Arifon retard tabs 1.5mg #30

User manual for Arifon retard

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Arifon retard is a diuretic, antihypertensive drug.

Release form and composition

Dosage form - controlled release tablets, film-coated: round biconvex, white (in a blister of 15 pcs., In a cardboard box 2 blisters; in a blister of 30 pcs., In a cardboard box of 1, 3, 10 or 30 blisters ).
1 tablet contains:
    active substance: indapamide - 1.5 mg;
    auxiliary components: povidone, hypromellose, lactose monohydrate, colloidal anhydrous silicon dioxide, magnesium stearate;
    composition of the film shell: macrogol 6000, glycerol, hypromellose, titanium dioxide, magnesium stearate.

Pharmacodynamics

The active substance of Arifon retard is indapamide, a sulfonamide derivative of quinazoline, a thiazide-like diuretic and a vasodilator with an antihypertensive effect.
The pharmacological properties of indapamide are close to thiazide diuretics, which act by inhibiting the reverse absorption of sodium ions in the cortical segment of Henle's loop. This causes an increase in urinary excretion of chlorine and sodium ions, to a lesser extent - potassium and magnesium ions, accompanied by increased diuresis and the hypotensive effect of Arifon retard.
When indapamide was used in monotherapy at a dose that did not have a pronounced diuretic effect, clinical studies of phases II and III showed its antihypertensive effect, which lasted for 24 hours. This is due to the effect of the substance on improving the elasticity of large arteries, reducing the resistance of arterial vessels and the general peripheral resistance of blood vessels.
Indapamide causes a decrease in left ventricular hypertrophy.
When choosing the optimal dose, thiazide-like and thiazide diuretics reach the peak of the therapeutic effect and a further increase in the dose only linearly increases the frequency of undesirable effects. Therefore, in the absence of clinically significant results from taking the recommended dose, it is not advisable to increase it further.
Arifon retard does not affect lipid metabolism (including the level of triglycerides, high and low density lipoproteins, cholesterol) and carbohydrate metabolism, including diabetes.

Pharmacokinetics

A gradual controlled release of indapamide occurs in the gastrointestinal tract (GIT), this is facilitated by the placement of the active substance in a special carrier matrix inside the tablet.
After release, indapamide is fully rapidly absorbed from the gastrointestinal tract. The presence of food in the gastrointestinal tract has an insignificant effect on the increase in the absorption time of Arifon retard, but not on the completeness of absorption. The maximum concentration in blood plasma occurs 12 hours after taking a single oral dose. In the course of further treatment, fluctuations in the concentration of the drug in the blood plasma between repeated doses are smoothed out. The variability of the absorption parameters of Arifon retard is individual.
Plasma protein binding of indapamide is about 79%, the equilibrium concentration of Arifon retard is achieved after 7 days of regular intake. Re-admission does not cause cumulation.
After biotransformation, 70% of the active substance in the form of inactive metabolites is excreted in the urine and 22% in the feces.
The half-life lasts 14-24 hours.
In renal failure, the pharmacokinetics of Arifon retard does not change.

Indications for use

The indication for Arifon retard is arterial hypertension.

Contraindications

    severe renal failure [creatinine clearance (CC) less than 30 ml / min];
    severe liver dysfunction;
    hepatic encephalopathy;
    lactose intolerance, galactosemia, glucose-galactose malabsorption syndrome (due to the presence of lactose in the composition);
    hypokalemia;
    period of pregnancy;
    breast-feeding;
    age under 18;
    hypersensitivity to sulfonamide derivatives or drug components.
Care should be taken when prescribing the drug to patients with an extended QT interval, impaired renal and / or liver function, in combination with other antiarrhythmic drugs, diabetes mellitus, hyperparathyroidism, imbalance in water and electrolyte balance, increased uric acid levels, and a weakened patient's condition.

Instructions for use of Arifon retard: method and dosage

The tablets are taken orally, swallowing whole (without violating the integrity of the shell), washed down with water.
Recommended dosage: 1 pc. per day, preferably in the morning.

