USA - engelska - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine 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 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.

USA - engelska - NLM (National Library of Medicine)

precision dose, inc. - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine 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 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.

USA - engelska - NLM (National Library of Medicine)

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

USA - engelska - NLM (National Library of Medicine)

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

USA - engelska - NLM (National Library of Medicine)

chartwell rx, llc - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine 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 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.

USA - engelska - NLM (National Library of Medicine)

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

USA - engelska - NLM (National Library of Medicine)

major pharmaceuticals - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine hydrochloride 1 mg

USA - engelska - NLM (National Library of Medicine)

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

USA - engelska - NLM (National Library of Medicine)

a-s medication solutions - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine 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 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.

USA - engelska - NLM (National Library of Medicine)

avkare - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine 1 mg - 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 is contraindicated in patients with a history of a hypersensitivity reaction to guanfacine extended-release or its inactive ingredients, or other products containing guanfacine. rash and pruritus have been reported. pregnancy category b risk summary there are no adequate and well-controlled studies of guanfacine extended-release in pregnant women. no fetal harm was observed in rats and rabbits with administration of guanfacine at 4 and 2.7 times, respectively, the maximum recommended human dose. because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. animal data reproduction studies conducted in rats have shown that guanfacine crosses the placenta. however, administration of guanfacine to rats and rabbits at 4 and 2.7 times, respectively, the maximum recommended human dose of 0.12 mg/kg/day on a mg/m 2 basis resulted in no evidence of harm to the fetus. higher doses (13.5 times the maximum recommended human dose in both rabbits and rats) were associated with reduced fetal survival and maternal toxicity. it is not known whether guanfacine is excreted in human milk; however, guanfacine is excreted in rat milk. because many drugs are excreted in human milk, caution should be exercised when guanfacine extended-release is administered to a nursing woman. observe human milk-fed infants for sedation and somnolence. safety and efficacy of guanfacine extended-release in pediatric patients less than 6 years of age have not been established. the efficacy of guanfacine extended-release was studied for the treatment of adhd in three controlled monotherapy clinical trials (up to 8 weeks in duration), 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 )]. additional pediatric use information for patients ages 6 to 17 years is approved for shire us inc.’s intuniv ® (guanfacine) extended-release tablet product. however, due to shire us inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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/m 2 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/m 2 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 extended-release 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 extended-release is not a controlled substance and has no known potential for abuse or dependence.