Coaprovel

1 tablet contains irbesartan 300 mg,

hydrochlorothiazide 12.5 mg,

auxiliary substances :

microcrystalline cellulose,

croscarmellose sodium,

lactose monohydrate,

magnesium stearate,

hydrated colloidal silicon dioxide,

pregelatinized corn starch,

iron oxide red,

iron oxide yellow.

Coaprovel has a hypotensive effect.

Arterial hypertension.

- II and III trimesters of pregnancy;

- hypersensitivity to Coaprovel's components;

- hypersensitivity to other drugs derived from sulfonamide.

For hydrochlorothiazide use:

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

- refractory hypokalemia, hypercalcemia;

- severe form of liver failure;

- biliary cirrhosis of the liver;

- cholestasis.

From the hematopoietic 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 blurred vision, xanthopsia.

From the side of 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, necrotic angiitis (vasculitis, cutaneous vasculitis), photosensitivity reactions, rash, exacerbation of skin manifestations of lupus erythematosus, urticaria.

From the musculoskeletal system: muscle spasms, weakness.

From the urinary system: interstitial nephritis, renal dysfunction.

Others: increased body temperature.

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

Other antihypertensive drugs: The antihypertensive effect of COAPROVEL can be enhanced by the use of other antihypertensive drugs. Irbesartan and hydrochlorothiazide (at doses: 300 mg irbesartan / 25 hydrochlorothiazide) should be used with caution in conjunction with other antihypertensive drugs, including calcium channel blockers and beta-blockers. Prior therapy with high doses of diuretics can lead to hypovolemia and the 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 may be increased. Therefore the combination of lithium and COAPROVEL is not recommended. If a combination is necessary, close monitoring of serum lithium levels is recommended.

Medicines affecting blood potassium levels: the hypokalemic effect of hydrochlorothiazide is weakened 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 salt, salicylic acid derivatives). Conversely, based on experience with other drugs that reduce the activity of the renin-angiotensin system, the concomitant use of potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that can increase serum potassium levels (eg, heparin sodium salt), may lead to an increase in the amount of potassium in the blood serum.

Medicines that are affected by impaired serum potassium balance: periodic monitoring of serum potassium levels is recommended in the case of the combined use of COAPROVEL and drugs that are affected by an imbalance in serum potassium balance (for example, digitalis glycosides, antiarrhythmics).

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

As with ACE inhibitors, the combined use of angiotensin II antagonists and NSAIDs may increase the risk of impaired renal function, including the likelihood of acute renal failure, and lead to an increase in serum potassium, especially in patients with already impaired renal function. When administering this combination, precautions should be taken, especially in elderly patients. Patients should not be dehydrated. Kidney function should be monitored after initiation of combination therapy and periodically thereafter.

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

pharmacokinetic and pharmacodynamic interactions when irbesartan was used in conjunction with warfarin, a drug metabolized by CYP2C9. The effects of CYP2C9 inducers, such as rifampicin, on the
pharmacokinetics of irbesartan have not been evaluated. 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 be observed;

Hypoglycemic drugs (oral agents and insulin): dose adjustment of the hypoglycemic agent 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: possibly more pronounced disturbance of the electrolyte composition, in particular, increased hypokalemia;

Digitalis glycosides: hypokalemia and hypomagnesemia caused by a thiazide diuretic contribute to the manifestation of arrhythmias caused by digitalis (see section “Special warnings and precautions for use”);

Non-steroidal anti-inflammatory drugs: The use of non-steroidal anti-inflammatory drugs may reduce the effects of thiazide diuretics in some patients;

Catecholamines (eg norepinephrine): The effect of these drugs may be weakened;

Non-depolarizing muscle relaxant: The effect of non-depolarizing muscle relaxants may be enhanced by hydrochlorothiazide;

Anti-gout drugs: dosage adjustments of anti-gout drugs may be necessary, as hydrochlorothiazide can increase serum uric acid levels. It may be necessary to increase the dosage of probenecid or sulfinpyrazone.

