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Loniten 2.5 mg Tablets (60)

Loniten 2.5 mg Tablets (60)

Loniten

Prescription-only medicine
  • Licensed prescription Only medicine in the UK with Marketing Authorisation PL 00057/1006 held by Pfizer Limited, as listed on the electronic Medicines Compendium (emc).
  • Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the indication of severe hypertension.
  • Manufactured and controlled in accordance with Good Manufacturing Practice (GMP) for medicinal products.
  • Supplied in the UK via GPhC Registered pharmacies and wholesalers such as Teleta Pharma (GPhC Pharmacy Number 9011283).
Oral antihypertensive vasodilator (minoxidil)

Description

Loniten 2.5 mg Tablets contain minoxidil, a potent oral peripheral vasodilator used for the treatment of severe hypertension that is difficult to control with standard therapy. Minoxidil lowers blood pressure by relaxing and widening small arterial blood vessels, thereby reducing peripheral vascular resistance. Because it can cause significant salt and water retention and reflex tachycardia, Loniten must be given in combination with an appropriate diuretic and a beta-adrenergic blocking agent (or suitable alternative). Treatment is initiated and supervised by a specialist, typically in patients with severe or resistant hypertension.

Bnefits

  • Powerful blood pressure reduction in patients with severe or resistant hypertension when standard antihypertensives alone are insufficient.
  • Reduces elevated systolic and diastolic blood pressure by decreasing peripheral vascular resistance through direct arteriolar vasodilation.
  • Allows improved control of hypertension and reduction of associated cardiovascular risk when used as part of combination therapy.
  • Oral tablet formulation enables systemic treatment under specialist supervision.
  • Licensed and monitored medicine with comprehensive safety and efficacy data in severe hypertension.

Indications

  • Treatment of severe hypertension that is difficult to control with standard antihypertensive therapy.
  • Use in combination with a diuretic to control salt and water retention and with a beta-adrenergic blocking agent (or suitable substitute) to control reflex tachycardia.
  • Use in adults and in selected paediatric patients with severe hypertension associated with target organ damage where other treatments have failed, under specialist supervision.

Composition

  • Each tablet contains 2.5 mg minoxidil (active substance).
  • Each tablet contains 95.8 mg lactose monohydrate (excipient with known effect).
  • Other excipients: microcrystalline cellulose, starch, colloidal silicon dioxide, magnesium stearate.

Formulation

  • Pharmaceutical form: tablet for oral use.
  • Appearance: round white to light tan biconvex tablets, with "2½" imprinted on one side, scored on the reverse with a "U" on one side of the score and "121" on the other side; the tablet can be divided into equal halves.
  • Pharmacotherapeutic group: pyrimidine derivatives, antihypertensives (ATC code C02DC01).

Packaging

  • Blister packs: 20–25 micron aluminium foil / 250 micron opaque PVC blister; pack size of 60 tablets.
  • HDPE bottles with LDPE caps: 100-tablet bottles are also described in the SmPC (not all pack sizes may be marketed).
  • Teleta product listing specifies carton containing 60 tablets (Loniten 2.5 mg Tablets (60)).

Usage

  • For oral use only.
  • Swallow tablets whole with water; the 2.5 mg tablet can be divided into equal halves if needed for dose adjustment.
  • Adults and children over 12 years: the SmPC-recommended starting dose is generally 5 mg minoxidil per day (for severe hypertension), with dose titration performed by a specialist based on blood pressure response; maximum recommended dose is typically up to 100 mg/day in divided doses as per SmPC guidance.
  • Elderly patients (over 65 years): an initial starting dose of 2.5 mg per day is suggested, with cautious titration due to increased sensitivity to blood pressure-lowering effects and risk of orthostatic hypotension.
  • Children under 12 years: use is restricted to cases of severe hypertension with target organ damage where other treatment has failed; therapy should only be initiated under close hospital-based specialist supervision, with weight-based dosing (starting around 0.2 mg/kg/day and careful titration as per SmPC).
  • Loniten must be used together with a diuretic to prevent significant salt and water retention and with a beta-adrenergic blocking agent (or suitable alternative) to control reflex tachycardia.
  • Patients should strictly follow the dosing schedule prescribed by their doctor and should not stop or change the dose without medical advice.
  • Regular monitoring of blood pressure, heart rate, body weight, fluid balance and renal function is required during treatment.

Contraindications

  • Hypersensitivity to minoxidil or to any of the excipients (including lactose monohydrate).
  • Phaeochromocytoma, because minoxidil may stimulate secretion of catecholamines from the tumour via its antihypertensive action.
  • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine due to lactose content.
  • Use in pregnancy is not recommended due to limited human data and reports of neonatal hypertrichosis; women of childbearing potential should use effective contraception.
  • Breast-feeding is not recommended while taking minoxidil, as it is excreted in human milk and a risk to the suckling child cannot be excluded.
  • Use should be approached with caution or avoided in patients with significant cardiac disease (e.g. recent myocardial infarction, heart failure, pericardial disease) unless managed by a specialist, given the risk of fluid retention, tachycardia and pericardial complications.

Adverse Effects

  • Very common: tachycardia, pericarditis, hypertrichosis (increased hair growth), hair colour changes, ECG abnormalities.
  • Common: fluid retention, oedema, pericardial effusion, cardiac tamponade.
  • Rare: leucopoenia, thrombocytopenia, Stevens–Johnson syndrome, bullous dermatitis, rash.
  • Not known (frequency cannot be estimated from available data): angina pectoris, pleural effusion, gastrointestinal disorders, breast tenderness, peripheral oedema associated with or independent of weight gain, increases in blood creatinine and blood urea.
  • Other clinically important adverse effects described in the SmPC include salt and water retention with possible heart failure exacerbation, pericardial effusion and tamponade, and hypertrichosis that typically appears 3–6 weeks after initiation and may reverse within 1–6 months after stopping therapy.
  • Dizziness, orthostatic hypotension and symptoms related to low blood pressure or reflex sympathetic activation may also occur, particularly at the start of therapy or with dose increases.

Storage Conditions

  • Store below 25°C.
  • Blisters: store in the original package in order to protect from moisture.
  • Bottles: store below 25°C and keep the bottle tightly closed to protect from moisture.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date shown on the packaging.
  • No special requirements for disposal; unused medicine should be disposed of in accordance with local regulations.

Duration

Minoxidil treatment for severe hypertension is usually long-term and may continue as long as required to maintain adequate blood pressure control, with periodic review by a specialist. Duration is individualised based on clinical response and tolerability.

Onset

After oral administration, at least 90% of minoxidil is absorbed; plasma levels are detectable within 30 minutes and peak around 60 minutes. The antihypertensive effect generally develops over several hours and can persist for days due to sustained vasodilation, despite a plasma half-life of approximately 4 hours.

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