Description

CATAPRES 150MCG TABLET

Description :

1 tablet contains 75, 150 mcg.

1 ampoule of 1 mL contains 150 mcg.

2,6-dichloro-N-2-imidazolidinylidenebenzenamine hydrochloride (=clonidine hydrochloride).

Excipients/Inactive Ingredients: Tablets: Lactose monohydrate, calcium hydrogen phosphate anhydrous, maize starch dried, silica colloidal anhydrous, povidone, starch soluble, stearic acid.

Ampoules: Sodium chloride, hydrochloric acid.

Indications / Uses :

Clonidine HCl (CATAPRES) is indicated in the treatment of hypertension. Clonidine HCl (CATAPRES) may be employed alone or concomitantly with other antihypertensive agents.

For the treatment of hypertensive crisis, slow parenteral administration is especially suitable due to rapid onset of action.

Administration :

CATAPRES 75MCG TAB 100S

Contraindications :

Clonidine HCl (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 Precautions) the use of the product is contraindicated.

Special Precaution :

Clonidine HCl (CATAPRES) should be used with caution in patients with mild to moderate bradyarrhythmia such as low sinus rhythm, with disorders of cerebral or peripheral perfusion, depression, polyneuropathy and constipation.

In hypertension caused by phaeochromocytoma no therapeutic effect of Clonidine HCl (CATAPRES) can be expected.

Clonidine, the active ingredient of CATAPRES, and its metabolites are extensively excreted with the urine. Renal insufficiency requires particularly careful adjustment of dosage (see Dosage & Administration).

As with other antihypertensive drugs, treatment with Clonidine HCl (CATAPRES) should be monitored particularly carefully in patients with heart failure or severe coronary heart disease. Patients should be instructed not to discontinue therapy without consulting their physician. Following sudden discontinuation of Clonidine HCl (CATAPRES) after prolonged treatment with high doses, restlessness, palpitations, rapid rise in blood pressure, nervousness, tremor, headache or nausea have been reported.

When discontinuing therapy with Clonidine HCl (CATAPRES), the physician should reduce the dose gradually over 2-4 days.

An excessive rise in blood pressure following discontinuation of Clonidine HCl (CATAPRES) therapy can be reversed by intravenous phentolamine or tolazoline (see Interactions).

If long-term treatment with a beta-receptor blocker has to be interrupted, then the beta-receptor blocker should first be phased out gradually and then clonidine.

Patients who wear contact lenses should be warned that treatment with Clonidine HCl (CATAPRES) may cause decreased lacrimation.

The use and safety of clonidine in children and adolescents has little supporting evidence in randomized controlled trials and therefore can not be recommended for use in this population.

In particular, when clonidine is used off-label concomitantly with methylphenidate in children with ADHS, serious adverse reactions, including death, have been observed. Therefore, clonidine in this combination is not recommended.

Tablets 75 mcg or 150 mcg: This product contains 205.5 mg of Lactose per maximum recommended daily dose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia should not take this medicine.

Effects on Ability to Drive and Use Machines: 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 Clonidine HCl (CATAPRES). Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the side effects mentioned as follows they should avoid potentially hazardous tasks such as driving or operating machinery.