Tritace-A (ramipril, amlodipine) hard capsules 10 mg/5 mg. №28

Description

Tritace-A (ramipril, amlodipine) hard capsules 10 mg/5 mg. №28

Composition

active substances: ramipril / amlodipine;

1 capsule contains ramipril 5 mg and amlodipine 5 mg (corresponding to amlodipine besylate 6.934 mg) or ramipril 10 mg and amlodipine 5 mg (corresponding to amlodipine besylate 6.934 mg) or ramipril 10 mg and amlodipine 10 mg (corresponding to amlodipine besylate 13.868 mg) ;

Excipients: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, pregelatinized corn starch, low humidity pregelatinized corn starch, sodium starch glycolate (type A), sodium stearyl fumarate;

capsule shell:

• capsules of 5 mg / 5 mg, capsules of 10 mg / 5 mg: iron oxide red (E 172), titanium dioxide (E 171), gelatin;
• capsules of 10 mg / 10 mg: iron oxide yellow (E 172), iron oxide black (E 172), iron oxide red (E 172), titanium dioxide (E 171), gelatin.

Dosage form

Hard capsules.

Basic physical and chemical properties:

• capsules of 5 mg / 5 mg: hard gelatin capsules, size № 1; cover: opaque, pink; body: opaque, white; capsule content: white or almost white powder;
• capsules of 10 mg / 5 mg: hard gelatin capsules, size № 1; cover: opaque, dark pink; body: opaque, white; capsule content: white or almost white powder;
• capsules of 10 mg / 10 mg: hard gelatin capsules, size № 1; cover: opaque, brown; body: opaque, white; capsule content: white or almost white powder.

Pharmacotherapeutic group

Angiotensin-converting enzyme inhibitor and calcium channel blocker.
ATX code C09B B07.

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.

Indications

Tritace-A hard capsules is used for arterial hypertension.

Contraindications

You cannot assign Tritace-A hard capsules:

• with known sensitivity to amlodipine, dihydropyridines, ramipril;
• 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

Tritace-A hard capsules should not be used as initial therapy for hypertension. The dosage of each component of the drug should be selected individually according to the patient’s characteristics and blood pressure control.

If you need to change the dosage, first select the doses of ramipril and amlodipine separately, and after determining the dosing schedule, these drugs can be replaced by the drug Tritace-A hard capsules.

The recommended dose is one capsule once a day. The maximum daily dose is one capsule of 10 mg / 10 mg.

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.