Clonidine Hydrochloride: Package Insert and Label Information (Page 2 of 2)

Maintenance Dose

Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.

Renal Impairment

Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.

HOW SUPPLIED

Clonidine hydrochloride tablets USP are supplied as follows:

Clonidine hydrochloride tablets USP 0.1 mg, yellow, round, debossed MP 657 on one side and plain on the other side.

Bottles of 100 NDC 52817-180-10
Bottles of 500 NDC 52817-180-50
Bottles of 1000 NDC 52817-180-00

Clonidine hydrochloride tablets USP 0.2 mg, white, round, debossed MP 658 on one side and plain on the other side.

Bottles of 100 NDC 52817-181-10
Bottles of 500 NDC 52817-181-50
Bottles of 1000 NDC 52817-181-00

Clonidine hydrochloride tablets USP 0.3 mg, green, round, debossed MP 659 on one side and plain on the other side.

Bottles of 100 NDC 52817-182-10
Bottles of 500 NDC 52817-182-50
Bottles of 1000 NDC 52817-182-00

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Add ress medical inquiries to: 1-877-541-5504 .

Manufactured by: Frontida BioPharm, Inc

Philadelphia, PA 19124

Distributed by: TruPharma, LLC

Tampa, FL 33609

Rev00, March 2017

PRINCIPAL DISPLAY PANEL

NDC 52817-180 -10
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only 100 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-180-10
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only
100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-180 -00
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only 1000 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-180-00
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only
1000 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-18 1 -10
Clonidine
Hydrochloride
Tablets, USP
0.2 mg
Rx Only 100 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-181-10
Clonidine
Hydrochloride
Tablets, USP
0.2 mg
Rx Only
100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-18 1 -00
Clonidine
Hydrochloride
Tablets, USP
0.2 mg
Rx Only 10 0 0 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-181-00
Clonidine
Hydrochloride
Tablets, USP
0.2 mg
Rx Only
1000 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-182 -10
Clonidine
Hydrochloride
Tablets, USP
0.3 mg
Rx Only 100 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-182-10
Clonidine
Hydrochloride
Tablets, USP
0.3 mg
Rx Only
100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-182 -00
Clonidine
Hydrochloride
Tablets, USP
0.3 mg
Rx Only 10 0 0 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-182-00
Clonidine
Hydrochloride
Tablets, USP
0.3 mg
Rx Only
1000 Tablets
(click image for full-size original)
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;657
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-180-10 100 TABLET in 1 BOTTLE None
2 NDC:52817-180-50 500 TABLET in 1 BOTTLE None
3 NDC:52817-180-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070925 06/01/2017
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-181
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;658
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-181-10 100 TABLET in 1 BOTTLE None
2 NDC:52817-181-50 500 TABLET in 1 BOTTLE None
3 NDC:52817-181-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070924 06/01/2017
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-182
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.3 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10
FD&C BLUE NO. 1
ALUMINUM OXIDE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;659
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-182-10 100 TABLET in 1 BOTTLE None
2 NDC:52817-182-50 500 TABLET in 1 BOTTLE None
3 NDC:52817-182-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070923 06/01/2017
Labeler — TruPharma, LLC (078533947)

Revised: 01/2020 TruPharma, LLC

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