Adults:Initially 2 tablets twice daily. If after two weeks there has been no remission, increase to 3 tablets twice daily.The duration of treatment depends upon the severity of the condition. If symptoms continue to occur the patient should be informed that it may take 2 - 4 weeks until clonidine is fully effective.
Older poeple:No specific information on the use of this product in the older people is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
Paediatric population:There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years.
Patients with renal impairment:Clonidine should be used with caution in patients with renal insufficiency. Careful monitoring of blood pressure is required.
Method of administrationFor oral administration.
This medicine contains less than 1 mmol sodium (23 mg) per tablet , that is to say essentially 'sodium-free'.
PregnancyThere are limited amount of data from the use of clonidine in pregnant women. As with all medicines, clonidine should not be used in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus.In animal studies involving doses higher than the equivalent maximum therapeutic dose in man, effects on foetal development were only seen in one species. Foetal malformations did not occur.Careful monitoring of mother and child is recommended.Clonidine passes the placental barrier and may lower the heart rate of the foetus. Postpartum a transient rise in blood pressure in the newborn cannot be excluded.There is no adequate experience regarding the long term effects of prenatal exposure.
Breast-feedingClonidine is excreted in human milk. However, there is insufficient information on the effect on newborns. The use of clonidine is therefore not recommended during breast feeding.
FertilityNo clinical studies on the effect on human fertility have been conducted with clonidine. Non-clinical studies with clonidine indicate no direct or indirect harmful effects with respect to the fertility index.
|Very common||≥ 1/10|
|Common||≥ 1/100 to <1/10|
|Uncommon||≥ 1/1,000 to <1/100|
|Rare||≥ 1/10,000 to <1/1,000|
|Not known||Cannot be estimated from the available data|
|confusional state||not known|
|libido decreased||not known|
|Nervous system disorders:|
|accommodation disorder||not known|
|orthostatic hypotension||very common|
|Respiratory, thoracic and mediastinal disorders:|
|dry mouth||very common|
|salivary gland pain||common|
|Skin and subcutaneous tissue disorders:|
|Reproductive system and breast disorders:|
|General disorders and administration site conditions:|
|blood glucose increased||rare|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
Symptoms:Manifestations of intoxication are due to a generalised sympathetic depression and include pupillary constriction, somnolence including coma, hypotension, orthostatic hypotension, bradycardia, hypothermia, respiratory depression including apnoea, occasionally vomiting, very occasionally hypertension and dryness of the mouth.
Treatment:There is no specific antidote for clonidine overdose. Administration of activated charcoal should be performed where appropriate. Supportive care may include atropine sulfate for symptomatic bradycardia, and intravenous fluids and/or inotropic sympathomimetic agents for hypotension. Severe persistent hypertension may require correction with alpha-adrenoceptor blocking drugs. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression.
Paediatric populationThe efficacy of clonidine in the treatment of hypertension has been investigated in five clinical studies in paediatric patients. The efficacy data confirms the properties of clonidine in reduction of systolic and diastolic blood pressure. However, due to limited data and methodological insufficiencies, no definitive conclusion can be drawn on the use of clonidine for hypertensive children.The efficacy of clonidine has also been investigated in a few clinical studies with paediatric patients with ADHD, Tourette syndrome and stuttering. The efficacy of clonidine in these conditions has not been demonstrated.There were also two small paediatric studies in migraine, neither of which demonstrated efficacy.In the paediatric studies the most frequent adverse events were drowsiness, dry mouth, headache, dizziness and insomnia. These adverse events might have serious impact on daily functioning in paediatric patients.Overall, the safety and efficacy of clonidine in children and adolescents have not been established (see section 4.2).
Absorption and distributionThe pharmacokinetics of clonidine is dose-proportional in the range of 75-300 micrograms; over this range, dose linearity has not been fully demonstrated. Clonidine, the active ingredient of Clonidine Tablets, is highly absorbed and undergoes a minor first pass effect. Peak plasma concentrations are reached within 1-3 h after oral administration. The plasma protein binding is 30-40 %. Clonidine is rapidly and extensively distributed into tissues and crosses the blood-brain barrier, as well as the placental barrier. Clonidine is excreted in human milk. However, there is insufficient information on the effect on newborns.
Biotransformation and eliminationThe terminal elimination half-life of clonidine has been found to range from 5 to 25.5 hours. It can be prolonged in patients with severely impaired renal function up to 41 hours.About 70 % of the dose administered is excreted with the urine mainly in form of the unchanged parent drug (40-60 % of the dose). The main metabolite p-hydroxy-clonidine is pharmacologically inactive. Approximately 20% of the total amount is excreted with the faeces. There is no definitive data about food or race effects on the pharmacokinetics of clonidine.The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/ml in patients with normal renal function. The hypotensive effect is attenuated or decreases with plasma concentrations above 2.0 ng/ml.
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