Loading…
BROMOCRIPTINE is a brand name for Bromocriptine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BROMOCRIPTINE (Bromocriptine Mesylate) is indicated for: Galactorrhea with or without amenorrhea due to hyperprolactinemia. Prolactin-dependent menstrual disorders and infertility: e.g. secondary amenorrhea, ovulatory insufficiency and short luteal phase. Prolactin-secreting adenomas: as a treatment for…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations BROMOCRIPTINE (bromocriptine mesylate) should always be taken with food. 5 mg (1/2 - 1 tablet), depending on the indication should be given at bedtime with food. Please consult the detailed dosage recommendations for each indication.
5 mg (1 tablet) twice daily with meals. 5 mg three times daily. Continue treatment until milk secretion has ceased completely or, in the case of menstrual dysfunction, until the menstrual cycle has returned to normal. 5 mg (1/2 to 1 tablet) at bedtime with food to establish tolerance.
Gradually increase after 2-3 days to one tablet twice daily with meals. 5 mg three times daily. 5 mg daily). If necessary to keep plasma prolactin adequately suppressed, dosage may be increased gradually over a period of several weeks to 10 - 20 mg (4 to 8 tablets or 2 to 4 capsules) daily with meals.
5 mg (1/2 to 1 tablet) at bedtime to establish tolerance. 5 mg three times per day with meals. 5 mg (1/2 to 1 tablet) at bedtime with food to establish tolerance, increasing gradually over a period of 2 to 4 weeks to 10 -20 mg (4 to 8 tablets or 2 to 4 capsules) daily with meals, depending on clinical response.
Daily requirements of 20 mg should be taken in four equally divided doses. For convenience and after initial titration, some patients may use the 5 mg capsules for maintenance therapy. 5 mg tablets or four 5 mg capsules). 25 mg (1/2 tablet) and increased again gradually to the recommended dose.
If reactions such as nausea, vomiting, vertigo or headaches continue to be severe, BROMOCRIPTINE should be discontinued.
Parkinson’s Disease:
BROMOCRIPTINE should be added to levodopa therapy. It is desirable to combine a slow increase of bromocriptine with a concomitant, limited and gradual reduction of levodopa. BROMOCRIPTINE dosage should be individualized. 25 mg (1/2 tablet) at bedtime to establish tolerance.
5 mg daily in two divided doses, with meals. 5 mg per day, once every 2 to 4 weeks, taken in 2 or 3 divided doses with meals. The maximum recommended daily dosage is 40 mg. Clinical assessments are recommended during dosage titration to ensure that the lowest effective dose is employed.
Where dose levels permit, use of the 5 mg capsule may be found more convenient by many patients.
1 Adverse Reaction Overview The most frequently observed adverse reactions are nausea, vomiting, headache and gastrointestinal side effects such as abdominal pain, diarrhea and constipation. All these effects may be minimized or even prevented by giving small initial doses of bromocriptine and by taking it with food.
Postural hypotension can, on rare occasions, lead to fainting, and shock-like syndromes have been reported in sensitive patients. This is most likely to occur during the first few days of BROMOCRIPTINE (bromocriptine mesylate) treatment.
25 mg two or three times daily. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
In clinical studies to date, the following adverse reactions were noted:
In postpartum women treated with bromocriptine mesylate, some rare serious adverse events (about 1 in 100,000) have been reported. These include hypertension, visual disturbances, myocardial infarction, seizures and strokes, or psychic disorders.
In some patients, the occurrence of seizures or strokes was preceded by severe headache and/or visual disturbances. Causal relationship of these events to the drug is uncertain.
Amenorrhea/Galactorrhea/Female Infertility/Acromegaly:
The incidence of side effects in these indications is higher (68%), reflecting the larger doses required, but they are generally mild to moderate in degree. Therapy was discontinued in approximately 6% of patients because of adverse effects.
General As with all medication, BROMOCRIPTINE should be kept safely out of the reach of children. To date, there have been seven (7) reported cases of retroperitoneal fibrosis occurring in parkinsonian patients on long-term treatment (15 months - 10 years) with bromocriptine at daily doses higher than 30 mg.
g. back pain, edema of the lower limbs, impaired kidney function) in this category of patients. BROMOCRIPTINE medication should be withdrawn immediately if fibrotic changes in the retroperitoneum are diagnosed or suspected. Cardiovascular Particular attention should be paid to patients who have recently received other drugs that can alter the blood pressure.
