Coaprovel, pills 150/12.5mg, 28pcs

Composition

1 tablet contains irbesartan 150 mg, hydrochlorothiazide 12.5 mg,

excipients:

microcrystalline cellulose,

sodium croscarmellose,

lactose monohydrate,

magnesium stearate,

colloidal hydrated silicon dioxide,

pregelatinized corn starch,

red

iron oxide, yellow iron oxide.

Pharmacological action

Coaprovel 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 insufficiency (creatinine clearance < 30 ml / min);

— refractory hypokalemia, hypercalcemia;

— severe hepatic insufficiency;

— biliary cirrhosis of the liver;

— cholestasis.

Side effects

Hematopoietic disorders: aplastic anemia, bone marrow depression, hemolytic anemia, leukopenia, neutropenia/agranulocytosis, thrombocytopenia.

From the central nervous system and peripheral nervous system: depression, sleep disorders, dizziness, paresthesia, anxiety.

From the side of the visual organ: transient blurred vision, xanthopsy.

From the cardiovascular system: arrhythmias, postural hypotension.

Respiratory system disorders: respiratory distress syndrome (including pneumonitis and pulmonary edema).

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

Allergic reactions: anaphylactic reactions, toxic necrosis of the epidermis, skin reactions such as lupus erythematosus, necrotic angiitis (vasculitis, cutaneous vasculitis), photosensitivity reactions, rash, exacerbation of skin manifestations of lupus erythematosus, urticaria.

Musculoskeletal system disorders: muscle spasms, weakness.

Urinary system disorders: interstitial nephritis, renal dysfunction.

Other: increased body temperature.

From laboratory parameters: electrolyte balance disorders (including hypokalemia and hyponatremia), glucosuria, hyperglycemia, hyperuricemia, increased cholesterol and TG.

Interaction

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

Lithium: Reversible increases in serum lithium concentrations and toxic effects were observed when lithium was co-administered with angiotensin converting enzyme (ARP) inhibitors. For irbesartan, similar effects have been extremely rare to date. In addition, the renal clearance of lithium is reduced by thiazides, so in the case of COAPROVEL, the risk of lithium toxicity may 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.

Drugs that affect 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 medications that reduce the activity of the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other medications that can increase serum potassium levels (for example, sodium salt of heparin) may lead to an increase in the amount of potassium in the blood serum. Patients at risk should be adequately monitored for serum potassium levels.

Medicines that are affected by a violation of the potassium balance in serum: it is recommended to periodically monitor the levels of potassium in the blood serum in the case of co-use of COAPROVEL and medicines that are affected by a violation of the potassium balance in the blood serum (for example, digitalis glycosides, antiarrhythmics).

Non-steroidal anti-inflammatory drugs: concomitant 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) may weaken the antihypertensive effect.

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 levels, especially in patients with already impaired renal function. Precautions should be taken when using this combination, especially in elderly patients. Patients should not be dehydrated. Monitoring of renal function should be performed after initiation of combination therapy and periodically thereafter.

Additional information on irbesartan interactions: The pharmacokinetics of irbesartan are not affected when co-administered with hydrochlorothiazide. Irbesartan is mainly metabolized by SUR2C9 and, to a lesser extent, by glucuronidation. No significant

pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was co-administered with warfarin, a drug metabolized by CYP2C9. The effects of inducers of SUR2 and SUR9, such as rifampicin, on the pharmacokinetics of irbesartan were not evaluated. The pharmacokinetics of digoxin did not change when co-administered with irbesartan.

Additional information on hydrochlorothiazide interactions: the following medications may interact with thiazide diuretics: :

Alcohol, barbiturates or narcotic medications: increased orthostatic hypotension may occur; Hypoglycemic medications (oral medications and insulin): it may be necessary to adjust the dose of the hypoglycemic agent (see the section “Special warnings and precautions for use”);

Kolestiraminom and colestyramine resins: absorption of hydrochlorothiazide is reduced in the presence of anion-exchange resins;Corticosteroids, ACTH: perhaps a more pronounced disturbance of electrolyte composition, in particular, increased hypokalemia;the digitalis Glycosides: hypokalemia and hypomagnesemia caused by thiazide-diuretic, contribute to the manifestation of arrhythmias caused by digitalis (see section “Special warnings and precautions for use”);

Nonsteroidal anti-inflammatory drugs: the use of nonsteroidal anti-inflammatory drugs may reduce the effects of thiazide diuretics in some patients.

