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LONITEN is a brand name for Minoxidil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Minoxidil is indicated for the treatment of severe hypertension. It should not be used as the sole agent to initiate therapy. It is a peripheral vasodilator and should be given in conjunction with a diuretic, to control salt and water retention, and a beta adrenergic blocking agent, or appropriate substitute, to…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Patients over 12 years and adults The recommended starting dose is 5 mg per day. If required, this dosage can later be increased up to 20 mg, and then to 40 mg daily (given as a single dose or in two divided doses). Dose increases should be made at increments of 5 mg to 10 mg minoxidil per day at intervals of three or more days.
If a dose of 50 mg of minoxidil has been reached, the dose may be increased by 25 mg minoxidil per day to a maximum dose of 100 mg per day. If the desired decrease of diastolic blood pressure exceeds 30 mmHg, dosage should be divided to two daily doses to keep daily blood pressure fluctuations as low as possible.
Patients younger than 12 years of age The use of minoxidil in children is restricted to children with severe hypertension associated with target organ damage where other treatment has failed. The data regarding the use of minoxidil in children is very limited, especially in infants.
The dosage recommendations can only be considered as a rough guide to treatment at present as this is based on the publication of a few case reports and studies involving a small number of children. 2 mg/kg of minoxidil as a single or divided dose.
2 mg/kg/day at intervals of at least 3 days is essential. 0 mg/kg/day. The maximum dose is 50 mg/day. Treatment of children with minoxidil should only be initiated under the close supervision of a specialist in hospital. Elderly patients At present there are no extensive clinical studies with minoxidil in patients over age 65.
There is data indicating that elevated systolic and diastolic pressures are important risk factors for cardiovascular disease in individuals over age 65. However, elderly patients may be sensitive to the blood pressure lowering effect of minoxidil and thus caution is urged in initiating therapy as orthostatic hypotension may occur.
5 mg per day be used as the initial starting dose in patients over 65 years of age. Renal failure or dialysis patients Dosage requirements may be lower in dialysis patients. Minoxidil is removed from the blood by dialysis, but its pharmacological action, once established is not reversed.
Therefore haemodialysis patients should take minoxidil either after or at least two hours before dialysis. Rapid reduction of blood pressure Under hospital monitoring conditions, rapid reduction of blood pressure can be achieved using continuous blood pressure monitoring and incremental doses of 5 mg every six hours.
Most patients receiving minoxidil experience a diminution of pre-existing side-effects attributable to their disease or previous therapy.
New events or side-effects likely to increase are included in the following table:
Frequencies are defined as: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data). 4. 4. 4. Post authorisation experience has shown that, in a particular study, out of 50 patients on oral minoxidil, one case involved a two year old female with a history of chronic renal failure and peritoneal dialysis who developed pericardial effusion from which she recovered after treatment.
In addition, the estimated total exposure (based on only nine months of data) was about 17,000 patient-years with however no appreciable use in children. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Salt and water retention If used alone, minoxidil can cause a significant retention of salt and water leading to physical signs such as oedema, and to clinical deterioration of some patients with heart failure. Diuretic treatment alone, or in combination with restricted salt intake is, therefore, necessary for all patients taking minoxidil.
Haemodilution may occur leading to temporary decrease in haematocrit, haemoglobin, and erythrocyte count (by approximately 7% initially which then recovers to pre-treatment levels). The patient’s bodyweight, fluid and electrolyte balance should be monitored for evidence of fluid retention.
5 kg may diminish the effectiveness of minoxidil. Patients should, therefore, be carefully instructed about compliance with diuretic therapy and a detailed record of body weight should be maintained. The product should be used with particular attention to maintenance of salt and water balance in patients with renal impairment, but who are not on dialysis.
2). Myocardial infarction Patients who have had myocardial infarction should only be treated with minoxidil after a stable post-infarction state has been established. Tachycardia Because minoxidil is a vasodilator, reflex tachycardia may occur and possibly angina pectoris may occur in patients at risk; it is recommended that minoxidil be used in combination with beta-adrenergic blocking agent or other sympathetic nervous system suppressants to blunt or prevent such a response.
