Ampril® HD tablets are used in the treatment of hypertension. This fixed combination is indicated for patients whose blood pressure is not adequately controlled with ramipril or hydrochlorothiazide monotherapy.
Composition
One tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide.
Excipients: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch, sodium stearyl fumarate.
Contraindication
Hypersensitivity to ramipril or other angiotensin-converting enzyme inhibitors, hydrochlorothiazide, other thiazide diuretics, sulfonamides or any other component of the drug; hepatic encephalopathy, severe liver dysfunction; hypotension or hemodynamically unstable state; anuria; history of angioedema (hereditary, idiopathic or previously suffered against the background of the use of ACE inhibitors or angiotensin II receptor antagonists); primary hyperaldosteronism; extracorporeal treatment leading to contact of blood with negatively charged surfaces; significant bilateral renal artery stenosis or stenosis of the artery to a solitary functioning kidney; severe renal failure (creatinine clearance <30 ml / minute) in patients not undergoing hemodialysis; clinically significant electrolyte imbalances that may worsen after treatment; symptomatic hyperuricemia (gout); concomitant use with aliskiren-containing drugs is contraindicated in patients with diabetes mellitus or renal dysfunction (glomerular filtration rate (GFR) <60 mL/minute/1.73 m2); pregnant women or women planning to become pregnant; breastfeeding.
Method of application
The fixed-dose combination of ramipril and hydrochlorothiazide is recommended only after prior individual dose titration and blood pressure monitoring.
Start treatment with the lowest possible dose. If necessary, the daily dose can be gradually increased over 2-3 weeks until the target blood pressure is reached. The usual maintenance dose is 2.5 mg ramipril and 12.5 mg daily in the morning, and the maximum dose is 5 mg ramipril and 25 mg hydrochlorothiazide daily.
The drug is taken once a day at the same time, preferably in the morning. The drug can be taken before, during and after meals, as food intake does not affect the bioavailability of the drug. The tablet should not be chewed or crushed, but should be swallowed whole with liquid.
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose.
Caution is recommended in patients taking diuretics, as hypotension may occur after initiation of treatment. The diuretic dose should be reduced or discontinued before initiating treatment with the drug.
Application features
Children
The drug is not recommended for use in children and adolescents under the age of 18, as there is insufficient data on its efficacy and safety for such patients.
Drivers
Especially at the beginning of treatment, when increasing the dose, replacing the drug, and depending on the individual response to treatment, adverse reactions (low blood pressure, dizziness) may occur. In these cases, you should refrain from driving vehicles and operating machinery for several hours after taking the drug.
Overdose
Depending on the degree of overdose, the following symptoms may occur: excessive peripheral vasodilation (with severe hypotension, shock), impaired consciousness up to coma and cerebral convulsions, paresis, arrhythmia, bradycardia, acute renal failure, electrolyte imbalance and paralytic intestinal obstruction.
Overdose of hydrochlorothiazide may lead to acute urinary retention in patients predisposed to this (e.g. with benign prostatic hyperplasia).
The patient should be closely monitored. Treatment is symptomatic and supportive.
Side effects
The safety profile of the combination of ramipril and hydrochlorothiazide includes adverse reactions that occur in the event of hypotension and/or hypovolemia due to increased diuresis. The active substance ramipril may cause persistent dry cough, and the active substance hydrochlorothiazide may disrupt glucose, lipid and uric acid metabolism. The two active substances have opposite effects on plasma potassium levels. Serious adverse reactions include angioedema or anaphylactic reactions, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Storage conditions
Store at a temperature not exceeding 30 °C, out of the reach of children.
Shelf life - 2 years.
