Guanfacine (Page 4 of 4)

DRUG ABUSE AND DEPENDENCE

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

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 30-40 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 AND ADMINISTRATION

The recommended initial dose of guanfacine hydrochloride 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 2-4 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 2-4 days) without ill effects.

HOW SUPPLIED

Product: 68151-0623

NDC: 68151-0623-0 1 TABLET in a PACKAGE

Guanfacine 1 MG TAB

Label Image

GUANFACINE guanfacine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-0623(NDC:0591-0444) 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 ANHYDROUS LACTOSE FD&C RED NO. 40 MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STEARIC ACID ALUMINUM OXIDE

Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code WATSON;444 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68151-0623-0 1 TABLET in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074145 10/17/1995

Labeler — Carilion Materials Management (079239644)

Establishment
Name	Address	ID/FEI	Operations
Carilion Materials Management		079239644	REPACK (68151-0623)

Revised: 07/2017 Carilion Materials Management