Renipril GT
Renipril GT: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Renipril HT
ATX code: C09BA02
Active ingredient: enalapril (enalapril), hydrochlorothiazide (hydrochlorothiazide)
Manufacturer: Pharmstandard, JSC (Russia)
Description and photo update: 2018-27-07
Prices in pharmacies: from 55 rubles.
Buy
Renipril GT is a combined antihypertensive drug: an angiotensin-converting enzyme (ACE) inhibitor and a diuretic.
Release form and composition
The drug is available in the form of tablets: flat-cylindrical, with a chamfer and dividing line, white with a cream shade or white, marbling of the surface is allowed (10 or 20 pcs. In blisters, in a cardboard box 1, 2 or 3 packages and instructions for use Renipril GT).
1 tablet contains:
- active ingredients: enalapril maleate - 10 mg, hydrochlorothiazide - 12.5 mg;
- auxiliary components: lactose monohydrate, potato starch, povidone (low molecular weight medical polyvinylpyrrolidone), aerosil (colloidal silicon dioxide), calcium stearate (calcium stearic acid).
Pharmacological properties
Pharmacodynamics
Renipril GT is a combined antihypertensive drug. The mechanism of action is due to the properties of its active ingredients: enalapril and hydrochlorothiazide.
Enalapril is a prodrug; as a result of its hydrolysis, enalaprilat, an ACE inhibitor, is formed. Hydrochlorothiazide is a thiazide diuretic that increases the excretion of sodium and chlorine ions by acting at the level of the distal renal tubules. For treatment with hydrochlorothiazide, it is characteristic that in its initial period, a decrease in blood pressure (BP) and a decrease in cardiac output occur due to a decrease in the volume of fluid in the vessels caused by an increase in the amount of excreted fluid and sodium. Further, its antihypertensive effect is due to a decrease in the total peripheral vascular resistance. The inhibitory effect of enalapril on the renin-angiotensin-aldosterone system causes a decrease in the production of angiotensin II and its effects and enhances the hypotensive effect of hydrochlorothiazide. Besides,enalapril enhances the release of prostaglandins and the action of bradykinin, reduces the production of aldosterone, has its own diuretic effect. It contributes to the regression of hypertrophy as a result of a decrease in pre- and afterload and unloading of the left ventricle. This provides a slowdown in the heart rate, in chronic heart failure - a decrease in the load on the heart, an improvement in coronary blood flow, a decrease in oxygen consumption by cardiomyocytes, a decrease in the sensitivity of the heart to ischemia. Enalapril has a beneficial effect on blood circulation in the vessels of the brain and spinal cord with arterial hypertension and chronic cardiovascular pathologies. Prevents the development of glomerulosclerosis, supports renal function, helps to slow down the course of chronic kidney disease, even in the absence of arterial hypertension.
The antihypertensive effect of ACE inhibitors increases with hyponatremia, hypovolemia, elevated serum renin levels. The activity of hydrochlorothiazide does not depend on the level of renin in the blood serum. Their combination provides an additional antihypertensive effect. The presence of enalapril prevents or weakens the metabolic effects of diuretic therapy, has a beneficial effect on structural changes in the heart and blood vessels.
The appointment of Renipril HT is advisable in cases where the use of each of the active substances separately does not provide a sufficient therapeutic effect or maximum doses of drugs are used for monotherapy, increasing the risk of undesirable effects.
The antihypertensive effect of Renipril HT usually lasts for 24 hours.
Pharmacokinetics
After taking Renipril HT inside, enalapril is rapidly absorbed in the gastrointestinal tract in a volume of 60%. Simultaneous food intake does not affect its absorption. The maximum concentration (C max) in the blood plasma of enalapril is reached after 1 hour, its active metabolite - after 3–6 hours.
Enalapril metabolism occurs in the liver with the formation of enalaprilat, which has therapeutic activity and penetrates into most body tissues. It is found in large quantities in the kidneys, lungs and blood vessels.
The binding of enalaprilat to blood plasma proteins is 50-60%.
Enalapril and enalaprilat cross the placental barrier and are excreted in breast milk.
Renal clearance of enalapril - 0.005 ml / s, enalaprilat - from 0.002 25 to 0.002 64 ml / s.
The half-life (T 1/2) of enalaprilat from serum is approximately 11 hours.
Enalapril is excreted in several stages, mainly in the form of an active metabolite, through the kidneys - 60%, through the intestines - 33%.
With heart failure, the absorption and metabolism of enalapril slows down, and the volume of distribution decreases.
In case of impaired renal function, the elimination of the ACE inhibitor slows down, especially in severe renal failure, therefore, a dose adjustment of Renipril HT is required.
