Parlodel?
SnapTabs?
(bromocriptine mesylate) Tablets, USP
(bromocriptine mesylate) Capsules, USP
DRUG DESCRIPTION
Parlodel? (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel? (bromocriptine mesylate) SnapTabs? tablet for oral administration contains 2? mg and each capsule contains 5 mg bromocriptine (as the mesylate).
2? mg SnapTabs?
Active Ingredient: bromocriptine mesylate, USP
Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, povidone, starch, and another ingredient
5 mg Capsules
Active Ingredient: bromocriptine mesylate, USP
Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, titanium dioxide, yellow iron oxide, and another ingredient
INDICATIONS
Hyperprolactinemia-Associated Dysfunctions
Parlodel? (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size 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.
Acromegaly
Parlodel therapy is indicated in the treatment of acromegaly. Parlodel therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ? of patients treated, although not usually to normal levels.
Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with Parlodel offers potential benefit before the effects of irradiation are manifested.
Parkinson's Disease
Parlodel SnapTabs? or capsules are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), Parlodel therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing end of dose failure'' on levodopa therapy. Parlodel therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (on-off'' phenomenon). Continued efficacy of Parlodel therapy during treatment of more than 2 years has not been established.
Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson's disease with Parlodel. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in Parlodel-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for Parlodel therapy.
SIDE EFFECTS
Adverse Reactions from Clinical Trials
Hyperprolactinemic Indications
The incidence of adverse effects is quite high (69%) but these are generally mild to moderate in degree. Therapy was discontinued in approximately 5% of patients because of adverse effects. These in decreasing order of frequency are: nausea (49%), headache (19%), dizziness (17%), fatigue (7%), lightheadedness (5%), vomiting (5%), abdominal cramps (4%), nasal congestion (3%), constipation (3%), diarrhea (3%) and drowsiness (3%).
A slight hypotensive effect may accompany Parlodel? (bromocriptine mesylate) treatment. The occurrence of adverse reactions may be lessened by temporarily reducing dosage to ? SnapTabs? tablet 2 or 3 times daily. A few cases of cerebrospinal fluid rhinorrhea have been reported in patients receiving Parlodel for treatment of large prolactinomas. This has occurred rarely, usually only in patients who have received previous transsphenoidal surgery, pituitary radiation, or both, and who were receiving Parlodel for tumor recurrence. It may also occur in previously untreated patients whose tumor extends into the sphenoid sinus.
Acromegaly
The most frequent adverse reactions encountered in acromegalic patients treated with Parlodel were: nausea (18%), constipation (14%), postural/orthostatic hypotension (6%), anorexia (4%), dry mouth/nasal stuffiness (4%), indigestion/dyspepsia (4%), digital vasospasm (3%), drowsiness/tiredness (3%) and vomiting (2%).
Less frequent adverse reactions (less than 2%) were: gastrointestinal bleeding, dizziness, exacerbation of Raynaud's sy
