Guanfacine Hydrochloride: Package Insert and Label Information (Page 3 of 3)

DRUG ABUSE AND DEPENDENCE

No reported abuse or dependence has been associated with the administration of guanfacine hydrochloride.

OVERDOSAGE

Signs and Symptoms

Drowsiness, lethargy, bradycardia and hypotension have been observed following overdose with guanfacine.

A 25-year-old female intentionally ingested 60 mg. She presented with severe drowsiness and bradycardia of 45 beats/minute. Gastric lavage was performed and an infusion of isoproterenol (0.8 mg in 12 hours) was administered. She recovered quickly and without sequelae.

A 28-year-old female who ingested 30 to 40 mg developed only lethargy, was treated with activated charcoal and a cathartic, was monitored for 24 hours, and was discharged in good health.

A 2-year-old male weighing 12 kg who ingested up to 4 mg of guanfacine developed lethargy. Gastric lavage (followed by activated charcoal and sorbitol slurry via NG tube) removed some tablet fragments within 2 hours after ingestion, and vital signs were normal. During 24-hour observation in ICU, systolic pressure was 58 and heart rate 70 at 16 hours post-ingestion. No intervention was required, and child was discharged fully recovered the next day.

Treatment of Overdosage

Gastric lavage and supportive therapy as appropriate. Guanfacine is not dialyzable in clinically significant amounts (2.4%).

DOSAGE & ADMINISTRATION

The recommended initial dose of guanfacine tablets, USP when given alone or in combination with another antihypertensive drug is 1 mg daily given at bedtime to minimize somnolence. If after 3 to 4 weeks of therapy 1 mg does not give a satisfactory result, a dose of 2 mg may be given, although most of the effect of guanfacine is seen at 1 mg (see CLINICAL PHARMACOLOGY). Higher daily doses have been used, but adverse reactions increase significantly with doses above 3 mg/day.

The frequency of rebound hypertension is low, but it can occur. When rebound occurs, it does so after 2 to 4 days, which is delayed compared with clonidine hydrochloride. This is consistent with the longer half-life of guanfacine. In most cases, after abrupt withdrawal of guanfacine, blood pressure returns to pretreatment levels slowly (within 2 to 4 days) without ill effects.

HOW SUPPLIED

Guanfacine tablets, USP are available in 2 tablet strengths of guanfacine (as the hydrochloride salt) as follows:

1 mg: white, oval, flat-faced, beveled-edge tablet with “AN” on one side and “711” on the other side.

NDC 50268-373-15 (10 tablets per card, 5 cards per carton).

2 mg: white, oval, flat-faced, beveled-edge tablet with “AN” on one side and “713” on the other side.

NDC 50268-374-15 (10 tablets per card, 5 cards per carton).

Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20º to 25 ºC (68 ºF to 77 ºF) [see USP Controlled Room Temperature].

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 11-2015-00
AV Rev. 10/18 (P) AvPAK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3
(click image for full-size original)

GUANFACINE HYDROCHLORIDE guanfacine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-374(NDC:65162-713)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE HYDROCHLORIDE (GUANFACINE) GUANFACINE 2 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score no score
Shape OVAL Size 11mm
Flavor Imprint Code AN;713
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-374-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-374-11)
1 NDC:50268-374-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-374-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075109 06/07/2017
GUANFACINE HYDROCHLORIDE guanfacine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-373(NDC:65162-711)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUANFACINE HYDROCHLORIDE (GUANFACINE) GUANFACINE 1 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score no score
Shape OVAL Size 11mm
Flavor Imprint Code AN;711
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-373-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-373-11)
1 NDC:50268-373-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-373-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075109 09/27/2018 09/30/2019
Labeler — AvPAK (832926666)

Revised: 10/2019 AvPAK

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