Guanfacine (Page 4 of 4)

Postmarketing Experience

An open-label postmarketing study involving 21,718 patients was conducted to assess the safety of guanfacine (as the 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 postmarketing 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

MUSCULOSKELETAL 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.

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 (as the 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, 1 mg are available as white, round, flat-faced beveled-edge tablets, debossed “ Є 48” on one side and plain on the other side. These are supplied:

NDC 24658-730-01 Bottles of 100 Tablets

Guanfacine Tablets USP, 2 mg are available as yellow, round, flat-faced beveled-edge tablets, debossed “ Є 49” on one side and plain on the other side. These are supplied:

NDC 24658-731-01 Bottles of 100 Tablets

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]
Dispense in a tight, light-resistant container.

Distributed by:

PuraCap Laboratories, LLC

DBA Blu Pharmaceuticals

Franklin, KY 42134 USA

Manufactured in USA

Issued August 2016

MF048ISS08/16

OE2589

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 mg

Guanfacine Tablets USP, 1 mg

Rx Only

100 Tablets

Guanfacine Tablets 1 mg 100.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 2 mg

Guanfacine Tablets USP, 2 mg

Rx Only

100 Tablets

Guanfacine Tablets 2 mg 100.jpg
(click image for full-size original)
GUANFACINE
guanfacine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-730
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
TALC
Product Characteristics
Color white, white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code E48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-730-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074673 11/14/2016
GUANFACINE
guanfacine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-731
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
TALC
D&C YELLOW NO. 10
Product Characteristics
Color yellow, yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code E49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-731-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074673 11/14/2016
Labeler — PuraCap Laboratories LLC dba Blu Pharmaceuticals (080210964)
Registrant — Epic Pharma, LLC (827915443)
Establishment
Name Address ID/FEI Operations
Epic Pharma, LLC 827915443 manufacture (24658-730), manufacture (24658-731)

Revised: 01/2019 PuraCap Laboratories LLC dba Blu Pharmaceuticals

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