Concomitant use with thiazide diuretics may increase the frequency of allergic reactions to allopurinol;

Calcium salts: Thiazide diuretics can increase serum calcium levels due to decreased excretion. If calcium supplements or drugs that affect calcium levels are to be prescribed (for example, with vitamin D therapy), then monitoring of serum calcium levels is necessary and appropriate adjustment of the dosage of the calcium preparation.
Other interactions: the hyperglycemic effect of beta-blockers and diazoxide can be enhanced by thiazides.

Anticholinergics (eg, atropine) can increase the bioavailability of thiazide diuretics by reducing gastrointestinal motility. Thiazides may increase the risk of side effects caused by amantadine. Thiazides can reduce the urinary excretion of cytotoxic drugs (eg, cyclophosphamide, methotrexate) and enhance their myelosuppressive effects.

Coaprovel can be used 1 time / day. before or during meals in patients whose blood pressure is insufficiently controlled by irbesartan or hydrochlorothiazide alone.

Coaprovel 300 / 12.5 mg is prescribed for patients in whom blood pressure is insufficiently controlled by irbesartan (300 mg) or Coaprovel (150 / 12.5 mg).

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

There is no special information about Coaprovel overdose.

- Symptoms: with an overdose of irbesartan, arterial hypotension, tachycardia, bradycardia are most likely; with an overdose of hydrochlorothiazide - hypokalemia, hyponatremia, dehydration as a result of excessive diuresis. The most common signs and symptoms of overdose are nausea and drowsiness. Hypokalemia can lead to seizures and / or increased arrhythmias in case of concomitant use of digitalis glycosides and antiarrhythmics.

- Treatment: recommended measures depending on the time elapsed since taking the drug, and on the severity of symptoms - provoking vomiting and / or gastric lavage, the use of activated carbon, careful monitoring of the patient's condition, symptomatic and supportive therapy.

Serum electrolytes and creatinine should be monitored frequently. In the case of arterial hypotension, the patient should be laid on his back with raised lower limbs and the replacement of salts and fluid should be carried out as soon as possible. Irbesartan is not excreted during hemodialysis. The degree of elimination of hydrochlorothiazide during hemodialysis has not been established.

The risk of developing a pronounced decrease in blood pressure increases against the background of a decrease in BCC and hyponatremia caused by the use of diuretics, a diet low in Na +, diarrhea, vomiting, so these conditions should be corrected before starting drug therapy. In patients with chronic renal failure during therapy with thiazide diuretics, azotemia may occur. Periodic monitoring of serum K +, creatinine, and uric acid concentrations is recommended. There is no experience of using 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 mellitus, 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.

With thiazide diuretic therapy, hyperuricemia or exacerbation of gout may occur. Lechenin with hydrochlorothiazide can lead to disruption of the water-electrolyte balance (hypokalemia, hyponatremia and hypochloremic alkalosis). Concomitant use of irbesartan can reduce diuretic-induced hypokalemia. The risk of hypokalemia increases with concomitant treatment with GCS or ACTH.

Irbesartan can lead to hyperkalemia, especially in the presence of renal failure and / or CHF or diabetes mellitus. Periodic monitoring of serum K + concentration is recommended during the treatment period. There is no evidence that irbesartan can reduce or prevent diuretic-induced hyponatremia. Cl- deficiency is usually mild and does not require treatment. Thiazide diuretics can cause hypomagnesemia, as well as reduce the excretion of calcium by the kidneys and cause mild hypercalcemia, provided that there are no disorders of Ca2 + metabolism.

Hypercalcemia may be a sign of latent hyperparathyroidism; in this case, the drug should be discontinued before the study of the function of the parathyroid glands. Hydrochlorothiazide can 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 CHF, 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 artery disease or other diseases of the CVS can lead to myocardial infarction or stroke. The development of allergic reactions to hydrochlorothiazide is more likely in patients with a history of similar reactions. With the use of thiazide diuretics, exacerbation of SLE was noted. It should be borne in mind that in rare cases during the treatment period, dizziness and increased fatigue may occur, therefore, care should be taken when engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reaction (including when driving a car).

Pills.