Australia - engelsk - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - clonidine hydrochloride, quantity: 150 microgram/ml - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections - mz clonidine hcl injection is indicated for acute hypertensive crisis and as an alternative to oral therapy where the oral route of administration is inappropriate.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - clonidine hydrochloride, quantity: 150 microgram/ml - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections - clonidine hci injection medsurge is indicated for acute hypertensive crisis and as an alternative to oral therapy where the oral route of administration is inappropriate.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

medsurge pharma limited - clonidine hydrochloride 150 µg/ml - solution for injection - 150 mcg/ml - active: clonidine hydrochloride 150 µg/ml excipient: hydrochloric acid sodium chloride water for injection - for the treatment of hypertensive crises, slow parenteral administration is especially suitable due to the rapid onset of action.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

viatris limited - clonidine 2.52mg equivalent to 0.1 mg/24hr - transdermal patch - 0.1 mg/24h - active: clonidine 2.52mg equivalent to 0.1 mg/24hr excipient: adhesive 8400e/000 colloidal silicon dioxide durotak 87-613a ethylenevinylacetate copolymer heptane light liquid paraffin no tox ink brown- fgn4476 - clonidine transdermal system usp is indicated for the treatment of mild to moderate hypertension. it can be used as monotherapy or concomitantly with other antihypertensive agents if required to enhance hypotensive effect.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

viatris limited - clonidine 5.04mg equivalent to 0.2 mg/24hr - transdermal patch - 0.2 mg/24h - active: clonidine 5.04mg equivalent to 0.2 mg/24hr excipient: adhesive 8400e/000 colloidal silicon dioxide durotak 87-613a ethylenevinylacetate copolymer heptane light liquid paraffin no tox ink brown- fgn4476 - clonidine transdermal system usp is indicated for the treatment of mild to moderate hypertension. it can be used as monotherapy or concomitantly with other antihypertensive agents if required to enhance hypotensive effect.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

viatris limited - clonidine 7.56mg equivalent to 0.3mg/24hr - transdermal patch - 0.3 mg/24h - active: clonidine 7.56mg equivalent to 0.3mg/24hr excipient: adhesive 8400e/000 colloidal silicon dioxide durotak 87-613a ethylenevinylacetate copolymer heptane light liquid paraffin no tox ink brown- fgn4476 - clonidine transdermal system usp is indicated for the treatment of mild to moderate hypertension. it can be used as monotherapy or concomitantly with other antihypertensive agents if required to enhance hypotensive effect.

Canada - engelsk - Health Canada

pro doc limitee - clonidine hydrochloride - tablet - .2mg - clonidine hydrochloride .2mg - central alpha-agonists

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - 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.