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 30698-202-30
Parlodel®
(bromocriptine mesylate)
tablets, USP
2 ½ mg
30 Snap Tabs®
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 30698-202-01
Parlodel®
(bromocriptine mesylate) tablets, USP
2 ½ mg 100 Snap Tabs® Rx Only

PRINCIPAL DISPLAY PANEL
NDC 30698-202-01
Parlodel®
(bromocriptine mesylate)
tablets, USP
2 ½ mg
100 Snap Tabs®
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 30698-201-30
Parlodel®
(bromocriptine mesylate) capsules, USP
5 mg 30 CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 30698-201-30
Parlodel®
(bromocriptine mesylate)
capsules, USP
5 mg
30 Capsules
Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 30698-201-01
Parlodel®
(bromocriptine mesylate) capsules, USP
5 mg 100 CapsulesRx Only

PRINCIPAL DISPLAY PANEL
NDC 30698-201-01
Parlodel®
(bromocriptine mesylate)
capsules, USP
5 mg
100 Capsules
Rx Only
(click image for full-size original)
PARLODEL bromocriptine mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:30698-202
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMOCRIPTINE MESYLATE (BROMOCRIPTINE) BROMOCRIPTINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MALEIC ACID
POVIDONE
STARCH, CORN
Product Characteristics
Color white (off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code PARLODEL;2;1;2;017
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30698-202-30 30 TABLET in 1 BOTTLE None
2 NDC:30698-202-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017962 04/28/2014
PARLODEL bromocriptine mesylate capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:30698-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMOCRIPTINE MESYLATE (BROMOCRIPTINE) BROMOCRIPTINE 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
GELATIN
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
STARCH, CORN
MALEIC ACID
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color brown (Caramel) , white Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code PARLODEL;5;mg;102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30698-201-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE None
2 NDC:30698-201-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017962 04/28/2014
Labeler — Validus Pharmaceuticals LLC (801194619)

Revised: 12/2023 Validus Pharmaceuticals LLC

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