Download Pritor® 40(80) mg and Co-Pritor® 40(80/12.5 mg)

Pritor® 40(80) mg
and Co-Pritor® 40(80/12.5 mg)
Approved indication
Telmisartan (Pritor® 40(80) mg) and telmisartan/hydrochlorothiazide (Co-Pritor® 40(80)/12.5 mg) tablets are indicated for the
treatment of mild to moderate hypertension. Pritor® and Co-Pritor®
tablets are identical to the original products, Micardis® and CoMicardis®, are manufactured at the same factory and provide
patients with an additional and more affordable presentation pack.
biliary obstructive disorders or severe hepatic insufficiency.
Use telmisartan cautiously in patients who have previously
experienced angioedema with an ACE inhibitor.
Hydrochlorothiazide is contraindicated in patients allergic to
sulphonamides.
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Such conditions should first be corrected before starting therapy.
Mode of action
Pregnancy and lactation
Abnormalities in the renin-angiotensin system (RAS) play a critical
role in the pathogenesis and maintenance of hypertension. Telmisartan is an angiotensin ll receptor antagonist/blocker (ARB). It
displays potent and selective affinity for the AT1 receptor, thereby
directly blocking angiotensin ll-induced arteriolar vasoconstriction.
Hydrochlorothiazide is a low-ceiling diuretic recommended as firstline therapy in uncomplicated hypertension.
Like the ACE inhibitors and other angiotensin ll receptor antagonists, telmisartan is contraindicated during pregnancy. Since
there is no information available on the use of telmisartan during
lactation, telmisartan is contraindicated for use during lactation.
Telmisartan may be used alone or in combination with hydrochlorothiazide if further blood pressure reductions are required.
Dosage
Adults: 40 mg telmisartan once daily, which may be increased
after 4 to 8 weeks to a maximum of 80 mg once daily. Alternatively, hydrochlorothiazide 12.5 mg once daily may be added.
No dosage adjustment is required in elderly patients.
Evidence of efficacy
Published data on the use of telmisartan in humans confirms
its sustained 24-hour antihypertensive effects and clinical efficacy. The BP-lowering efficacy over the entire 24-hour dose
administration interval is consistent with the pharmacokinetic
profile of telmisartan, which has the longest elimination half-life
among currently available ARBs.
Several controlled studies have demonstrated that the fixeddose combination of telmisartan/hydrochlorothiazide is superior
in lowering blood pressure than either telmisartan or hydrochlorothiazide alone. Recent data show that telmisartan 80 mg controls the early morning blood pressure surge more effectively
than ramipril 5–10 mg and, thus, may have a greater beneficial
effect on long-term cardiovascular risk.
Independent of its effect on blood pressure, telmisartan displays favourable effects on insulin resistance, lipid levels, left
ventricular hypertrophy and renal function.
Precautions
General
Telmisartan should not be given to patients with cholestasis,
SA Pharmaceutical Journal – August 2010
SAPJAug10pp46-51.indd 51
Major adverse effects
Telmisartan has a tolerability profile similar to that of placebo.
Most commonly reported side effects include headache and
dizziness.
The excellent clinical tolerability of telmisartan is not affected
by the association with the low-dose thiazide.
Drug interactions
Concomitant administration with potassium-sparing diuretics,
potassium supplements, salt substitutes containing potassium or
other medicines that may increase potassium levels is not recommended. Co-administration with lithium is not recommended.
Telmisartan may increase serum digoxin concentrations.
Cost: SEP (Incl VAT)
Pritor® 40(80 mg) tablets: R125.40/28
Co-Pritor® 40(80)/12.5 mg tablets: R125.40/28
Manufacturer: Boehringer Ingelheim
Patient information
Tablets may be taken with food or on an empty stomach.
Adequate contraceptive measures are advised for women of
childbearing age.
Conclusion
Telmisartan is approved for the treatment of hypertension,
either as monotherapy or in combination with other antihypertensive agents, including a fixed-dose combination with
hydrochlorothiazide. The long elimination half-life of telmisartan ensures the drug provides effective reductions in blood
pressure across the entire 24-hour dosage interval. Extensive
evidence from clinical trials indicates that telmisartan, either
as monotherapy or in combination with other antihypertensive
agents, provides long-term antihypertensive efficacy.r
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