Tritace – composition, action, indications, contraindications, dosage and side effects

Proven content

Tritace is a drug that affects the cardiovascular system. The active substance of the drug, i.e. ramipril, has properties in reducing arterial hypertension. Tritace is therefore used to treat hypertension. What should you know about Tritace? When should this preparation not be used? What precautions should you take? How do I dose Tritace? Can its use cause side effects? Can other medicines be taken simultaneously with TRITACE?

Tritace – drug characteristics

Tritace is a drug belonging to the ACE inhibitors, i.e. angiotensin converting enzyme inhibitors.

Tritace is a drug with antihypertensive and protective properties. It is used in the treatment of hypertension and in the prevention of cardiac episodes. It contains the active substance ramipril. This relationship is distinguished by a complex mechanism of action:

1. inhibits the formation of angiotensin II that shrinks the walls of blood vessels;
2. reduces the breakdown of bradykinin causing their relaxation;
3. reduces the secretion of aldosterone, which, for example, retains water in the body;

Due to these properties, Tritace has an antihypertensive effect, which is the normalization of high blood pressure and the maintenance of its normal parameters.

Tritace has a protective effect on the heart and kidneys, including by lowering the pressure in these organs, reducing the peripheral resistance of the vessels and improving glomerular filtration and increasing work efficiency.

Tritace is available in tablets of 2,5, 5 and 10 mg:

1. 2,5 mg tablets They are yellow or yellowish, oblong, divisible, 8 x 4mm, embossed with “2,5” and the company logo on one side and “2,5” and “HMR” on the other side. The tablet can be divided into equal doses;
2. 5 mg tablets They are pale red, oblong, divisible, 8 x 4 mm, embossed with “5” and the company logo on one side and “5” and “HMP” on the other side. The tablet can be divided into equal doses;
3. 10 mg tablets they are white to off-white, oblong, divisible, 7 x 4,5 mm, debossed with “HMO / HMO” on one side. The tablet can be divided into equal doses.

Tritace tablets are packaged in packs of 28 tablets in PVC / Aluminum blisters and packs of 500 tablets in a brown glass Type III bottle with an HDPE screw cap.

Currently, several pharmaceutical companies are responsible for the production and distribution of Tritace. These are:

1. Delfarma Sp. z o. o – is a leader in parallel import. This company supplies the Polish market with cheaper drugs and thus significantly contributes to the reduction of health care costs. The Delfarma company was established in 2004 and offers over 500 drugs. The company’s head office is located in Łódź;
2. InPharm Sp. z oo – is a company that has been dealing with parallel import and distribution of medicinal products, medical devices and cosmetics since 2006. The company has an extensive network of suppliers throughout the European Union. The company’s head office is located in Warsaw;
3. Medicine Sp. z oo – is a company that offers a wide range of services in the area of ​​distribution, storage, manufacturing in the field of repackaging, import, labeling for clinical trials, transport, marketing and sales for manufacturers and a selection of medicinal products for wholesalers and pharmacies;
4. Sanofi-Aventis Germany GmbH – Sanofi is an international pharmaceutical company specializing in the research, development, production and sale of innovative and generic drugs, vaccines, over-the-counter (OTC) drugs, health and beauty products (Consumer Healthcare). The company’s headquarters are located in Paris. The CEO of Sanofi Worldwide is Paul Hudson. The company is listed on the stock exchanges in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). Sanofi has 112 manufacturing plants in 41 countries and more than 20 research and development centers around the world;
5. Forfarm Sp. z o. o – direct parallel importer. The company has over 400 licenses for pharmaceutical products. The company Forfarm Sp. z o. o. started its commercial activity in 2006. It is primarily a pharmaceutical wholesaler with an established position on the pharmaceutical market. The main activity of the company is trade in medicinal products under the parallel import procedure and export to licensed entities in the European Union countries. The company’s head office is located in Warsaw;
6. PharmaVitae Sp. z o. o. sp. k. – is a company dealing with parallel import on the Polish pharmaceutical market. Since 2011, the company has been building a leading position, cooperating with business partners from the European Union, as well as expanding the portfolio of imported medicinal products, private labels and logistics services. The company’s headquarters is located in Warsaw.

Which Polish pharmaceutical companies do Poles trust the most? Check: Customer satisfaction from Polish pharmaceutical companies: which is the most convincing?

