Hydrohlorotyazyd, Yrbesartan |

Release form

Tablets.

Packing

28 pcs

Pharmacological action

Coaproval has a hypotensive effect.

Indications

Arterial hypertension.

Contraindications

- II and III trimesters of pregnancy

- hypersensitivity to the components of Coaprovel

- hypersensitivity to other drugs derived from sulfonamide.

For the use of hydrochlorothiazide:

- severe renal failure (CC <30 ml / min)

- refractory hypokalemia, hypercalcemia

- severe liver failure

- biliary cirrhosis

- cholestasis.

Special instructions

The risk of developing a marked decrease in blood pressure increases with a decrease in bcc and hyponatremia caused by the use of diuretics, diets low in Na +, diarrhea, and vomiting, so these conditions should be adjusted before starting treatment with the drug. In patients with chronic renal failure during treatment with thiazide diuretics, azotemia may occur. Periodic monitoring of serum K +, creatinine, and uric acid concentrations is recommended. There is no experience with the use of the drug in patients with recent kidney transplantation. Thiazide diuretic therapy can cause minifestation of latent diabetes mellitus, as well as reduce glucose tolerance. In patients with diabetes, dose adjustment of insulin or oral hypoglycemic drugs may be required. Therapy with hydrochlorothiazide at a dose of 12.5 mg contained in the preparation has practically no effect on the concentration of cholesterol and triglycerides. During therapy with thiazide diuretics, hyperuricemia or exacerbation of gout may occur. Treatment with hydrochlorothiazide can lead to a violation of the water-electrolyte balance (hypokalemia, hyponatremia and hypochloremic alkalosis). The simultaneous use of irbesartan can reduce hypokalemia caused by a diuretic. The risk of hypokalemia increases with concomitant treatment of corticosteroids or ACTH. Irbesartan can lead to hyperkalemia, especially in the presence of renal failure and / or heart failure or diabetes mellitus. During treatment, periodic monitoring of serum K + concentration is recommended. There is no evidence that irbesartan can reduce or prevent hyponatremia caused by diuretics. Cl- deficiency is usually minor and does not require treatment. Thiazide diuretics can cause hypomagnesemia, as well as reduce the excretion of calcium by the kidneys and cause slight hypercalcemia, provided there are no Ca2 + metabolic disturbances. Hypercalcemia may be a sign of latent hyperparathyroidism, in which case the drug should be discontinued before the parathyroid function is examined. Hydrochlorothiazide may cause a positive doping test result. In patients whose vascular tone and renal function depends mainly on the activity of the renin-angiotensin-aldosterone system (including heart failure, kidney disease, including renal artery stenosis), therapy with angiotensin II receptor antagonists can cause a marked decrease in blood pressure , azotemia, oliguria or, in rare cases, acute renal failure. An excessive decrease in blood pressure in coronary heart disease or other diseases of CVD can lead to myocardial infarction or stroke. The development of allergic reactions to hydrochlorothiazide is more likely in patients with a similar history of reactions. When thiazide diuretics were used, exacerbation of SLE was noted. It is necessary to take into account that in rare cases during the treatment period dizziness and increased fatigue can be observed, therefore caution should be exercised when practicing potentially dangerous activities that require an increased concentration of attention and speed of the psychomotor reaction (including when driving a car).

Composition

1 tablet contains irbesartan 150 mg, hydrochlorothiazide 12.5 mg, excipients: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, hydrated colloidal silicon dioxide, ferrous iron starch, red iron oxide.

Dosage and administration

Coaprovel can be used 1 time / day. before or during meals in patients whose blood pressure is not adequately controlled with irbesartan or hydrochlorothiazide alone.

Coaprovel150 / 12.5 mg is prescribed for patients in whom blood pressure is not sufficiently controlled by hydrochlorothiazide or irbesartan (150 mg / day) during monotherapy.

Use of the drug in doses of more than 300 mg of irbesartan / 25 mg of hydrochlorothiazide 1 time / day. not recommended.