Side effects

    from the central nervous system (CNS): rarely - headache, vertigo, asthenia, paresthesia; frequency unknown - fainting;
    from the hematopoietic system: very rarely - leukopenia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia;
    on the part of the cardiovascular system: very rarely - a pronounced decrease in blood pressure (BP), arrhythmia; the frequency is unknown - arrhythmia of the "pirouette" type (up to death);
    from the hepatobiliary system: very rarely - liver dysfunction; the frequency is unknown - against the background of the existing liver failure, the development of hepatic encephalopathy, hepatitis is possible;
    from the digestive system: infrequently - vomiting; rarely - a feeling of dry mouth, nausea, constipation; very rarely - pancreatitis;
    from the urinary system: very rarely - renal failure;
    dermatological reactions: with a predisposition to allergic and asthmatic responses - hypersensitivity reactions; often maculopapular rash; infrequently - hemorrhagic vasculitis; very rarely - urticaria, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis; frequency unknown - photosensitivity, in acute form of systemic lupus erythematosus - worsening of the course of the disease;
    laboratory parameters: hypokalemia (the level of potassium in the blood plasma is less than 3.2 mmol / l after 4-6 weeks of treatment); very rarely - hypercalcemia; the frequency is unknown - the development of hypokalemia, hyponatremia, dehydration, hypovolemia, orthostatic hypotension, metabolic alkalosis of a compensatory nature, hypochloremia, an increase in the concentration of glucose and uric acid in the blood, an increase in the activity of hepatic transaminases, an increase in the QT interval on the electrocardiogram.

Overdose

Since even very high doses of indapamide (up to 40 mg) have no toxic effect, acute drug poisoning can occur only in patients with impaired water and electrolyte balance (hyponatremia, hypokalemia).
Symptoms: drowsiness, nausea, vomiting, dizziness, low blood pressure, convulsions, confusion, polyuria or oliguria, resulting in anuria due to hypovolemia.
Treatment: urgent gastric lavage, the appointment of activated charcoal, measures aimed at restoring normal water and electrolyte balance.

Special instructions

If photosensitivity reactions develop against the background of taking a diuretic, treatment should be discontinued. If it is necessary to continue therapy with Arifon retard, the patient should avoid exposure to the skin of direct sunlight or artificial ultraviolet rays.
Before starting the course of therapy with Arifon retard, according to indications, it is necessary to check the state of the water-electrolyte balance in the patient.
Thiazide diuretics can cause hyponatremia (sometimes with extremely severe consequences), therefore, regular monitoring of the content of sodium ions in the blood plasma is required, especially in patients with cirrhosis of the liver and the elderly. The initial decrease in the sodium content in the blood plasma may not cause the development of pathological symptoms.
There is a risk of developing hypokalemia against the background of a sharp decrease in the plasma concentration of potassium levels. Hypokalemia in elderly patients, debilitated patients, while taking other antiarrhythmic or QT-increasing drugs, in patients with liver cirrhosis, ascites, peripheral edema, ischemic heart disease, heart failure increases the toxic effect of Arifon retard and increases the risk of arrhythmias. Severe arrhythmias (pirouette-type ventricular arrhythmias) can be fatal. It is impossible to allow the development of hypokalemia in these patients with an increased (congenital or acquired) QT interval, therefore, 7 days after starting Arifon retard, the first analysis should be performed for the content of potassium ions in the blood.
A decrease in the excretion of calcium ions by the kidneys is possible, causing a transient insignificant increase in the level of calcium in the blood plasma. Before examining the function of the parathyroid glands, Arifon retard should be discontinued.
Patients with diabetes mellitus require monitoring of the concentration of glucose in the blood, especially with hypokalemia.
With gout, an exacerbation or increase in the incidence of gout attacks is possible.
Arifon retard is fully effective only with normal or slightly impaired renal function (plasma creatinine content is not less than 25 mg / l). In elderly patients, the normal level of creatinine in blood plasma should be calculated taking into account age, body weight and gender.
When doping control in athletes, indapamide can give a positive result.

Influence on the ability to drive vehicles and complex mechanisms

The action of Arifon retard does not cause disturbances in the patient's psychomotor reactions. But due to the possible development of individual side effects, caution should be exercised when driving vehicles and mechanisms, especially at the beginning of the use of the drug.

