Description
Release form
Tablets.
Packing
20 pcs.
Pharmacological action of
RENIPRIL GT – antihypertensive drug, ACE inhibitor. The mechanism of action of enalapril is associated with inhibition of ACE activity, which reduces the formation of angiotensin II, which contributes to the narrowing of blood vessels, and simultaneously activates the formation of kinins and prostacyclin, which have a vasodilating effect. Enalapril refers to prodrugs, after its hydrolysis in the body enalaprilat is formed, which inhibits the specified enzyme. Enalapril also has some diuretic effect associated with moderate inhibition of aldosterone synthesis. Along with a decrease in blood pressure, the drug reduces pre- and afterload on the myocardium in heart failure, improves pulmonary circulation and respiratory function, reduces resistance in the vessels of the kidneys, which helps normalize blood circulation in them.
Indications
– various forms of arterial hypertension (including renovascular)
– chronic heart failure (as part of combination therapy).
Contraindications
– angioedema associated with the use of ACE inhibitors (history)
– progressive azotemia with bilateral renal artery stenosis or stenosis of a single kidney artery
– childhood srrdlkp – pregnancy enalapril and other components of the drug
– hypersensitivity to other ACE inhibitors.
Special instructions
A pronounced decrease in blood pressure with all the clinical consequences can be observed after the first use of Renipril® GT tablets in patients with severe heart failure and hyponatremia, severe renal failure, left ventricular dysfunction, and especially in patients in a state of hypovolemia as a result of diuretic therapy, a salt-free diet, diarrhea, vomiting, or hemodialysis. Arterial hypotension after taking the first dose and its more serious consequences is a rare and passing phenomenon. It can be avoided by the abolition of diuretics, if possible, before starting treatment with Renipril® GT.
In case of arterial hypotension, it is necessary to lay the patient on his back with a low headboard and, if necessary, adjust the plasma volume by infusion of saline. Transient arterial hypotension is not a contraindication for continued treatment. After normalizing blood pressure and replenishing the volume of circulating blood, patients usually tolerate subsequent doses well.
Caution is necessary when used in patients with impaired renal function (creatinine clearance from 0.5 to 1, 3 ml / s). Patients taking hydrochlorothiazide may develop azotemia. Patients with impaired renal function may show signs of drug accumulation. If necessary, a combination of enalapril with a lower amount of hydrochlorothiazide may be used, or combination therapy with enalapril and hydrochlorothiazide should be discontinued.
Regular monitoring of serum electrolyte concentrations during treatment is necessary to identify possible imbalances. Determination of serum concentration of electrolytes is mandatory for patients with prolonged diarrhea, vomiting and receiving intravenous infusions.
In patients taking Renipril® GT, it is necessary to detect signs of electrolyte imbalance, such as dry mouth, thirst, weakness, drowsiness, lethargy, agitation, muscle pain and cramps (mainly calf muscles), decreased blood pressure, tachycardia, oliguria and gastrointestinal disturbances (nausea, vomiting).
During treatment with Renipril® GT, hypomagnesemia and sometimes hypercalcemia may occur, resulting from increased excretion of magnesium and slowed excretion of calcium in the urine under the influence of hydrochlorothiazide. A significant increase in serum calcium levels may be a sign of latent hyperparathyroidism. In some patients, hyperuricemia or worsening of gout may result from hydrochlorothiazide. If there is an increase in the concentration of uric acid in the blood serum, treatment should be discontinued. It can be resumed after normalization of laboratory parameters and in the future, carried out under their control. Caution is needed in all patients receiving treatment with oral hypoglycemic agents or insulin, since hydrochlorothiazide can weaken, and enalapril enhance their effect. Patients with diabetes should be observed more often, and if necessary, some change in the dose of hypoglycemic agents may be required. If angioedema of the face or neck occurs, treatment cancellation and the appointment of antihistamines are usually sufficient. In more severe cases (swelling of the tongue, pharynx and larynx), angioedema is treated with adrenaline, it is necessary to maintain airway patency (intubation or laryngotomy). The antihypertensive effect of Renipril® GT may be enhanced after sympathectomy. Due to the increased risk of anaphylactic reactions, Renipril® GT should not be prescribed to patients hemodialysis using polyacrylonitrile membranes undergoing apheresis with dextransulfate and immediately before the procedure for desensitization to aspen or bee venom.
During treatment with Renipril® GT, hypersensitivity reactions may occur in patients without prior allergies or bronchial asthma. A deterioration in the course of systemic lupus erythematosus has been reported.
In case of jaundice and increased activity of liver enzymes, treatment should be stopped immediately, patients should be monitored.
Caution is also needed in patients taking sulfonamides or oral hypoglycemic agents from the sulfonylurea group (cross-sensitivity is possible).
During treatment, periodic white blood cell counts are required, especially in patients with connective tissue or kidney disease.
During treatment, periodic monitoring of serum concentrations of electrolytes, glucose, urea, creatinine and the activity of liver enzymes, as well as urine protein, is necessary. Treatment with Renipril® GT should be discontinued before conducting parathyroid function tests.