Slowing down the metabolism of enalapril in liver failure does not affect the pharmacodynamic effect of the drug.
Enalaprilat is removed from the bloodstream during hemodialysis or peritoneal dialysis, after a session lasting 4 hours, the serum concentration of enalaprilat decreases by 45-57%. The hemodialysis clearance of enalaprilat is 0.63–1.03 ml / s.
Absorption of hydrochlorothiazide occurs mainly in the proximal small intestine and duodenum. Absorption is 70%, when taking Renipril HT with food, it increases by 10%. C max in serum is reached after 1.5-5 hours. The volume of distribution is 3 l / kg.
Plasma protein binding is 40%, accumulates in erythrocytes.
It overcomes the placental barrier, accumulates in the amniotic fluid. The concentration level of hydrochlorothiazide in the serum of the umbilical vein and maternal blood is almost identical, and in the amniotic fluid it is 19 times higher. Hydrochlorothiazide passes into breast milk in small quantities.
It is not metabolized in the liver.
Has a biphasic hatching profile. The initial phase T 1/2 is 2 hours, the final phase is about 10 hours. It is excreted through the kidneys: unchanged - 95%, in the form of hydrolyzate-2-amino-4-chloro-t-benzenedisulfonamide - about 4%. Renal clearance is approximately 5.58 ml / s.
It was found that the absorption of hydrochlorothiazide in heart failure decreases by 20–70%, in proportion to the severity of the disease. T 1/2 increases to 28.9 hours. Renal clearance averages 1.28 ml / s.
It should be borne in mind that the absorption of hydrochlorothiazide and its serum concentration after intestinal bypass surgery for obesity can be reduced by 30% and 50%, respectively, compared with healthy volunteers.
Enalapril and hydrochlorothiazide do not affect each other's pharmacokinetics.
Indications for use
The use of Renipril HT is indicated for the treatment of hypertension in patients who need to use combination therapy, including an ACE inhibitor and a diuretic.
Contraindications
- severe renal dysfunction [creatinine clearance (CC) less than 30 ml / min];
- anuria;
- bilateral stenosis of the renal arteries, stenosis of the arteries of a single kidney;
- idiopathic or hereditary angioedema;
- an indication of a history of angioedema with the use of ACE inhibitors;
- primary hyperaldosteronism;
- porphyria;
- Addison's disease;
- period of pregnancy;
- breast-feeding;
- age up to 18 years;
- established individual intolerance to sulfonamides;
- hypersensitivity to the components of the drug.
With caution, Renipril HT tablets should be prescribed in case of impaired renal function (CC 30-75 ml / min), chronic heart failure, idiopathic hypertrophic subaortic stenosis, severe stenosis of the aortic orifice, ischemic heart disease, cerebrovascular pathologies (including cerebrovascular insufficiency), severe autoimmune systemic diseases of the connective tissue (including systemic lupus erythematosus, scleroderma), inhibition of bone marrow hematopoiesis, diabetes mellitus, hyperkalemia, severe liver dysfunction, gout, a decrease in the volume of circulating blood (arising on the background of diuretic therapy, limiting the consumption of table salt, diarrhea, vomiting), patients in old age, in the period after kidney transplantation.
Renipril GT, instructions for use: method and dosage
Renipril HT tablets are taken orally, swallowed whole and washed down with a sufficient amount of liquid, during or after a meal.
The appointment of an individual dose of Renipril HT is carried out after preliminary administration of enalapril and hydrochlorothiazide separately, during which an adequate dose of each of the active substances is determined for the patient.
Recommended dosage: 1 pc. Once a day, preferably in the morning. If you accidentally skip taking the next dose, it should be taken as soon as you remember, during the day. Do not take the missed dose a few hours before the next dose to prevent it from doubling.
Patients on diuretic therapy should stop taking or reduce the dose of diuretics 3 days before starting treatment with Renipril HT.
In the absence of the desired therapeutic effect, a doctor should be consulted to include an additional drug in the treatment or change the therapy.
In case of impaired renal function with CC more than 30 ml / min or serum creatinine up to 265 mol / l, the usual dosing regimen is not changed.
