Co-exforge pills 5mg + 160 + 12.5mg №28

Indications for use:
Arterial hypertension II and III degrees.

Contraindications:
- increased sensitivity to Amlodipine, valsartan, hydrochlorothiazide, other sulfonamide derivatives, dihydropyridine derivatives and other auxiliary components of the drug;
- pregnancy and breastfeeding period;
- severe liver dysfunction (more than 9 points on the Child-Pough scale);
- marked dysfunction of the night (Cl creatinine less than 30 ml / min), anuria;
• hypokalemia, hyponatremia, hypercalcemia, and hyperuricemia with clinical manifestations;
- age up to 18 years (efficacy and safety have not been established).

Dosage and administration:
Inside, (preferably in the morning), with a small amount of water, regardless of the meal.
For convenience, patients receiving therapy with amlodipine, valsartan and hydrochlorothiazide in separate pills can be transferred to therapy with Co-Exforge, containing the same doses of active ingredients, as well as in case of insufficient blood pressure control against the background of double combined therapy (valsartan + hydrochlorothiazide, amlodipine + valsartan and amlodipine + hydrochlorothiazide), patients can be transferred to a triple combination treatment with Co-Exforge in appropriate doses.
If a patient has dose-dependent side effects when using dual-combination therapy with any of the components of Co-Exforge, Co-Exforge may be prescribed to achieve a similar reduction in blood pressure, containing a lower dose of the active component that caused this side effect.
Recommended daily doses of Co-Exforge:
- 5 mg + 160 mg + 12.5 mg (1 tab. Containing amlodipine + valsartan + hydrochlorothiazide in doses of 5 mg + 160 mg + 12.5 mg);
- 10 mg + 160 mg + 12.5 mg (1 tab. Containing amlodipine + valsartan + hydrochlorothiazide at doses of 5 mg + 160 mg + 12.5 mg);
- 10 mg + 320 mg + 25 mg (2 tablets, containing amlodipine + valsartan + hydrochlorothiazide in doses of 5 mg + 160 mg + 12.5 mg).
The maximum antihypertensive effect of the drug is observed 2 weeks after increasing the dose. The maximum dose of the drug - 10 mg + 320 mg + 25 mg / day.
Use in patients older than 65 years. Dosage adjustment of the drug is not required.
Use in children and adolescents under the age of 18 years. Since the safety and efficacy of Co-Exforge in children and adolescents (under 18) have not yet been established, the drug is not recommended for use in this category of patients.
Use in patients with impaired renal or hepatic function. In patients with mild and moderate renal impairment (creatinine Cl over 30 ml / min) and liver (5–9 points on the Child-Pough scale), dose adjustment is not required.