Tritace – composition and action of the drug

The main ingredient of Tritace, responsible for its healing properties, is ramipril.

Ramipril is a medicine that belongs to the group of angiotensin converting enzyme inhibitors. These are drugs that act on one of the enzymes in the renin-angiotensin-aldosterone system.

This system plays an important role in regulating blood pressure. This is due to the action of angiotensin II and aldosterone, which affect the cardiovascular system, the central nervous system and the water and electrolyte balance.

In this process, renin, which is produced in the kidneys, increases the production of angiotensin I, which is then converted to angiotensin II by the enzyme angiotensin-converting enzyme, which in turn has a variety of biological effects. The mechanism of action is primarily related to the cardiovascular and central nervous systems. However, attention is also paid to the prothrombotic action within the kidneys and adrenal glands. Aldosterone also increases sodium ion reabsorption and the excretion of potassium and hydrogen in the kidney. In turn, the activation of the RAA system results in an increase in blood pressure.

ACE inhibitors, including the main ingredient of TRITACE, inhibit the conversion of angiotensin I to angiotensin II. Thanks to their action, blood vessels relax and blood pressure is lowered.

This drug increases the cardiac output, reduces the load on the heart and improves the systolic and diastolic function of the heart chambers. It also causes the reversal of structural changes in the heart and vessels. In turn, in congestive heart failure, it reduces clinical symptoms and increases exercise tolerance. Importantly, it significantly reduces the risk of a heart attack.

Ramipril is rapidly absorbed and converted to the active form, ramiprilat, by the liver. Peak levels of ramipril are achieved within 1 hour of ingestion, and ramiprilat concentrations within 2-4 hours. hours after taking the drug. The antihypertensive effect is noticeable within 1-2 hours after taking the drug and is strongest between 3-6 months of use. hour. The antihypertensive effect develops fully after approximately 3-4 years. weeks of taking TRITACE.

The other ingredients of Tritace depending on the content of the active substance:

1. excipients in 2,5 mg tablets – hypromellose, modified maize starch, microcrystalline cellulose, sodium stearyl fumarate and yellow iron oxide (E172);
2. excipients in 5 mg tablets – hypromellose, modified maize starch, microcrystalline cellulose, sodium stearyl fumarate and red iron oxide (E172);
3. auxiliary ingredients in 10 mg tablets – hypromellose, modified maize starch, microcrystalline cellulose and sodium stearyl fumarate.

How to properly select drugs for hypertension? Check: Drugs for hypertension – selection and effectiveness

Tritace – indications for the use of the drug

Tritace is a preparation that is used in cases of problems with blood pressure. Your doctor may recommend this medication, especially in:

1. treat high blood pressure (hypertension);
2. lowering the risk of a heart attack or stroke;
3. reducing the risk or delaying the worsening of kidney problems (whether or not you have diabetes);
4. treat the heart when it cannot pump enough blood to the rest of the body (heart failure)
5. treatment after myocardial infarction complicated with heart failure.

How to recognize and treat hypertension? Read: Hypertension – Causes, Symptoms and Treatment. How to take a measurement?

Tritace – contraindications to the use of the drug

Tritace, despite its effectiveness in treating hypertension, cannot be used by every patient struggling with this type of ailments.

Contraindications to the use of Tritace are:

1. hypersensitivity to the active substance or any of the excipients or to another ACE (angiotensin converting enzyme) inhibitor;
2. History of angioedema (hereditary, idiopathic or induced by previous ACE inhibitors or angiotensin II receptor antagonists AIIRAs);
3. extracorporeal treatments leading to contact of blood with negatively charged surfaces;
4. significant bilateral renal artery stenosis or artery stenosis to a single functioning kidney;
5. renal dysfunction;
6. diabetes;
7. the second and third trimesters of pregnancy;
8. age under 18;
9. hypotension and haemodynamic instability.

What medications to avoid in diagnosed hypertension? Check: Do you have high blood pressure? You have to be careful with medications

Tritace – precautions

Before and during the use of TRITACE, follow the precautions included in the package leaflet.

