Tritace Plus (ramipril, hydrochlorothiazide) tablets 10 mg/12.5 mg. №28

Description

Tritace Plus (ramipril, hydrochlorothiazide) tablets 10 mg/12.5 mg. №28

Composition

active substances: ramipril, hydrochlorothiazide;

1 tablet contains ramipril 5 mg and hydrochlorothiazide 12.5 mg or ramipril 10 mg and hydrochlorothiazide 12.5 mg;

excipients:

• Tritace Plus 5 mg / 12.5 mg: hydroxypropylmethylcellulose, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide (E 172);
• Tritace Plus 10 mg / 12.5 mg: hydroxypropylmethylcellulose, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide (E 172), yellow iron oxide (E 172).

Dosage form

Tablets.

Basic physical and chemical properties:

• Tritace Plus 5 mg / 12.5 mg: pink oblong tablets with a score line on both sides. Top stamp: 41 / AV.
• Tritace Plus 10 mg / 12.5 mg: Orange orange tablets with a score line on both sides. Top stamp: 42 / AV.

Pharmacotherapeutic group

Combined drugs of angiotensin-converting enzyme (ACE) inhibitors. ACE inhibitors in combination with diuretics.
ATX code C09B A05.

Pharmacological properties

This is a combination antihypertensive (blood pressure lowering) drug. Ramipril breaks down in the liver to form ramiprilat. It acts by inhibiting the renin-angiotensin-aldosterone system. Suppresses the effect of the angiotensin-converting enzyme, which catalyzes the conversion of angiotensin-I into the vasoconstrictor peptide angiotensin-II, while preventing its stimulating effect on the process of aldosterone secretion by the adrenal glands. Hydrochlorothiazide reduces sodium reabsorption 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

Tritace Plus tablets is used for the treatment of hypertension (arterial hypertension) in patients whose blood pressure is not controlled with ramipril or hydrochlorothiazide alone.

Contraindications

Do not use Tritace Plus tablets:

• with intolerance to the components;
• with intolerance to other ACE inhibitors;
• with a history of angioedema;
• with stenosis of the renal artery (a. renalis) of the only kidney or bilateral stenosis of the renal artery (aa. renalis dextra et sinistra);
• during extracorporeal treatment, which is accompanied by blood contact with negatively charged surfaces;
• with unstable hemodynamics;
• with arterial hypotension;
• with hepatic encephalopathy, severe liver failure;
• with primary hyperaldosteronism;
• with anuria;
• with a significant electrolyte imbalance;
• with symptomatic hyperuricemia (gout);
• with severe renal failure (creatinine clearance rate less than 30 ml / minute);
• during pregnancy / lactation, planning pregnancy.

Application during pregnancy and lactation

This medicine is contraindicated in pregnant women, as well as in women planning pregnancy. Not applicable to nursing mothers.

Method of administration and dosage

Tritace Plus tablets is administered orally.
Treatment begins with the lowest effective dose possible. The maximum dose is 10 / 12.5 mg / day.
The prescribed dose should be taken once a day, every day at the same time, regardless of food.

Overdose

Symptoms: vascular insufficiency, renal failure, drop in blood pressure, electrolyte imbalance, anxiety, tachycardia / bradycardia, hyperventilation, palpitations, dizziness, cough, paralytic intestinal obstruction, acute urinary retention, paresis.
It is necessary to take measures to remove the drug from the body (artificially induce vomiting or rinse the stomach, apply sorbents). In case of overdose, symptomatic therapy is recommended.

Side effects:

• Cardiovascular disorders: myocardial ischemia, angina pectoris, tachycardia, arrhythmia, peripheral edema, myocardial infarction.
• Hematological disorders: leukocytopenia, thrombocytopenia, hemolytic anemia, neutropenia, pancytopenia, hemoconcentration, eosinophilia.
• Neurological disorders: parosmia, tremor, headache, vertigo, imbalance, dysgeusia / ageusia, paresthesia, cerebral ischemia, stroke, TIA, impaired psychomotor functions.
• Ophthalmic disorders: decrease, blurred vision, conjunctivitis, lacrimation, xanthopsia.
• Otolaryngological disorders: ringing in the ears, hearing impairment.
• Respiratory disorders: shortness of breath, irritating unproductive cough, bronchitis, noncardiogenic pulmonary edema, sinusitis, nasal congestion, bronchospasm, allergic alveolitis.
• Digestive disorders: inflammation in the gastrointestinal tract, dyspepsia, abdominal pain, gastritis, nausea, gingivitis, constipation, vomiting, glossitis, stomatitis, diarrhea, dry mouth, pancreatitis.
• Genitourinary disorders: renal dysfunction, acute renal failure, increased blood urea / creatinine levels, interstitial nephritis, transient erectile dysfunction, decreased libido, gynecomastia.
• Dermatological disorders: polymorphic erythema, hyperhidrosis, angioneurotic edema, psoriatic dermatitis, maculopapular rash, purpura, toxic epidermal necrolysis, exanthema, pruritus, alopecia, Stevens-Johnson syndrome, exacerbation of psoriasis, pemphigus dermatitis, expholigus / exfoliate , urticaria, systemic lupus erythematosus.
• Musculoskeletal disorders: tetanic convulsions, arthralgia, muscle spasms and weakness, myalgia.
• Metabolic disorders: decompensation of diabetes mellitus, hyperglucosemia, hyperuricemia, exacerbation of gout, hyperlipidemia, anorexia, hypocalcemia, decreased appetite, thirst, hyperkalemia, hyponatremia, hypercalcemia, glucosuria, hypochloremia, metabolic alkalosis, hypomagnesemia.
• Cardiovascular disorders: arterial hypotension, syncope, orthostatic hypotension, hot flashes, thrombosis, vascular stenosis, Raynaud’s syndrome, hypoperfusion, vasculitis.
• General disorders: fatigue, asthenia, chest pain, pyrexia.
• Immune disorders: anaphylactic / anaphylactoid reactions, increased levels of antinuclear antibodies.
• Hepatobiliary disorders: cholestasis, cytolytic hepatitis, calculous cholecystitis, acute renal failure, jaundice.
• Mental disorders: depression, apathy, nervousness, anxiety, sleep disturbances, drowsiness, confusion, decreased attention.