CoAprovel® [Hydrochlorothiazide, Irbesartan]
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Coaprovel has a hypotensive effect.
1 tablet contains irbesartan 300 mg, hydrochlorothiazide 12.5 mg, excipients: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hydrated colloidal silicon dioxide, pregelatinized corn starch, red iron oxide, yellow iron oxide.
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Dosage and Administration
Co-aprovel can be applied 1 time / day. before or during meals in patients whose blood pressure is not sufficiently controlled by irbesartan or hydrochlorothiazide separately.
Coaprovel 300 / 12.5 mg is prescribed to patients whose blood pressure is not sufficiently controlled by irbesartan (300 mg) or Coaprovel (150 / 12.5 mg).
Use of the drug in doses of more than 300 mg of irbesartan / 25 mg of hydrochlorothiazide 1 time / day. not recommended.
On the part of the hematopoietic system: aplastic anemia, bone marrow depression, hemolytic anemia, leukopenia, neutropenia / agranulocytosis, thrombocytopenia.
On the part of the central nervous system and peripheral nervous system: depression, sleep disturbances, dizziness, paresthesias, anxiety.
On the part of the organ of vision: transient blurred vision, xantopsia.
Since the cardiovascular system: arrhythmias, postural hypotension.
On the part of the respiratory system: respiratory distress syndrome (including pneumonitis and pulmonary edema).
On the part of the digestive system: jaundice (intrahepatic cholestatic jaundice).
Allergic reactions: anaphylactic reactions, toxic necrosis of the epidermis, skin reactions such as lupus erythematosus, necrotized angiitis (vasculitis, skin vasculitis), photosensitivity reactions, rash, exacerbation of skin manifestations of lupus erythematosus, urticaria.
From the musculoskeletal system: muscle spasms, weakness.
On the part of the urinary system: interstitial nephritis, renal dysfunction.
On the part of laboratory parameters: electrolyte imbalance (including hypokalemia and hyponatremia), glycosuria, hyperglycemia, hyperuricemia, increased cholesterol and TG.
- II and III trimesters of pregnancy;
- hypersensitivity to the components of Coaprovel;
- Hypersensitivity to other drugs derived sulfonamida.
To use hydrochlorothiazide:
- renal failure severe (CC <30 ml="" min="" p="">
- refractory hypokalemia, hypercalcemia;
- severe form of liver failure;
- biliary cirrhosis;
Other antihypertensive drugs: the antihypertensive effect of COAPROL can be enhanced by using other antihypertensive drugs. Irbesartan and hydrochlorothiazide (at doses: 300 mg of irbesartan / 25 hydrochlorothiazide) should be used with caution along with other antihypertensive drugs, including calcium channel blockers and beta-blockers. High-dose pre-treatment with diuretics can lead to hypovolemia and risk of arterial hypotension (see the section on “Special Warnings and Precautions for Use”).
Lithium: reversible increases in serum lithium concentrations and toxic effects were observed with the concomitant use of lithium with angiotensin-converting enzyme inhibitors (ARP). With regard to irbesartan, similar effects have been extremely rare to date. In addition, 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 co-suspension is not recommended. If a combination is necessary, careful monitoring of serum lithium levels is recommended.
Drugs affecting blood potassium: the hypokalemic effect of hydrochlorothiazide is weakened by the potassium-saving 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).Conversely, based on the experience of using other drugs that reduce the activity of the renin-angiotensin system, the concomitant use of potassium-saving diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that can increase serum potassium levels (for example, heparin sodium salt), may lead to an increase in the amount of potassium in the blood serum. Patients at risk are recommended to adequately control serum potassium levels.
Drugs affected by serum imbalance: Periodic monitoring of serum potassium levels is recommended when co-administered with drugs and drugs that are affected by serum imbalance (eg, digitalis glycosides, antiarrhythmic drugs) are recommended.
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 hypotensive effect may occur.
As in the case of ACE inhibitors, the combined use of angiotensin II antagonists and NSAIDs can increase the risk of renal dysfunction, including the likelihood of acute renal failure, and lead to an increase in serum potassium, especially in patients with impaired renal function. At introduction of this combination it is necessary to observe precautionary measures, especially for elderly patients. Patients should not be dehydrated. Monitoring of the kidney function should be carried out after the initiation of combination therapy and periodically thereafter.