Application during pregnancy and lactation

According to the instructions, Arifon retard is contraindicated during pregnancy. It cannot be used to treat physiological edema, since diuretic drugs can contribute to the manifestation of placental ischemia and impaired fetal development.
Indapamide is excreted in breast milk, therefore, it is not recommended to prescribe Arifon retard during lactation.

Childhood use

It is contraindicated for use in children and adolescents under the age of 18 due to the lack of sufficient clinical experience.

In case of impaired renal function

The use of the drug is contraindicated in severe renal failure.
At the beginning of treatment in patients with normal renal function while taking Arifon retard, a decrease in glomerular filtration is possible, which is a consequence of hypovolemia caused by dehydration and loss of sodium ions. In this case, the increase in the concentration of urea and creatinine in the blood plasma passes, as a rule, without consequences. Caution should be exercised in patients with renal insufficiency, as such disorders may worsen their condition.

If liver function is impaired

The use of the drug is contraindicated in hepatic encephalopathy.
Since there is a risk of developing hepatic encephalopathy in patients with hepatic impairment, they should be careful and discontinue the drug immediately if symptoms appear.

Use in the elderly

For elderly patients, the drug can be taken in the usual dose with normal or slightly impaired renal function. Plasma creatinine levels should be monitored taking into account age, body weight and gender.

Drug interactions

    lithium preparations - reduce their excretion and can cause an increase in the concentration of lithium in the blood plasma, which is accompanied by signs of an overdose;
    disopyramide, quinidine, hydroquinidine (class IA antiarrhythmics), amiodarone, ibutilide, sotalol, dofetilide (class III antiarrhythmics), chlorpromazine, levomepromazine, thioridazine, cyamemazine, trifluoroperazine (phenothiazines), benothiazines sulphide, thiapridazines droperidol, haloperidol (butyrophenones), halofantrine, astemizole, bepridil, diphemanil, cisapride, mizolastine, pentamidine, moxifloxacin, sparfloxacin; intravenous (iv): erythromycin and vincamine - can cause arrhythmias of the "pirouette" type, therefore, the combination with any of these drugs requires special control;
    non-steroidal anti-inflammatory drugs for systemic use, including salicylates (in a daily dose of more than 3 g), selective COX-2 inhibitors - can reduce the antihypertensive effect of indapamide;
    angiotensin-converting enzyme (ACE) inhibitors - increase the risk of developing acute renal failure (more often with renal artery stenosis) and / or sudden arterial hypotension;
    amphotericin B (i.v.), glucocorticoids and mineralocorticoids for systemic use, tetracosactide, laxatives that stimulate intestinal motility and other drugs that can cause hypokalemia - due to their additive effect, they increase the risk of hypokalemia;
    baclofen - enhances the hypotensive effect of indapamide;
    cardiac glycosides - can enhance their toxic effects;
    potassium-sparing diuretics - can contribute to the development of hypokalemia (patients with diabetes mellitus and renal failure are at greater risk) or hyperkalemia;
    metformin - increases the risk of developing lactic acidosis, therefore, when the creatinine level in men is more than 15 mg / l and in women - 12 mg / l, this combination is not recommended;
    iodine-containing contrast agents - against the background of dehydration of the body, they increase the risk of developing acute renal failure, if necessary, their use (especially high doses), it is necessary to provide the patient with compensation for fluid loss;
    tricyclic antidepressants, antipsychotics - increase the hypotensive effect of indapamide and, against the background of an additive effect, increase the risk of orthostatic hypotension;
    calcium salts - can cause the development of hypercalcemia;
    cyclosporine and tacrolimus - can increase the level of creatinine in the blood plasma, including with a normal body water balance;
    glucocorticosteroids, tetracosactide (for systemic administration) - reduce the hypotensive effect of indapamide.

Terms and conditions of storage

Keep out of the reach of children.
Store at temperatures up to 30 ° C.
Shelf life is 2 years.

Reviews about Arifon retard

According to reviews, Arifon retard helps with arterial hypertension, reducing blood pressure and allowing you to monitor its performance for a long time. On the positive side, the possibility of using tablets with other antihypertensive drugs and a lower likelihood of negative side effects is noted.
Some patients note that over time, therapy causes a feeling of addiction to the drug. They also note a relatively high cost, but despite the price, they prefer this particular drug.

Terms of sell

You can buy Arifon retard without a prescription.