Composition, form of production and packaging
Tablets are white or white with a creamy shade of color, with a risk.
1 tab.
enalapril maleate 10 mg
hydrochlorothiazide 12.5 mg
[PRING] starch, polyvinylpyrrolidone, aerosil, lactose, calcium stearate.
20 pcs. - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Combined antihypertensive drug. Due to the combination of enalapril maleate and hydrochlorothiazide, Renipril В® HT has a stronger antihypertensive effect than each component alone. Reduces potassium losses.
The duration of action of Renipril GT after a single oral intake is about 24 hours.
PHARMACOKINETICS
C max enalapril in blood plasma is achieved in 3-4 hours.
The intake of food does not affect the absorption of Renipril GT.
INDICATIONS
- arterial hypertension (if necessary combined therapy).
DOSING MODE
The dose of the drug and the duration of treatment are set individually.
The initial dose of the drug is 1-2 tablets / day, regardless of food intake.
The dose should always be adjusted depending on the patient's individual response to treatment. The maximum daily dose is 4 tablets.
If the patient already receives diuretics, then it is recommended to cancel the treatment or to reduce the dose of the diuretic, at least 2-3 days before the start of Renipril therapy, to avoid a sharp drop in blood pressure.
SIDE EFFECT
From the side of the central nervous system and peripheral nervous system: dizziness, headache, fatigue are possible.
From the cardiovascular system: possible arterial hypotension, orthostatic hypotension.
On the part of the digestive system: nausea, increased activity of hepatic transaminases in the serum; rarely vomiting, diarrhea.
Allergic reactions: rarely - skin rash, angioedema.
From the urinary system: an increase in the content of urea, creatinine.
On the part of the respiratory system: a dry cough is possible.
From the hemopoietic system: rarely - anemia, thrombocytopenia, leukopenia, agranulocytosis.
Other: muscular cramps are possible.
Adverse reactions are usually poorly expressed and have a transient nature and, as a rule, do not require withdrawal of the drug.
CONTRAINDICATIONS
- pronounced violations of the liver function;
- conditions after kidney transplantation;
- severe renal dysfunction (KK less than 0.5 ml / sec or serum creatinine more than 265 Ојmol / l or more than 3 mg / dL);
- angioedema in history;
- porphyria;
- primary hyperaldosteronism;
- childhood;
- Pregnancy (especially II and III trimesters);
- lactation (breastfeeding);
- hypersensitivity to the components of the drug;
- hypersensitivity to sulfonamides.
PREGNANCY AND LACTATION
Renipril В® HT is contraindicated in pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated use of the drug in a state after kidney transplantation, expressed renal dysfunction (KK less than 0.5 ml / sec or serum creatinine more than 265 Ојmol / l or, respectively, more than 3 mg / dL).
Do not prescribe the drug to patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney.
Caution should be given to patients with impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated use of the drug in severe violations of the liver, porphyria.
APPLICATION FOR CHILDREN
Contraindication: children's age.
SPECIAL INSTRUCTIONS
Do not prescribe the drug to patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney.
Caution should be given to patients with impaired renal function.
Patients receiving allopurinol (or combinations with allopurinol), cytotoxic agents, immunosuppressants or corticosteroids for systemic use should monitor the peripheral blood picture regularly, since there is a risk of developing leukopenia, anemia, or pancytopenia.
It is necessary to prescribe with caution the preparation of Renipril В® GT to patients receiving oral hypoglycemic agents or insulin, as hydrochlorothiazide weakens the effect of hypoglycemic drugs, and enalapril may strengthen it, and a dose adjustment of hypoglycemic agents may be required.
In patients with severe heart failure and hyponatremia, expressed by renal insufficiency, hypertrophy or left ventricular dysfunction, and especially in patients with hypovolemia due to diuretics, salt-free diet, diarrhea, vomiting or hemodialysis, even after taking the first Renipril GT tablet, hypotension may develop .
Caution should be given to patients with severe aortic stenosis or with idiopathic subaortic muscular stenosis and generalized atherosclerosis.
During the treatment period, it is necessary to periodically monitor the concentration of electrolytes, urea, creatinine, the activity of hepatic transaminases in the blood serum, and the protein content in the urine.
Before the study of the function of parathyroid glands, treatment with the drug should be discontinued.
OVERDOSE
Symptoms: most often - increased diuresis, severe arterial hypotension with bradycardia or other cardiac arrhythmias, convulsions, paresis, clouding of consciousness, renal insufficiency, a decrease in the electrolytes in the blood serum, a violation of the acid-base balance.
Treatment: recommended gastric lavage, the reception of activated carbon and laxatives. It is necessary to monitor blood pressure, pulse, respiratory function, urea, creatinine and electrolytes in the blood serum, as well as diuresis. In the case of development of arterial hypotension, 0.9% solution of sodium chloride is administered. It is possible to use hemodialysis.
DRUG INTERACTION
With the simultaneous administration of other antihypertensive agents, tricyclic antidepressants, phenothiazines, and also ethanol, the antihypertensive effect of Renipril GT is enhanced.
Analgesics-antipyretics and NSAIDs, elevated salt content in food and simultaneous administration of colestyramine or colestipol weakens the action of Renipril GT.
The simultaneous use of Renipril В® GT and lithium preparations can cause lithium intoxication due to reduced lithium clearance.
Simultaneous use of potassium-sparing diuretics (spironolactone, amiloride, triamterene) or additional potassium intake can lead to hyperkalemia.
Simultaneous reception of allopurinol, cytostatics, immunosuppressants or systemic corticosteroids can cause leukopenia, anemia, or pancytopenia; simultaneous application of cyclosporine can lead to the development of renal failure.
Simultaneous reception of sulfonamides or hypoglycemic agents - derivatives of sulfonylureas can cause allergic reactions (a possible allergic reaction is possible).
With caution, it is necessary to simultaneously prescribe digitalis preparations, since their toxicity can increase due to hypovolemia, hypokalemia and hypomagnesemia.
Simultaneous reception of corticosteroids increases the risk of hypokalemia.
The risk of developing arterial hypotension increases with general anesthesia or with the simultaneous use of nondepolarizing muscle relaxants (for example, tubocurarine).
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, dry, protected from light at room temperature. Shelf life - 2 years.
