Below are all the undesirable events (AEs) observed with concomitant use of amlodipine, valsartan and HCTZ (Ko-Exforge preparation), as well as amlodipine, valsartan and HCTZ monotherapy.
Ko-Exforge (amlodipine + valsartan + HCHP)
The safety of the Ko-Exforge preparation at a maximum dose of 10/320/25 mg was studied in a study involving 2271 patients, 582 of whom received valsartan in combination with HCTZ and amlodipine.
With the use of the drug Ko-Exforge, no new AEs were detected compared to monotherapy with individual components.
A good tolerance of the preparation Ko-Exforzh was observed even with its long-term use.
The frequency of AE was not related to gender, age or race. When using the drug Ko-Exforzh changes in laboratory indicators were minimal and did not differ from those on the background of monotherapy by individual components. With the simultaneous administration of HCTT together with valsartan (triple combination therapy), a decrease in the hypokalemic effect of HCTZ is noted.
Amlodipine
To assess the frequency, the following criteria were used (according to WHO classification): very often (> 1/10 appointments); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), the frequency is unknown (insufficient data to estimate the frequency of development). Within the limits of each group allocated according to the frequency of occurrence, adverse reactions are distributed in order of decreasing importance.
From the blood and lymphatic system: very rarely - leukopenia, thrombocytopenia.
From the immune system: very rarely - allergic reactions.
Disorders from the metabolism and nutrition: very rarely - hyperglycemia. Disorders of the psyche: infrequently - insomnia, lability of mood, anxiety.
From the nervous system: often - headache, drowsiness, dizziness; infrequently - tremor, hypoesthesia, taste disorders, paresthesia, syncope; very rarely - muscle hypertonia, neuropathy.
From the side of the organ of vision: infrequently - visual disturbances, diplopia.
On the part of the hearing organs and labyrinthine disturbances: infrequently, noise in the ears.
From the cardiovascular system: often - a feeling of palpitations, "hot flashes" of blood to the face; infrequent - marked decrease in blood pressure, very rarely - vasculitis, arrhythmias (including bradycardia, ventricular tachycardia, atrial fibrillation), myocardial infarction.
From the respiratory system, the thoracic and mediastinal organs: infrequently - shortness of breath, rhinitis; very rarely, a cough.
From the digestive system: often - pain in the upper abdomen, nausea; infrequently - vomiting, indigestion, dry mouth, constipation, diarrhea; very rarely - pancreatitis, gastritis, gingival hyperplasia.
From the liver and biliary tract: very rarely - hepatitis, jaundice.
From the skin and subcutaneous fat: rarely - alopecia, increased sweating, itching, skin rash, purpura, skin discoloration, photosensitivity, very rarely angioedema, urticaria, erythema multiforme, Stephen-Johnson syndrome.
From the musculoskeletal system and connective tissue: infrequently - back pain, muscle spasms, myalgia, arthralgia.
From the side of the kidneys and urinary tract: infrequently - disturbances of urination, nocturia, pollakiuria.
From the genitals and mammary glands: infrequently - gynecomastia, erectile dysfunction.
General disorders and disorders at the injection site: often - peripheral edema, increased fatigue; infrequently - asthenia, discomfort, general weakness, pain in the chest.
Laboratory and instrumental data: infrequently - increase or decrease in body weight; very rarely - increased activity of "liver" transaminases.
Valsartan
Below are the AEs detected in patients with arterial hypertension during clinical trials, as well as in clinical practice and laboratory studies. For AEs, identified in clinical practice and laboratory studies, establish frequency of occurrence is impossible, therefore for these AEs it is indicated: "frequency is unknown".
To assess the frequency, the following criteria were used (according to WHO classification): very often (> 1/10 appointments); often (> 1/100, <1/10); infrequently (> 1/1000,<1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), the frequency is unknown (insufficient data to estimate the frequency of development). Within each group allocated according to frequency of occurrence, the reactions are distributed in order of decreasing importance.
