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

Guanfacine tablets, USP are available in the following dosing strengths (expressed in equivalent amounts of guanfacine):

Guanfacine tablets, USP 2 mg, are peach, round tablets, debossed with WATSON 453 and are available in bottles of 100.

NDC: 70518-1371-00

PACKAGING: 30 in 1 BLISTER PACK

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Guanfacine

GENERIC: Guanfacine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1371-0

COLOR: red

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: WATSON;453

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • GUANFACINE HYDROCHLORIDE 2mg in 1

INACTIVE INGREDIENT(S):

  • ALUMINUM OXIDE
  • CELLULOSE, MICROCRYSTALLINE
  • STEARIC ACID
  • ANHYDROUS LACTOSE
  • D&C YELLOW NO. 10
  • FD&C RED NO. 40
  • POVIDONE
MM1
(click image for full-size original)
GUANFACINE guanfacine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1371(NDC:0591-0453)
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
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
FD&C RED NO. 40
POVIDONE
STEARIC ACID
CELLULOSE, MICROCRYSTALLINE
ALUMINUM OXIDE
Product Characteristics
Color red (Peach) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code WATSON;453
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1371-0 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074145 08/14/2018
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2021 REMEDYREPACK INC.

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