Influence on the ability to drive a car and machinery. In some patients, mainly at the beginning of treatment, arterial hypotension and dizziness may occur, which may reduce the ability to drive a car and work with mechanisms. At the beginning of treatment, it is recommended to avoid work that requires attention until a response to treatment is established.
Composition
Composition per tablet:
Active ingredients:
enalapril maleate – 10 mg,
hydrochlorothiazide – 12.5 mg.
Excipients:
potato starch – 59.3 mg, lactose monohydrate (milk sugar) – 111.5 mg, povidone (low molecular weight polyvinylpyrrolidone medical) – 4 mg, colloidal silicon dioxide (aerosil) – 0.7 mg, calcium stearate ( calcium stearic acid) – 2 mg.
Dosage and Administration
Renipril is administered orally regardless of food intake.
In the treatment of essential arterial hypertension, the initial dose of Renipril is 10-20 mg / day. In the future, the dose is selected individually.
With moderate arterial hypertension, a dose of 10 mg / day is sufficient. The maximum daily dose is 80 mg.
For renovascular hypertension, renipril is prescribed in lower doses. The initial dose is usually 5 mg / day, then the dose is selected individually. The maximum dose is 20 mg / day.
In heart failure, Renipril is prescribed starting with 2.5 mg, then the dose is gradually increased to 10-20 mg (1-2 times / day).
The duration of treatment depends on the effectiveness of the therapy.
In all cases, with a too pronounced decrease in blood pressure, the dose of the drug is gradually reduced.
The drug is used both for monotherapy and in combination with other antihypertensive drugs.
In patients with impaired renal function, a single dose should be reduced or the intervals between doses should be increased.
Side effects
General: weakness, hypersensitivity reactions, necrotizing angiitis, respiratory distress syndrome, including pneumonitis and pulmonary edema.
From the cardiovascular system: palpitations, fainting, chest pain, various cardiac arrhythmias, marked decrease in blood pressure, orthostatic hypotension.
From the digestive tract: dry mouth, glossitis, stomatitis, inflammation of the salivary glands, anorexia, nausea, vomiting, diarrhea, constipation, flatulence, epigastric pain, intestinal colic, ileus, pancreatitis, liver failure, hepatitis, jaundice.
From the respiratory system: unproductive “dry” cough, rhinitis, sinusitis, pharyngitis, hoarseness, bronchospasm, eosinophilic pneumonia.
From the genitourinary system: oliguria, gynecomastia, decreased potency, decreased libido, renal failure, impaired renal function, interstitial nephritis.
Allergic reactions: angioedema (face, tongue, lips, vocal cords, larynx, limbs, intestines), sweating, exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.
From the skin: skin rash, itching, alopecia.
On the part of the sensory organs: impaired vision, impaired taste, impaired smell, tinnitus, conjunctivitis.
From the central nervous system: dizziness, headache, fatigue, depression, ataxia, asthenia, drowsiness, insomnia, anxiety, nervousness, peripheral neuropathy (paresthesia, dysesthesia).
Laboratory indicators: hypomagnesemia, hypercalcemia, hyponatremia, hypochloremic alkalosis, hyperglycemia, hypercreatininemia, hyper- or hypokalemia, glucosuria, hyperuricemia, hypercholesterolemia, hypertriglyceridemia, increased activity of “liver” enzymes, hyperbilirubinemia, leukocytosis, eosinophilia, neutropenia, leukopenia, agranulocytosis, anemia, pancytopenia, decreased hemoglobin and hematocrit.
Other: lupus-like syndrome (fever, myalgia / myositis and arthralgia / arthritis, serositis, vasculitis, increased erythrocyte sedimentation rate, positive test for antinuclear antibodies), photosensitivity, muscle cramps.
Drug interaction
With the simultaneous administration of Renipril and NSAIDs, it is possible to decrease the effectiveness of Renipril with potassium-sparing diuretics (spironolactone, triamterene, amiloride) – it is possible to develop hyperkalemia with lithium salts – a decrease in blood concentration of lithium is indicated (it is indicated that blood concentration in lithium is reduced).
When used concomitantly with antipyretic analgesics, a decrease in the effectiveness of renipril is possible.
Renipril weakens the effects of theophylline-containing drugs.
Cimetidine prolongs the action of renipril.
The simultaneous use of renipril with diuretics, beta-blockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin enhances the hypotensive effect.
Ethanol enhances the antihypertensive effect of the drug.
Overdose of
Symptoms: arterial hypotension.
Treatment: place the patient in a position with raised legs. In mild cases, prescribe a saline solution inside. In more severe cases, in a hospital environment, measures are taken to stabilize blood pressure: intravenous administration of saline or plasma substitutes. Perhaps the use of hemodialysis.
The Expiration of
is 3 years.
Deystvuyuschee substances
Hydrohlorotyazyd, enalapril
pharmacy terms for
pharmacy s14lf45 prescription p14ff60 p14ff60 p14ff14f1414f14f1414pff1414ff60
Prescription
The dosage form of
tablet
Pharmstandard-Leksredstva, Russia