Side effect:
Below are all adverse events (AEs) that were observed with the simultaneous use of amlodipine, valsartan and hydrochlorothiazide (Co-Exforge),as well as monotherapy with amlodipine, valsartan and hydrochlorothiazide.
Co-Exforge preparation (amlodipine + valsartan + hydrochlorothiazide)
The safety of Co-Exforge was evaluated in more than 2,200 patients. When using the drug Ko-Exforge, the AEs were mostly low or moderately severe. Termination of drug treatment due to the development of AE was required in rare cases. Most often, the drug was discontinued due to the development of dizziness and a pronounced decrease in blood pressure (0.7%).
When using the drug Co-Exforge, no new AEs were detected compared with dual combination therapy and monotherapy with individual components. As with the short-term intake, the good tolerability of Co-Exforge was observed with its long-term use (during the year).
The frequency of AE was not related to gender, age, or race.
When using Co-Exforge, changes in laboratory parameters were minimal and did not differ from those on the background of monotherapy with individual components. While taking hydrochlorothiazide together with valsartan (double combination therapy), a decrease in the hypokalemic effect of hydrochlorothiazide is noted.
The most frequent AEs (frequency more than 2%), noted in clinical studies (regardless of the identification of a connection with the use of Co-Exforge), were dizziness (7.7%), peripheral edema (4.5%), headache (4, 3%), dyspepsia (2.2%), fatigue (2.2%), muscle spasm (2.2%), back pain (2.1%), nasopharyngitis (2.1%), nausea (2.1%).
The following criteria were used to estimate the frequency (according to the WHO classification): very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), the frequency is unknown (not enough data to estimate the frequency of development).
Metabolic and nutritional disorders: often - hypokalemia; infrequently - anorexia, hypercalcemia, hyperlipidemia, hyponatremia.
Mental disorders: infrequently - insomnia / sleep disturbances, drowsiness.
The nervous system: often - dizziness, headache; infrequently - lack of coordination; postural dizziness and dizziness due to physical exertion, taste disturbances, lethargy, paresthesia, neuropathy, incl. peripheral, fainting.
On the part of the organ of vision: infrequently - visual disturbances.
On the part of the organ of hearing and labyrinth disorders: infrequently - vertigo.
Cardiovascular: often - pronounced decrease in blood pressure; infrequently - tachycardia, orthostatic hypotension, phlebitis, thrombophlebitis.
The respiratory system, organs of the chest and mediastinum: infrequently - cough, shortness of breath, irritation in the throat.
From the digestive system: often - dyspepsia; infrequently - abdominal discomfort, pain in the upper abdomen, bad breath, diarrhea, dry mouth, nausea, vomiting.
From the skin and subcutaneous fat: infrequently - excessive sweating, itching.
From the musculoskeletal system and connective tissue: infrequently - back pain, swelling in the joints, muscle spasms, muscle weakness, myalgia, pain in the limbs.
Kidney and urinary tract: often - pollakiuria; infrequently - an increase in plasma creatinine, acute renal failure.
From the genital and breast: infrequently - erectile dysfunction.
General disorders and disorders at the site of administration: often - peripheral edema, fatigue; infrequently - abasia, gait disturbances, asthenia, general weakness, pain in the chest.
Laboratory and instrumental data: infrequently - an increase in the urea nitrogen content in blood plasma, hyperuricemia, increase in body weight.
Amlodipine
The following criteria were used to estimate the frequency (according to the WHO classification): very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), the frequency is unknown (not enough data to estimate the frequency of development).
From the side of blood and lymphatic system: very rarely - leukopenia, thrombocytopenia.
The immune system: very rarely - hypersensitivity reactions.
Metabolic and nutritional disorders: very rarely - hyperglycemia.
Mental disorders: infrequently - insomnia / sleep disturbances, drowsiness, mood lability.
The nervous system: often - dizziness, headache; infrequently - taste disorders, paresthesias, syncope, tremor; very rarely - muscle hypertonus, peripheral neuropathy, neuropathy; frequency unknown - extrapyramidal disorders.
On the part of the organ of vision: infrequently - visual disturbances.
Hearing and labyrinth disorders: infrequently - tinnitus.
Cardiovascular: often - a feeling of palpitations, flushing of the face; infrequently - pronounced decrease in blood pressure; very rarely - vasculitis, arrhythmias (including bradycardia, ventricular tachycardia, atrial fibrillation).
The respiratory system, organs of the chest and mediastinum: infrequently - shortness of breath, rhinitis; very rarely - cough.
From the digestive system: often - abdominal discomfort, pain in the upper abdomen, nausea; infrequently - a change in the frequency of bowel movements, diarrhea, dry mouth, dyspepsia, vomiting; very rarely - gastritis, gingival hyperplasia, pancreatitis.
Liver and biliary tract: very rarely - an increase in liver enzymes, an increase in plasma bilirubin concentration, hepatitis, intrahepatic cholestasis, jaundice.
