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Parlodel
Overview
What is Parlodel?
Parlodel (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel (bromocriptine mesylate) SnapTabs tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′- hydroxy-2′- (1-methylethyl)-5′-(2-methylpropyl)-, (5′α)-monomethanesulfonate (salt).
The structural formula is:
2
½ mg SnapTabs
Active Ingredient:
Inactive Ingredients:
5 mg Capsules
Active Ingredient:
Inactive Ingredients:
What does Parlodel look like?
What are the available doses of Parlodel?
Sorry No records found.
What should I talk to my health care provider before I take Parlodel?
Sorry No records found
How should I use Parlodel?
Parlodel (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with including with or without Parlodel treatment is indicated in patients with
which may be the basic underlying endocrinopathy contributing to the above clinical presentations. in has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.
What interacts with Parlodel?
Sorry No Records found
What are the warnings of Parlodel?
Sorry No Records found
What are the precautions of Parlodel?
Sorry No Records found
What are the side effects of Parlodel?
Sorry No records found
What should I look out for while using Parlodel?
Hypersensitivity to bromocriptine or to any of the excipients of Parlodel (bromocriptine mesylate), uncontrolled hypertension and sensitivity to any ergot alkaloids. In patients being treated for hyperprolactinemia, Parlodel should be withdrawn when pregnancy is diagnosed
. In the event that Parlodel is reinstituted to control a rapidly expanding macroadenoma
and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing Parlodel must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When Parlodel is being used to treat acromegaly, prolactinoma, or Parkinson’s disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Parlodel is considered to be medically contraindicated.
The drug should not be used during the postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions unless withdrawal is considered medically contraindicated. If the drug is used in the postpartum period, the patient should be observed with caution.
Since hyperprolactinemia with amenorrhea/galactorrhea and infertility has been found in patients with pituitary tumors, a complete evaluation of the pituitary is indicated before treatment with Parlodel (bromocriptine mesylate).
If pregnancy occurs during Parlodel administration, careful observation of these patients is mandatory. Prolactin-secreting adenomas may expand and compression of the optic or other cranial nerves may occur, emergency pituitary surgery becoming necessary. In most cases, the compression resolves following delivery. Reinitiation of Parlodel treatment has been reported to produce improvement in the visual fields of patients in whom nerve compression has occurred during pregnancy. The safety of Parlodel treatment during pregnancy to the mother and fetus has not been established.
Parlodel has been associated with somnolence, and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported. Patients must be informed of this and advised not to drive or operate machines during treatment with bromocriptine. Patients who have experienced somnolence and/or an episode of sudden sleep onset must not drive or operate machines. Furthermore, a reduction of dosage or termination of therapy may be considered.
Symptomatic hypotension can occur in patients treated with Parlodel for any indication. In postpartum studies with Parlodel, decreases in supine systolic and diastolic pressures of greater than 20 mm and 10 mm Hg, respectively, have been observed in almost 30% of patients receiving Parlodel. On occasion, the drop in supine systolic pressure was as much as 50-59 mm of Hg.
Since, especially during the first days of treatment, hypotensive reactions may occasionally occur and result in reduced alertness, particular care should be exercised when driving a vehicle or operating machinery.
While hypotension during the start of therapy with Parlodel occurs in some patients, in rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, have been reported in postpartum women treated with Parlodel for the inhibition of lactation. Hypertension have been reported, sometimes at the initiation of therapy, but often developing in the second week of therapy; seizures have also been reported both with and without the prior development of hypertension; stroke have been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated. Many of these patients experiencing seizures (including cases of status epilepticus) and/or strokes reported developing a constant and often progressively severe headache hours to days prior to the acute event. Some cases of strokes and seizures were also preceded by visual disturbances (blurred vision, and transient cortical blindness). Cases of acute myocardial infarction have also been reported.
Although a causal relationship between Parlodel administration and hypertension, seizures, strokes, and myocardial infarction in postpartum women has not been established, use of the drug for prevention of physiological lactation, or in patients with uncontrolled hypertension is not recommended. In patients being treated for hyperprolactinemia, Parlodel should be withdrawn when pregnancy is diagnosed
. In the event that Parlodel is reinstituted to control a rapidly expanding macroadenoma
and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing Parlodel must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When Parlodel is being used to treat acromegaly or Parkinson’s disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Parlodel is considered to be medically contraindicated. Because of the possibility of an interaction between Parlodel and other ergot alkaloids, the concomitant use of these medications is not recommended. Periodic monitoring of the blood pressure, particularly during the first weeks of therapy is prudent. If hypertension, severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, drug therapy should be discontinued and the patient should be evaluated promptly. Particular attention should be paid to patients who have recently been treated or are on concomitant therapy with drugs that can alter blood pressure. Their concomitant use in the puerperium is not recommended.
