A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Parlodel Indications, Dosage, Storage, Stability - Bromocriptine
Parlodel Indications, Dosage, Storage, Stability - Bromocriptine
INDICATIONS
Hyperprolactinemia-Associated Dysfunctions
Bromocriptine mesylate is indicated for the treatment of dysfunctions
associated with hyperprolactinemia including amenorrhea with or
without galactorrhea, infertility or hypogonadism. Bromocriptine
mesylate 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 bromocriptine mesylate therapy may be used to
reduce the tumor mass prior to surgery.
Acromegaly
Bromocriptine mesylate therapy is indicated in the treatment of acromegaly.
Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary
irradiation or surgery, reduces serum growth hormone by 50% or more in
approximately ½ 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 bromocriptine mesylate offers
potential benefit before the effects of irradiation are manifested.
Parkinson’s Disease
Bromocriptine mesylate tablets 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), bromocriptine mesylate 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. Bromocriptine mesylate 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 bromocriptine mesylate 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 bromocriptine mesylate. Studies have
shown, however, significantly more adverse reactions (notably nausea,
hallucinations, confusion and hypotension) in bromocriptine mesylate treated
patients than in levodopa/carbidopa treated patients. Patients unresponsive
to levodopa are poor candidates for bromocriptine mesylate therapy.
DOSAGE AND ADMINISTRATION
General
It is recommended that bromocriptine mesylate be taken with food. Patients
should be evaluated frequently during dose escalation to determine the
lowest dosage that produces a therapeutic response.
Hyperprolactinemic Indications
The initial dosage of bromocriptine mesylate is ½ to one 2½ mg tablet
daily. An additional 2½ mg tablet may be added to the treatment regimen
as tolerated every 3-7 days until an optimal therapeutic response is achieved.
The therapeutic dosage usually is 5-7.5 mg and ranges from 2.5-15 mg/day.
In order to reduce the likelihood of prolonged exposure to bromocriptine
mesylate should an unsuspected pregnancy occur, a mechanical contraceptive
should be used in conjunction with bromocriptine mesylate therapy until
normal ovulatory menstrual cycles have been restored. Contraception may
then be discontinued in patients during pregnancy.
Thereafter, if menstruation does not occur within 3 days of the expected
date, bromocriptine mesylate therapy should be discontinued and a pregnancy
test performed.
Acromegaly
Virtually all acromegalic patients receiving therapeutic benefit from
bromocriptine mesylate also have reductions in circulating levels of growth
hormone. Therefore, periodic assessment of circulating levels of growth
hormone will, in most cases, serve as a guide in determining the therapeutic
potential of bromocriptine mesylate. If, after a brief trial with bromocriptine
mesylate therapy, no significant reduction in growth hormone levels has
taken place, careful assessment of the clinical features of the disease
should be made, and if no change has occurred, dosage adjustment or discontinuation
of therapy should be considered.
The initial recommended dosage is ½ to one 2½ mg bromocriptine mesylate
tablet on retiring (with food) for 3 days An additional ½ to 1 tablet
should be added to the treatment regimen as tolerated every 3-7 days until
patient obtains optimal therapeutic benefit. Patients should be reevaluated
monthly and the dosage adjusted based on reductions of growth hormone
or clinical response. The usual optimal therapeutic dosage range of bromocriptine
mesylate varies from 20-30 mg/day in most patients. The maximal dosage
should not exceed 100 mg/day.
Patients treated with pituitary irradiation should be withdrawn from
bromocriptine mesylate therapy on a yearly basis to assess both the clinical
effects of radiation on the disease process as well as the effects of
bromocriptine mesylate therapy. Usually a 4-8 week withdrawal period is
adequate for this purpose. Recurrence of the signs/symptoms or increases
in growth hormone indicate the disease process is still active and further
courses of bromocriptine mesylate should be considered.
Parkinson’s Disease
The basic principle of bromocriptine mesylate therapy is to initiate
treatment at a low dosage and, on an individual basis, increase the daily
dosage slowly until a maximum therapeutic response is achieved. The dosage
of levodopa during this introductory period should be maintained, if possible.
The initial dose of bromocriptine mesylate is ½ of a 2½ mg tablet twice
daily with meals. Assessments are advised at 2-week intervals during dosage
titration to ensure that the lowest dosage producing an optimal therapeutic
response is not exceeded. If necessary, the dosage may be increased every
14-28 days by 2½ mg/day with meals. Should it be advisable to reduce the
dosage of levodopa because of adverse reactions, the daily dosage of bromocriptine
mesylate, if increased, should be accomplished gradually in small (2½
mg) increments.
The safety of bromocriptine mesylate has not been demonstrated in dosages
exceeding 100 mg/day.
HOW SUPPLIED
Bromocriptine Mesylate Tablets, USP
Round, off-white, scored tablets, each containing 2½ mg bromocriptine
(as the mesylate). Engraved “GG” and “211” one side; a facilitated bisect
engraved on the other side.
Bottles of 30 (NDC 0781-1817-31)
Bottles of 100 (NDC 0781-1817-01)
Bromocriptine Mesylate Capsules, USP
Yellow and white capsules, each containing 5 mg bromocriptine
(as the mesylate). Spin-printed with red “GG” one half and “537” other
half.
Bottles of 30 (NDC 0781-2819-31)
Bottles of 100 (NDC 0781-2819-01)
Store and Dispense
Below 77°F (25°C); tight, light-resistant container.
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