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Cabergoline
Overview
What is Cabergoline?
Cabergoline Tablets contain cabergoline, a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea. Its molecular formula is CHNO, and its molecular weight is 451.62. The structural formula is as follows:
Cabergoline is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water.
Each tablet, for oral administration, contains 0.5 mg of cabergoline. Inactive ingredients consist of citric acid, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.
What does Cabergoline look like?
What are the available doses of Cabergoline?
Sorry No records found.
What should I talk to my health care provider before I take Cabergoline?
Sorry No records found
How should I use Cabergoline?
Cabergoline Tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.
The recommended dosage of Cabergoline Tablets for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient’s serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease.
Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient's response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long term treatment with Cabergoline should undergo periodic assessment of their cardiac status and echocardiography should be considered.
After a normal serum prolactin level has been maintained for 6 months, cabergoline may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with cabergoline should be reinstituted. The durability of efficacy beyond 24 months of therapy with cabergoline has not been established.
What interacts with Cabergoline?
- Cabergoline Tablets are contraindicated in patients with:
- Uncontrolled hypertension or known hypersensitivity to ergot derivatives.
- History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis (See WARNINGS)
- History of pulmonary, pericardial, or retroperitoneal fibrotic disorders. (See WARNINGS).
What are the warnings of Cabergoline?
a. Cardiac Valvulopathy:
All patients should undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of valvular disease. If valvular disease is detected, the patient should not be treated with Cabergoline . Post marketing cases of cardiac valvulopathy have been reported in patients receiving Cabergoline. These cases have generally occurred during administration of high doses of Cabergoline (>2mg/day) used for the treatment of Parkinson's disease. Cases of cardiac valvulopathy have also been reported in patients receiving lower doses for the treatment of hyperprolactinemic disorders.
A multi-country, retrospective cohort study using general practice records and record linkage systems in the UK, Italy and the Netherlands was conducted to assess the association between new use of dopamine agonists including cabergoline (n=27,812) for Parkinson’s disease and hyperprolactinemia and cardiac valvular regurgitation (CVR), other fibroses, and other cardiopulmonary events over a maximum of 12 years of follow up. In this study, the use of cabergoline among persons with Parkinson’s disease was associated with an increased risk of CVR when compared to non-ergot-derived dopamine agonists (DAs) and levodopa [Incidence Rate (IR) per 10,000 person years of 68.1 (95% confidence interval (CI): 37.2 – 115.3) for cabergoline vs. 10.0 (95% CI: 5.2 – 19.4) for non-ergot DAs and 11.3 (95% CI: 7.2 – 17.0) for levodopa]. In the study analysis confined to persons with dopamine agonist-treated hyperprolactinemia (n=8,386), when compared to non-use (n=15,147), persons exposed to cabergoline did not have an elevated risk of CVR. The findings with respect to the risk of CVR associated with cabergoline treatment for persons with Parkinson’s disease (increased risk) and those with hyperprolactinemia (no increased risk) are consistent with the findings in other published studies.
Physicians should use the lowest effective dose of Cabergoline for the treatment of hyperprolactinemic disorders and should periodically reassess the need for continuing therapy with Cabergoline. Following treatment initiation, clinical and diagnostic monitoring (for example, chest x-ray, CT scan and cardiac echocardiogram) should be conducted to assess the risk of cardiac valvulopathy. The recommended frequency of routine echocardiographic monitoring is every 6 to 12 months or as clinically indicated with the presence of signs and symptoms such as edema, new cardiac murmur, dyspnea or congestive heart failure.
Cabergoline should be discontinued if an echocardiogram reveals new valvular regurgitation, valvular restriction or valve leaflet thickening.
Cabergoline should be used with caution in patients exposed to other medications associated with valvulopathy.
b. Extracardiac Fibrotic Reactions:
Postmarketing cases of pleural, pericardial and retroperitoneal fibrosis have been following administration of Cabergoline. Some reports were in patients previously treated with other ergotinic dopamine agonists. Cabergoline should not be used in patients with a history of cardiac or extracardiac fibrotic disorders.
Fibrotic disorders can have an insidious onset and patients should be monitored for manifestations of progressive fibrosis. Therefore, during treatment, attention should be paid to the signs and symptoms of:
Clinical and diagnostic monitoring such as erythrocyte sedimentation rate, chest x-ray, serum creatinine measurements, and other investigations should be considered at baseline and as necessary while patients are treated with Cabergoline.
Following diagnosis of pleural effusion or pulmonary fibrosis, the discontinuance of Cabergoline was reported to result in improvement of signs and symptoms.
What are the precautions of Cabergoline?
