heartbeat


• headache (unusual)


• increased sweating


• nausea and vomiting (continuing or severe)


• nervousness


• shortness of breath (unexplained)


• vision changes (such as blurred vision or temporary blindness)


• weakness (sudden)

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:

Less common

• Constipation


• diarrhea


• drowsiness or tiredness


• dry mouth


• leg cramps at night


• loss of appetite


• mental depression


• stomach pain


• stuffy nose


• tingling or pain in the fingers and toes when exposed to cold


• vomiting

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 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.

See also: Cycloset side effects (in more detail)

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More Cycloset resources

• Cycloset Side Effects (in more detail)
• Cycloset Use in Pregnancy & Breastfeeding
• Cycloset Drug Interactions
• Cycloset Support Group
• 0 Reviews for Cycloset - Add your own review/rating

• Cycloset Consumer Overview


• Cycloset Prescribing Information (FDA)


• Cycloset MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromocriptine Prescribing Information (FDA)


• Bromocriptine MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromocriptine Mesylate Monograph (AHFS DI)


• Parlodel Prescribing Information (FDA)

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