Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom
Catapres should not be used in patients with known hypersensitivity to the active ingredient or other components of the product, and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree.
In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to section 4.4 Special Warnings and Precautions for Use) the use of the product is contraindicated.
Caution should be exercised in patients with Raynaud’s disease or other peripheral vascular disease. As with all drugs used in hypertension Catapres should be used with caution in patients with cerebrovascular or coronary insufficiency.
Catapres should also be used with caution in patients with mild to moderate bradyarrhythmia such as low sinus rhythm, and with polyneuropathy or constipation.
Patients with a known history of depression should be carefully supervised while under long-term treatment with Catapres as there have been occasional reports of further depressive episodes during oral treatment in such patients.
As with other antihypertensive drugs, treatment with Catapres should be monitored particularly carefully in patients with heart failure.
In hypertension caused by phaeochromocytoma no therapeutic effect of Catapres can be expected.
Clonidine, the active ingredient of Catapres, and its metabolites are extensively excreted in the urine. Dosage must be adjusted to the individual antihypertensive response, which can show high variability in patients with renal insufficiency (See Section 4.2); careful monitoring is required. Since only a minimal amount of clonidine is removed during routine haemodialysis there is no need to give supplemental clonidine following dialysis.
Sudden withdrawal of Catapres, particularly in those patients receiving high doses, may result in rebound hypertension. Cases of agitation, restlessness, palpitations, nervousness, tremor, headache and abdominal symptoms have also been reported. Patients should be instructed not to discontinue therapy without consulting their physician. When discontinuing therapy the physician should reduce the dose gradually. However, if withdrawal symptoms should nevertheless occur, these can usually be treated with reintroduction of clonidine or with alpha and beta adrenoceptor blocking agents.
If Catapres is being given concurrently with a beta-blocker, Catapres should not be discontinued until several days after the withdrawal of the beta-blocker.
Patients who wear contact lenses should be warned that treatment with Catapres may cause decreased lacrimation.
This product contains 36.1 mg of lactose monohydrate per tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The use and the safety of clonidine in children and adolescents has little supporting evidence in randomized controlled trials and therefore cannot be recommended for use in this population.
Serious adverse events, including sudden death, have been reported in concomitant use with methylphenidate. The safety of using methylphenidate in combination with clonidine has not been systematically evaluated.
The reduction in blood pressure induced by clonidine can be further potentiated by concurrent administration of other hypotensive agents. This can be of therapeutic use in the case of other antihypertensive agents such as diuretics, vasodilators, beta-receptor blockers, calcium antagonists and ACE-inhibitors, but the effect of alpha1-blockers is unpredictable.
The antihypertensive effect of clonidine may be reduced or abolished and orthostatic hypotension may be provoked or aggravated by concomitant administration of tricyclic antidepressants or neuroleptics with alpha-receptor blocking properties.
Substances which raise blood pressure or induce a sodium ion (Na+) and water retaining effect such as non-steroidal anti-inflammatory agents can reduce the therapeutic effect of clonidine.
Substances with alpha2-receptor blocking properties, such as mirtazapine, may abolish the alpha2-receptor mediated effects of clonidine in a dose-dependent manner.
Concomitant administration of substances with a negative chronotropic or dromotropic effect such as beta-receptor blockers or digitalis glycosides can cause or potentiate bradycardic rhythm disturbances.
It cannot be ruled out that concomitant administration of a beta-receptor blocker will cause or potentiate peripheral vascular disorders.
Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for antihypertensive treatment have not been established.
The effects of centrally depressant substances or alcohol can be potentiated by clonidine.
There are limited amount of data from the use of clonidine in pregnant women. This product should only be used in pregnancy if considered essential by the physician. Careful monitoring of mother and child is recommended.
Clonidine passes the placental barrier and may lower the heart rate of the foetus. Post partum 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.
During pregnancy the oral forms of clonidine should be preferred. Intravenous injection of clonidine should be avoided.
Non-clinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Clonidine is excreted in human milk. However, there is insufficient information on the effect on newborns. The use of Catapres is therefore not recommended during breastfeeding.
No 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.
No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that they may experience undesirable effects such as dizziness, sedation and accommodation disorder during treatment with Catapres. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.
Most adverse effects are mild and tend to diminish with continued therapy.
Adverse events have been ranked under headings of frequency using the following convention: Very common ≥/10, Common ≥1/100, <1/10, Uncommon ≥1/1000, <1/100, Rare ≥1/10000, <1/1000, Very rare <1/10000, Not known Cannot be estimated from the available data.
Rare: Gynaecomastia
Common: Depression, Sleep disorder
Uncommon: Delusional perception, Hallucination, Nightmare
Not known: Confusional state, Libido decreased
Very common: Dizziness, Sedation
Common: Headache
Uncommon: Paraesthesia
Rare: Lacrimation decreased
Not known: Accommodation disorder
Uncommon: Sinus bradycardia
Rare: Atrioventricular block
Not known: Bradyarrhythmia
Very common: Orthostatic hypotension
Uncommon: Raynaud’s phenomenon
Rare: Nasal dryness
Very common: Dry mouth
Common: Constipation, Nausea, Salivary gland pain, Vomiting
Rare: Colonic pseudo-obstruction
Uncommon: Pruritus, Rash, Urticaria
Rare: Alopecia
Common: Erectile dysfunction
Common: Fatigue
Uncommon: Malaise
Rare: Blood glucose increased
There are occasional reports of fluid retention during initial stages of oral treatment. This is usually transitory and can be corrected by the addition of a diuretic.
Occasional reports of abnormal liver function tests and two cases of hepatitis have also been reported.
Reporting 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 website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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