Triplixam (perindopril arginine, indapamide, amlodipine) coated tablets 10 mg/2.5 mg/10 mg. №30 vial

Description

Triplixam (perindopril arginine, indapamide, amlodipine) coated tablets 10 mg/2.5 mg/10 mg. №30 vial

Composition:

• Triplixam 5 mg/1.25 mg/5 mg
  active ingredients: 1 tablet contains perindopril arginine 5 mg (corresponding to 3.395 mg of perindopril), indapamide 1.25 mg and amlodipine besylate 6.935 mg (corresponding to 5 mg of amlodipine);
• Triplixam 5 mg/1.25 mg/10 mg
  active ingredients: 1 tablet contains perindopril arginine 5 mg (corresponding to 3.395 mg of perindopril), indapamide 1.25 mg and amlodipine besylate 13.870 mg (corresponding to 10 mg of amlodipine);
• Triplixam 10 mg/2.5 mg/5 mg
  active ingredients: 1 tablet contains perindopril arginine 10 mg (corresponding to 6.790 mg of perindopril), indapamide 2.5 mg and amlodipine besylate 6.935 mg (corresponding to 5 mg of amlodipine);
• Triplixam 10 mg/2.5 mg/10 mg
  active ingredients: 1 tablet contains perindopril arginine 10 mg (corresponding to 6.790 mg of perindopril), indapamide 2.5 mg and amlodipine besylate 13.870 mg (corresponding to 10 mg of amlodipine);

excipients: tablet: a mixture of calcium carbonate and starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, anhydrous colloidal silicon dioxide, pregelatinized starch; film coat: glycerin, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

• Triplixam 5 mg/1.25 mg/5 mg white, oblong, film-coated tablet, embossed on one side and on the other.
• Triplixam 5 mg/1.25 mg/10 mg white, oblong, film-coated tablet, embossed on one side and on the other.
• Triplixam 10 mg/2.5 mg/5 mg is a white, oblong, film-coated tablet, embossed on one side and on the other.
• Triplixam 10 mg/2.5 mg/10 mg white, oblong, film-coated tablet, embossed on one side and on the other.

Pharmacological group

ACE inhibitors, other combinations. Perindopril, amlodipine and indapamide.
ATX code C09B X01.

Pharmacological properties

It is a combined agent (calcium ion antagonist + angiotensin-converting enzyme inhibitor). The drug blocks the flow of Ca ions through the L-type channels (slow calcium channels) of the membranes into the cells of the smooth muscle fibers of the heart and blood vessels. Thus, providing a direct relaxing effect on vascular smooth muscles, it helps to reduce blood pressure. It also reduces ischemia (insufficient blood supply to tissues) in angina pectoris, reducing energy consumption, their need for oxygen. It inhibits the action of the angiotensin-converting enzyme, acting on the renin-angiotensin system. Inhibits the reabsorption of sodium in the cortical segment of the kidneys, increasing the excretion of sodium, chlorides, potassium, magnesium in the urine, enhancing the antihypertensive effect of the drug.

Indications

Triplixam is indicated for the treatment of hypertension in patients requiring treatment with fixed dose perindopril, indapamide and amlodipine.

Contraindications

It is impossible to assign to Triplexam 10 mg/2.5 mg/10 mg:

• with known sensitivity to amlodipine, dihydropyridines, perindopril, indapamide;
• 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.

Application during pregnancy and lactation

Not applicable.

Method of administration and dosage

Triplixam 10 mg/2.5 mg/10 mg is administered orally (inside).
The standard dose for adults is 1 tablet x 1 time per day.

Overdose

Overdose symptoms: prolonged decrease in blood pressure, tachycardia.
Treatment: carrying out measures aimed at maintaining the function of the cardiovascular system, monitoring the work of the heart / lungs, controlling the BCC, diuresis, prescribing vasopressors, administering calcium gluconate. Dialysis is ineffective.

Side effects:

• Disturbances from the lymphatic system, blood: leukopenia, thrombocytopenia.
• Metabolic disorders: hyperglycemia.
• Mental disorders: depression, mood changes, anxiety, confusion, insomnia.
• Neurological disorders: hypertonicity, dizziness, drowsiness, headache, tremor, dysgeusia, hypesthesia, syncope, paresthesia, peripheral neuropathy, extrapyramidal disorders.
• Perceptual disorders: visual impairment, including double vision (diplopia).
  Hearing disorders, labyrinth: tinnitus (ringing in the ears).
• Cardiac disorders: rapid heartbeat, arrhythmia (including tachycardia, bradycardia, atrial flutter), myocardial infarction.
• Vascular disorders: hot flashes, hypotension, vasculitis.
• Respiratory disorders: dyspnea, cough, rhinitis.
• Digestive disorders: abdominal pain, nausea, intestinal motility disturbances, diarrhea / constipation, vomiting, gastritis, dry mouth, pancreatitis, gingival hyperplasia, jaundice, hepatitis, increased liver enzymes, cholestasis.
• Skin changes: itching, Quincke’s edema, rashes, skin discoloration, alopecia, purpura, sweating, exanthema, urticaria, angioedema, exfoliative dermatitis, erythema multiforme, photosensitivity, Stevens-Johnson syndrome.
• Changes in the musculoskeletal system: swelling of the legs, arthralgia, muscle pain, muscle cramps, back pain.
• Disorders of the genitourinary system: urinary disorders, nocturia, frequent urination.
• Reproductive disorders: gynecomastia, impotence.
• Others: edema, fatigue, chest pain, weight loss / gain.