Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Mild to moderate essential hypertension.
Treatment must be instituted with the lowest dosage of Moxonidine. This means a daily dose of 0.2 mg moxonidine in the morning. If the therapeutic effect is insufficient, the dose can be increased after three weeks to 0.4 mg. This dose can be given as a single dose (to be taken in the morning) or as a divided daily dose (morning and evening). If the results are still insufficient after a further three weeks treatment, the dosage can be increased further to a maximum of 0.6 mg given divided in the morning and evening. A single dose of 0.4 mg Moxonidine and a daily dose of 0.6 mg Moxonidine should not be exceeded.
Moxonidine should not be given to children and adolescents under 16 years of age as insufficient therapeutic data are available for this.
Provided that renal function is not impaired, dosage recommendation is the same as for adults.
In patients with moderately impaired renal function (GFR >30 ml/min but <60 ml/min), the single dose should be not more than 0.2 mg and the daily dose not more than 0.4 mg moxonidine.
No studies are available in patients with impaired hepatic function. However, as moxonidine lacks extensive hepatic metabolism no major influence on the pharmacokinetics may be expected and dosage recommendation is the same for patients with mild to moderate hepatic impairment as for adults.
The treatment should not be stopped abruptly, but withdrawn over a period of two weeks (see also section 4.4).
As concomitant ingestion of food does not affect the pharmacokinetics of moxonidine, moxonidine can be taken before, during or after meals. The tablets should be taken with sufficient fluid.
In the few cases of overdose that have been reported, a dose of 19.6 mg was ingested acutely without fatality. Signs and symptoms reported included: headache, sedation, somnolence, hypotension, dizziness, asthenia, bradycardia, dry mouth, vomiting, fatigue and upper abdominal pain. In case of a severe overdose close monitoring of especially consciousness disturbances and respiratory depression is recommended.
In addition, based on a few high dose studies in animals, transient hypertension, tachycardia, and hyperglycaemia may also occur.
No specific antidote is known. In case of hypotension, circulatory support such as fluids and dopamine administration may be considered. Bradycardia may be treated with atropine. Αlpha-receptor antagonists may diminish or abolish the paradoxical hypertensive effects of a moxonidine overdose.
Shelf life: 2 years.
Do not store above 30°C.
PVC/PVDC/Al blister pack with 10, 20, 28, 30, 50, 60, 98, 100, 400 (20 × 20, 10 × 40, as hospital pack sizes only) film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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