General:
Postpartum Lactation Inhibition or Suppression:
Hepatic Impairment:
Psychiatric:
Post-marketing Surveillance data
Information for Patients
Patients should be instructed to notify their physician if they suspect they are pregnant, become pregnant, or intend to become pregnant during therapy. A pregnancy test should be done if there is any suspicion of pregnancy and continuation of treatment should be discussed with their physician.
A patient should notify their physician if they develop shortness of breath, persistent cough, difficulty with breathing when lying down, or swelling in their extremities.
Drug Interactions
Cabergoline should not be administered concurrently with D-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.
Array
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenicity studies were conducted in mice and rats with cabergoline given by gavage at doses up to 0.98 mg/kg/day and 0.32 mg/kg/day, respectively. These doses are 7 times and 4 times the maximum recommended human dose calculated on a body surface area basis using total mg/m /week in rodents and mg/m/week for a 50 kg human.
There was a slight increase in the incidence of cervical and uterine leiomyomas and uterine leiomyosarcomas in mice. In rats, there was a slight increase in malignant tumors of the cervix and uterus and interstitial cell adenomas. The occurrence of tumors in female rodents may be related to the prolonged suppression of prolactin secretion because prolactin is needed in rodents for the maintenance of the corpus luteum. In the absence of prolactin, the estrogen/progesterone ratio is increased, thereby increasing the risk for uterine tumors. In male rodents, the decrease in serum prolactin levels was associated with an increase in serum luteinizing hormone, which is thought to be a compensatory effect to maintain testicular steroid synthesis. Since these hormonal mechanisms are thought to be species-specific, the relevance of these tumors to humans is not known.
The mutagenic potential of cabergoline was evaluated and found to be negative in a battery of tests. These tests included the bacterial mutation (Ames) test with , the gene mutation assay with and V79 Chinese hamster cells, DNA damage and repair in , and chromosomal aberrations in human lymphocytes. Cabergoline was also negative in the bone marrow micronucleus test in the mouse.
In female rats, a daily dose of 0.003 mg/kg for 2 weeks prior to mating and throughout the mating period inhibited conception. This dose represents approximately 1/28 the maximum recommended human dose calculated on a body surface area basis using total mg/m /week in rats and mg/m/week for a 50 kg human.
Pregnancy: Teratogenic Effects: Category B
Reproduction studies have been performed with cabergoline in mice, rats, and rabbits administered by gavage.
(Multiples of the maximum recommended human dose in this section are calculated on a body surface area basis using total mg/m /week for animals and mg/m/week for a 50 kg human.)
There were maternotoxic effects but no teratogenic effects in mice given cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose) during the period of organogenesis.
A dose of 0.012 mg/kg/day (approximately 1/7 the maximum recommended human dose) during the period of organogenesis in rats caused an increase in post-implantation embryofetal losses. These losses could be due to the prolactin inhibitory properties of cabergoline in rats. At daily doses of 0.5 mg/kg/day (approximately 19 times the maximum recommended human dose) during the period of organogenesis in the rabbit, cabergoline caused maternotoxicity characterized by a loss of body weight and decreased food consumption. Doses of 4 mg/kg/day (approximately 150 times the maximum recommended human dose) during the period of organogenesis in the rabbit caused an increased occurrence of various malformations. However, in another study in rabbits, no treatment-related malformations or embryofetotoxicity were observed at doses up to 8 mg/kg/day (approximately 300 times the maximum human dose).
In rats, doses higher than 0.003 mg/kg/day (approximately 1/28 the maximum recommended human dose) from 6 days before parturition and throughout the lactation period inhibited growth and caused death of offspring due to decreased milk secretion.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cabergoline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use of cabergoline for the inhibition or suppression of physiologic lactation is not recommended (see
).
The prolactin-lowering action of cabergoline suggests that it will interfere with lactation. Due to this interference with lactation, cabergoline should not be given to women postpartum who are breastfeeding or who are planning to breastfeed.
Pediatric Use
Safety and effectiveness of cabergoline in pediatric patients have not been established.
Geriatric Use
Clinical studies of cabergoline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of Cabergoline?
The safety of Cabergoline Tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity.
In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table.
In the 8-week, double-blind period of the comparative trial with bromocriptine, cabergoline (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from cabergoline were headache, nausea and vomiting (3, 2, and 2 patients, respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10, 3, 3, and 3 patients, respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table.
Other adverse events that were reported at an incidence of <1.0% in the overall clinical studies follow.
Body as a Whole:
Cardiovascular System:
Digestive System:
Metabolic and Nutritional System:
Nervous System:
Respiratory System:
Skin and Appendages:
Special Senses:
Urogenital System:
The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson’s disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson’s disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.