Catecholamines (such as norepinephrine): the effect of these funds may be weakened.

Non-depolarizing muscle relaxant : The effect of non-depolarizing muscle relaxants may be enhanced by hydrochlorothiazide; Anti-gouty agents: dosage adjustment of anti-gouty agents may be necessary, as hydrochlorothiazide may 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 may increase serum calcium levels due to reduced excretion. If calcium supplements or drugs that affect the calcium level are to be prescribed (for example, during vitamin D therapy), then it is necessary to monitor the serum calcium levels and adjust the dosage of the calcium preparation accordingly. Other interactions: the hyperglycemic effect of beta-blockers and diazoxide may be enhanced by thiazides.

Anticholinergic agents (e. g., atropine) may 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 the urinary excretion of cytotoxic drugs (for example, cyclophosphamide, methotrexate) and increase their myelosuppressive effects.

How to take it, course of use and dosage

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

Coaprovel 150/12.5 mg is prescribed to patients whose blood pressure is insufficiently controlled by hydrochlorothiazide or irbesartan (150 mg / day) with monotherapy.

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

Overdose

There is no specific information on overdose during COAPROVEL therapy. In case of overdose, careful monitoring of the patient’s condition is required, and therapy should be symptomatic and supportive. The type of treatment depends on the time that has elapsed since taking the medication and the severity of the symptoms. Recommended measures include provoking vomiting and / or gastric lavage. In case of overdose, the use of activated carbon may be useful.Frequent monitoring of the level of electrolytes and creatinine in the blood serum should be carried out. In case of arterial hypotension, the patient should be placed on his back with the lower limbs raised and the salts and fluids should be replaced as soon as possible.

Hypotension and tachycardia can be expected as the most likely manifestations of an overdose of irbesartan; bradycardia can also occur.

Overdose of hydrochlorothiazide is accompanied by a decrease in the body’s electrolyte content (hypokalemia, hyponatremia) and 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 if digitalis glycosides and antiarrhythmic agents are used concomitantly.

Irbesartan is not eliminated by hemodialysis. The degree of elimination of hydrochlorothiazide during hemodialysis has not been established.

Special instructions

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 with a low Na+ content, diarrhea, vomiting, so these conditions should be corrected before starting therapy with the drug. Azotemia may occur in patients with CRF treated with thiazide diuretics. Periodic monitoring of serum K+, creatinine, and uric acid concentrations is recommended.

There is no experience of using the drug in patients with a recent kidney transplant. Therapy with thiazide diuretics may cause a mini-manifestation of latent diabetes mellitus, as well as reduce glucose tolerance. In patients with diabetes mellitus, it may be necessary to adjust the dose of insulin or oral hypoglycemic drugs. Treatment with hydrochlorothiazide at a dose of 12.5 mg contained in the preparation practically does not affect the concentration of cholesterol and triglycerides. Hyperuricemia or exacerbation of gout may occur with thiazide diuretics.

Treatment with non-hydrochlorothiazide may lead to a violation of the water-electrolyte balance (hypokalemia, hyponatremia and hypochloremic alkalosis). Concomitant use of irbesartan may reduce diuretic-induced hypokalemia. The risk of hypokalemia increases with concomitant treatment with corticosteroids or ACTH. Irbesartan may lead to hyperkalemia, especially in the presence of renal failure and / or CHF or diabetes mellitus.

During treatment, periodic monitoring of the K+ concentration in the blood serum 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 minor hypercalcemia, provided that there are no violations of Ca2+metabolism. Hypercalcemia may be a sign of latent hyperparathyroidism; in this case, the drug should be discontinued until the parathyroid gland function is evaluated.

Hydrochlorothiazide can cause a positive doping test result. In patients whose vascular tone and renal function depend 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 pronounced decrease in blood pressure, azotemia, oliguria or, in rare cases, acute renal failure.

Excessive lowering of blood pressure in CHD or other CVD diseases can lead to myocardial infarction or stroke. The development of allergic reactions to hydrochlorothiazide is more likely in patients with a history of such reactions. When using thiazide diuretics, an exacerbation of SLE was noted. It should be taken into account that in rare cases, dizziness and increased fatigue may occur during treatment, so caution should be exercised when engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reaction (including when driving a car).

Form of production

Pills.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Hydrochlorothiazide, Irbesartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets