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LONITEN is a brand name for Minoxidil, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations 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.
Recommended Dose and Dosage Adjustment 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.
2 mg/kg LONITEN in two divided doses. 2 mg/kg/day increments, at 3 day intervals or longer, until optimum blood pressure control is achieved. 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).
Special Population:
Renal Impairment: Renal failure or dialysis patients may require smaller doses of LONITEN and should have close medical supervision to prevent exacerbation of renal failure or precipitation of cardiac failure.
SERIOUS 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.
General Salt and Water Retention:
Congestive Heart Failure - 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.
When using a concomitant diuretic to prevent or treat fluid retention, careful attention to adjusting the dosage of the diuretic is required for maximum safety and efficacy (See DOSAGE AND ADMINISTRATION: Concomitant Therapy). If LONITEN is used without a diuretic, retention of several hundred mili-equivalents of salt and corresponding volumes of water can occur within a few days, leading to increased plasma and interstitial fluid volume and local and generalized edema.
Diuretic treatment, alone or in combination with restricted salt intake, will usually minimize fluid retention, although reversible edema did develop in approximately 10% of non-dialysis patients so treated. Diuretic effectiveness was limited mostly by disease-related impaired renal function.
The condition of patients with pre-existing congestive heart failure occasionally deteriorated in association with fluid retention although because of the fall in blood pressure (reduction of afterload), more than twice as many improved than worsened.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Mild to moderate Hepatic Impairment:
Dosage adjustment should be considered, starting therapy at a reduced dosage and titrating to the lowest dose to obtain desired therapeutic effect. See LONITEN (minoxidil tablets USP) Product Monograph Page 11 of 25 WARNINGS and PRECAUTIONS section.
Dosage Adjustment with concomitant therapy:
Strong UGT inhibitors: Consider lower doses when initiating treatment or avoid coadministration with minoxidil (See Drug Interactions section).
Diuretics:
To prevent fluid retention and possible congestive heart failure, LONITEN must be used in conjunction with a high ceiling (loop) diuretic in patients relying on renal function for maintaining salt and water balance. d). 0 kg, diuretic therapy should be changed to furosemide; if the patient is already taking furosemide, dosage should be increased in accordance with the patient's requirements.
Rarely, refractory fluid retention may require discontinuation of LONITEN. Provided that the patient is under close medical supervision, it may be possible to resolve refractory fluid retention by discontinuing LONITEN for 1 or 2 days and then resuming treatment in conjunction with vigorous diuretic therapy.
In dialysis patients also receiving diuretic therapy, use of LONITEN may create the need to raise diuretic dosage or to increase the frequency or duration of dialysis in order to maintain salt and water balance.
Sympathetic Nervous System Suppressants:
The preferred agent to achieve sympathetic nervous system suppression is a ß-blocker equivalent to an adult propranolol dosage of 80 to 160 mg/day. Higher doses may be required when patients, pretreated with a ß-blocker, have an increase in heart rate exceeding 20 beats per minute or when simultaneous introduction of LONITEN and a ß-blocker causes an increase in heart rate exceeding 10 beats per minute.
) may be used instead. Methyldopa must be given for at least 24 hours before starting therapy with LONITEN because of the delay in the onset of methyldopa's action. 2 mg twice daily. Sympathetic nervous system suppressants may not completely prevent an increase in heart rate due to LONITEN but usually do prevent tachycardia.
Typically, patients receiving a beta blocker prior to initiation of therapy with LONITEN have a bradycardia and can be expected to have an increase in heart rate toward normal when LONITEN is added. When treatments with LONITEN and a beta blocker, or other sympathetic nervous system suppressant, are begun simultaneously, their opposing cardiac effects usually nullify each other, leading to little change in heart rate.
LONITEN (minoxidil tablets USP) Product Monograph Page 12 of
Rarely, refractory fluid retention may require discontinuation of LONITEN. Provided that the patient is under close medical supervision, it may be possible to resolve refractory salt retention by discontinuing LONITEN for 1 or 2 days and then resuming treatment in conjunction with vigorous diuretic therapy.
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 LONITEN (minoxidil tablets USP) Product Monograph Page 5 of 25 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. When using a concomitant sympatholytic to prevent tachycardia, careful attention to adjusting the dosages of the beta blocker or other sympathetic nervous system suppressant is required for maximum safety and efficacy (see DOSAGE AND ADMINISTRATION: Concomitant Therapy).
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.
Although in many cases the pericardial effusion was associated with a connective tissue disease, the uremic syndrome, congestive heart failure, or marked fluid retention, there have been instances in which these potential causes of effusion were not present.
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 in light or other means of controlling the hypertension and the patient's clinical status. Endocrine and Metabolism Hair Change Abnormal hair growth is a common occurrence with LONITEN (minoxidil) treatment (See ADVERSE REACTIONS).
This is especially disturbing to women and children and patients should be thoroughly informed about this effect before therapy with LONITEN is begun. Skin Hypersensitivity Hypersensitivity to LONITEN, manifested as a skin rash including rare reports bullous eruptions and Stevens-Johnson syndrome, has been seen.
LONITEN (minoxidil tablets USP) Product Monograph Page 6 of 25 Special Populations Pregnant Women: The safety for use of LONITEN in pregnancy has not been established. Studies in animals have shown reproductive toxicity (see TOXICOLOGY).
Minoxidil has been shown to reduce the conception rate in rats and to show evidence of increased fetal absorption in rabbits when administered at five times the human dose. There was no evidence of teratogenic effects in rats and rabbits.
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.
Nursing Women:
Minoxidil has been reported to be excreted in human milk. A risk to the suckling child cannot be excluded. As a general rule, nursing should not be undertaken while a patient is on LONITEN.
Hypertension:
Hazard of Rapid Control of Blood Pressure in patients with […]