(and dosage form):
Each tablet contains 25 micrograms clonidine hydrochloride.
A 7.3 Migraine preparations
Clonidine hydrochloride has both central and peripheral action on alpha2-adrenergic receptors. It reduces vascular responses to vasoconstrictor as well as vasodilator stimuli.
Clonidine is well absorbed after oral administration, and bioavailability is nearly 100%.
The peak concentration in plasma and the maximal hypotensive effect are observed 1 to 3 hours after an oral dose. The elimination half-life of clonidine ranges from 6 to 24 hours, with a mean of about 12 hours. About half of an administered dose can be recovered unchanged in the urine, and the half-life of Clonidine may increase with renal failure.
For the prevention of migraine and in the treatment of menopausal flushing.
Hypersensitivity to clonidine.
Patients with porphyria.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned not to take charge of vehicles or machinery or perform potentially hazardous tasks where loss of concentration may lead to accidents.
DOSAGE AND DIRECTIONS:
One tablet morning and night, increasing to three tablets twice daily if necessary.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Drowsiness, dry mouth, dizziness, and headache commonly occur during the initial stages of therapy with clonidine. Constipation is also common, and other adverse effects which have been reported include depression, anxiety, fatigue, nausea, anorexia, parotid pain, sleep disturbances, vivid dreams, impotence and loss of libido, urinary retention or incontinence, slight orthostatic hypotension, and dry, itching, or burning sensations in the eye. Fluid retention may occur and is usually transient, but may be responsible for a reduction in the hypotensive effect during continued treatment.
Clonidine may cause rashes and pruritis. Less frequently, bradycardia including sinus bradycardia with atrioventricular block, other electro cardiographic disturbances, heart failure, hallucinations, cramp, Raynaud's syndrome, gynaecomastia, and transient abnormalities in liver function tests have been reported. Large doses have been associated with initial increases in blood pressure and transient hyperglycaemia, although these do not persist during continued therapy.
Use with caution in pregnancy and lactation.
Should not be used in patients with a previous history of depressive illness, since further depressive episodes have been reported in such patients.
Clonidine should be used with caution in patients with cerebrovascular disease, ischaemic heart disease including myocardial infarction, renal impairment, occlusive peripheral vascular disorders such as Raynaud's disease, or those with a history of depression.
Withdrawal of clonidine therapy should be gradual as sudden discontinuation may cause rebound hypertension, sometimes severe. Symptoms of increased catecholamine release such as agitation, sweating, tachycardia, headache, and nausea may also occur. Beta blockers can exacerbate the rebound hypertension and if clonidine is being given concurrently with a beta-blocking agent, clonidine should not be discontinued until several days after the withdrawal of the beta blocker. Patients should be warned of the risk of missing a dose or stopping the medicine without consulting their doctor and should carry a reserve supply of tablets.
Although hypotension may occur during anaesthesia in clonidine-treated patients clonidine should not be withdrawn, indeed if necessary it should be given intravenously during the operation to avoid the risk of rebound hypertension. Intravenous injections of clonidine should be given slowly to avoid possible transient pressor effect especially in patients already receiving other antihypertensive agents such as guanethidine or reserpine.
The hypotensive effect may be antagonised by tricyclic antidepressants, and enhanced by diuretics or other antihypertensive agents. Beta-blockers can cause severe rebound hypertension. Central nervous system depressants can cause enhanced sedation.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include transient hypertension or profound hypotension, bradycardia, sedation, miosis, respiratory depression, convulsions and coma. Treatment is supportive and symptomatic. An alpha adreno receptor blocking agent may be given if necessary.
Blue, biconvex sugar-coated tablets.
Securitainers of 30 and 100 tablets.
Store below 25°C.
Keep container tightly closed.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
A & S PRINTERS
Updated on this site: June 2006
Source: Community Pharmacy
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