On the part of the blood and lymphatic system: the frequency is unknown - a decrease in hemoglobin and hematocrit, neutropenia, thrombocytopenia.
On the part of the immune system: the frequency is unknown - hypersensitivity reactions, including serum sickness.
Disorders from the metabolism and nutrition: the frequency is unknown - an increase in the potassium content in the blood serum.
On the part of the hearing organs and labyrinthine disturbances: infrequently - vertigo.
From the side of the vessels: the frequency is unknown - vasculitis.
From the respiratory system, chest and mediastinum: rarely-cough.
From the side of the digestive system: infrequently - pain in the abdomen.
On the part of the liver and bile ducts: the frequency is unknown - increased activity of "liver" enzymes, an increase in the concentration of bilirubin in the blood plasma.
From the skin and subcutaneous fat: the frequency is unknown - angioedema, skin itching, rash.
From the musculoskeletal system and connective tissue: the frequency is unknown - myalgia.
From the side of the kidneys and urinary tract: the frequency is unknown - an increase in the concentration of creatinine in the blood plasma, impaired renal function, including acute renal failure.
General disorders and disorders at the site of administration: infrequently - increased fatigue.
In clinical studies with valsartan in patients with hypertension, the following AEs were observed (regardless of their causal relationship with the study drug): viral infections, upper respiratory tract infections, pharyngitis, rhinitis, sinusitis, insomnia, decreased libido.
HCHP
The experience of using HCTZ is very long, the doses often exceed those contained in the preparation of Ko-Exforge. The following AEs were detected with the use of thiazide diuretics (including GTC) in monotherapy.
To assess the frequency, the following criteria were used (according to WHO classification): very often (> 1/10 appointments); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), the frequency is unknown (insufficient data to estimate the frequency of development). Within the limits of each group allocated according to the frequency of occurrence, adverse reactions are distributed in order of decreasing importance.
On the part of metabolism and food: very often - (especially against the background of high doses of HCTZ), hypokalemia, increased lipid concentrations in blood plasma, often - hyponatremia, hypomagnesemia and hyperuricemia, seldom - hypercalcemia, hyperglycemia, glycosuria and worsening of diabetes, it is very rare hypochloraemic alkalosis.
From the skin and subcutaneous tissues: often - hives and other skin rashes; rarely - photosensitivity; very rarely - necrotizing vasculitis and toxic epidermal necrolysis, lupus reaction exacerbation of cutaneous manifestations of systemic lupus erythematosus, the frequency is unknown - erythema multiforme.
On the part of the digestive system: often - decreased appetite, mild nausea, vomiting; rarely - discomfort in the abdomen, constipation, diarrhea; very rarely - pancreatitis.
Of the liver and biliary tract: rarely - intrahepatic cholestasis or jaundice.
On the part of the vessels: often orthostatic hypotension (may be aggravated by the use of alcohol, sedatives or anesthetics).
From the heart: rarely - arrhythmias.
From the nervous system: rarely - headache, paresthesia, dizziness.
From the psyche: rarely - sleep disorders, depression.
From the side of the organ of vision: rarely - visual impairment (especially in the first few weeks of treatment); frequency unknown - acute development of closed-angle glaucoma.
From the blood and lymphatic system: rarely - thrombocytopenia, sometimes in combination with purpura; very rarely - agranulocytosis, oppression of bone marrow hematopoiesis, hemolytic anemia, leukopenia, frequency unknown - aplastic anemia.
From the genitals and the breast: often - impotence.
From the side of the immune system: very rarely - hypersensitivity reactions.
On the part of the respiratory system, chest and mediastinal organs: very rarely - respiratory distress syndrome, including non-cardiogenic pulmonary edema and pneumonitis.
From the side of the kidneys and urinary tract: the frequency is unknown - acute renal failure, impaired renal function.
General disorders and disorders at the injection site: the frequency is unknown - hyperthermia, asthenia.
From the muscles, skeleton and connective tissue: the frequency is unknown - muscle spasms.
If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.