Additional information on the interactions of irbesartan: The pharmacokinetics of irbesartan are not affected when combined with hydrochlorothiazide. Irbesartan is mainly metabolized by CYP2C9 and, to a lesser extent, by glucuronidation. Not significant
pharmacokinetic and pharmacodynamic interactions, when irbesartan was used in conjunction with warfarin, a drug that is metabolized by CYP2C9. Effects of CYP2C9 inducers, such as rifampicin, on
pharmacokinetics of irbesartan were not 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 occur;
Hypoglycemic drugs (oral agents and insulin): a dose adjustment of the hypoglycemic agent may be necessary (see section “Special warnings and precautions for use”);
Colestiramine and colestyrene resins: the absorption of hydrochlorothiazide is reduced in the presence of anion exchange resins;
Glucocorticosteroids, ACTH: a more pronounced violation of the electrolyte composition is possible, in particular, increased hypokalemia;
Digitalis glycosides: hypokalemia and hypomagnesemia caused by thiazide diuretics contribute to the development 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 (for example, norepinephrine): the effect of these agents may be weakened;
Non-depolarizing muscle relaxant: The effect of non-depolarizing muscle relaxants can be enhanced by hydrochlorothiazide;
Anti-gouty agents: Correction of anti-gouting dosages may be necessary, since hydrochlorothiazide may increase serum uric acid levels. It may be necessary to increase the dosage of probenecid or sulfinpyrazone. Combined use with thiazide diuretics may increase the frequency of allergic reactions to allopurinol;
Calcium salts: Thiazide diuretics may increase serum calcium levels due to decreased clearance. If calcium supplements or drugs affecting calcium levels are to be prescribed (for example, with vitamin D therapy), then serum calcium levels should be monitored and the dosage of calcium should be adjusted accordingly.
Other interactions: the hyperglycemic effect of beta-blockers and diazoxide can be enhanced by thiazides. Anticholinergics (for example, 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 decrease the excretion of cytotoxic drugs with urine (for example, cyclophosphamide, methotrexate) and increase their myelosuppressive effects.
The risk of developing a pronounced 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, therefore, these conditions must be corrected before starting therapy with the drug. In patients with chronic renal failure in the treatment of 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. Therapy with thiazide diuretics can cause minifestation of latent diabetes mellitus, as well as reduce glucose tolerance. In patients with diabetes mellitus, dosage 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 virtually no effect on the concentration of cholesterol and triglycerides. In therapy with thiazide diuretics, hyperuricemia or exacerbation of gout may occur. Hydrochlorothiazide treatment can lead to disruption of water and electrolyte balance (hypokalemia, hyponatremia and hypochloraemic alkalosis). The simultaneous use of irbesartan may reduce the hypokalemia caused by diuretic. The risk of hypokalemia increases with the concomitant treatment of GCS or ACTH. Irbesartan can lead to hyperkalemia, especially in the presence of renal failure and / or CHF or diabetes mellitus. During treatment, periodic monitoring of serum K + concentrations 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 calcium excretion by the kidneys and cause minor hypercalcemia, provided that there are no metabolic disorders of Ca2 +. Hypercalcemia can be a sign of latent hyperparathyroidism; in this case, the drug should be discontinued prior to the study of the function of the parathyroid glands. Hydrochlorothiazide may cause a positive doping test. 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), angiotensin II receptor antagonist therapy can cause a pronounced decrease in blood pressure , azotemia, oliguria or, in rare cases, acute renal failure. An excessive decrease in blood pressure in CHD or others.cardiovascular diseases can lead to myocardial infarction or stroke. The development of allergic reactions to hydrochlorothiazide is more likely in patients with similar reactions in history. When using thiazide diuretics, exacerbation of SLE was noted. It is necessary to take into account that in rare cases during the period of treatment dizziness and increased fatigue may occur, so care should be taken when practicing potentially hazardous activities that require increased concentration and psychomotor speed (including when driving).
There is no specific information about the overdose of Coaprovel.
- Symptoms: in case of overdose of irbesartan, arterial hypotension, tachycardia, bradycardia are most likely; with hydrochlorothiazide overdose, hypokalemia, hyponatremia, dehydration due to excessive diuresis. The most common signs and symptoms of overdose are nausea and drowsiness. Hypokalemia can lead to convulsions and / or increased arrhythmias in the case of concomitant use of digitalis glycosides and antiarrhythmic agents.