BROMOCRIPTINE (bromocriptine mesylate) may cause hypotension, primarily postural; periodic monitoring of the blood pressure, particularly during the first days of therapy, is advisable. Care should be exercised when administering BROMOCRIPTINE concomitantly with phenothiazines or with other medications known to lower blood pressure.
Dosage should be adjusted accordingly. 2 Pharmacodynamics, Effects on the Cardiovascular System. Although there is no conclusive evidence demonstrating interactions between bromocriptine and other ergot derivatives, it is not recommended to administer concomitantly BROMOCRIPTINE and any drug with potential vasoconstrictor activity.
Symptomatic hypotension can occur and, therefore, caution should be exercised when administering BROMOCRIPTINE, particularly in patients receiving antihypertensive medication. Dependence/Tolerance Alcohol should be avoided during treatment with bromocriptine.
In some patients the concomitant use of bromocriptine and alcohol has given rise to alcohol intolerance and an increase in the severity and incidence of bromocriptine’s possible adverse reactions. Driving and Operating Machinery In some patients, dizziness (vertigo) may occur with bromocriptine; patients should therefore be cautioned against activities requiring rapid and precise responses such as driving an automobile or operating dangerous machinery until their response has been determined.
BROMOCRIPTINE is contraindicated in: Patients with sensitivity to ergot alkaloids or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Patients with uncontrolled hypertension of pregnancy. Patients who had a history of toxemia of pregnancy. BROMOCRIPTINE (Bromocriptine Mesylate) Page 5 of 29
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Pediatrics:
Health Canada has not authorized an indication for pediatric use. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.
BROMOCRIPTINE (Bromocriptine Mesylate) Page 11 of 29 Table 2 - Adverse reactions reported in patients who received BROMOCRIPTINE for Amenorrhea/Galactorrhea/Female Infertility/Acromegaly BROMOCRIPTINE (%) Gastrointestinal disorders nausea abdominal cramps vomiting constipation diarrhea 51% 7% 5% 3% 3% General disorders and administration site conditions fatigue 8% Nervous system disorders headache dizziness lightheadedness 18% 16% 6% Respiratory, thoracic and mediastinal disorders nasal congestion 5% USE IN COMBINATION WITH OTHER DRUGS: Parkinson’s Disease: When bromocriptine is added to levodopa therapy, the incidence of adverse reactions may increase.
The most common newly appearing adverse reactions in combination therapy with levodopa are: nausea, abnormal involuntary movements, hallucinations, confusion, “on-off” phenomenon, dizziness, drowsiness, faintness, fainting, vomiting, asthenia, abdominal discomfort, visual disturbance, ataxia, insomnia, depression, hypotension, shortness of breath, constipation and vertigo.
3 Less Common Clinical Trial Adverse Reactions General: Less common adverse reactions include, anorexia, anxiety, blepharospasm, dry mouth, dysphagia, edema of the feet and ankles, erythromelalgia, epileptiform seizures, fatigue, headache, lethargia, mottling of skin, nasal stuffiness, nervousness, nightmares, paresthesia, skin rash, changes in urinary frequency, urinary incontinence, urinary retention and rarely signs and symptoms of ergotism such as tingling of fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud’s syndrome.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Abnormalities in laboratory tests may include elevation of blood urea nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase and uric acid, which are usually transient and not of clinical significance.
5 Post-Market Adverse Reactions The following adverse reactions have been reported during post approval use of BROMOCRIPTINE (All Indications Combined). Because adverse reactions from spontaneous reports are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorders:
Pericardial effusion, constrictive pericarditis, tachycardia, bradycardia, arrhythmia, cardiac valve fibrosis.
Eye disorders:
Visual disturbance, vision blurred.
Ear and labyrinth disorders:
Tinnitus.
