Normipress

Clonidine hydrochloride.

Each tablet contains Clonidine hydrochloride USP 150 mcg.

Pharmacology: Pharmacokinetics: Clonidine is well absorbed from the gastrointestinal tract, and peak plasma concentrations occur about 3 to 5 hours after an oral dose. It is about 20 to 40% protein bound. About 50% of a dose metabolized in the liver. It is excreted in the urine as unchanged drug and metabolites, 40 to 60% of an oral dose being excreted in 24 hours as unchanged drug; about 20% of a dose is excreted in the faeces, probably via enterohepatic circulation. The elimination half-life has been variously reported to range between 6 and 24 hours, extended to up to 41 hours in patients with renal impairment. Clonidine crosses the placenta and is distributed into breast milk.

Used in the management of hypertension.

The usual dose for mild to moderate hypertension is 75-150 mcg twice daily. The usual dose for severe hypertension is single dose of 300 mcg, could be repeated up to three times a day (900 mcg). Or as prescribed by the physician.

Symptoms: Clonidine has a wide therapeutic range. Manifestations of intoxication are due to generalized sympathetic depression and include pupillary constriction, lethargy, bradycardia, hypotension, hypothermia, somnolence including coma, respiratory depression including apnea. Paradoxic hypertension caused by stimulation of peripheral alpha1-receptors may occur.
Treatment: Careful monitoring and symptomatic measures.

Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine.

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. Clonidine causes drowsiness and patients should not drive or operate machinery where loss of attention could be dangerous. Systemic effects also occur after epidural use and patients should be closely monitored, particularly during the first few days of therapy.
Intravenous injections of clonidine should be given slowly to avoid a possible transient pressor effects especially in patients already receiving other antihypertensives such as guanethidine or reserpine.

Pregnancy: There are limited amount of data from the use of clonidine in pregnant women. During pregnancy Clonidine HCI, as any drug, should only be administered if clearly needed. Careful monitoring of mother and child is recommended. Clonidine passes the placental barrier and may lower the heart rate of the fetus. 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. Postpartum a transient rise in blood pressure in the newborn cannot be excluded.
Lactation: Clonidine is excreted in human milk. However, there is insufficient information on the effects on newborns. The use of Clonidine HCI is therefore not recommended during breast feeding.
Fertility: 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.

Drowsiness, dry mouth, dizziness, and headache commonly occur during the initial stages of therapy with Clonidine. Constipation is common, and other adverse effects that have been reported include depression, anxiety, fatigue, nausea, anorexia, parotid pain, sleep disturbances, vivid dreams, impotence and loss of libido, urinary retention or incontinence, 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 pruritus, and these are more common with the use of transdermal delivery systems. Less frequently, bradycardia, including sinus bradycardia with antrioventricular block, other ECG disturbance, heart failure, hallucinations, cramp, Raynaud's syndrome, gynaecomastia, and transient abnormalities, in liver function test has been reported. Large doses have been associated with initial increases in blood pressure and transient hyperglycemia, although these do not persist during continued therapy.

The hypertensive effect of Clonidine may be enhanced by diuretics, other antihypertensives, and drugs that cause hypotension. However, beta blockers may exact drawal and tricyclic antidepressants may antagonize the hypotensive effect. The sedative effect of Clonidine may be enhanced by CNS depressants.

Store at temperatures not exceeding 30°C.

Other Antihypertensives

C02AC01 - clonidine ; Belongs to the class of imidazoline receptor agonists, centrally-acting antiadrenergic agents. Used in the treatment of hypertension.

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