- Treatment: recommended measures depending on the time elapsed from the moment of taking the drug, and on the severity of symptoms - provoking vomiting and / or gastric lavage, the use of activated charcoal, careful monitoring of the patient’s condition, symptomatic and supportive therapy. Should be carried out frequent monitoring of electrolytes and creatinine in the serum. In case of arterial hypotension, the patient should be laid on his back with raised lower limbs and as soon as possible to replace the salts and fluids. Irbesartan is not displayed during hemodialysis. The degree of elimination of hydrochlorothiazide with hemodialysis has not been established.
- Brand name: Coaprovel
- Active ingredient: Hydrochlorothiazide, Irbesartan
- Dosage form: Pills.
- Manufacturer: Sanofi-aventis
- Country of Origin: France
Studies and clinical trials of Hydrochlorothiazide, Irbesartan (Click to expand)
- Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma using HPLC coupled with tandem mass spectrometry: Application to bioequivalence studies
- Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma by liquid chromatography
- The effects of irbesartan added to hydrochlorothiazide for the treatment of hypertension in patients non-responsive to hydrochlorothiazide alone
- Economic evaluation of irbesartan in combination with hydrochlorothiazide in the treatment of hypertension in Greece
- HPLC–DAD Analysis of Hydrochlorothiazide and Irbesartan in Hypertensive Patients on Fixed-Dose Combination Therapy
- Lichenoid drug eruption due to an antihypertonic drug containing irbesartan and hydrochlorothiazide
- Maximising antihypertensive effects of angiotensin II receptor blockers with thiazide diuretic combination therapy: focus on irbesartan/hydrochlorothiazide
- The long-term antihypertensive activity and tolerability of irbesartan with hydrochlorothiazide
- Effect of delapril–manidipine combination vs irbesartan–hydrochlorothiazide combination on fibrinolytic function in hypertensive patients with type II diabetes mellitus
- Determination of hydrochlorothiazide and irbesartan in pharmaceuticals by fourth-order UV derivative spectrophotometry
- Efficacy and Safety of Fixed Combinations of Irbesartan/Hydrochlorothiazide in Older vs Younger Patients With Hypertension Uncontrolled With Monotherapy
- The Risks and Benefits of Initial Irbesartan/Hydrochlorothiazide Combination Therapy in Patients With Severe Hypertension
- The Efficacy and Safety of Low- and High- Dose Fixed Combinations of Irbesartan/Hydrochlorothiazide in Patients With Uncontrolled Systolic Blood Pressure on Monotherapy: The INCLUSIVE Trial
- Predictors of Blood Pressure Response to Angiotensin Receptor Blocker/Diuretic Combination Therapy: A Secondary Analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) Study
- The Efficacy and Safety of Initial Use of Irbesartan/Hydrochlorothiazide Fixed-Dose Combination in Hypertensive Patients With and Without High Cardiovascular Risk
- Initial Combination Therapy With Irbesartan/Hydrochlorothiazide for Hypertension: An Analysis of the Relationship Between Baseline Blood Pressure and the Need for Combination Therapy
- A comparative analysis of the efficacy of olmesartan medoxomil (O)/hydrochlorothiazide (HCTZ), valsartan (V)/HCTZ, irbesartan (I)/HCTZ and telmisartan (T)/HCTZ combinations
- Antihypertensive efficacy and tolerability of irbesartan/hydrochlorothiazide in hypertensive patients stratified by body mass index and type 2 diabetes mellitus status: A post hoc subgroup analysis of the Irbesartan/HCTZ Blood Pressure Reductions in Diverse Patient Populations trial
- Antihypertensive efficacy of the fixed combination of benazepril and hydrochlorothiazide: a comparison study with the fixed combination of irbesartan and hydrochlorothiazide
- Effects of nebivolol or irbesartan in combination with hydrochlorothiazide on vascular functions in newly-diagnosed hypertensive patients: The NINFE (Nebivololo, Irbesartan Nella Funzione Endoteliale) study
- Once-daily fixed-combination irbesartan 300 mg/ hydrochlorothiazide 25 mg and circadian blood pressure profile in patients with essential hypertension
- Antihypertensive efficacy of irbesartan 300 mg alone or in combination with hydrochlorothiazide in essential hypertensives
- Effect of the fixed combination of irbesartan 300 mg/hydrochlorothiazide 25 mg on the circadian blood pressure profile in essential hypertension
- D5 Irbesartan in combination with hydrochlorothiazide in mild-to-moderate hypertension