Description
Bromocriptine belongs to the group of medicines known as ergot alkaloids. Bromocriptine blocks the 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 (eg, amenorrhea) in women and stops milk production in some men and women who have abnormal milk leakage. It is also used to treat infertility in both men and women that occurs because the body is making too much prolactin.
Bromocriptine is also used to treat acromegaly (overproduction of growth hormone) and pituitary prolactinomas (tumors of the pituitary gland).
Bromocriptine is also used to treat the signs and symptoms of Parkinson's disease, often in combination with levodopa.
Bromocriptine is also used together with proper diet and exercise to lower blood sugar levels in patients with type 2 diabetes.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Capsule
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 bromocriptine to treat acromegaly, Parkinson's disease, and type 2 diabetes in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of bromocriptine in children 16 years of age and older with prolactin-secreting pituitary adenomas. However, safety and efficacy have not been established in children younger than 16 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bromocriptine in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and are more likely to have confusion, hallucinations, or uncontrolled body movements, and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving bromocriptine.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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.
- Atazanavir
- Cobicistat
- Darunavir
- Eletriptan
- Frovatriptan
- Itraconazole
- Letermovir
- Naratriptan
- Nirmatrelvir
- Rizatriptan
- Sulpiride
- Sumatriptan
- Zolmitriptan
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.
- Abametapir
- Almotriptan
- Amoxapine
- Avacopan
- Boceprevir
- Carbamazepine
- Ceritinib
- Chlorothiazide
- Chlorthalidone
- Clarithromycin
- Clomipramine
- Conivaptan
- Cyclosporine
- Epinephrine
- Fedratinib
- Fexinidazole
- Fosnetupitant
- Furosemide
- Haloperidol
- Hydrochlorothiazide
- Hydroflumethiazide
- Idelalisib
- Indapamide
- Indinavir
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glargine, Recombinant
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Isometheptene
- Ketoconazole
- Lopinavir
- Mavacamten
- Metoclopramide
- Metolazone
- Nefazodone
- Nelfinavir
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
- Kava
- Thioridazine
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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:
- Coronary artery disease or other serious heart or blood vessel disorder, history of or
- Hypertension (high blood pressure), uncontrolled or
- Pregnancy-induced high blood pressure—Parlodel® should not be used in patients with these conditions unless medically necessary.
- Diabetic ketoacidosis (ketones in the blood) or
- Syncopal (fainting) migraine headaches or
- Type I diabetes or
- Postpartum patients (women who had recently given birth)—Cycloset® 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.
- Galactose intolerance (a rare genetic disorder) or
- Glucose-galactose malabsorption (a rare genetic disorder) or
- Lactase deficiency (a rare genetic disorder), severe—Use of Parlodel® is not recommended in patients with these conditions.
- Heart attack, history of or
- Heart or blood vessel disease (eg, pericardial effusion) or
- Heart rhythm problems or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Lung disease (eg, pleural effusion, pulmonary fibrosis) or
- Mental illness (eg, psychosis, dementia), history of or
- Retroperitoneal fibrosis or
- Seizures, history of or
- Stomach ulcers or bleeding, or history of or
- Stroke, history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only 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.
Cycloset® comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Carefully follow 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.
Take this medicine with food.
Take Cycloset® within 2 hours after you wake up in the morning.
Take Parlodel® at bedtime to help lessen nausea if it occurs. If stomach upset continues, check with your doctor.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
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, pituitary tumors, male hormone problem (male hypogonadism), starting the menstrual cycle (amenorrhea), or stopping abnormal milk secretion from the nipples (galactorrhea):
- Adults and children 16 years of age or older—At first, 1.25 to 2.5 milligrams (mg) once a day. Your doctor may increase your dose by 2.5 mg every 2 to 7 days as needed and tolerated. However, the dose is usually not more than 15 mg per day.
- Children 11 to 15 years of age—At first, 1.25 to 2.5 mg once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 10 mg per day.
- Children younger than 11 years of age—Use and dose must be determined by your doctor.
- For lowering growth hormone (acromegaly):
- Adults—At first, 1.25 to 2.5 milligrams (mg) once a day taken at bedtime with a snack for 3 days. Your doctor may increase your dose by 1.25 or 2.5 mg every 3 to 7 days as needed. However, the dose is usually not more than 100 mg per day.
