MINT-CLONIDINE 0.2 MG — DIN 02462206

What is MINT-CLONIDINE?

MINT-CLONIDINE 0.2 MG contains CLONIDINE HYDROCHLORIDE : 0.2 MG. It is listed in the Health Canada Drug Product Database under DIN 02462206, held by MINT PHARMACEUTICALS INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 23-Jun-2017. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MINT-CLONIDINE used for?

MINT-CLONIDINE (clonidine hydrochloride) is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Clonidine should normally be used in those patients in whom treatment with diuretic or beta-blocker was found ineffective or has been associated with unacceptable adverse effects. MINT-CLONIDINE can also be tried as an initial agent in those patients in whom use of diuretics and/or beta blockers is contraindicated or in patients with medical conditions in which these drugs frequently cause serious adverse effects.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Treatment of hypertension requires regular medical supervision. The dose of MINT-CLONIDINE (clonidine hydrochloride) must be adjusted according to the patient's individual blood pressure response. Recommended Dose and Dosage Adjustment Initial Dose: 0.1 mg tablet twice daily (morning and bedtime). Maintenance Dose: After a period of 2-4 weeks, further increments of 0.1 mg per day may be necessary until the desired response is achieved. In those instances where it is not possible to have equal amounts of drug at each of the dosing intervals, taking the larger portion of the total daily dose at bedtime may minimize transient adjustment effect of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Usually doses above 0.6 mg per day do not result in a further marked reduction in blood pressure. Discontinuation of Treatment: If MINT-CLONIDINE (clonidine hydrochloride) is to be discontinued, reduce dosage gradually (see WARNINGS AND PRECAUTIONS). Missed Dose: If a dose of MINT-CLONIDINE is missed, patients should take the dose as soon as possible and then return to their normal schedule. Administration: The tablets should be swallowed whole with water. Use in Elderly: Elderly patients may benefit from a lower initial dose. Use in Impaired Renal Function: Doses must be adjusted according to the degree of impairment and patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine during dialysis. Use in Impaired Hepatic Function: Dosage instructions for patients with impaired hepatic function have not been established. Use in Children: The safety and efficacy of clonidine have not been established in children.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

MINT-CLONIDINE is contraindicated in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or atrioventricular (AV) block of 2nd or 3rd degree; patients with sinus node function impairment. Patients who are hypersensitive to this drug or to any ingredients in the formulation or component of the container. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING. MINT-CLONIDINE is also contraindicated in patients with the rare hereditary condition of galactose intolerance e.g. galactosaemia. MINT-CLONIDINE tablets contain approximately 210 mg of lactose per maximum recommended daily dose (0.6 mg) and thus should not be used by patients with this condition.

Warnings and precautions

Patients should be instructed not to discontinue therapy without consulting their physician. A pronounced withdrawal reaction with symptoms suggesting sympathetic over-activity may develop within 12 to 48 hours when clonidine is discontinued. High serum levels of catecholamines have been found during such episodes (see DRUG INTERACTIONS). When discontinuing MINT-CLONIDINE (clonidine hydrochloride) therapy, the physician should reduce the dose gradually over 2 to 4 days to avoid a possible rapid rise in blood pressure and associated subjective symptoms such as nervousness, agitation, restlessness, palpitations, tremor, nausea and headache. Rare instances of hypertensive encephalopathy and death have been recorded after abrupt cessation of clonidine hydrochloride therapy. A withdrawal reaction is most likely to occur in patients who have been receiving large doses (greater than 1.2 mg/day) or in those who are continuing to receive a concomitant beta-blocker. If therapy is to be discontinued in patients receiving clonidine and a ẞ adrenergic blocking agent concomitantly, the ẞ blocker should be first phased out gradually before clonidine therapy is discontinued. An excessive rise in blood pressure following discontinuation of MINT-CLONIDINE therapy can be reversed by intravenous phentolamine. Clonidine is not indicated in pheochromocytoma. However, in contrast to guanethidine and reserpine the drug has no crisis-inducing properties, in this condition. Clonidine does not affect the urinary vanilmandelic acid (VMA) and catecholamine excretion significantly in patients with pheochromocytoma, so that no false positive or false negative results will occur during the administration of the drug. Safety and effectiveness in children have not been established and therefore cannot be recommended for use in this population. Because it lowers blood pressure, MINT-CLONIDINE (clonidine hydrochloride) should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease or chronic renal failure.