PARLODEL- bromocriptine mesylate tablet PARLODEL- bromocriptine mesylate capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BROMOCRIPTINE MESYLATE (UNII: FFP983J3OD) (BROMOCRIPTINE - UNII:3A64E3G5ZO)

Available from:

Validus Pharmaceuticals LLC

INN (International Name):

BROMOCRIPTINE MESYLATE

Composition:

BROMOCRIPTINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 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 Parlodel offers potential benefit before the effects of irradiation are manifested. 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. 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 ( s ee PRECAUTIONS, Hyperprolactinemic States ) . In the event that Parlodel is reinstituted to control a rapidly expanding macroadenoma ( s ee PRECAUTIONS, Hyperprolactinemic States ) 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.

Product summary:

Parlodel (bromocriptine mesylate) SnapTabs 2½ mg Parlodel 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 30698-202-01 Parlodel (bromocriptine mesylate) Capsules 5 mg Caramel 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 Store at 68º to 77ºF (20º to 25ºC); excursions permitted to 59º to 86ºF (15º to 30ºC) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.   Manufactured for and Distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054 [e-mail] www.validuspharma.com 1-866-982-5438 Product of Italy © 2021 Validus Pharmaceuticals LLC 60004-05             July 2021

Authorization status:

New Drug Application

Summary of Product characteristics

PARLODEL- BROMOCRIPTINE MESYLATE TABLET
PARLODEL- BROMOCRIPTINE MESYLATE CAPSULE, GELATIN COATED
VALIDUS PHARMACEUTICALS LLC
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PARLODEL CAPSULES AND TABLETS
PARLODEL
SNAPTABS
_(BROMOCRIPTINE MESYLATE)_ TABLETS, USP
_(BROMOCRIPTINE MESYLATE)_ CAPSULES, USP
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
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:
2½ MG SNAPTABS
_Active Ingredient:_ bromocriptine mesylate, USP
_Inactive Ingredients:_ colloidal silicon dioxide, lactose, magnesium
stearate, maleic acid,
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, maleic
acid, titanium dioxide,
yellow iron oxide, and another ingredient
CLINICAL PHARMACOLOGY
Parlodel (bromocriptine mesylate) is a dopamine receptor agonist,
which activates post-
synaptic dopamine receptors. The dopaminergic neurons in the
tuberoinfundibular
process modulate the secretion of prolactin from the anterior
pituitary by secreting a
prolactin inhibitory factor (thought to be dopamine); in the corpus
striatum the
dopaminergic neurons are involved in the control of motor function.
Clinically, Parlodel
significantly reduces plasma levels of prolactin in patients with
physiologically elevated
prolactin as well as in patients with hyperprolactinemia. The
inhibition of physiological
lactation as well as galactorrhea in pathological hyperprolactinemic
states is obtained at
dose levels that do not aff