parlodel

Contraindications: Uncontrolled hypertension of pregnancy, a history of toxemia of pregnancy, sensitivity to ergot alkaloids. For procedure during pregnancy, see Pregnancy under Precautions. Warnings: In women with nonpuerperal 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. Treatment with bromocriptine may effectively lower prolactin levels in patients with pituitary tumors but does not obviate the necessity for radiotherapy or surgical intervention where appropriate. Long-term treatment (6 to 36 months) with bromocriptine in doses ranging from 20 to 100 mg/day has been associated with pulmonary infiltrates, pleural effusion and thickening of the pleura in a few patients. In those instances in which bromocriptine treatment was terminated, the changes slowly reverted toward normal. To date, there have been 7 reported cases of retroperitoneal fibrosis occurring in parkinsonian patients on long-term treatment (15 months to 10 years) with bromocriptine at daily doses higher than 30 mg. To recognize retroperitoneal fibrosis at an early, reversible stage it is recommended to look for its manifestations (e.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 Bromocriptine medication should be withdrawn immediately if fibrotic changes in the retroperitoneum are diagnosed or suspected. Although there is no conclusive evidence which demonstrates the interaction between bromocriptine and other ergot alkaloids, the concomitant use of these medications is not recommended. Particular attention should be paid to patients who have recently received other drugs that can alter the blood pressure. Precautions: Bromocriptine may cause hypotension, primarily postural; periodic monitoring of the blood pressure, particularly during the first days of therapy, is advisable. Occupational Hazards: 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. Care should be exercised when administering bromocriptine concomitantly with phenothiazines or with other medications known to lower blood pressure. Dosage should be adjusted accordingly. 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. 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. 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 4 weeks during the amenorrheic period, and, once menses are reinitiated, every time a patient misses a menstrual period. 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. The use of bromocriptine is not recommended for patients with uncontrolled hypertension or toxemia of pregnancy. In postpartum women treated with bromocriptine, 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. Safety and efficacy of bromocriptine has not been established in patients with severe renal or hepatic disease. 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 continuous dosage in this indication or in patients given repeated courses of treatment following recurrence of amenorrhea/galactorrhea after initial treatment. Recurrence rates are reportedly very high, ranging from 70 to 80%. Bromocriptine should always be taken with food. In cases where adverse effects, such as nausea, vomiting and vertigo, are severe or persistent, the therapeutic dosage of bromocriptine should be reduced to half of 1 tablet daily (1.25 mg) and increased gradually to that recommended. The dopamine antagonist domperidone may be useful in the control of severe gastrointestinal side effects in parkinsonian patients receiving bromocriptine (see Drug Interactions). As with all medication, bromocriptine should be kept safely out of the reach of children. Pregnancy: In patients receiving bromocriptine, immunological confirmation of suspected conception should be performed as soon as possible and bromocriptine treatment stopped unless, in the opinion of the treating physician, the possible benefit to the patient outweighs the potential risk to the fetus. In any event, the patient must be monitored closely throughout pregnancy for signs and symptoms which may develop if a previously undetected prolactin-secreting tumor enlarges. In human studies with bromocriptine, there were 1 410 reported pregnancies, which yielded 1 236 live and 5 stillborn infants from women who took bromocriptine during early pregnancy. Among the 1 241 infants, 43 cases (31 minor and 12 major) of congenital anomalies were reported. The incidence (3.46%) and type of congenital malformations and the incidence of spontaneous abortions (11.13%) in this group of pregnancies do not exceed that generally reported for such occurrences in the population at large. Patients with pronounced enlargement of the sella turcica or a visual field defect should, in the first instance, be treated by surgery and/or radiotherapy. If pregnancy occurs in the presence of a pituitary microadenoma, close supervision throughout pregnancy is essential. This includes regular checking of the visual fields. Small prolactin-secreting adenomas not detected previously may rapidly increase in size during pregnancy. Optic nerve compression may occur and emergency pituitary surgery or other appropriate measures may be necessary. 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. Symptomatic hypotension can occur and, therefore, caution should be exercised when administering bromocriptine, particularly in patients receiving antihypertensive medication. Periodic evaluation of hepatic, hematopoietic, cardiovascular and renal function is recommended. Drug Interactions: The concomitant use of erythromycin may increase bromocriptine plasma levels. Domperidone, a peripheral dopamine antagonist, may cause increases in serum prolactin. In so doing, domperidone may antagonize the therapeutically relevant prolactin-lowering effect of bromocriptine. It is possible that the anti-tumorigenic effect of bromocriptine in patients with prolactinomas may be partially blocked by domperidone administration. Adverse Effects: 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 treatment. In clinical studies to date, the following adverse events were noted: In postpartum women treated with bromocriptine, 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. In decreasing order of frequency these are: nausea 51%, headache 18%, dizziness 16%, fatigue 8%, abdominal cramps 7%, lightheadedness 6%, vomiting 5%, nasal congestion 5%, constipation 3% and diarrhea 3%. 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. 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. Rarely signs or symptoms of ergotism such as tingling of fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud's syndrome may occur. Abnormalities in laboratory tests may include elevation of blood urea nitrogen, AST, ALT, GGPT, CPK, alkaline phosphatase and uric acid, which are usually transient and not of clinical significance. The occurrence of adverse reactions may be lessened by temporarily reducing dosage to 1.25 mg 2 or 3 times daily. Overdose: Symptoms: There have been several reports of acute overdosage with bromocriptine in children and adults. No life-threatening reactions have occurred. Symptoms reported could have resulted from over-stimulation of dopaminergic receptors: they included nausea, vomiting, dizziness, drowsiness, hypotension, sweating and hallucinations.