Trinomia (acetylsalicylic acid, atorvastatin, ramipril) hard capsules 100 mg/20 mg/10 mg. №28

Description

Trinomia (acetylsalicylic acid, atorvastatin, ramipril) hard capsules 100 mg/20 mg/10 mg. №28

Composition

active substances:

• 1 capsule contains 100 mg of acetylsalicylic acid, 20 mg of atorvastatin (as atorvastatin calcium trihydrate) and 2.5 mg of ramipril;
• 1 capsule contains 100 mg of acetylsalicylic acid, 20 mg of atorvastatin (as atorvastatin calcium trihydrate) and 5 mg of ramipril;
• 1 capsule contains 100 mg of acetylsalicylic acid, 20 mg of atorvastatin (as atorvastatin calcium trihydrate) and 10 mg of ramipril;

excipients:

• for 100 mg / 20 mg / 2.5 mg capsules:
  for acetylsalicylic acid tablets: microcrystalline cellulose; sodium starch glycolate (type A); talc; Opadry AMV white OY-B-28920;
  for atorvastatin tablets: lactose monohydrate; pregelatinized starch 1500; calcium carbonate; hydroxypropylcellulose; polysorbate 80; crospovidone type A; colloidal anhydrous silica; magnesium stearate; Opadry green 06О21881;
  for ramipril tablets: hypromellose 2910; microcrystalline cellulose, pregelatinized starch 1500; sodium stearyl fumarate; Opadry AMV yellow 80W32039;
  hard capsule: gelatin; titanium dioxide (E 171); iron oxide, black (E 172); black ink;
• for 100 mg / 20 mg / 5 mg capsules:
  for acetylsalicylic acid tablets: microcrystalline cellulose; sodium starch glycolate (type A); talc; Opadry AMV white OY-B-28920;
  for atorvastatin tablets: lactose monohydrate; pregelatinized starch 1500; calcium carbonate; hydroxypropylcellulose; polysorbate 80; crospovidone type A; colloidal anhydrous silica; magnesium stearate; Opadry green 06О21881;
  for ramipril tablets: hypromellose 2910; microcrystalline cellulose, pregelatinized starch 1500; sodium stearyl fumarate; Opadry AMV yellow 80W32656;
  hard capsule: gelatin; titanium dioxide (E 171); iron oxide, black (E 172); iron oxide, red (E 172); black ink;
• for 100 mg / 20 mg / 10 mg capsules:
• for acetylsalicylic acid tablets: microcrystalline cellulose; sodium starch glycolate (type A); talc; Opadry AMV white OY-B-28920;
  for atorvastatin tablets: lactose monohydrate; pregelatinized starch 1500; calcium carbonate; hydroxypropylcellulose; polysorbate 80; crospovidone type A; colloidal anhydrous silica; magnesium stearate; Opadry green 06О21881;
  for ramipril tablets: hypromellose 2910; microcrystalline cellulose, pregelatinized starch 1500; sodium stearyl fumarate; Opadry AMV yellow 80W32880;
  hard capsule: gelatin; titanium dioxide (E 171); iron oxide, red (E 172); black ink.

Dosage form

Hard capsules.

Basic physical and chemical properties:

• for 100 mg / 20 mg / 2.5 mg capsules:
  opaque, hard gelatin capsules, size 0, with a light gray body and cap, marked “AAR 100/20 / 2.5”, containing two film-coated acetylsalicylic acid tablets, white or almost white, engraved with “AS” , two film-coated atorvastatin tablets, greenish-brown with engraving “AT” and one tablet of ramipril, film-coated, pale yellow with engraving “R2”;
• for 100 mg / 20 mg / 5 mg capsules:
  opaque, hard gelatin capsules size 0, with a pale pink cap and a light gray body, labeled “AAR 100/20/5”, containing two film-coated acetylsalicylic acid tablets, white or almost white with engraved “AS”, two film-coated tablets of atorvastatin, greenish-brown with engraving “AT” and one tablet of ramipril, film-coated, pale yellow with engraving “R5”.
• for 100 mg / 20 mg / 10 mg capsules:
  opaque, hard gelatin capsules size 0, with a body and cap of pale pink color, with the inscription “AAR 100/20/10”, containing two tablets of acetylsalicylic acid, film-coated, white or almost white with engraving “AS” , two film-coated atorvastatin tablets, greenish-brown with engraving “AT” and one film-coated tablet of ramipril, pale yellow with engraving “R1”.

