Parlodel (Page 6 of 6)
Parkinson’s Disease
The basic principle of Parlodel 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 Parlodel is one ½ of a 2½ mg SnapTabs 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 to 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 Parlodel, if increased, should be accomplished gradually in small (2½ mg) increments.
The safety of Parlodel has not been demonstrated in dosages exceeding 100 mg/day.
HOW SUPPLIED
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 and Dispense
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
info@validuspharma.com
www.validuspharma.com
1-866-982-5438
Product of Italy
© 2021 Validus Pharmaceuticals LLC
60004-05 July 2021
PRINCIPAL DISPLAY PANEL
NDC 30698-202-30
Parlodel®
(bromocriptine mesylate) tablets, USP
2 ½ mg 30 Snap Tabs® Rx Only
PRINCIPAL DISPLAY PANEL
NDC 30698-202-01
Parlodel®
(bromocriptine mesylate) tablets, USP
2 ½ mg 100 Snap Tabs® Rx Only
PRINCIPAL DISPLAY PANEL
NDC 30698-201-30
Parlodel®
(bromocriptine mesylate) capsules, USP
5 mg 30 CapsulesRx Only
PRINCIPAL DISPLAY PANEL
NDC 30698-201-01
Parlodel®
(bromocriptine mesylate) capsules, USP
5 mg 100 CapsulesRx Only
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PARLODEL bromocriptine mesylate capsule, gelatin coated | ||||||||||||||||||||||||
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Labeler — Validus Pharmaceuticals LLC (801194619) |
Revised: 12/2023 Validus Pharmaceuticals LLC
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