Particular care should be taken when taking TRITACE in the following cases:

1. if you have heart, liver or kidney problems;
2. if you have recently lost a significant amount of electrolytes or fluids through vomiting, diarrhea, sweating more than usual, being on a low sodium diet, taking diuretics (water tablets) for a long time or taking dialysis.
3. if you are going to have treatment to reduce your allergic reactions to bee or wasp stings (desensitization);
4. if you are going to receive medicines for anesthesia. They can be used during surgical or dental procedures. You may need to stop taking TRITACE one day before surgery, if you are unsure, check with your doctor;
5. if you have high levels of potassium in your blood (shown in blood test results);
6. if you are taking medicines or have conditions that can lower the amount of sodium in your blood;
7. if you are taking medicines that may increase the risk of angioedema (severe allergic reaction) such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin (NEP) inhibitors (such as racecadotril) or sacubitril in combination with valsartan ;
8. if you suffer from collagen disease, such as scleroderma or systemic lupus erythematosus;
9. if you are pregnant, think you are pregnant or plan to become pregnant. Tritace is not recommended during the first three months of pregnancy, and may cause harm to your baby if used after the third month of pregnancy;
10. if you are taking any of the following medicines used to treat high blood pressure: angiotensin II receptor antagonist (AIIRA), also known as sartan (for example valsartan, telmisartan, irbesartan, aliskiren).

How do drugs for hypertension affect potency? Check: Can medications for high blood pressure cause impotence?

Tritace – method of use and dosage

Always use Tritace exactly as described in the package leaflet or as directed by your doctor or pharmacist.

It is recommended to take TRITACE every day at the same time of the day. Tritace can be taken before, during or after a meal, as food intake does not alter its therapeutic effect. Tritace tablets should be taken with fluids. They must not be crushed or chewed.

In hypertensive patients receiving diuretics, treatment with TRITACE should be started at a dose of 1,25 mg. Renal function and serum potassium should be monitored. The next dose of the drug is determined depending on the target blood pressure values.

Correct dose of Tritace depends on the disease being treated, as well as its severity and stage of advancement.

In the case of hypertension, TRITACE is started gradually with an initial dose of 2,5 mg per day. Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive fall in blood pressure following the initial dose. Therefore, in this patient group it is recommended to start with a dose of 1,25 mg and initiation of treatment under medical supervision. The dose may be doubled over a period of two to four weeks to achieve target blood pressure. However, remember that the maximum dose of TRITACE is 10 mg per day.

For cardiovascular disease prevention, the recommended starting dose of Tritace is 2,5 mg once a day. Depending on the patient’s tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose after one to two weeks of treatment and after another two to three weeks to increase it to the target maintenance dose of 10 mg TRITACE once daily.

When Tritace is used in patients with diabetes and microalbuminuria, the recommended starting dose of TRITACE is 1,25 mg once a day. Depending on the patient’s tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose to 2,5 mg once daily after two weeks of treatment and then to 5 mg after a further two weeks.

If you have diabetes and have at least one cardiovascular risk factor, the recommended starting dose of TRITACE is 2,5 mg once a day. Depending on the patient’s tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose to 5 mg once daily after one to two weeks of treatment and then to 10 mg after another two or three weeks. The target dose is 10 mg.

For patients with symptomatic heart failure, the recommended starting dose of TRITACE is 1,25 mg daily. Doubling the dose of TRITACE should be made every one to two weeks, up to a maximum dose of 10 mg. It is preferable to administer the drug in two divided doses.

For prevention after acute myocardial infarction with heart failure, 48 hours after acute myocardial infarction, the starting dose is 2,5 mg twice a day for three days. If the starting dose of 2,5 mg is not tolerated, 1,25 mg twice daily for two days should be given before increasing the dose to 2,5 mg, then 5 mg twice daily. If the dose cannot be increased to 2,5 mg twice a day, treatment should be withdrawn. The daily dose should be gradually doubled at intervals of one to three days until the target dose of 5 mg twice daily is reached. If possible, the maintenance dose should be administered in two divided doses.

How to take medication correctly? Check: How to take medications effectively?

Tritace – side effects

Tritace, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

The most common side effects with TRITACE are:

1. symptoms of a severe hypersensitivity reaction;
2. severe skin changes including rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

If you experience any of the following symptoms, please consult your doctor immediately:

1. fast heart beat, uneven or forceful heartbeat (palpitations), chest pain, tightness in the chest, or more severe, severe conditions including heart attack or stroke
2. shortness of breath or cough. These may indicate lung problems;
3. easy bruising, bleeding for longer than usual, any signs of bleeding (e.g. bleeding gums), purple spots on the skin or more frequent infections, sore throat and fever, tiredness, weakness, dizziness or pale skin. These can be signs of blood or bone marrow problems;
4. severe stomach pain which may reach through to your back. These could be symptoms of an inflammation of the pancreas;
5. fever, chills, weakness, loss of appetite, stomach pain, nausea, yellowing of the skin or the whites of the eyes (jaundice). These may be symptoms of liver problems such as liver inflammation or damage.