Gastrointestinal disorders:
Nausea, constipation, vomiting, dry mouth, diarrhoea, abdominal pain, retroperitoneal fibrosis, gastrointestinal ulcer, gastrointestinal haemorrhage.
General disorders and administration site conditions:
Fatigue, peripheral edema, a syndrome resembling Neuroleptic Malignant Syndrome on abrupt withdrawal of BROMOCRIPTINE.
Musculoskeletal and connective tissue disorders:
Leg cramps.
Nervous system disorders:
Headache, drowsiness, dizziness, dyskinaesia, somnolence, paraesthesia, excess daytime somnolence, sudden onset of sleep.
Psychiatric disorders:
Confusion, psychomotor agitation/excitation, hallucinations, psychotic disorders, insomnia, libido increase, hypersexuality.
Respiratory, thoracic and mediastinal disorders:
Nasal congestion, pleural effusion, pleural fibrosis, pleurisy, pulmonary fibrosis, dyspnoea.
Skin and subcutaneous tissue disorders:
Allergic skin reactions, hair loss.
Vascular disorders:
Hypotension, orthostatic hypotension (very rarely leading to syncope), reversible pallor of fingers and toes induced by cold (especially in patients with history of Raynaud's phenomenon).
Endocrine and Metabolism In women with non-puerperal galactorrhea, reduction of prolactin levels may lead to resumption of normal menses. Following discontinuation of medication, galactorrhea returns in some patients and leads to suspicion of pituitary adenomas; a complete investigation at specialized units to identify these patients is advisable.
BROMOCRIPTINE (Bromocriptine Mesylate) Page 8 of 29 Treatment with BROMOCRIPTINE (bromocriptine mesylate) may effectively lower prolactin levels in patients with pituitary tumors but does not obviate the necessity for radiotherapy or surgical intervention where appropriate.
Gastrointestinal There have been occasional reports of gastrointestinal bleeding in acromegalic patients, both in those treated with bromocriptine and in those given a different or no medication. Until further data are available, therefore, acromegalic patients with a history or evidence of peptic ulceration should preferably be given alternative treatment.
If bromocriptine must be used in such patients they should be instructed to report promptly any gastrointestinal reactions. Bromocriptine should always be taken with food. 25 mg) and increased gradually to the recommended dose. 4 Drug-Drug Interactions).
Hepatic/Biliary/Pancreatic Safety and efficacy of bromocriptine has not been established in patients with severe hepatic disease. Monitoring and Laboratory Tests Periodic evaluation of hepatic, hematopoietic, cardiovascular and renal function is recommended.
Neurologic Use in Parkinson’s Disease:
Use of BROMOCRIPTINE, particularly in high doses, may be associated with mental confusion and mental disturbances. Since patients with Parkinson’s Disease may manifest varying degrees of dementia, caution should be exercised when treating such patients with bromocriptine.
BROMOCRIPTINE administered alone or concomitantly with levodopa may cause visual or auditory hallucinations. These usually resolve with dosage reduction, but discontinuation of bromocriptine may be required in some cases. Rarely, after high doses, hallucinations have persisted for several weeks following discontinuation of bromocriptine.
Caution should be exercised when administering BROMOCRIPTINE to patients with a history of myocardial infarction, particularly if they have a residual atrial, nodal or ventricular arrhythmia. Renal Safety and efficacy of bromocriptine has not been established in patients with severe renal disease.
Reproductive Health:
Female and Male Potential Fertility In patients being treated with BROMOCRIPTINE for galactorrhea, prolactin induced amenorrhea, menstrual disorders or acromegaly, infertility might be reversed by restoration of normal menses and ovulation.
Women who do not wish to conceive should, therefore, use a reliable method of contraception. Since pregnancy may occur prior to initiation of menses it is recommended that a pregnancy test be conducted at least every four weeks during the amenorrheic period, and, once menses are reinitiated, every time a patient misses a menstrual period.
Bromocriptine therapy has been demonstrated to be effective in the short term management of amenorrhea/galactorrhea. Data are not available on the safety or effectiveness of its use in long- term BROMOCRIPTINE (Bromocriptine Mesylate) Page 9 of 29 continuous dosage in this indication or in patients given repeated courses of treatment following recurrence of […]