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mutual pharmaceutical company, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride tablets usp are indicated in the treatment of hypertension. clonidine hydrochloride tablets usp may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets usp should not be used in patients with known hypersensitivity to clonidine (see precautions ).

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

trupharma, llc - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride tablets usp are indicated in the treatment of hypertension. clonidine hydrochloride tablets usp may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets usp should not be used in patients with known hypersensitivity to clonidine (see precautions ).

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

rebel distributors corp - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride usp tablets are indicated in the treatment of hypertension. clonidine hydrochloride usp tablets may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride usp tablets should not be used in patients with known hypersensitivity to clonidine (see precautions).

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

xgen pharmaceuticals djb, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 100 ug in 1 ml - clonidine hydrochloride injection is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see clinical trials ). the safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. other use is of unproven safety and is not recommended. in a rare patient, the potential benefits may outweigh the known risks (see warnings ). clonidine hydrochloride injection is contraindicated in patients with a history of sensitization or allergic reactions to clonidine. epidural administration is contraindicated in the presence of an injection site infection, in patients on anticoagulant therapy, and in those with a bleeding diathesis. administration of clonidine hydrochloride injection above the c4 dermatome is contraindicated since there are no adequate safety data to support such use (see warnings ).

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

prasco laboratories - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride 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)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride 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 or visiting https://womensmentalhealth.org/adhd-medications/. risk summary prolonged experience with clonidine in pregnant women over several decades, based on published literature, including control

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

par pharmaceutical, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride 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)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions (6) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride 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 or visiting https://womensmentalhealth.org/adhd-medications/. risk summary prolonged experience with clonidine in pregnant women over several decades, based on published literature, including control

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

actavis pharma, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride 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)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride 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 or visiting https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/. risk summary prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes. in animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at 10 and 5 times, respectively, the maximum recommended human dose (mrhd) given to adolescents on a mg/m2 basis. no developmental effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the mrhd (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 background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data oral administration of clonidine hydrochloride to pregnant rabbits during the period of embryo/fetal organogenesis at doses of up to 80 mcg/kg/day (approximately 3 times the oral maximum recommended daily dose [mrhd] of 0.4 mg/day given to adolescents on a mg/m2 basis) produced no developmental effects. in pregnant rats, however, doses as low as 15 mcg/kg/day (1/3 the mrhd given to adolescents on a mg/m2 basis) were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating and throughout gestation. increased resorptions were not associated with treatment at the same or at higher dose levels (up to 3 times the mrhd) when treatment of the dams was restricted to gestation days 6 to 15. increases in resorptions were observed in both rats and mice at 500 mcg/kg/day (10 and 5 times the mrhd in rats and mice, respectively) or higher when the animals were treated on gestation days 1 to 14; 500 mcg/kg/day was the lowest dose employed in this study. risk summary based on published lactation studies, clonidine hydrochloride is present in human milk at relative infant doses ranging from 4.1 to 8.4% of the maternal weight-adjusted dosage. although in most cases, there were no reported adverse effects in breastfed infants exposed to clonidine, there is one case report of sedation, hypotonia, and apnea in an infant exposed to clonidine through breast milk. if an infant is exposed to clonidine hydrochloride through breastmilk, monitor for symptoms of hypotension and bradycardia, such as sedation, lethargy, tachypnea and poor feeding (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clonidine hydrochloride extended-release tablets and any potential adverse effects on the breastfed child from clonidine hydrochloride extended-release tablets or from the underlying maternal condition. exercise caution when clonidine hydrochloride extended-release tablets are administered to a nursing woman. clinical considerations monitor breastfeeding infants exposed to clonidine hydrochloride extended-release tablets through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding. infertility based on findings in animal studies revealed that clonidine hydrochloride extended-release tablets may impair fertility in females and males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and efficacy of clonidine hydrochloride extended-release tablets in the treatment of adhd have been established in pediatric patients 6 to 17 years of age. use of clonidine hydrochloride extended-release tablets in pediatric patients 6 to 17 years of age is supported by three adequate and well-controlled studies; a short-term, placebo-controlled monotherapy trial, a short-term adjunctive therapy trial and a longer-term randomized monotherapy trial [see clinical studies (14)] . safety and efficacy in pediatric patients below the age of 6 years has not been established. juvenile animal data in studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an effect on bone growth at clinically relevant doses and produced a slight delay in sexual maturation in males at 3 times the maximum recommended human dose (mrhd) for clonidine and methylphenidate. in a study where juvenile rats were treated orally with clonidine hydrochloride from day 21 of age to adulthood, a slight delay in onset of preputial separation (delayed sexual maturation) was seen in males treated with 300 mcg/kg/day, which is approximately 3 times the mrhd of 0.4 mg/day on a mg/m2 basis.  the no-effect dose was 100 mcg/kg/day, which is approximately equal to the mrhd. there was no drug effects on fertility or on other measures of sexual or neurobehavioral development.  in a study where juvenile rats were treated with clonidine alone (300 mcg/kg/day) or in combination with methylphenidate (10 mg/kg/day in females and 50/30 mg/kg/day in males; the dose was lowered from 50 to 30 mg/kg/day in males due to self-injurious behavior during the first week of treatment) from day 21 of age to adulthood, decreases in bone mineral density and mineral content were observed in males treated with 300 mcg/kg/day clonidine alone and in combination with 50/30 mg/kg/day methylphenidate and a decrease in femur length was observed in males treated with the combination at the end of the treatment period. these doses are approximately 3 times the mrhd of 0.4 mg/day clonidine and 54 mg/day methylphenidate on a mg/m2 basis. all these effects in male were not reversed at the end of a 4-week recovery period. in addition, similar findings were seen in males treated with a lower dose of clonidine (30 mcg/kg/day) in combination with 50 mg/kg/day of methylphenidate and a decrease in femur length was observed in females treated with clonidine alone at the end of the recovery period. these effects were accompanied by a decrease in body weight gain in treated animals during the treatment period but the effect was reversed at the end of the recovery period. a delay in preputial separation (sexual maturation) was observed in males treated with the combination treatment of 300 mcg/kg/day clonidine and 50/30 mg/kg/day methylphenidate. there was no effect on reproduction or sperm analysis in these males. the impact of renal impairment on the pharmacokinetics of clonidine in children has not been assessed. the initial dosage of clonidine hydrochloride extended-release tablets should be based on degree of impairment. monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine hydrochloride extended-release tablets following dialysis. clonidine hydrochloride extended-release tablets are not a controlled substance and have no known potential for abuse or dependence.

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

golden state medical supply, inc. - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride 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)] . clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions ( 6) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including clonidine hydrochloride 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 or visiting https://womensmentalhealth.org/adhd-medications/. risk summary prolonged experience with clonidine in p

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

american health packaging - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride 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)]. clonidine hydrochloride extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to clonidine. reactions have included generalized rash, urticaria, and angioedema [see adverse reactions ( 6) ] . pregnancy category c: risk summary there are no adequate or well-controlled studies with clonidine hydrochloride extended-release tablets in pregnant women. in animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at 10 and 5 times, respectively, the maximum recommended human dose (mrhd). no embryotoxic or teratogenic effects were seen in rabbits administered oral clonidine hydrochloride during organogenesis at doses up to 3 times the

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

cardinal health - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.1 mg - clonidine hydrochloride tablets, usp are indicated in the treatment of hypertension. clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see precautions ).