(Micardis HCT®, generics) 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg tablets 160 mg/25 mg/day valsartan/hydrochlorothiazide ... nebivolol/valsartan digitalis glycosides co-administration may increase bradycardia risk as both nebivolol and digitalis glycosides … The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
In addition, there was a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination arm. In preclinical studies, no effects of telmisartan and hydrochlorothiazide on male and female fertility were observed.MicardisPlus can have influence on the ability to drive and use machines. Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. Telmisartan: The pharmacokinetics of orally administered telmisartan are non-linear over doses from 20 – 160 mg with greater than proportional increases of plasma concentrations (CHydrochlorothiazide exhibits linear pharmacokinetics. Untreated acute angle-closure glaucoma can lead to permanent vision loss.
The degree to which hydrochlorothiazide is removed by haemodialysis has not been established. Periodic monitoring of serum potassium and ECG is recommended when MicardisPlus is administered with medicinal products affected by serum potassium disturbances (e.g.
Hydrochlorothiazide: Following oral administration of MicardisPlus peak concentrations of hydrochlorothiazide are reached in approximately 1.0 – 3.0 hours after dosing. • Second and third trimesters of pregnancy (see sections 4.4 and 4.6). If a photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Food slightly reduces the bioavailability of telmisartan with a reduction in the area under the plasma concentration time curve (AUC) of about 6 % with the 40 mg tablet and about 19 % after a 160 mg dose.
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. For more detailed information see above under the heading “Cardiovascular prevention”. Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60 %.
The terminal elimination half-life of hydrochlorothiazide is 10 – 15 hours. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol)- others (e.g. Store in the original package in order to protect from moisture. If calcium supplements or calcium sparing medicinal products (e.g. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. The maximum reduction in blood pressure is generally attained 4-8 weeks after the start of treatment and is sustained during long-term therapy. Such conditions should be corrected before the administration of MicardisPlus.
The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium (see section 4.4).If these medicinal products are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised. The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements. Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Do not start, stop, or change the dosage of any medicine before checking with them first.Selected from data included with permission and copyrighted by First Databank, Inc.