Side effects
- from the cardiovascular system: chest pain, heart rhythm disturbances, palpitations, a significant decrease in blood pressure, fainting, orthostatic hypotension;
- from the digestive system: dry mouth, nausea, vomiting, flatulence, epigastric pain, diarrhea, constipation, inflammation of the salivary glands, glossitis, stomatitis, intestinal colic, anorexia, ileus, pancreatitis, hepatitis, liver failure, jaundice;
- from the respiratory system: rhinitis, sinusitis, dry cough, hoarseness, bronchospasm, pharyngitis, eosinophilic pneumonia;
- from the genitourinary system: impaired renal function, renal failure, interstitial nephritis, oliguria, gynecomastia, decreased potency, decreased libido;
- from the immune system: sweating, angioedema (including the face, lips, tongue, vocal cords, larynx, intestines, limbs), erythema multiforme, exfoliative dermatitis, Stephen-Johnson syndrome, toxic epidermal necrolysis;
- from the senses: impaired sense of smell, visual impairment, conjunctivitis, tinnitus, taste disturbance;
- from the side of the central nervous system: increased fatigue, headache, dizziness, drowsiness, insomnia, ataxia, asthenia, anxiety, nervousness, peripheral neuropathy (paresthesia, dysesthesia), depression;
- dermatological reactions: itching, skin rash, alopecia;
- laboratory parameters: hyponatremia, hypomagnesemia, hypercalcemia, hyperuricemia, hypercholesterolemia, hypochloremic alkalosis, hypercreatininemia, hyperglycemia, hypertriglyceridemia, glucosuria, hyper- or hypokalemia, hyperbilirubinemia, increased hepatic enzyme levels, leukemia, leukemia decrease agranulocytosis, pancytopenia, anemia;
- general: hypersensitivity reactions, weakness, necrotizing angiitis, respiratory distress syndrome, including pulmonary edema, pneumonitis;
- others: photosensitization, lupus-like syndrome (fever, vasculitis, myalgia, myositis, arthralgia, arthritis, increased erythrocyte sedimentation rate, serositis, positive test for antinuclear antibodies), muscle cramps.
Overdose
Symptoms: a pronounced decrease in blood pressure, accompanied by an abnormal heart rhythm (including bradycardia), increased diuresis, convulsions and paresis, impaired consciousness (including coma), paralytic ileus, renal failure, a clinically significant change in the electrolyte balance of the blood, an acid-base balance disorder.
Treatment: the patient needs to ensure a horizontal position using a low headboard. Shows immediate gastric lavage, ingestion of saline. To stabilize a pronounced decrease in blood pressure, intravenous (i / v) administration of saline, plasma substitutes is used. Requires monitoring of blood pressure, respiratory rate, heart rate (HR), urine output, serum urea, creatinine and electrolytes. If necessary, intravenous administration of angiotensin II, hemodialysis is prescribed.
special instructions
The appointment of Renipril HT should be made taking into account the results of the study of renal function.
Treatment requires regular monitoring of serum concentrations of electrolytes, glucose, urea, creatinine, urine protein, liver enzyme activity, and leukocyte count, especially in the presence of connective tissue or kidney disease.
With an increase in the activity of liver enzymes or the appearance of symptoms of jaundice, treatment is stopped immediately.
Against the background of the first intake of Renipril HT, in rare cases, a pronounced decrease in blood pressure is observed, which may be accompanied by clinical consequences, in patients with severe heart failure, left ventricular dysfunction, hyponatremia, and severe renal failure. Patients with diuretic hypovolemia, diarrhea, vomiting, a salt-free diet, or hemodialysis are particularly at risk. To reduce the risk of developing transient arterial hypotension when taking the first dose, it is recommended, if possible, to stop taking diuretics a few days before starting treatment with Renipril HT.
With the development of arterial hypotension, the patient must be laid on his back with a low headboard. If necessary, it is recommended to use an infusion of saline to correct the plasma volume. Transient arterial hypotension is not a reason for discontinuation of treatment, after the restoration of blood pressure and volume of circulating blood, patients usually tolerate subsequent doses well.
In case of impaired renal function, taking hydrochlorothiazide may cause the development of azotemia or the accumulation of the drug. Therefore, it may be necessary to use a combination of enalapril with a lower content of hydrochlorothiazide or to discontinue combination therapy with enalapril and hydrochlorothiazide.
With prolonged diarrhea, vomiting, intravenous infusion, it is necessary to ensure regular monitoring of the serum electrolyte concentration. Patients should be informed that signs of electrolyte imbalance include the appearance of a feeling of thirst, dry mouth, drowsiness, weakness, lethargy, agitation, pain and cramps in the calf muscles, lowering blood pressure, tachycardia, oliguria and gastrointestinal disorders in the form of nausea and vomiting.
The presence of hydrochlorothiazide in Renipril HT can cause an increase in magnesium excretion and a slowdown in the excretion of calcium in the urine and related undesirable effects in the form of hypomagnesemia and hypercalcemia (including latent hyperparathyroidism). In addition, in some cases, the effect of hydrochlorothiazide may result in hyperuricemia or worsening of the course of gout. Therefore, when the level of uric acid concentration in the blood serum rises, you should stop taking the tablets until the laboratory parameters return to normal.