Among patients on Parlodel, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis, have been reported. Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of Parlodel therapy should be considered. In those instances in which Parlodel treatment was terminated, the changes slowly reverted towards normal.
In a few patients on Parlodel, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported. To ensure recognition of retroperitoneal fibrosis at an early reversible stage it is recommended that its manifestations (e.g., back pain, edema of the lower limbs, impaired kidney function) should be watched in this category of patients. Parlodel medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.
What might happen if I take too much Parlodel?
The most commonly reported signs and symptoms associated with acute Parlodel (bromocriptine mesylate) overdose are: nausea, vomiting, constipation, diaphoresis, dizziness, pallor, severe hypotension, malaise, confusion, lethargy, drowsiness, delusions, hallucinations, and repetitive yawning. The lethal dose has not been established and the drug has a very wide margin of safety. However, one death occurred in a patient who committed suicide with an unknown quantity of Parlodel and chloroquine.
Treatment of overdose consists of removal of the drug by emesis (if conscious), gastric lavage, activated charcoal, or saline catharsis. Careful supervision and recording of fluid intake and output is essential. Hypotension should be treated by placing the patient in the Trendelenburg position and administering I.V. fluids. If satisfactory relief of hypotension cannot be achieved by using the above measures to their fullest extent, vasopressors should be considered.
There have been isolated reports of children who accidentally ingested Parlodel. Vomiting, somnolence and fever were reported as adverse events. Patients recovered either spontaneously within a few hours or after appropriate management.
DOSAGE AND ADMINISTRATION
How should I store and handle Parlodel?
Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01Parlodel (bromocriptine mesylate) SnapTabs2½ mgParlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1. Packages of 30………………………………………………..NDC 30698-202-30 Packages of 100………………………………………………NDC 30698-202-01Parlodel (bromocriptine mesylate) Capsules 5 mgCaramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half. Packages of 30………………………………………………..NDC 30698-201-30 Packages of 100………………………………………………NDC 30698-201-01
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Absorption
Following single dose administration of Parlodel tablets, 2 x 2.5 mg to 5 healthy volunteers under fasted conditions, the mean peak plasma levels of bromocriptine, time to reach peak plasma concentrations and elimination half-life were 465 pg/mL ± 226, 2.5 hrs ± 2 and 4.85 hr, respectively. Linear relationship was found between single doses of Parlodel and C and AUC in the dose range of 1 to 7.5 mg. The pharmacokinetics of bromocriptine metabolites have not been reported.
Food did not significantly affect the systemic exposure of bromocriptine following administration of Parlodel tablets, 2.5 mg. It is recommended that Parlodel be taken with food because of the high percentage of subjects who vomit upon receiving bromocriptine under fasting conditions.
Following Parlodel 5 mg administered twice daily for 14 days, the bromocriptine C and AUC at steady-state were 628 ± 375 pg/mL and 2377 ± 1186 pg*hr/mL, respectively.
Distribution
In vitro
Metabolism
Bromocriptine undergoes extensive first-pass biotransformation, reflected by complex metabolite profiles and by almost complete absence of parent drug in urine and feces.
In vitro
(
s
ee PRECAUTIONS, drug interactions section)
Excretion
About 82% and 5.6 % of the radioactive dose orally administered was recovered in feces and urine, respectively. Bromolysergic acid and bromoisolysergic acid accounted for half of the radioactivity in urine.
___________________________________________________________________________
1
2
3
4
5
in vitro
Non-Clinical Toxicology
Hypersensitivity to bromocriptine or to any of the excipients of Parlodel (bromocriptine mesylate), uncontrolled hypertension and sensitivity to any ergot alkaloids. In patients being treated for hyperprolactinemia, Parlodel should be withdrawn when pregnancy is diagnosed . In the event that Parlodel is reinstituted to control a rapidly expanding macroadenoma and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing Parlodel must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When Parlodel is being used to treat acromegaly, prolactinoma, or Parkinson’s disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Parlodel is considered to be medically contraindicated.The drug should not be used during the postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions unless withdrawal is considered medically contraindicated. If the drug is used in the postpartum period, the patient should be observed with caution.
Since hyperprolactinemia with amenorrhea/galactorrhea and infertility has been found in patients with pituitary tumors, a complete evaluation of the pituitary is indicated before treatment with Parlodel (bromocriptine mesylate).
