Arterial hypotension
A marked decrease in blood pressure with the development of clinical symptoms can be observed in patients with a decrease in the volume of circulating blood and / or sodium in the blood serum due to diuretics, fluid loss or other
reasons, for example, with increased sweating, prolonged vomiting and / or diarrhea. It is necessary that the restoration of loss of fluid and / or sodium is carried out before the start of therapy with the drug Tenliza. It is necessary to monitor BP after taking the initial dose. Similar conditions apply to patients with coronary heart disease or cerebrovascular disease, in whom a marked decrease in blood pressure can lead to the development of myocardial infarction or stroke.
Aortic and mitral stenosis
Like all vasodilating drugs, the Tenliz preparation should be used with caution in patients with obstruction of the left ventricular outflow tract and stenosis of the mitral valve.
Impaired renal function
In some patients with arterial hypertension without pronounced manifestations of renovascular diseases, an increase in the concentration of serum creatinine and urea was observed, in most cases minimal or transient, more pronounced with concurrent administration of an ACE inhibitor and a diuretic. This is most typical for patients with a history of kidney disease.
To determine the optimal maintenance dose, it is necessary to determine the dosage regimen individually, using separately lisinopril and amlodipine, with simultaneous monitoring of kidney function. The TENLIZA preparation is indicated only for those patients in whom the optimal maintenance dose of lisinopril and amlodipine is titrated to 20 mg and 5 mg, respectively. In the case of a decrease in kidney function, the preparation of Tenliz should be discontinued and replaced by monotherapy with drugs in adequate doses. In addition, a dose reduction or elimination of diuretics may be required.
Angioedema
Angioedema of the face, extremities, lips, tongue, vocal folds and / or larynx was recorded in patients taking ACE inhibitors, including lisinopril. In such cases, taking Tenliza should be stopped immediately and the patient carefully followed up with the patient until the symptoms disappear completely.
Edema of the face, lips and extremities usually passes independently, however, to reduce the severity of symptoms should use antihistamines. Angioedema, accompanied by swelling of the larynx, can lead to death. If there is a swelling of the tongue, pharynx or larynx, which is the cause of airway obstruction, first aid.The proper measures include: the use of 0.1% epinephrine (adrenaline) solution subcutaneously in a dose of 0.3-0.5 mg or 0.1 mg intravenously slowly, followed by the use of glucocorticosteroids (intravenously) and antihistamines under the control of vital functions.
In patients taking LIF inhibitors, in rare cases, the development of angioedema edema of the intestine. Such patients complained of abdominal pain (with or without nausea and vomiting), in some cases of a previous angioedema edema, the ns were observed and the activity of C-1 esterase was within normal limits. Angioedema of the intestine was diagnosed by computed tomography of the gastrointestinal tract, either after ultrasound or in surgical intervention. Symptoms disappeared after the withdrawal of the ACE inhibitor. When performing differential diagnosis of abdominal pain in patients taking ACE inhibitors, you should also consider angioedema of the intestine. Anaphylactic reactions in patients, on hemodialysis In patients who underwent hemodialysis through polyacrylonitrile membranes (for example, AN69® ) and who at the same time received ACE inhibitors, cases of anaphylactic shock have been reported, so it is necessary to avoid this combination. Patients are recommended to use either another type of dialysis membrane, or an antihypertensive drug of another pharmacotherapeutic group.
Anaphylactic reactions in patients during apheresis of low-density lipoproteins (LDL)
Rarely in patients who used ACE inhibitors during apheresis of LDL with dextran sulfate, life-threatening anaphylactic reactions developed. Such reactions were prevented by withdrawal of an ACE inhibitor before each apheresis procedure.
Desensitization with bee or aspen poison
In some patients who took ACE inhibitors, anaphylactic reactions developed during the desensitization of Hymenoptera (eg, wasps or bees). Such life-threatening situations can be avoided with the abolition of the ACE inhibitor before the desensitization procedure.
Effects on the liver
In rare cases, the administration of ACE inhibitors was accompanied by a syndrome that began with cholestatic jaundice or hepatitis and subsequently led to fulminant necrosis of the liver and, in some cases, a lethal outcome.
The mechanism of this syndrome is not established.Patients taking the drug Tenliza, u which develops jaundice or there is an increase in the activity of "hepatic" enzymes, it is necessary to cancel the drug with subsequent monitoring of their condition.
Liver failure
In patients with impaired liver function T1 / 2 amlodipine is elongated. At the moment, there are no recommendations on the dosing regimen, so this drug should be used with caution, having previously estimated the expected benefit and the potential risk of treatment.
Neutropenia / agranulocytosis
In rare cases, neutropenia, agranulocytosis, thrombocytopenia and anemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and in the absence of other aggravating factors, neutropenia is rare. Neutropenia and agranulocytosis are reversible and disappear after the withdrawal of the ACE inhibitor. The preparation of Tenliza should be used with extreme caution in patients with systemic connective tissue diseases, with immunosuppressive therapy, during treatment with allopurinol or procainamide, or in a combination of these aggravating factors, especially in the presence of a previous impairment of kidney function.Some of these patients developed serious infectious diseases, in which a response to antibiotic treatment was not received in several cases. During treatment with the Tenliza preparation, periodic monitoring of leukocytes (blood count with counting of the leukocyte formula) in such patients is necessary, as well as to warn patients about the need to report the appearance of the first signs of an infectious disease.
Cough
Cough was often recorded during the use of ACE inhibitors. As a rule, cough is unproductive, persistent and stopped after the drug was discontinued. When a differential diagnosis of cough is necessary to consider and cough caused by the use of inhibitors APF.
Surgery / general anesthesia
In patients who undergo extensive surgery or during general anesthesia with drugs leading to hypotension, lisinopril can block the formation of angiotensin II after compensatory release of renin. If arterial hypotension develops, probably as a result of the above mechanism, it is possible to correct the increase in BCC.
Elderly patients
In elderly patients with impaired renal function, dose adjustment should be performed using separately lisinopril and amlodipine.
Hyperkalemia
In some patients who received ACE inhibitors, an increase in serum potassium was observed. Risk group for the development of hyperkalemia consists of patients with renal failure, diabetes, congestive heart failure, dehydration, metabolic acidosis or while receiving potassium-sparing diuretics, potassium-containing food additives, potassium-based salt substitutes or any other medications, leading to an increase of potassium in blood serum (e.g., heparin). If it is necessary to simultaneously take the above drugs, you need to monitor the potassium content in the blood serum.
Patients with reduced body weight, low growth patients and patients with severe liver dysfunction may need a dose reduction.
The preparation of Tenlise does not have any adverse effect on the metabolism and concentration of lipids in the blood plasma and can be used to treat patients with bronchial asthma, diabetes and gout.
During treatment, it is necessary to control body weight and monitor the dentist (to prevent soreness, bleeding and gingival hyperplasia).