Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Mylan Products Ltd, 20 Station Close, Potters Bar, Herts, EN6 1TL, UK
Mild to moderate essential or primary hypertension.
Treatment should be started with 200 micrograms of Physiotens in the morning. The dose may be titrated after three weeks to 400 micrograms, given as one dose or as divided doses (morning and evening) until a satisfactory response has been achieved. If the response is still unsatisfactory after a further three weeks' treatment, the dosage can be increased up to a maximum of 600 micrograms in divided doses (morning and evening).
A single dose of 400 micrograms of Physiotens and a daily dose of 600 micrograms in divided doses (morning and evening) should not be exceeded.
In patients with moderate renal dysfunction (GFR above 30 ml/min, but below 60 ml/min), the single dose should not exceed 200 micrograms and the daily dose should not exceed 400 micrograms of moxonidine.
The tablets should be taken with sufficient liquid. As the intake of food has no influence on the pharmacokinetic properties of moxonidine, the tablets may be taken before, during or after the meal.
Physiotens is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.
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. α-Receptor antagonists may diminish or abolish the paradoxal hypertensive effects of a moxonidine overdose.
2 years.
Do not store above 25°C.
The tablets are packed in blister strips made of PVC/PVdC or PVC film with covering Aluminium foil, within cartons. Each carton contains 14, 28 or 84 tablets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