Side effects of

From the hemopoietic system: aplastic anemia, bone marrow depression, hemolytic anemia, leukopenia, neutropenia / agranulocytosis, thrombocytopenia.

From the side of the central nervous system and peripheral nervous system: depression, sleep disturbances, dizziness, paresthesia, anxiety.

From the side of the organ of vision: transient blurry vision, xanthopsia.

From the cardiovascular system: arrhythmias, postural hypotension.

From the respiratory system: respiratory distress syndrome (including pneumonitis and pulmonary edema).

From the digestive system: jaundice (intrahepatic cholestatic jaundice).

Allergic reactions: anaphylactic reactions, toxic epidermal necrosis, skin reactions such as lupus erythematosus, necrotizing angiitis (vasculitis, skin vasculitis), photosensitivity reactions, rash, exacerbation of skin manifestations of lupus erythematosus, urticaria.

From the musculoskeletal system: muscle cramps, weakness.

From the urinary system: interstitial nephritis, renal dysfunction.

Other: fever.

On the part of laboratory indicators: electrolyte imbalance (including hypokalemia and hyponatremia), glucosuria, hyperglycemia, hyperuricemia, increased cholesterol and TG.

Drug Interactions

Other antihypertensive drugs: the antihypertensive effect of COAPROVEL may be enhanced by the use of other antihypertensive drugs. Irbesartan and hydrochlorothiazide (at doses: 300 mg of irbesartan / 25 hydrochlorothiazide) should be used with caution along with other antihypertensive agents, including calcium channel blockers and beta-blockers. Preliminary treatment with diuretics in high doses can lead to hypovolemia and a risk of arterial hypotension (see section “Special warnings and precautions for use”).

Lithium: reversible increases in serum lithium concentrations and toxic effects have been observed with concomitant use of lithium with angiotensin converting enzyme (ARF) inhibitors. For irbesartan, similar effects have been extremely rare to date. In addition, the renal clearance of lithium is reduced by thiazides, therefore, in the case of COAPROVEL, the risk of the toxic effect of lithium can be increased. Therefore, the combination of lithium and COAPROVEL is not recommended. If a combination is necessary, careful monitoring of serum lithium levels is recommended.

Medicines that affect blood potassium levels: the hypokalemic effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan. However, this effect of hydrochlorothiazide can be enhanced by other drugs that cause potassium loss and hypokalemia (for example, diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid derivatives). On the contrary, based on the experience of using other drugs that reduce the activity of the renin-angiotensin system, the concomitant use of potassium-sparing diuretics, potassium supplements, potassium-containing substitutes, or other drugs that can increase serum potassium levels (for example, heparin sodium salt), can lead to an increase in the amount of potassium in the blood serum. Patients at risk are recommended to conduct adequate control of serum potassium levels.

Medicines that are affected by serum potassium imbalance: periodic monitoring of serum potassium levels is recommended in case of combined use of COAPROVEL and drugs that are affected by serum potassium imbalance (e.g. digitalis glycosides, antiarrhythmic drugs).

Non-steroidal anti-inflammatory drugs: with the simultaneous use of angiotensin II antagonists and non-steroidal anti-inflammatory drugs (e.g., selective COX-2 inhibitors, acetylsalicylic acid (> 3 g / day) and non-selective NSAIDs), a hypotensive effect may weaken.

As with ACE inhibitors, the combined use of angiotensin II antagonists and NSAIDs can increase the risk of impaired renal function, including the likelihood of acute renal failure, and lead to an increase in serum potassium levels, especially in patients with already impaired renal function. With the introduction of this combination, precautions should be taken, especially in elderly patients. Patients should not be dehydrated. Monitoring of kidney function should be carried out after initiation of combination therapy and periodically thereafter.

Further information on irbesartan interactions: The pharmacokinetics of irbesartan is not affected when used together with hydrochlorothiazide. Irbesartan is mainly metabolized by CYP2C9 and, to a lesser extent, by glucuronidation. No significant

pharmacokinetic and pharmacodynamic interactions were observed when irbesartan was used in conjunction with warfarin, a drug metabolized by CYP2C9. The effects of CYP2C9 inducers, such as rifampicin, on

did not evaluate the pharmacokinetics of irbesartan. The pharmacokinetics of digoxin did not change when combined with irbesartan.

