Tritace Plus 5mg/12.5mg 28 tablets — Made in Italy — Free Delivery

(Tritace Plus)
Tritace Plus 5mg/12.5mg 28 tablets — Made in Italy — Free Delivery
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SANOFI Brand: SANOFI

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Description Tritace Plus 5mg/12.5mg 28 tablets — Made in Italy — Free Delivery

Product description 

Tablets "Tritace Plus® 5 mg / 12.5 mg" are used to treat arterial hypertension. The use of this fixed combination is indicated in patients whose blood pressure is not adequately controlled on monotherapy with ramipril or hydrochlorothiazide.

Compound

One tablet contains (active ingredients):
ramipril - 5 mg;
hydrochlorothiazide - 12.5 mg.
Excipients: hydroxypropyl methylcellulose, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide (E 172), yellow iron oxide (E 172).

Contraindications

  • hypersensitivity to the active substance ramipril or other ACE inhibitors (angiotensin-converting enzyme), hydrochlorothiazide, other thiazide diuretics, sulfonamides or any of the excipients that are part of the preparation;
  • a history of angioedema (hereditary, idiopathic or previously transferred against the background of the use of ACE inhibitors or angiotensin II receptor antagonists);
  • arterial hypotension or hemodynamically unstable conditions;
  • simultaneous use with sacubitril / valsartan;
  • the simultaneous use of ACE inhibitors and extracorporeal therapies that lead to blood contact with negatively charged surfaces (such use can lead to severe anaphylactic reactions); such extracorporeal therapies include dialysis or hemofiltration using certain high fluid permeability membranes (eg polyacrylonitrile) and low density lipoprotein apheresis using dextran sulfate;
  • significant bilateral stenosis of the renal arteries or unilateral stenosis of the renal artery of a single kidney;
  • severe renal dysfunction (creatinine clearance < 30 ml / minute) in patients who are not undergoing hemodialysis;
  • clinically significant electrolyte imbalance, the course of which may worsen during treatment;
  • treatment-resistant hypokalemia or hypercalcemia;
  • refractory hyponatremia;
  • symptomatic hyperuricemia (gout);
  • anuria;
  • severe liver dysfunction, hepatic encephalopathy;
  • pregnancy and pregnancy planning;
  • the period of breastfeeding;
  • simultaneous use of the preparation "Tritace Plus® 5 mg / 12.5 mg" with preparations containing aliskiren in patients with diabetes mellitus or renal dysfunction (glomerular filtration rate (GFR) < 60 ml / minute / 1.73 m2);
  • simultaneous use with angiotensin II receptor antagonists in patients with diabetic nephropathy.

Mode of application

For oral use. To achieve the recommended dose, tablets with the appropriate content of active ingredients are used.
The preparation is recommended to be taken once a day at the same time, preferably in the morning.
The preparation can be taken before, during and after meals, since food intake does not affect the bioavailability of the preparation. Tablets should be swallowed whole with water. They must not be chewed or crushed.
Adults. The dose should be adjusted individually, depending on the characteristics of the patient and blood pressure levels. The use of a fixed combination of ramipril and hydrochlorothiazide is generally recommended only after dose titration of each of its individual components.
Start treatment with the lowest possible dose. If necessary, the dose can be gradually increased until the target blood pressure is reached. The maximum daily dose is 10 mg of ramipril and 25 mg of hydrochlorothiazide per day, which corresponds to two tablets of Tritace Plus® 5 mg / 12.5 mg.

Application features

Children
The preparation is not recommended for use in children, since there is insufficient data on its efficacy and safety for such patients.
Drivers
Studies on the effect of the preparation on the ability to drive vehicles and work with other mechanisms have not been conducted. Some side effects (for example, symptoms of low blood pressure, such as dizziness) can impair the patient's ability to concentrate and react quickly, which is risky in situations where these qualities are especially important (for example, when driving vehicles or working with other mechanisms).
This is especially true when starting treatment or switching to other preparations. After taking the first dose or further increasing the dose, it is undesirable to drive a vehicle or work with other mechanisms for several hours.

Overdose

Overdose symptoms are persistent diuresis, excessive peripheral vasodilation (with severe arterial hypotension, shock), bradycardia, electrolyte imbalance, renal failure, cardiac arrhythmias, impaired consciousness, including coma, epileptic seizures, cerebral convulsions, paresis and paralytic ileus . Overdose of hydrochlorothiazide can lead to acute urinary retention in patients prone to this (for example, with prostatic hyperplasia), tachycardia, weakness, dizziness, muscle spasms, polyuria, oliguria, anuria, hypokalemia, hyponatremia, hypochloremia, alkalosis, increased levels of urea nitrogen in blood (mainly renal failure). It is necessary to carefully monitor the patient's condition.
Treatment is symptomatic and supportive. Treatment measures include primary detoxification (gastric lavage, administration of adsorbents), as well as measures aimed at restoring stable hemodynamics, including the administration of alpha-1 adrenoreceptor agonists or angiotensin II (angiotensinamide). Ramiprilat, the active metabolite of ramipril, is poorly excreted by hemodialysis.

Side effects

The safety profile of the preparation ramipril + hydrochlorothiazide contains data on side effects arising from arterial hypotension and / or a decrease in circulating blood volume due to increased diuresis. The active ingredient ramipril can cause a persistent cough, while the active ingredient hydrochlorothiazide can interfere with the metabolism of glucose, fats and uric acid. Both substances have an irreversible effect on the level of potassium in the blood plasma. Severe adverse reactions include angioedema or anaphylactoid reactions, hepatic or renal dysfunction, pancreatitis, severe skin reactions, and neutropenia/agranulocytosis.

Storage conditions

Store in the original packaging at a temperature not exceeding 30°C, out of the reach of children.
Shelf life - 3 years.

Tags: Tritace

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