It should be borne in mind that hydrochlorothiazide can reduce, and enalapril can increase the effect of oral hypoglycemic agents and insulin. In this regard, patients with diabetes mellitus need more frequent monitoring in order to timely change the dose of hypoglycemic agents. Sulfonamides and oral hypoglycemic agents from the sulfonylurea group can cause cross-hypersensitivity reactions.
To prevent and reduce the risk of anaphylactic reactions, it is not recommended to use Renipril HT for the treatment of patients undergoing hemodialysis sessions using polyacrylonitrile membranes, undergoing apheresis with dextran sulfate. Do not take the drug before the direct procedure for desensitization to bee or wasp poison. While taking the pills, the course of systemic lupus erythematosus may worsen, the development of hypersensitivity reactions, including in the absence of a previous bronchial asthma or allergy in the patient.
Before examining the function of the parathyroid glands, it is required to stop taking Renipril HT.
Strengthening the antihypertensive effect of Renipril HT can be caused by sympathectomy.
Influence on the ability to drive vehicles and complex mechanisms
Due to the possibility of arterial hypotension and dizziness at the beginning of treatment, it is recommended to refuse to perform work that requires concentration of attention, including driving vehicles and complex mechanisms, until an adequate response to treatment is established.
Application during pregnancy and lactation
The use of Renipril HT is contraindicated during gestation and lactation.
In case of conception during the treatment period, the drug should be discontinued immediately.
If necessary, the appointment of Renipril HT during breastfeeding, breastfeeding should be discontinued.
Pediatric use
Due to the lack of information about the efficacy and safety of Renipril HT for the treatment of patients under the age of 18, its use in this category of patients is contraindicated.
With impaired renal function
The appointment of Renipril HT is contraindicated for the treatment of patients with severe renal impairment (CC less than 30 ml / min), anuria, bilateral renal artery stenosis or stenosis of the arteries of a single kidney.
Renipril HT can be used with caution in the period after kidney transplantation and in case of impaired renal function (CC 30–75 ml / min) using the usual dosing regimen.
For violations of liver function
Pills should be taken with caution in severe liver dysfunction.
Use in the elderly
It is recommended to prescribe Renipril HT with caution to elderly patients.
Drug interactions
With the simultaneous use of other drugs, the development of interaction reactions is possible:
- other antihypertensive drugs, barbiturates, tricyclic antidepressants, phenothiazines, narcotic drugs, ethanol: enhance the antihypertensive effect of Renipril HT;
- non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, diet high in salt, cholestyramine, colestipol: cause a decrease in the therapeutic efficacy of Renipril HT;
- lithium preparations: the risk of lithium intoxication increases, since enalapril and hydrochlorothiazide slow down the excretion of lithium. It is recommended to avoid combination with lithium preparations; if necessary, joint administration requires monitoring the level of lithium concentration in the blood serum and correcting its dosage;
- NSAIDs, analgesics: increase the risk of deteriorating renal function and / or the course of heart failure;
- potassium-sparing diuretics (triamterene, spironolactone, amiloride): promote the development of hyperkalemia;
- allopurinol, cytostatics, immunosuppressants, systemic corticosteroids: increase the likelihood of developing leukopenia, anemia, pancytopenia, if necessary, combined therapy requires periodic monitoring of the hemogram;
- cardiac glycosides: should be used with caution, the presence of hydrochlorothiazide in Renipril HT increases the risk of hypovolemia, hypokalemia, hypomagnesemia and glycoside toxicity;
- corticosteroids: increase the likelihood of developing hypokalemia;
- theophylline: there is a decrease in the half-life of theophylline due to enalapril;
- cimetidine: may increase the half-life of enalapril;
- general anesthetic drugs, non-depolarizing muscle relaxants (including tubocurarine): increase the risk of arterial hypotension.
Analogs
The analogues of Renipril GT are: Berlipril plus, Enap-NL, Enalapril NL, Enam N, Ko-Renitek, Enalapril-Acri NL, Enafarm-N.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Renipril GT
The few reviews about Renipril GT are positive. Patients point to the effectiveness of the combined agent in the treatment of hypertension for many years. In some patients, at the beginning of therapy, the drug caused dizziness and nausea, but after dose adjustment, the undesirable effects stopped.
Price for Renipril GT in pharmacies
The price of Renipril GT for a pack containing 20 tablets can range from 95 rubles.
Renipril GT: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Renipril GT 12.5 mg + 10 mg tablets 20 pcs. RUB 55 Buy |
|
Renipril GT tablets 10mg + 12.5mg 20 pcs. 84 rbl. Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
