MINT-CLONIDINE 0.025 MG

What is MINT-CLONIDINE?

MINT-CLONIDINE 0.025 MG contains CLONIDINE HYDROCHLORIDE : 0.025 MG. It is listed in the Health Canada Drug Product Database under DIN 02534738, held by MINT PHARMACEUTICALS INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 10-May-2023. 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 relief of menopausal flushing in patients for whom hormonal replacement therapy is either unnecessary or not desirable.

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

Product details and regulatory record

How is it administered?

Recommended Dose and Dosage Adjustment: The recommended dose for the treatment of menopausal flushing is 0.05 mg of MINT-CLONIDINE (clonidine hydrochloride) twice daily. If after two to four weeks there has been no remission, the treatment should be discontinued and the patient reassessed. Attempts should be made to discontinue treatment at three to six month intervals for patient re-evaluation of menopausal symptoms. Following sudden discontinuation of clonidine hydrochloride 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 MINT-CLONIDINE, the physician should reduce the dose gradually over 2-4 days. 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.

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

How is it stored and handled?

MINT-CLONIDINE tablets should be stored between 15°C -30°C. Protect from moisture. Keep this medicine out of the sight and reach of children.

How is it supplied?

0.025 mg tablet: Round, blue colored, biconvex coated tablet, debossed “0.025” on one side and plain on the other side. MINT-CLONIDINE 0.025 mg tablets are supplied in bottles of 100 tablets.

Contraindications

MINT-CLONIDINE (clonidine hydrochloride) is contraindicated in patients with the following: • know hypersensitivity to the active substance or to any of the ingredients of the product. • severe bradyarrhythmia resulting from either sick sinus syndrome or atrioventricular block of 2nd or 3rd degree; patients with sinus node function impairment. • rare hereditary conditions that may be incompatible with an excipient of the product. This product contains 235.1 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.

Warnings and precautions

An abrupt withdrawal of higher doses of clonidine hydrochloride is followed in some cases by an excess of circulating catecholamines. Therefore, caution should be exercised in concomitant use of drugs which affect the metabolism, tissue uptake or pressor effects of these amines (monoamine oxidase inhibitors, tricyclic antidepressants and beta-blocking agents). MINT-CLONIDINE (clonidine hydrochloride 0.025 mg) should not be confused with higher strength dosage forms containing the same active ingredient (clonidine hydrochloride 0.1 mg or 0.2 mg) used for treating hypertension. Caution should however be exercised in patients receiving antihypertensive therapy because of the possibility of an additive effect. Note: MINT-CLONIDINE is only available in a 0.025 mg strength tablet. Patients who engage in potentially hazardous activities such as operating machinery or driving should be warned of the possible sedative effect of clonidine hydrochloride. Caution should be exercised in the concomitant administration of sedatives, tranquilizing drugs or alcohol. Patients should be instructed not to discontinue therapy without consulting their physician. Clonidine hydrochloride can have a hypotensive effect especially in high doses. In patients whose blood pressure decreases to an intolerable extent when taking MINT- CLONIDINE, treatment should be discontinued. An excessive rise in blood pressure following discontinuation of MINT-CLONIDINE therapy can be reversed by intravenous phentolamine. Because it can lower blood pressure at high doses, MINT-CLONIDINE (clonidine hydrochloride) should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebral vascular disease, or chronic renal failure. MINT-CLONIDINE should be used with caution in patients with mild to moderate bradyarrhythmia such as low sinus rhythm, with disorders of cerebral or peripheral perfusion, polyneuropathy, and constipation, patients with heart failure or severe coronary heart disease. Depending on the dose given, MINT-CLONIDINE can lower the heart and pulse rate. In patients with diseases affecting the rhythmic and atrioventricular conduction system of the heart, arrhythmias have been observed after high doses. Patients with heart failure or severe coronary disease should be monitored particularly carefully when using MINT-CLONIDINE. A few instances of a condition resembling Raynaud's phenomenon have been reported with the higher doses of clonidine as used in the therapy of hypertension. Caution should be observed if patients with Raynaud's disease or thromboangiitis obliterans are to be treated with MINT-CLONIDINE. In several studies clonidine hydrochloride produced a dose-dependent increase in the incidence and severity of spontaneously occurring retinal degeneration in albino rats treated for six months or longer. In view of this retinal degeneration, eye examinations were performed in 908 hypertensive patients prior to the start of clonidine hydrochloride therapy, who were then examined periodically thereafter. In 353 of these 908 patients, examinations were performed for periods of 24 months or longer. Except for the dryness of the eyes, no drug-related abnormal ophthalmologic findings were recorded and clonidine hydrochloride did not alter retinal function as shown by specialized tests such as the electroretinogram and macular dazzle. Patients who wear contact lenses should be warned that treatment with MINT-CLONIDINE may cause decreased lacrimation. Patients with a known history of depression should be carefully supervised while under treatment with clonidine as there have been occasional reports of further depressive episodes occurring in such patients. Clonidine and its metabolites are extensively excreted with urine. As a result, MINT-CLONIDINE should be used with caution in patients with renal insufficiency. Careful monitoring of blood pressure is required. As with any drug excreted primarily in the urine, smaller

What can be used instead?

Other Canadian products sharing ATC code C02AC01 CLONIDINE. 14 of 31 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies CLONIDINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. CLONIDINE appears in 41 registered pack listings across 8 markets, published on 7 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.