Safety and Tolerability
Adverse Effects
Pritor® / Kinzal® has been evaluated for safety in 27 studies in a total of 5363 patients with mild-to-moderate hypertension. Of these, 2921 patients have been treated for up to 6 months, 888 for 6-12 months, and1554 have been treated for over 1 year.
Adverse events occurring at an incidence of 1% or more in patients treated with Pritor® / Kinzal® and at a greater rate than in patients treated with placebo, irrespective of their causal association. Adverse events were usually mild and transient in nature and are presented in the following table.
Pritor® / Kinzal® has been evaluated for safety in 27 studies in a total of 5363 patients with mild-to-moderate hypertension. Of these, 2921 patients have been treated for up to 6 months, 888 for 6-12 months, and1554 have been treated for over 1 year.
Adverse events occurring at an incidence of 1% or more in patients treated with Pritor® / Kinzal® and at a greater rate than in patients treated with placebo, irrespective of their causal association. Adverse events were usually mild and transient in nature and are presented in the following table.
The incidence of adverse events was not dose-related and did not correlate with the gender, age or race of patients.
The incidence of dry cough was significantly lower in patients treated with Pritor® / Kinzal® than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments [2].
Selected important cautionary information
Pritor® / Kinzal® is contraindicated in patients who are hypersensitive to any component of this product.
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depletion (e.g., those receiving high doses of diuretics), symptomatic hypotension may occur after initiation of Pritor® / Kinzal® or PritorPlus / KinzalPlus® therapy. This condition should be corrected prior to administration of Pritor® / Kinzal® or PritorPlus / KinzalPlus®, and treatment should start under close medical supervision.
Thiazide diuretics have been reported to cause exacerbation of systemic lupus erythematosus.
Thiazides cross the placental barrier and appear in cord blood. There is a risk of foetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults. Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma but are more likely in patients with such a history.
Lithium generally should not be given with thiazides.
USE IN PREGNANCY
There are no adequate data from the use of Pritor®/Kinzalmono®/PritorPlus®/Kinzalkomb® in pregnant women. Therefore, it should preferably not be used during the first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause injury and even death in the developing foetus, therefore, Pritor®/Kinzalmono®/PritorPlus®/Kinzalkomb® is contraindicated in the second and third trimesters of pregnancy. If pregnancy is diagnosed Pritor®/Kinzalmono®/PritorPlus®/Kinzalkomb® should be discontinued as soon as possible.
The incidence of dry cough was significantly lower in patients treated with Pritor® / Kinzal® than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments [2].
Selected important cautionary information
Pritor® / Kinzal® is contraindicated in patients who are hypersensitive to any component of this product.
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depletion (e.g., those receiving high doses of diuretics), symptomatic hypotension may occur after initiation of Pritor® / Kinzal® or PritorPlus / KinzalPlus® therapy. This condition should be corrected prior to administration of Pritor® / Kinzal® or PritorPlus / KinzalPlus®, and treatment should start under close medical supervision.
Thiazide diuretics have been reported to cause exacerbation of systemic lupus erythematosus.
Thiazides cross the placental barrier and appear in cord blood. There is a risk of foetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults. Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma but are more likely in patients with such a history.
Lithium generally should not be given with thiazides.
USE IN PREGNANCY
There are no adequate data from the use of Pritor®/Kinzalmono®/PritorPlus®/Kinzalkomb® in pregnant women. Therefore, it should preferably not be used during the first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause injury and even death in the developing foetus, therefore, Pritor®/Kinzalmono®/PritorPlus®/Kinzalkomb® is contraindicated in the second and third trimesters of pregnancy. If pregnancy is diagnosed Pritor®/Kinzalmono®/PritorPlus®/Kinzalkomb® should be discontinued as soon as possible.
