DIUREXAN Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Diurexan Tablets.
Qualitative and quantitative composition
Xipamide 20 mg.
Pharmaceutical form
The tablets are white, round and biplanar with bisecting score on one side and debossed A on the other. They have a diameter of approximately 6 mm. For oral use.
Therapeutic indications
For treatment of hypertension, either alone or as an adjunct to treatment with anti-hypertensive drugs. For use as a diuretic.
Posology and method of administration
Treatment of hypertension Dosage Adults 1 tablet (20 mg) daily, as a single early morning dose. When using Diurexan in combination with other antihypertensive therapy, the same dose of 20 mg as a single ...
Contraindications
Diurexan is contra-indicated in severe electrolyte deficiency, precomatose states associated with liver cirrhosis, severe renal insufficiency, hypersensitivity to xipamide, untreated Addisons disease, ...
Special warnings and precautions for use
In patients with liver disease, therapy with thiazide diuretics and related substances may cause hepatic encephalopathy. In that case, treatment with Diurexan must be discontinued immediately. Some cases ...
Interaction with other medicinal products and other forms of interaction
The following interactions have been reported for thiazide diuretics and related substances and may therefore be relevant for xipamide as well. The antihypertensive effect of xipamide may be intensified ...
Pregnancy and lactation
Pregnancy There is no experience with the use of xipamide during pregnancy. In animal studies, reproduction toxic effects occurred (see section 5.3). Thiazide diuretics pass the placenta and may lead to ...
Effects on ability to drive and use machines
Xipamide may cause dizziness and electrolyte disturbances which may affect the patients concentration or alertness, and may affect their ability to safely drive or operate machinery. This particularly ...
Undesirable effects
With thiazide diuretics and drugs related to these including xipamide, the following undesirable effects may occur. Regarding clinical and chemical parameters the majority of undesirable effects are dose-dependent ...
Overdose
There is no specific antidote to xipamide. Acute intoxications express themselves especially with disturbances in the electrolytes and fluid balance (hyponatraemia, hypokalaemia). Clinical symptoms such ...
Pharmacodynamic properties
Xipamide is an anti-hypertensive diuretic which can be characterised pharmacologically neither as a thiazide nor as a specific loop diuretic. Although structurally similar to chlorthalidone, it has a markedly ...
Pharmacokinetic properties
Following single oral administration of 20 mg xipamide, peak plasma concentrations of up to 3 µg/ml occur within 1 hour. Absolute bioavailability after oral administration is about 73%. Xipamide is highly ...
Preclinical safety data
Not relevant.
List of excipients
Maize starch EP Mannitol BP Cellulose powder EP Colloidol silicon dioxide EP Magnesium stearate EP Purified water EP
Incompatibilities
None known.
Shelf life
5 years.
Special precautions for storage
None.
Nature and contents of container
Aluminium PVC Blister strip holds 14 tablets Ten blister strips in folded cardboard box.
Special precautions for disposal and other handling
Not relevant.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0127
Date of first authorization / renewal of the authorization
30 June 02
Date of revision of the text
August 2020
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