Due to the frequency of side effects after taking TRITACE, the following indications are:

Common side effects (may affect up to 1 in 10 people):

1. headache or feeling tired;
2. dizziness; the risk is greater when starting treatment with TRITACE and increasing the dose;
3. fainting, hypotension (abnormally low blood pressure), especially when you suddenly switch from lying down to sitting or standing;
4. dry, tiring cough, sinusitis or bronchitis, shortness of breath;
5. stomach or bowel pain, diarrhea, indigestion, nausea or vomiting;
6. rash with or without prominent lesions;
7. pain in the chest;
8. muscle cramps or pain;
9. blood tests showing higher potassium levels than usual in your blood.

Uncommon side effects (may affect up to 1 in 100 people):

1. balance problems (vertigo);
2. itching of the skin and sensory disturbances such as numbness, tingling, prickling, a burning sensation or a feeling of crawling on the skin (paraesthesia);
3. loss or disturbance of the sense of taste;
4. sleep disturbance;
5. depression, anxiety, nervousness or restlessness;
6. stuffy nose, difficulty breathing or worsening of asthma;
7. a swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhea;
8. heartburn, constipation or dry mouth;
9. Passing more urine than usual during the day;
10. increased sweating;
11. loss or decreased appetite (anorexia);
12. fast or irregular heartbeat;
13. swelling of the arms and legs; may be a symptom of holding more water than usual;
14. flushing of the face;
15. blurred vision;
16. arthralgia;
17. fever,
18. impotence, decreased sex drive in men and women;
19. increased amount of certain white blood cells (eosinophilia) shown in blood tests;
20. blood test results that show changes in the liver, pancreas or kidneys.

Rare side effects (may affect up to 1 in 1000 people):

1. feeling of uncertainty, distraction, confusion;
2. red, swollen tongue;
3. excessive peeling of the skin, itchy lumpy rash;
4. nail diseases (e.g., loosening or separation of a nail from its bed);
5. skin rash or bruising;
6. spots on the skin and cold extremities;
7. redness, itching, swelling and watery eyes;
8. hearing impairment and ringing in the ears;
9. weakness;
10. decrease in the amount of red blood cells, white blood cells or platelets, or hemoglobin shown in blood tests.

Very rare side effects (may affect up to 1 in 10 people):

1. hypersensitivity to sunlight.

What should I know about headaches in case of hypertension? Check: Headaches in hypertension, hypotension and atherosclerosis

Tritace – interactions with other drugs

Before starting treatment with TRITACE, inform the treating doctor or pharmacist about all the medicines they are taking or have recently taken. You should also inform what medications the patient plans to take in the near future.

Please tell your doctor if you are taking the following medicines. This is because they can reduce the effect of TRITACE:

1. medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] such as ibuprofen or indomethacin and aspirin);
2. medicines used to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, noradrenaline or adrenaline. Your doctor will check your blood pressure.

Tritace should also not be combined with the preparations indicated below, as their combination may increase the risk of side effects:

1. medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] such as ibuprofen or indomethacin and aspirin);
2. drugs for the treatment of cancer (chemotherapy);
3. drugs to prevent organ transplant rejection such as cyclosporine;
4. diuretics (water tablets) such as furosemide;
5. medicines that increase the amount of potassium in the blood, such as: spironolactone, triamterene, amiloride, potassium salts, trimethoprim either alone or in combination with sulfamethoxazole (used to treat bacterial infections) and heparin (a blood thinner);
6. steroidal anti-inflammatory drugs such as prednisolone;
7. allopurinol (used to lower uric acid levels in the blood);
8. procainamide (for heart rhythm problems);
9. temsirolimus (used to treat cancer);
10. sirolimus, everolimus (used to prevent rejection in a transplant);
11. vildagliptin (used to treat type 2 diabetes).

Which drugs should never be combined with each other? Check: Dangerous interactions