If pregnancy occurs during Parlodel administration, careful observation of these patients is mandatory. Prolactin-secreting adenomas may expand and compression of the optic or other cranial nerves may occur, emergency pituitary surgery becoming necessary. In most cases, the compression resolves following delivery. Reinitiation of Parlodel treatment has been reported to produce improvement in the visual fields of patients in whom nerve compression has occurred during pregnancy. The safety of Parlodel treatment during pregnancy to the mother and fetus has not been established.
Parlodel has been associated with somnolence, and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported. Patients must be informed of this and advised not to drive or operate machines during treatment with bromocriptine. Patients who have experienced somnolence and/or an episode of sudden sleep onset must not drive or operate machines. Furthermore, a reduction of dosage or termination of therapy may be considered.
Symptomatic hypotension can occur in patients treated with Parlodel for any indication. In postpartum studies with Parlodel, decreases in supine systolic and diastolic pressures of greater than 20 mm and 10 mm Hg, respectively, have been observed in almost 30% of patients receiving Parlodel. On occasion, the drop in supine systolic pressure was as much as 50-59 mm of Hg.
Since, especially during the first days of treatment, hypotensive reactions may occasionally occur and result in reduced alertness, particular care should be exercised when driving a vehicle or operating machinery.
While hypotension during the start of therapy with Parlodel occurs in some patients, in rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, have been reported in postpartum women treated with Parlodel for the inhibition of lactation. Hypertension have been reported, sometimes at the initiation of therapy, but often developing in the second week of therapy; seizures have also been reported both with and without the prior development of hypertension; stroke have been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated. Many of these patients experiencing seizures (including cases of status epilepticus) and/or strokes reported developing a constant and often progressively severe headache hours to days prior to the acute event. Some cases of strokes and seizures were also preceded by visual disturbances (blurred vision, and transient cortical blindness). Cases of acute myocardial infarction have also been reported.
Although a causal relationship between Parlodel administration and hypertension, seizures, strokes, and myocardial infarction in postpartum women has not been established, use of the drug for prevention of physiological lactation, or in patients with uncontrolled hypertension is not recommended. In patients being treated for hyperprolactinemia, Parlodel should be withdrawn when pregnancy is diagnosed . In the event that Parlodel is reinstituted to control a rapidly expanding macroadenoma and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing Parlodel must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When Parlodel is being used to treat acromegaly or Parkinson’s disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Parlodel is considered to be medically contraindicated. Because of the possibility of an interaction between Parlodel and other ergot alkaloids, the concomitant use of these medications is not recommended. Periodic monitoring of the blood pressure, particularly during the first weeks of therapy is prudent. If hypertension, severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, drug therapy should be discontinued and the patient should be evaluated promptly. Particular attention should be paid to patients who have recently been treated or are on concomitant therapy with drugs that can alter blood pressure. Their concomitant use in the puerperium is not recommended.
Among patients on Parlodel, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis, have been reported. Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of Parlodel therapy should be considered. In those instances in which Parlodel treatment was terminated, the changes slowly reverted towards normal.
In a few patients on Parlodel, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported. To ensure recognition of retroperitoneal fibrosis at an early reversible stage it is recommended that its manifestations (e.g., back pain, edema of the lower limbs, impaired kidney function) should be watched in this category of patients. Parlodel medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.
The risk of using Parlodel in combination with other drugs has not been systematically evaluated, but alcohol may potentiate the side effects of Parlodel. Parlodel may interact with dopamine antagonists, butyrophenones, and certain other agents. Compounds in these categories result in a decreased efficacy of Parlodel: phenothiazines, haloperidol, metoclopramide, and pimozide. Bromocriptine is a substrate of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors of this enzyme (such as azole antimycotics, HIV protease inhibitors). The concomitant use of macrolide antibiotics such as erythromycin was shown to increase the plasma levels of bromocriptine (mean AUC and C values increased 3.7-fold and 4.6-fold, respectively). The concomitant treatment of acromegalic patients with bromocriptine and octreotide led to increased plasma levels of bromocriptine (bromocriptine AUC increased about 38%).Concomitant use of Parlodel with other ergot alkaloids is not recommended. Dose adjustment may be necessary in those cases where high doses of bromocriptine are being used (such as Parkinson’s disease indication).
Safety and efficacy of Parlodel (bromocriptine mesylate) have not been established in patients with renal or hepatic disease. Care should be exercised when administering Parlodel therapy concomitantly with other medications known to lower blood pressure.
The drug should be used with caution in patients with a history of psychosis or cardiovascular disease. If acromegalic patients or patients with prolactinoma or Parkinson’s disease are being treated with Parlodel during pregnancy, they should be cautiously observed, particularly during the postpartum period if they have a history of cardiovascular disease.
Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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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