United States - English - NLM (National Library of Medicine)

avera mckennan hospital - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine 1 mg

United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine 1 mg

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine tablets, usp are indicated in the management of hypertension. guanfacine tablets, usp may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. guanfacine tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride. no reported abuse or dependence has been associated with the administration of guanfacine.

United States - English - NLM (National Library of Medicine)

epic pharma, llc - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine hydrochloride tablets are indicated in the management of hypertension. guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. guanfacine hydrochloride tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride. no reported abuse or dependence has been associated with the administration of guanfacine.

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine hydrochloride tablets are indicated in the management of hypertension. guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. guanfacine hydrochloride tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride. no reported abuse or dependence has been associated with the administration of guanfacine.

United States - English - NLM (National Library of Medicine)

ajanta pharma usa inc. - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine tablets, usp are indicated in the management of hypertension. guanfacine tablets, usp may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. guanfacine tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride. 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-

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine tablets, usp are indicated in the management of hypertension. guanfacine tablets, usp may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. guanfacine tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride. no reported abuse or dependence has been associated with the administration of guanfacine.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies (14)] . guanfacine extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to guanfacine extended-release tablets or its inactive ingredients, or other products containing guanfacine. rash and pruritus have been reported. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including guanfacine extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388.   risk summary available data with guanfacine over decades of use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies (14)] . guanfacine extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to guanfacine extended-release tablets or its inactive ingredients, or other products containing guanfacine. rash and pruritus have been reported. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including guanfacine extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388.   risk summary available data with guanfacine over decades of use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

United States - English - NLM (National Library of Medicine)

northstar rxllc - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) as monotherapy and as adjunctive therapy to stimulant medications [see clinical studies (14)] . guanfacine is contraindicated in patients with a history of a hypersensitivity reaction to guanfacine extended-release tablets or its inactive ingredients, or other products containing guanfacine. rash and pruritus have been reported. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including guanfacine extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388. risk summary available data with guanfacine over decades of use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. however, use of guanfacine in pregnant women over this time has been infrequent. in animal reproduction studies, rabbits and rats exposed to 3 and 4 times the maximum recommended human dose (mrhd), respectively, showed no adverse outcomes. however, higher doses were associated with reduced fetal survival and maternal toxicity (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data reproduction studies conducted in rats have shown that guanfacine crosses the placenta. however, administration of guanfacine to rabbits and rats during organogenesis at 3 (rabbit) and 4 (rat) times the mrhd of 0.12 mg/kg/day on a mg/m2 basis resulted in no evidence of harm to the fetus. higher doses (13.5 times the mrhd in both rabbits and rats) were associated with reduced fetal survival and maternal toxicity. risk summary there are no data on the presence of guanfacine in human milk or the effects on the breastfed infant. the effects on milk production are also unknown. guanfacine is present in the milk of lactating rats (see data) . if a drug is present in animal milk, it is likely that the drug will be present in human milk. if an infant is exposed to guanfacine through breastmilk, monitor for symptoms of hypotension and bradycardia such as sedation, lethargy and poor feeding (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for guanfacine and any potential adverse effects on the breastfed child from guanfacine or from the underlying maternal condition. clinical considerations monitor breastfeeding infants exposed to guanfacine through breastmilk for sedation, lethargy, and poor feeding. data guanfacine was excreted in breast milk of lactating rats at a concentration comparable to that observed in blood, but slightly less than the concentration in plasma when administered following a single oral dose of 5 mg/kg. the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk. safety and efficacy of guanfacine in pediatric patients less than 6 years of age have not been established. the efficacy of guanfacine was studied for the treatment of adhd in five controlled monotherapy clinical trials (up to 15 weeks in duration), one randomized withdrawal study and one controlled adjunctive trial with psychostimulants (8 weeks in duration) in children and adolescents ages 6 to 17 who met dsm-iv® criteria for adhd [see adverse reactions (6) and clinical studies (14)] . animal data in studies in juvenile rats, guanfacine alone produced a slight delay in sexual maturation in males and females at 2 to 3 times the maximum recommended human dose (mrhd). guanfacine in combination with methylphenidate produced a slight delay in sexual maturation and decreased growth as measured by a decrease in bone length in males at a dose of guanfacine comparable to the mrhd and a dose of methylphenidate approximately 4 times the mrhd. in a study where juvenile rats were treated with guanfacine alone from 7 to 59 days of age, development was delayed as indicated by a slight delay in sexual maturation and decreased body weight gain in males at 2 mg/kg/day and in females at 3 mg/kg/day. the no adverse effect level (noael) for delayed sexual maturation was 1 mg/kg/day, which is equivalent to the mrhd of 4 mg/day, on a mg/m2 basis. the effects on fertility were not evaluated in this study. in a study where juvenile rats were treated with guanfacine in combination with methylphenidate from 7 to 59 days of age, a decrease in ulna bone length and a slight delay in sexual maturation were observed in males given 1 mg/kg/day of guanfacine in combination with 50 mg/kg/day of methylphenidate. the noaels for these findings were 0.3 mg/kg of guanfacine in combination with 16 mg/kg/day of methylphenidate, which are equivalent to 0.3 and 1.4 times the mrhd of 4 mg/day and 54 mg/day for guanfacine and methylphenidate, respectively, on a mg/m2 basis. these findings were not observed with guanfacine alone at 1 mg/kg/day or methylphenidate alone at 50 mg/kg/day. the safety and efficacy of guanfacine in geriatric patients have not been established. it may be necessary to reduce the dosage in patients with significant impairment of renal function [see clinical pharmacology (12.3)] . it may be necessary to reduce the dosage in patients with significant impairment of hepatic function [see clinical pharmacology (12.3)] . guanfacine is not a controlled substance and has no known potential for abuse or dependence.