Clonidine Hydrochloride (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Adults

The dose of clonidine hydrochloride tablets USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.

Initial Dose

0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.

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 12 NDC 71205-588-12
Bottles of 30 NDC 71205-588-30
Bottles of 60 NDC 71205-588-60
Bottles of 90 NDC 71205-588-90

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Address medical inquiries to: 1-877-541-5504.

Manufactured by:

Frontida BioPharm, Inc

Philadelphia, PA 19124

Distributed by:

TruPharma, LLC

Tampa, FL 33609

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Rev00, March 2017

PRINCIPAL DISPLAY PANEL

NDC 71205-588 -12
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only
12 Tablets

71205-588-12
(click image for full-size original)
CLONIDINE HYDROCHLORIDE
clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-588(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:71205-588-12 12 TABLET in 1 BOTTLE None
2 NDC:71205-588-30 30 TABLET in 1 BOTTLE None
3 NDC:71205-588-60 60 TABLET in 1 BOTTLE None
4 NDC:71205-588-90 90 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
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-588), RELABEL (71205-588)

Revised: 07/2021 Proficient Rx LP

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