Post-marketing Surveillance data:
WARNINGS, Cardiac Valvulopathy and Extracardiac Fibrotic Reactions
Others events have been reported in association with cabergoline: hypersexuality, increased libido, pathological gambling (see ). In addition, during post-marketing surveillance, cases of alopecia, aggression and psychotic disorder have been reported in patients taking Cabergoline. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.
| Adverse Event* | Cabergoline (n = 168) 0.125 to 1 mg two times a week | Placebo (n = 20) |
| Number (percent) | ||
| Gastrointestinal | ||
| Nausea | 45 (27) | 4 (20) |
| Constipation | 16 (10) | 0 |
| Abdominal pain | 9 (5) | 1 (5) |
| Dyspepsia | 4 (2) | 0 |
| Vomiting | 4 (2) | 0 |
| Central and Peripheral Nervous System | ||
| Headache | 43 (26) | 5 (25) |
| Dizziness | 25 (15) | 1 (5) |
| Paresthesia | 2 (1) | 0 |
| Vertigo | 2 (1) | 0 |
| Body As Hyperlink Whole | ||
| Asthenia | 15 (9) | 2 (10) |
| Fatigue | 12 (7) | 0 |
| Hot flashes | 2 (1) | 1 (5) |
| Psychiatric | ||
| Somnolence | 9 (5) | 1 (5) |
| Depression | 5 (3) | 1 (5) |
| Nervousness | 4 (2) | 0 |
| Autonomic Nervous System | 6 (4) | 0 |
| Reproductive - Female | ||
| Breast pain | 2 (1) | 0 |
| Dysmenorrhea | 2 (1) | 0 |
| Vision Abnormal vision | 2 (1) | 0 |
| Cabergoline | Bromocriptine | |
| Adverse Event* | (n = 221) | (n = 231) |
| Number (percent) | ||
| Gastrointestinal | ||
| Nausea | 63 (29) | 100 (43) |
| Constipation | 15 (7) | 21 (9) |
| Abdominal pain | 12 (5) | 19 (8) |
| Dyspepsia | 11 (5) | 16 (7) |
| Vomiting | 9 (4) | 16 (7) |
| Dry mouth | 5 (2) | 2 (1) |
| Diarrhea | 4 (2) | 7 (3) |
| Flatulence | 4 (2) | 3 (1) |
| Throat irritation | 2 (1) | 0 |
| Toothache | 2 (1) | 0 |
| Central and Peripheral Nervous System | ||
| Headache | 58 (26) | 62 (27) |
| Dizziness | 38 (17) | 42 (18) |
| Vertigo | 9 (4) | 10 (4) |
| Paresthesia | 5 (2) | 6 (3) |
| Body As Hyperlink Whole | ||
| Asthenia | 13 (6) | 15 (6) |
| Fatigue | 10 (5) | 18 (8) |
| Syncope | 3 (1) | 3 (1) |
| Influenza-like symptoms | 2 (1) | 0 |
| Malaise | 2 (1) | 0 |
| Periorbital edema | 2 (1) | 2 (1) |
| Peripheral edema | 2 (1) | 1 |
| Psychiatric | ||
| Depression | 7 (3) | 5 (2) |
| Somnolence | 5 (2) | 5 (2) |
| Anorexia | 3 (1) | 3 (1) |
| Anxiety | 3 (1) | 3 (1) |
| Insomnia | 3 (1) | 2 (1) |
| Impaired concentration | 2 (1) | 1 |
| Nervousness | 2 (1) | 5 (2) |
| Cardiovascular | ||
| Hot flashes | 6 (3) | 3 (1) |
| Hypotension | 3 (1) | 4 (2) |
| Dependent edema | 2 (1) | 1 |
| Palpitation | 2 (1) | 5 (2) |
| Reproductive - Female | ||
| Breast pain | 5 (2) | 8 (3) |
| Dysmenorrhea | 2 (1) | 1 |
| Skin and Appendages | ||
| Acne | 3 (1) | 0 |
| Pruritus | 2 (1) | 1 |
| Musculoskeletal | ||
| Pain | 4 (2) | 6 (3) |
| Arthralgia | 2 (1) | 0 |
| Respiratory Rhinitis | 2 (1) | 9 (4) |
| Vision Abnormal vision | 2 (1) | 2 (1) |
What should I look out for while using Cabergoline?
