Reproduced by "The Pink Sheet" from initial labeling for Maxzide and most recent PDR labeling version for Dyazide. MAXZIDE DOSAGE AND ADMINISTRATION -- The recommended dosage of MAZXIDE is one tablet daily with appropriate monitoring of serum potassium levels (see WARNINGS). Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to MAXZIDE directly. In patients requiring 50 mg of hydrochlorothiazide in whom hypokalemia cannot be risked, therapy may be initiated with MAXZIDE. There is no clinical experience with doses exceeding one tablet daily. Clinical studies have shown that patients already taking less bioavailable formulations of triamterene and hydrochlorothiazide (totaling 50-100 mg of hydrochlorothiazide and 100-200 mg of triamterene) may be safely changed to one MAXZIDE tablet per day.; these patients should be monitored clinically and with serum potassium after the transfer. DYAZIDE DOSAGE AND ADMINISTRATION -- As determined by individual titration. Adults: The usual dose is one or two capsules twice daily after meals. Some patients may be maintained on one capsule daily or every other day. Maximum daily dose should not exceed four capsules, and at this dosage, the incidence of side effects may increase. Since 'Dyazide' has an antihypertensive effect, hypotensive drugs used concomitantly should be added at reduced dosage -- at least one half the usual dosage -- particularly if it is a ganglionic or peripheral adrenergic blocking agent. Adjust dosage as indicated. Children: Adequate information on the use of 'Dyazide' in children is not available. Note: Potassium supplementation used concurrently with other diuretics should be discontinued when titrating with Dyrenium (triamterene, SK&F Co.). They should not be reinstituted when the patient is placed on 'Dyazide' unless the triamterene component does not completely compensate for the potassium loss.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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