Guanfacine Hydrochloride (Page 3 of 3)

Post-marketing Experience

An open-label post-marketing study involving 21,718 patients was conducted to assess the safety of guanfacine hydrochloride 1 mg/day given at bedtime for 28 days. Guanfacine was administered with or without other antihypertensive agents. Adverse events reported in the postmarketing study at an incidence greater than 1% included dry mouth, dizziness, somnolence, fatigue, headache and nausea. The most commonly reported adverse events in this study were the same as those observed in controlled clinical trials.

Less frequent, possibly guanfacine-related events observed in the post-marketing study and/or reported spontaneously include:

  • Body as a Whole: asthenia, chest pain, edema, malaise, tremor
  • Cardiovascular: bradycardia, palpitations, syncope, tachycardia
  • Central Nervous System: paresthesias, vertigo
  • Eye Disorders: blurred vision
  • Gastrointestinal System: abdominal pain, constipation, diarrhea, dyspepsia
  • Liver and Biliary System: abnormal liver function tests
  • Musculo-Skeletal System: arthralgia, leg cramps, leg pain, myalgia
  • Psychiatric: agitation, anxiety, confusion, depression, insomnia, nervousness
  • Reproductive System, Male: impotence
  • Respiratory System: dyspnea
  • Skin and Appendages: alopecia, dermatitis, exfoliative dermatitis, pruritus, rash
  • Special Senses: alterations in taste
  • Urinary System: nocturia, urinary frequency

Rare, serious disorders with no definitive cause and effect relationship to guanfacine have been reported spontaneously and/or in the postmarketing study. These events include acute renal failure, cardiac fibrillation, cerebrovascular accident, congestive heart failure, heart block, and myocardial infarction.

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 mg 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 mmHg and heart rate 70 beats per minute, 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 tablets 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 1 tablet strength of guanfacine (as the hydrochloride salt) as follows:

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

They are supplied as follows:
NDC 68094-065-62
Unit Dose Packages of 30 Tablets (3×10) per carton

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense contents in a tight, light resistant container as defined in the USP.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1561 Rev. 09/22

PRINCIPAL DISPLAY PANEL — 30 Tablet Blister Pack Carton Label

Precision Dose™

NDC 68094-065-62
Unit Dose

guanFACINE
Tablets, USP

1 mg*

30 Tablets

(3×10)

*Each tablet contains:
Guanfacine 1 mg
(equivalent to 1.15 mg guanfacine hydrochloride, USP).

USUAL DOSAGE: SEE ENCLOSED INSERT.

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

KEEP THIS AND ALL DRUGS
OUT OF REACH OF CHILDREN.

Rx Only
LC1563 R0

Packaged by:
Precision Dose, Inc.South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL -- 30 Tablet Blister Pack Carton Label
(click image for full-size original)
GUANFACINE HYDROCHLORIDE guanfacine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68094-065(NDC:53746-711)
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
MICROCRYSTALLINE CELLULOSE
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:68094-065-62 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68094-065-59)
1 NDC:68094-065-59 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68094-065-62)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075109 01/31/2023
Labeler — Precision Dose, Inc. (035886746)

Revised: 01/2023 Precision Dose, Inc.

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