Hypertrichosis Hypertrichosis occurs in most patients treated with minoxidil and all patients should be warned of this possibility before starting therapy. Most patients will experience an elongation, thickening and enhanced pigmentation of fine body hair.
Usually these signs will emerge 3 to 6 weeks after starting treatment. They initially emerge in the face, and they may slightly subside with continued treatment. However, hypertrichosis was hardly or not at all tolerable in less than 10% of patients.
1 Minoxidil is contra-indicated in patients with a phaeochromocytoma because it may stimulate secretion of catecholamines from the tumour through its antihypertensive action.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Concomitant antihypertensive therapy It is recommended that, where possible, antihypertensive therapy, other than a beta-adrenergic blocking agent and a diuretic be discontinued before minoxidil treatment is started. It is recognised that some antihypertensive agents should not be abruptly discontinued.
These drugs should be gradually discontinued during the first week of minoxidil treatment. Minoxidil causes sodium retention and if used alone can result in several hundred milli-equivalents of salt being retained together with a corresponding volume of water.
Therefore, in all patients who are not on dialysis, minoxidil must be given in conjunction with a diuretic in sufficient dosage to maintain salt and water balance. Examples of the daily dosages of diuretics commonly used when starting therapy with minoxidil include: 1.
Hydrochlorothiazide (100 mg) - or other thiazides at equi-effective dosage. 2. Chlortalidone (100 mg). 3. Furosemide (80 mg). If excessive water retention results in a weight gain of more than 3 pounds when a thiazide or chlortalidone is being used, diuretic therapy should be changed to furosemide, the dose of which may be increased in accordance with the patient's requirements.
Diuretic dosage in children should be proportionally less in relation to weight. Patients will require a sympathetic nervous system suppressant to limit a minoxidil-induced rise in heart rate. The preferred agent is a beta-blocker equivalent to an adult propranolol dosage of 80 - 160 mg/day.
Higher doses may be required when pre-treated patients have an increase in heart rate exceeding 20 beats per minute or when simultaneous introduction causes an increase exceeding 10 beats per minute. When beta-blockers are contra-indicated, alternatives such as methyldopa may be used instead and should be started 24 hours prior to minoxidil.
Method of Administration Oral administration
Spontaneous reversal to the pre-treatment state can be expected one to six months after cessation of therapy. ECG alterations Soon after starting minoxidil therapy approximately 60% of patients exhibit ECG alterations in the direction and magnitude of their T waves.
Large changes may encroach on the ST segment, unaccompanied by evidence of ischaemia. These asymptomatic changes usually disappear with continuing minoxidil treatment. The ECG reverts to the pre-treatment state when minoxidil is discontinued.
Thrombocytopenia and leucopoenia Thrombocytopenia and leucopoenia have been rarely reported. Pericarditis, Pericardial Effusion and Tamponade Although there is no evidence of a causal relationship, there have been multiple reports of pericarditis occurring in association with minoxidil.
Pericardial effusion and occasionally tamponade, has been observed in about 3% - 5% of treated patients not on dialysis. While in many cases, the pericardial effusion is associated with other potential aetiologies, there have been cases in which these potential causes of effusion were not present.
Patients should be observed closely for any suggestion of a pericardial effusion and pericardiocentesis, or surgery may be required. If the effusion persists, withdrawal of minoxidil should be considered in light of other means of controlling the hypertension and the patient’s clinical status.
Paediatric population Children strictly require appropriate and individualised dosing of minoxidil, beta-blockers and diuretics. They should be under close specialist supervision in hospital. Caution is required when there is significant renal impairment.
The development of peripheral oedema or any signs suggestive of congestive heart failure or of pericardial or pleural effusion should be carefully watched for. Renal function should be monitored. Body weight and urine output should be monitored.
Regular follow up must be ensured during treatment with minoxidil. Before starting treatment parents and carers should be warned of the likely occurrence of hypertrichosis. This medicine contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.