- Children—Use and dose must be determined by your doctor.
- For Parkinson's disease:
- Adults—At first, 1.25 milligrams (mg) two times a day. Your doctor may increase your dose over several weeks as needed. However, the dose is usually not more than 100 mg per day.
- 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.
- For infertility, pituitary tumors, male hormone problem (male hypogonadism), starting the menstrual cycle (amenorrhea), or stopping abnormal milk secretion from the nipples (galactorrhea):
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you missed a dose of Cycloset®, skip the missed dose and wait until the next morning to take it.
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 to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
For females using Parlodel® who are not trying to get pregnant:
- Use an effective form of birth control (other than oral contraceptives) to keep from getting pregnant. A pregnancy test is needed every 4 weeks during the amenorrheic period or every time you miss a monthly period. If you think you have become pregnant while using the medicine, tell your doctor right away.
- Check with your doctor right away if you develop blurred vision, a sudden headache, or severe nausea and vomiting.
Do not use Cycloset® if you had recently given birth to a child (postpartum). This medicine may cause serious and life-threatening problems when given to postpartum women, including high blood pressure, heart attack, seizures, stroke, or mental illness.
This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Do not drive or do anything else that could be dangerous unless you know how this medicine affects you.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine or when the dose is increased.
Parlodel® may increase your risk of having a condition called retroperitoneal fibrosis. This is more likely to occur if you are receiving this medicine on high doses and have been using it for a long time. Check with your doctor if you have continuing or severe stomach pain, increased frequency of urination, continuing loss of appetite, lower back pain, continuing or severe nausea and vomiting, or weakness while taking this medicine.
It is very important to follow carefully any instructions from your health care team about taking Cycloset®:
- 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.
Too much Cycloset® 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). 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 you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.
Symptoms of 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 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.
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. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This will decrease your chance of having withdrawal symptoms including anxiety, depression, difficulty in breathing, fast heartbeat, high fever, high or low blood pressure, lack of feeling or emotion, loss of bladder control, seizures, severe muscle stiffness, sweating, trouble sleeping, unusually pale skin, or unusual tiredness or weakness.
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.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling, compulsive shopping, or increased sex drive while using this medicine.
It is important that your doctor check you for melanoma (skin cancer) regularly if you have Parkinson's disease.
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:
More common
- Blurred vision
- chest pain or discomfort
- difficulty in speaking
- dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position
- double vision
- feeling, seeing, or hearing things that are not there
- feeling of constant movement of self or surroundings
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- lack or loss of strength
- nausea
- nervousness
- pain or discomfort in the arms, jaw, back, or neck
- pounding in the ears
- sensation of spinning
- severe mood or mental changes
- shakiness and unsteady walk
- slow or fast heartbeat
- slow speech
- sweating
- trouble breathing
- trouble sleeping
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual behavior
- vomiting
Less common—reported more often in patients with Parkinson's disease
- Confusion
- 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
- Increased frequency of urination
- loss of appetite, continuing
- lower back pain
- runny nose, continuing
- stomach pain, continuing or severe
- weakness
Rare
- Black, tarry stools
- bloody vomit
- fainting
- nausea
- nervousness
- seizures
- sudden weakness
- temporary blindness
- unusual headache
- vomiting, continuing or severe
Incidence not known
- Agitation
- anxiety
- blue or pale skin
- chest pain, possibly moving to the left arm, neck, or shoulder
- chills
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- cough
- diarrhea
- difficulty in speaking
- double vision
- false beliefs that cannot be changed by facts
- fever
- headache
- hearing loss
- heartburn
- high fever
- high or low blood pressure
- inability to move the arms, legs, or facial muscles
- inability to speak
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased frequency of urination
- indigestion
- loss of bladder control
- lower back pain
- severe muscle stiffness
- stuffy nose
- unusual tiredness or weakness
- unusually pale skin
- vomiting of blood or material that looks like coffee grounds
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
- Drowsiness
- dry mouth
- leg cramps at night
- loss of appetite
- mental depression
- stomach pain
- tingling or pain in the fingers and toes when exposed to cold temperatures
Incidence not known
- Hair loss
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.
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