Cabergoline Tablets are contraindicated in patients with:
a. Cardiac Valvulopathy:
All patients should undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of valvular disease. If valvular disease is detected, the patient should not be treated with Cabergoline . Post marketing cases of cardiac valvulopathy have been reported in patients receiving Cabergoline. These cases have generally occurred during administration of high doses of Cabergoline (>2mg/day) used for the treatment of Parkinson's disease. Cases of cardiac valvulopathy have also been reported in patients receiving lower doses for the treatment of hyperprolactinemic disorders.
A multi-country, retrospective cohort study using general practice records and record linkage systems in the UK, Italy and the Netherlands was conducted to assess the association between new use of dopamine agonists including cabergoline (n=27,812) for Parkinson’s disease and hyperprolactinemia and cardiac valvular regurgitation (CVR), other fibroses, and other cardiopulmonary events over a maximum of 12 years of follow up. In this study, the use of cabergoline among persons with Parkinson’s disease was associated with an increased risk of CVR when compared to non-ergot-derived dopamine agonists (DAs) and levodopa [Incidence Rate (IR) per 10,000 person years of 68.1 (95% confidence interval (CI): 37.2 – 115.3) for cabergoline vs. 10.0 (95% CI: 5.2 – 19.4) for non-ergot DAs and 11.3 (95% CI: 7.2 – 17.0) for levodopa]. In the study analysis confined to persons with dopamine agonist-treated hyperprolactinemia (n=8,386), when compared to non-use (n=15,147), persons exposed to cabergoline did not have an elevated risk of CVR. The findings with respect to the risk of CVR associated with cabergoline treatment for persons with Parkinson’s disease (increased risk) and those with hyperprolactinemia (no increased risk) are consistent with the findings in other published studies.
Physicians should use the lowest effective dose of Cabergoline for the treatment of hyperprolactinemic disorders and should periodically reassess the need for continuing therapy with Cabergoline. Following treatment initiation, clinical and diagnostic monitoring (for example, chest x-ray, CT scan and cardiac echocardiogram) should be conducted to assess the risk of cardiac valvulopathy. The recommended frequency of routine echocardiographic monitoring is every 6 to 12 months or as clinically indicated with the presence of signs and symptoms such as edema, new cardiac murmur, dyspnea or congestive heart failure.
Cabergoline should be discontinued if an echocardiogram reveals new valvular regurgitation, valvular restriction or valve leaflet thickening.
Cabergoline should be used with caution in patients exposed to other medications associated with valvulopathy.
b. Extracardiac Fibrotic Reactions:
Postmarketing cases of pleural, pericardial and retroperitoneal fibrosis have been following administration of Cabergoline. Some reports were in patients previously treated with other ergotinic dopamine agonists. Cabergoline should not be used in patients with a history of cardiac or extracardiac fibrotic disorders.
Fibrotic disorders can have an insidious onset and patients should be monitored for manifestations of progressive fibrosis. Therefore, during treatment, attention should be paid to the signs and symptoms of:
Clinical and diagnostic monitoring such as erythrocyte sedimentation rate, chest x-ray, serum creatinine measurements, and other investigations should be considered at baseline and as necessary while patients are treated with Cabergoline.
Following diagnosis of pleural effusion or pulmonary fibrosis, the discontinuance of Cabergoline was reported to result in improvement of signs and symptoms.
What might happen if I take too much Cabergoline?
Overdosage might be expected to produce nasal congestion, syncope, or hallucinations. Measures to support blood pressure should be taken if necessary.
How should I store and handle Cabergoline?
Storage and StabilitySTELARA vials and prefilled syringes must be refrigerated at 2°C to 8°C (36°F to 46°F). Store STELARA vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.Storage and StabilitySTELARA vials and prefilled syringes must be refrigerated at 2°C to 8°C (36°F to 46°F). Store STELARA vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.Cabergoline Tablets are a white to off-white, oval shape, flat face, beveled edge tablet containing 0.5 mg cabergoline. Each tablet is debossed “P” bisect line “P” on one side and “673" on the other side.Cabergoline Tablets are available as follows:Cabergoline Tablets are a white to off-white, oval shape, flat face, beveled edge tablet containing 0.5 mg cabergoline. Each tablet is debossed “P” bisect line “P” on one side and “673" on the other side.Cabergoline Tablets are available as follows:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action:
in vitro
Clinical Studies:
In the 8-week, double-blind period of the comparative trial with bromocriptine (cabergoline n=223; bromocriptine n=236 in the intent-to-treat analysis), prolactin was normalized in 77% of the patients treated with cabergoline at 0.5 mg twice weekly compared with 59% of those treated with bromocriptine at 2.5 mg twice daily. Restoration of menses occurred in 77% of the women treated with cabergoline, compared with 70% of those treated with bromocriptine. Among patients with galactorrhea, this symptom disappeared in 73% of those treated with cabergoline compared with 56% of those treated with bromocriptine.
