Normopresan

/ Rafa

Treatment of hypertension requires regular medical supervision. The dose of Normopresan must be individualized according to the patient’s blood pressure response. As an initial daily dose in mild to moderate forms of hypertension, 0.075 mg (half a tablet) to 0.150 mg (one tablet) twice daily are sufficient in most cases. After a period of 2-4 weeks the dose may be increased if necessary until the desired response is achieved.Usually doses above 0.6mg per day do not result in a further marked drop in blood pressure. In severe hypertension it might be necessary to increase the single dose further to 0.3mg; this could be repeated up to three times daily (0.9mg). In patients with renal insufficiency careful monitoring is required and the dosage must be adjusted appropriately, according to the individual antihypertensive response. Since only a minimal amount of clonidine is removed during routine hemodialysis there is no need to give supplemental clonidine following dialysis. Patients changing to treatment with Normopresan should have their existing therapy reduced gradually, while Normopresan is added to the regimen. Although concurrent use of a thiazide diuretic may be a valuable adjuvant in many hypertensive patients, when administered alone, Normopresan will, in many cases, provide full control of blood pressure. Nevertheless, the use of a diuretic may aid in overcoming tolerance to clonidine and permit reduction of clonidine dosage.
See prescribing information for full details.

Mild to severe hypertension, renal hypertension.

Known hypersensitivity to clonidine. Severe bradycardia resulting from sick sinus syndrome or atrio-ventricular block of the second or third degree. Warnings: Clonidine should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, mild to moderate bradycardia, cerebrovascular disease, chronic renal function impairment, or polyneuropathy. Tolerance to clonidine may develop in some patients, necessitating a re-evaluation of therapy. Concomitant use of a diuretic may aid in overcoming tolerance to clonidine and may permit a reduction in dosage of clonidine.
Perioperative Use: Administration of clonidine should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.
Information for Patients: Patients should be cautioned against interruption of clonidine therapy without their physician’s advice. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. They should also be informed that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine may cause dryness of eyes, Pregnancy, lactation.

Reduce dose gradually over 2-4 days, in order to avoid a possible rapid rise in blood pressure and associated subjective symptoms. Patients should undergo periodic eye examinations. May be unsuitable for patients who have co-existing or a previous history of depressive illness, since further depressive episodes have occasionally been reported in such patients.

Dry mouth, drowsiness and sedation. Constipation, dizziness, headache and fatigue. In general these effects tend to diminish with continued therapy. Anorexia, malaise, nausea, vomiting and mild transient abnormalities in liver function tests. Weight gain, transient elevation of blood glucose or serum creatinine phosphokinase and gynecomastia. Congestive heart failure, Raynaud’s phenomenon and electrocardiographic abnormalities manifested as Wenckebach period and ventricular trigeminy. Vivid dreams or nightmares, insomnia, restlessness, anxiety and mental depression. Rash, angioneurotic edema, hives, urticaria, thinning of the hair and pruritus not associated with rash. Occasional impotence and urinary retention. Increased sensitivity to alcohol, dryness, itching or burning of the eyes, dryness of the nasal mucosa, pallor or a weakly positive Coomb’s test.

Alcohol, other CNS depressants, antihypertensives and diuretics, tricyclic antidepressants, MAOI.

Pregnancy: Since embryotoxicity has been reported in animals who prior to mating received an extremely low dose of clonidine (0.015 mg/kg body weight; one-third of the maximum recommended human dose), the use of clonidine is not recommended in women who are or who may become pregnant, unless the potential benefits outweigh the possible hazards to mother and fetus.
Breastfeeding : Safety of use in nursing mothers has not been established. Clonidine hydrochloride is excreted in human milk.

Manifestations: Hypertension may develop early and may be followed by hypotension, drowsiness, bradycardia, CNS depression, respiratory depression, apnea, hypothermia, miosis, seizures, lethargy, agitation, irritability, diarrhea, arrhythmias and transient hypertension have been reported. Profound hypotension, weakness, somnolence, diminished or absent reflexes and vomiting followed accidental ingestion by several children aged 19 months to 5 years of age. Signs and symptoms of clonidine overdose usually occur within 30-60 minutes after ingestion and may persist for 36-48 hours.