From the skin and subcutaneous fat: infrequently - alopecia, increased sweating, itching, rash, incl. exanthema, purpura, discoloration of the skin; very rarely - angioedema, erythema multiforme, urticaria.
From the musculoskeletal system and connective tissue: infrequently - arthralgia, back pain, muscle spasms, myalgia.
Kidney and urinary tract: infrequently - urination disorders, nocturia, pollakiuria.
From the genital and breast: infrequently - erectile dysfunction, gynecomastia.
General disorders and disorders at the site of administration: often - increased fatigue, edema; infrequently - asthenia, discomfort, general weakness, pain in the chest, pain of different localization.
Laboratory and instrumental data: infrequently - increase or decrease in body weight.
Valsartan
The following criteria were used to estimate the frequency (according to the 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 (not enough data to estimate the frequency of development).
Blood and lymphatic system: frequency is unknown - decrease in hemoglobin and hematocrit, leukopenia, thrombocytopenia. On the immune system: frequency is unknown - hypersensitivity reactions.
Hearing and labyrinth disorders: infrequently - vertigo.
Cardiovascular: frequency is unknown - vasculitis.
The respiratory system, organs of the chest and mediastinum: Infrequently - cough.
From the digestive system: infrequently - abdominal discomfort, pain in the upper abdomen.
Liver and biliary tract: frequency is unknown - increased activity of liver enzymes, increased concentration of bilirubin in the blood plasma.
From the skin and subcutaneous fat: frequency is unknown - angioedema, pruritus, rash.
From the musculoskeletal system and connective tissue: frequency is unknown - myalgia.
Kidney 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.
Laboratory and instrumental data: The frequency is unknown - an increase in the content of potassium in the blood plasma.
In clinical studies with the use of valsartan in monotherapy, the following AEs were noted (regardless of their causal relationship with the studied drug): viral infections, upper respiratory tract infections, sinusitis, rhinitis, neutropenia, insomnia.
In rare cases, the use of valsartan may be accompanied by a decrease in hemoglobin and hematocrit. In controlled studies, 0.8 and 0.4% of patients treated with valsartan showed a significant decrease (over 20%) in hematocrit and hemoglobin, respectively. For comparison, in patients receiving placebo, a decrease in both hematocrit and hemoglobin was observed in 0.1% of cases. Neutropenia was detected in 1.9% of patients who received valsartan and 1.6% of patients who received an ACE inhibitor.
In controlled studies, 3.9 and 16.6% of patients with chronic heart failure treated with valsartan showed an increase in the concentration of creatinine and blood urea nitrogen by more than 50%, respectively. For comparison, in patients receiving placebo, an increase in the concentration of creatinine and urea nitrogen is observed in 0.9 and 6.3% of cases.
Doubling of serum creatinine concentration was detected in 4.2% of patients after myocardial infarction who received valsartan and 3.4% of those who received Captopril.
In controlled studies, an increase in the serum potassium content of more than 20% was observed in 10% of patients with chronic heart failure. For comparison, in patients receiving placebo, an increase in potassium content was observed in 5.1% of cases.
Hydrochlorothiazide
The following criteria were used to estimate the frequency (according to the WHO classification): very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), the frequency is unknown (not enough data to estimate the frequency of development).
Blood and lymphatic system: rarely - thrombocytopenia; very rarely - agranulocytosis, inhibition of bone marrow hematopoiesis, hemolytic anemia, leukopenia.
The immune system: very rarely - hypersensitivity reactions.
Metabolic and nutritional disorders: often - hypokalemia; infrequently - hyperuricemia, hypomagnesemia, hyponatremia; rarely - hypercalcemia, hyperglycemia; very rarely - hypochloremic alkalosis.
Mental disorders: rarely - insomnia / sleep disorders, depression.
The nervous system: rarely - dizziness, headache, lethargy.
On the part of the organ of vision: infrequently - visual disturbances.
Cardiovascular: infrequently - orthostatic hypotension; rarely, arrhythmias (including bradycardia, ventricular tachycardia, atrial fibrillation).
The respiratory system, organs of the chest and mediastinum: very rarely - respiratory distress syndrome, pulmonary edema and pneumonitis.
From the digestive system: rarely - loss of appetite, nausea, vomiting; rarely - abdominal discomfort, pain in the upper abdomen, constipation, diarrhea; very rarely - pancreatitis.
Liver and biliary tract: rarely - hepatitis, intrahepatic cholestasis, jaundice.
From the skin and subcutaneous fat: infrequently - rash, urticaria; rarely, increased photosensitivity, purpura; very rarely - necrotizing vasculitis, toxic epidermal necrolysis, lupus-like reactions; exacerbation of cutaneous manifestations of systemic lupus erythematosus.
Kidney and urinary tract: rarely - renal dysfunction, including acute renal failure.
From the genital and breast: infrequently - erectile dysfunction.
Laboratory and instrumental data: often - hyperlipidemia; rarely - glycosuria.

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