Absorption:
Distribution:
Metabolism:
Excretion:
Non-Clinical Toxicology
Cabergoline Tablets are contraindicated in patients with:a. Cardiac Valvulopathy:
All patients should undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of valvular disease. If valvular disease is detected, the patient should not be treated with Cabergoline . Post marketing cases of cardiac valvulopathy have been reported in patients receiving Cabergoline. These cases have generally occurred during administration of high doses of Cabergoline (>2mg/day) used for the treatment of Parkinson's disease. Cases of cardiac valvulopathy have also been reported in patients receiving lower doses for the treatment of hyperprolactinemic disorders.
A multi-country, retrospective cohort study using general practice records and record linkage systems in the UK, Italy and the Netherlands was conducted to assess the association between new use of dopamine agonists including cabergoline (n=27,812) for Parkinson’s disease and hyperprolactinemia and cardiac valvular regurgitation (CVR), other fibroses, and other cardiopulmonary events over a maximum of 12 years of follow up. In this study, the use of cabergoline among persons with Parkinson’s disease was associated with an increased risk of CVR when compared to non-ergot-derived dopamine agonists (DAs) and levodopa [Incidence Rate (IR) per 10,000 person years of 68.1 (95% confidence interval (CI): 37.2 – 115.3) for cabergoline vs. 10.0 (95% CI: 5.2 – 19.4) for non-ergot DAs and 11.3 (95% CI: 7.2 – 17.0) for levodopa]. In the study analysis confined to persons with dopamine agonist-treated hyperprolactinemia (n=8,386), when compared to non-use (n=15,147), persons exposed to cabergoline did not have an elevated risk of CVR. The findings with respect to the risk of CVR associated with cabergoline treatment for persons with Parkinson’s disease (increased risk) and those with hyperprolactinemia (no increased risk) are consistent with the findings in other published studies.
Physicians should use the lowest effective dose of Cabergoline for the treatment of hyperprolactinemic disorders and should periodically reassess the need for continuing therapy with Cabergoline. Following treatment initiation, clinical and diagnostic monitoring (for example, chest x-ray, CT scan and cardiac echocardiogram) should be conducted to assess the risk of cardiac valvulopathy. The recommended frequency of routine echocardiographic monitoring is every 6 to 12 months or as clinically indicated with the presence of signs and symptoms such as edema, new cardiac murmur, dyspnea or congestive heart failure.
Cabergoline should be discontinued if an echocardiogram reveals new valvular regurgitation, valvular restriction or valve leaflet thickening.
Cabergoline should be used with caution in patients exposed to other medications associated with valvulopathy.
b. Extracardiac Fibrotic Reactions:
Postmarketing cases of pleural, pericardial and retroperitoneal fibrosis have been following administration of Cabergoline. Some reports were in patients previously treated with other ergotinic dopamine agonists. Cabergoline should not be used in patients with a history of cardiac or extracardiac fibrotic disorders.
Fibrotic disorders can have an insidious onset and patients should be monitored for manifestations of progressive fibrosis. Therefore, during treatment, attention should be paid to the signs and symptoms of:
Clinical and diagnostic monitoring such as erythrocyte sedimentation rate, chest x-ray, serum creatinine measurements, and other investigations should be considered at baseline and as necessary while patients are treated with Cabergoline.
Following diagnosis of pleural effusion or pulmonary fibrosis, the discontinuance of Cabergoline was reported to result in improvement of signs and symptoms.
Cabergoline should not be administered concurrently with D-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.
General:
Postpartum Lactation Inhibition or Suppression:
Hepatic Impairment:
Psychiatric:
Post-marketing Surveillance data
The safety of Cabergoline Tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity.
In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table.
In the 8-week, double-blind period of the comparative trial with bromocriptine, cabergoline (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from cabergoline were headache, nausea and vomiting (3, 2, and 2 patients, respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10, 3, 3, and 3 patients, respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table.
Other adverse events that were reported at an incidence of <1.0% in the overall clinical studies follow.
Body as a Whole:
Cardiovascular System:
Digestive System:
Metabolic and Nutritional System:
Nervous System:
Respiratory System:
Skin and Appendages:
Special Senses:
Urogenital System:
The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson’s disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson’s disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.
Post-marketing Surveillance data:
WARNINGS, Cardiac Valvulopathy and Extracardiac Fibrotic Reactions
Others events have been reported in association with cabergoline: hypersexuality, increased libido, pathological gambling (see ). In addition, during post-marketing surveillance, cases of alopecia, aggression and psychotic disorder have been reported in patients taking Cabergoline. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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