Pharmacotherapeutic group

Drugs that affect the cardiovascular system. Lipid-modifying drugs, combinations. Atorvastatin, acetylsalicylic acid and ramipril.
ATC code C10B X06.

Pharmacological properties

It is a combined agent (antiplatelet agent + lipid-lowering agent + angiotensin-converting enzyme inhibitor). The drug disrupts the process of aggregation (gluing) of platelets, reduces the level of “harmful” fats in the blood, inhibits the action of the angiotensin-converting enzyme, affecting the renin-angiotensin system.

Indications

Trinomia is used for the secondary prevention of cardiac complications in adults:

• for the prevention of ischemic stroke in individuals with stroke, transient ischemic attack in the past;
• with ischemic heart disease or the presence of several risk factors for its development;
• with unstable angina pectoris;
• with a painless form of myocardial ischemia;
• for the prevention of thromboembolism in vasculitis (inflammation) of the coronary arteries (Kawasaki’s disease, Takayasu’s aortoarteritis), atrial fibrillation, mitral valve defects, mitral valve prolapse.

Contraindications

You cannot assign Trinomia:

• with known sensitivity to drug components;
• with intolerance to soybeans, peanuts;
• with erosive / ulcerative lesions of the intestine or stomach in the acute phase;
• with allergies to the components of the drug;
• with portal hypertension;
• with “aspirin” asthma;
• with gastrointestinal bleeding;
• with hemorrhagic diathesis (thrombocytopenic purpura, von Willebrand disease, telangiectasias), hemophilia, hypoprothrombinemia;
• with dissecting aortic aneurysm;
• with a deficiency of vitamin K;
• when taking methotrexate at a dose of more than 15 mg / week;
• with kidney / liver failure;
• during pregnancy, breastfeeding;
• with gout, gouty arthritis;
• with arterial hypotension of severe degree;
• in shock (including cardiogenic shock);
• with obstruction of the outflow tract of the left ventricle (for example, severe aortic stenosis);
• with unstable angina pectoris;
• concurrently with some medications (see package insert);
• within 28 days after the acute phase of myocardial infarction;
• when using some extracorporeal treatment methods;
• with stenosis of the renal arteries;
• children;
• with recent injuries, operations.

Application during pregnancy and lactation

Not applicable.

Method of application and dosage

The drug Trinomia , hard capsules, is intended for oral use. The drug should be taken once a day, preferably after meals. The capsule should be swallowed whole with plenty of water. The capsule should not be chewed, crushed or opened. The capsule closure system preserves the pharmacological properties of the active substances.

Grapefruit juice is not recommended during treatment with Trinomia .

Patients who are adequately controlled on acetylsalicylic acid, atorvastatin, and ramipril in equivalent therapeutic doses may be switched to Trinomia hard capsules.

Treatment should be started under medical supervision).

To prevent complications from the cardiovascular system, the maintenance dose of ramipril should be 10 mg once daily.

Overdose

Overdose symptoms: prolonged decrease in blood pressure, tachycardia, ringing in the ears, hyperventilation (due to stimulation of the respiratory center), alkalosis or metabolic acidosis, severe shortness of breath, fever, collapse (drop in blood pressure), coma, hypoprothrombinemia, convulsions, respiratory and renal failure.
Treatment: carrying out activities aimed at maintaining the function of the cardiovascular system, monitoring the work of the heart / lungs, controlling the BCC, diuresis, prescribing symptomatic therapy.

Side effects

Possible erosive and ulcerative lesions of the stomach / intestines, nausea, stomach pain, loss of appetite, gastrointestinal bleeding, liver failure, allergic reactions (skin rash, “aspirin” asthma, angioedema), the development of interstitial nephritis, nephrotic syndrome, papillary necrosis , renal failure (when used for a long time), Reye’s syndrome, heart failure, neurological disorders (tinnitus, dizziness, blurred vision, headache, aseptic meningitis, hearing loss), the development of addiction after drug withdrawal, thrombocytopenia, anemia (anemia ), leukopenia.