LONITEN 10MG 10 MG — DIN 00514500

What is LONITEN 10MG?

LONITEN 10MG 10 MG contains MINOXIDIL : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 00514500, held by PFIZER CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 09-Mar-2006. 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 LONITEN 10MG used for?

Because of the potential for serious adverse effects, LONITEN (minoxidil) is indicated only for: The treatment of severe hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time, use in milder degrees of hypertension is not recommended because of the benefit-risk relationship in such patients has not been defined.

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?

If LONITEN therapy must be discontinued in a patient who has been treated effectively, the drug should be phased out gradually or replaced with another antihypertensive agent. Careful monitoring of the patient's blood pressure during the treatment adjustment is necessary. Patients over 12 Years of Age: The recommended initial daily dosage of LONITEN (minoxidil) is 5 mg given in two divided doses. Daily dosage can be increased to 10, 20 and then to 40 mg per day in divided doses, at 3 day intervals or longer, if required for optimum blood pressure control. The effective dosage range is usually 10 to 40 mg per day. In certain patients, doses up to a maximum of 100 mg per day may be attempted, recognizing the probability of an increase in the incidence and severity of adverse reactions. Patients under 12 Years of Age: The initial recommended daily dosage is 0.2 mg/kg LONITEN in two divided doses. The dosage may be increased by 0.1 to 0.2 mg/kg/day increments, at 3 day intervals or longer, until optimum blood pressure control is achieved. The effective dosage range is usually 0.25 to 1.0 mg/kg/day. The maximum recommended dose is 50 mg/day. Dose Regimen: The magnitude of within-day fluctuation of arterial pressure during therapy with LONITEN is directly proportional to the extent of pressure reduction. When the targeted blood pressure has been reached, a change from twice daily to once daily dosing with LONITEN may be tried in those patients in whom the diastolic pressure has been reduced less than 30 mm Hg. If supine diastolic pressure has been reduced more than 30 mm Hg, the twice daily dosage schedule should be maintained. Dosage Adjustment: Dosage must be titrated carefully according to individual response. Intervals between dosage adjustments normally should be at least 3 days since the full response to a given dose is not obtained for at least that amount of time. Where a more rapid management of hypertension is required, a 5 mg dose can be given every 6 hours if the patient is hospitalized and carefully monitored (See WARNINGS).

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

Contraindications

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. In pheochromocytoma because it may reflexively stimulate secretion of catecholamines from the tumor. In pulmonary hypertension associated with mitral stenosis. In patients with severe hepatic impairment.

Warnings and precautions

LONITEN is not recommended during pregnancy and in women of childbearing potential not using contraception. Neonatal hypertrichosis has been reported following exposure to minoxidil during pregnancy. Salt and Water Retention: Concomitant use of an adequate diuretic is required. LONITEN (minoxidil) must usually be administered concomitantly with a diuretic adequate to prevent fluid retention and possible congestive heart failure, a high-ceiling (loop) diuretic is almost always required. Hemodilution may occur leading to a temporary (during the first 28 weeks of treatment) decrease in hematocrit, hemoglobin, and erythrocyte count (by approximately 7% initially which then recovers to pretreatment levels). Fluid and electrolyte balance and body weight should be monitored closely. Cardiovascular: Tachycardia: LONITEN increases the heart rate. This increase can be partly or entirely prevented by the concomitant administration of a beta-adrenergic blocking drug or other sympathetic nervous system suppressant. Round-the-clock effectiveness of the sympathetic suppressant should be assured. In addition, angina may worsen or appear for the first time during LONITEN treatment, probably because of the increased oxygen demands associated with increased heart rate and cardiac output. This can usually be prevented by sympathetic blockade. Concomitant treatment to prevent tachycardia is usually required. Myocardial Infarction: LONITEN has not been used in patients who have had a myocardial infarction within the preceding month. It is possible that a reduction of arterial pressure with LONITEN might further limit blood flow to the myocardium, although this might be compensated by decreased oxygen demand because of lower blood pressure. Pericarditis, Pericardial Effusion and Tamponade: Observe patients for signs and symptoms of pericardial effusion. Although there is no evidence of a causal relationship, there have been multiple reports of pericarditis occurring in association with minoxidil. Pericardial effusion, occasionally with tamponade, has been observed in about 3% of treated patients not on dialysis, especially those with inadequate or compromised renal function. Patients should be observed closely for any suggestion of a pericardial disorder, and echocardiographic studies should be carried out if suspicion arises. More vigorous diuretic therapy, dialysis, pericardiocentesis, or surgery may be required. If the effusion persists, withdrawal of LONITEN should be considered. Hypersensitivity: Hypersensitivity to LONITEN, manifested as a skin rash including rare reports bullous eruptions and Stevens-Johnson syndrome, has been seen.