Additional information on hydrochlorothiazide interactions: the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or narcotic drugs: increased orthostatic hypotension may occur

Hypoglycemic drugs (oral and insulin): dose adjustment of a hypoglycemic may be required (see. section “Special warnings and precautions for use”)

Colestyramine and colestyrene resins: absorption of hydrochlorothiazide is reduced in the presence of anion exchange resins

Glucocorticosteroids, ACTH: a more pronounced electrolyte disturbance is possible, in particular, increased hypokalemia

ermagemia thiazide diuretic, contribute to the manifestation of arrhythmias caused by digitalis (see section “Special warnings and precautions when applied and ")

Nonsteroidal anti-inflammatory drugs: nonsteroidal antiinflammatory drugs may reduce the effects of thiazides in some patients

catecholamines (e.g., norepinephrine): The effect of these agents may be attenuated

non-depolarising muscle relaxant: The effect of non-depolarizing muscle relaxants can be enhanced by

hydrochlorothiazide. Anti-gout agents: dosage adjustments of anti-gout agents may be necessary, since hydrochlorothiazide may increase serum uric acid levels. It may be necessary to increase the dosage of probenecid or sulfinpyrazone. Co-administration with thiazide diuretics can increase the frequency of allergic reactions to allopurinol

Calcium salts: Thiazide diuretics can increase serum calcium levels due to reduced excretion. If calcium supplements or preparations should be prescribed that affect the level of calcium (for example, during therapy with vitamin D), it is necessary to control the levels of calcium in the blood serum and carry out an appropriate dosage adjustment of the calcium preparation.

Other interactions: The hyperglycemic effect of beta-blockers and diazoxide can be enhanced by thiazides. Anticholinergics (e.g., atropine) can increase the bioavailability of thiazide-type diuretics by reducing gastrointestinal motility. Thiazides may increase the risk of side effects caused by amantadine. Thiazides can reduce urinary excretion of cytotoxic drugs (e.g. cyclophosphamide, methotrexate) and enhance their myelosuppressive effects.

Overdose

There is no specific information on an overdose with COOPROVEL. In case of overdose, careful monitoring of the patient's condition is required, and therapy should be symptomatic and supportive. The type of care depends on the time elapsed since the medication was taken and the severity of the symptoms. Recommended measures include vomiting and / or gastric lavage. Activated charcoal may be useful for overdose. Frequent monitoring of serum electrolytes and creatinine levels should be performed. In case of hypotension of the patient it is necessary to lay on a back with raising of lower extremities and as soon as possible to carry out compensation of salts and liquids.

Arterial hypotension and tachycardia can also be expected as the most likely manifestations of irbesartan overdose, and bradycardia may also occur.

Hydrochlorothiazide overdose is accompanied by a decrease in the content of electrolytes in the body (hypokalemia, hyponatremia) and dehydration as a result of excess diuresis. The most common signs and symptoms of overdose are nausea and drowsiness. Hypokalemia can lead to convulsions and / or aggravation of arrhythmias in the case of concomitant use of digitalis glycosides and antiarrhythmic agents.

Irbesartan is not excreted by hemodialysis. The degree of removal of hydrochlorothiazide in hemodialysis has not been established.

Storage Conditions

In a dark place at a temperature not exceeding 25 РC.

Shelf life

3 years.

Active ingredient

Hydrochlorothiazide, Irbesartan

Terms of dispatch from

pharmacies Prescription

tablet dosage form of tablets



Possible product names

COAPROVEL 0.15 + 0.0125 N28 TABLE

COPROVEL 0.15 + 0.0125 N28 TA

Coaprovel 150 / 12.5mg Tab. p / pl / rev X28

COAPROVEL 150MG. + 12.5MG. No. 28 TAB.

Co-control tab 150mg + 12.5mg x 28

Sanofi-Aventis, France