Lorvas SR (Indapamide) controlled release tablets 1.5 mg, No. 30

Arterial hypertension.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Inside, preferably in the morning. The recommended starting dose is 2.5 mg 1 time / day, depending on the initial level of systolic blood pressure.

The maximum daily dose is 2.5 mg. It is not recommended to exceed the maximum daily dose. Higher doses do not increase the antihypertensive effect of indapamide, but increase its diuretic effect.

1 tablet contains:

tablet core:

active substance : indapamide 1.5 mg;

excipients: lactose monohydrate 144.22 mg, pregelatinized starch 6.88 mg, hypromellose (Metocel K100 MCR) 50 mg, colloidal silicon dioxide 0.4 mg, magnesium stearate 1.0 mg;

film coat: hypromellose 6 cps (pharmacoate 606) 0.43 mg, macrogol (polyglycol 6000 PF) 0.43 mg, titanium dioxide 0.85 mg.

• Hypersensitivity to indapamide, other sulfonamide derivatives;

• severe renal failure;

• severe hepatic impairment and hepatic encephalopathy;

• hypokalemia;

• pregnancy;

• breastfeeding period;

• age up to 18 years (efficacy and safety have not been established).

With care: impaired liver and kidney function, impaired water and electrolyte balance, hyperparathyroidism, diabetes mellitus, hyperuricemia and gout; debilitated patients, ascites, coronary artery disease, chronic heart failure; in patients with an increased QT interval or in patients receiving concomitant therapy with drugs that can increase the QT interval.

Clinical and pharmacological group: Diuretic. Antihypertensive drug

Pharmaco-therapeutic group: Diuretic

pharmachologic effect

Thiazide-like diuretic, antihypertensive agent. It causes a decrease in the tone of the smooth muscles of the arteries, a decrease in OPSS, also has a moderate saluretic activity due to a violation of the reabsorption of sodium, chlorine and water ions in the cortical segment of Henle's loop and the proximal convoluted tubule of the nephron. The decrease in OPSS is due to several mechanisms: a decrease in the sensitivity of the vascular wall to norepinephrine and angiotensin II; increased synthesis of prostaglandins with vasodilating activity; inhibition of the influx of calcium ions into the smooth muscle elements of the vascular wall. In therapeutic doses, it practically does not affect lipid and carbohydrate metabolism.

The antihypertensive effect is manifested only with an initially elevated blood pressure, develops by the end of the first week and reaches a maximum after 3 months of systematic administration.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract, Cmax in plasma is achieved after 1-2 hours. Plasma protein binding is 79%. It is widely distributed in the body. Does not cumulate.

T1 / 2 is 18 hours. It is excreted by the kidneys mainly in the form of metabolites, 5% - unchanged.

Indications

Arterial hypertension.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Inside, preferably in the morning. The recommended starting dose is 2.5 mg 1 time / day, depending on the initial level of systolic blood pressure.

The maximum daily dose is 2.5 mg. It is not recommended to exceed the maximum daily dose. Higher doses do not increase the antihypertensive effect of indapamide, but increase its diuretic effect.

Side effect

From the hematopoietic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia.

From the nervous system: rarely - dizziness, fatigue, headache, paresthesia.

From the side of the organ of vision: the frequency is unknown - myopia (myopia), blurred vision, visual impairment.

From the side of the cardiovascular system: very rarely - arrhythmia, arterial hypotension; frequency unknown - arrhythmia of the 'pirouette' type.

From the digestive system: infrequently - vomiting; rarely - nausea, constipation, dryness of the oral mucosa; very rarely - pancreatitis.

From the liver and biliary tract: very rarely - liver dysfunction; the frequency is unknown - the development of hepatic encephalopathy in the case of hepatic failure.

On the part of the skin and subcutaneous tissues: hypersensitivity reactions, mainly dermatological, in patients with a predisposition to allergic and asthmatic reactions. Often - maculopapular rash; infrequently, purple; very rarely - angioedema and / or urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome; the frequency is unknown - in patients with an acute form of systemic lupus erythematosus, a worsening of the course of the disease, photosensitivity is possible.

From the urinary system: very rarely - renal failure.

On the part of laboratory parameters: very rarely - hypercalcemia; the frequency is unknown - an increase in the QT interval on the ECG, hyperuricemia, an increase in the concentration of uric acid and glucose in the blood, an increase in the activity of hepatic transaminases, a decrease in potassium with the development of hypokalemia (especially important for patients in high-risk groups), hyponatremia with hypovolemia (which leads to to dehydration and orthostatic hypotension), hypochloremia (can cause secondary metabolic alkalosis).

Contraindications for use

• Hypersensitivity to indapamide, other sulfonamide derivatives;

• severe renal failure;

• severe hepatic impairment and hepatic encephalopathy;

• hypokalemia;

• pregnancy;

• breastfeeding period;

• age up to 18 years (efficacy and safety have not been established).

With care: impaired liver and kidney function, impaired water and electrolyte balance, hyperparathyroidism, diabetes mellitus, hyperuricemia and gout; debilitated patients, ascites, coronary artery disease, chronic heart failure; in patients with an increased QT interval or in patients receiving concomitant therapy with drugs that can increase the QT interval.

Application during pregnancy and lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Application for violations of liver function

Contraindicated in severe hepatic failure and hepatic encephalopathy. It should be used with caution in patients with impaired liver function.

Application for impaired renal function

Contraindicated in severe renal failure. It should be used with caution in patients with impaired renal function.

Application in children

Contraindicated for use in children and adolescents under the age of 18 years.

Use in elderly patients

Caution should be given to elderly patients in order to avoid worsening of the course of concomitant diseases.

special instructions

In case of impaired liver function, thiazide and thiazide-like diuretics can lead to the development of hepatic encephalopathy. In this case, the use of diuretics must be stopped immediately.

When taking thiazide and thiazide-like diuretics, cases of photosensitivity reactions have been reported. If photosensitivity reactions develop during therapy, you must immediately stop taking indapamide. If it is necessary to continue diuretic therapy, it is recommended to protect the skin from exposure to sunlight or artificial ultraviolet rays.

The concentration of sodium ions in blood plasma must be determined before starting treatment and then regularly monitor this indicator. Hyponatremia and hypovolemia can lead to dehydration and orthostatic hypotension. A concomitant decrease in the concentration of chlorine ions can lead to secondary metabolic alkalosis. For patients with cirrhosis of the liver and elderly patients, more frequent monitoring of the concentration of sodium ions in the blood plasma is indicated.

Long-term use of thiazide and thiazide-like diuretics poses a risk of a decrease in the concentration of potassium in the blood plasma and the development of hypokalemia. It is necessary to prevent the risk of hypokalemia (<3.4 mmol / l), especially in elderly patients, weakened or receiving combined drug therapy, in patients with cirrhosis of the liver, accompanied by edema and ascites, in patients with coronary artery disease and heart failure, since hypokalemia entails the likelihood of arrhythmia (hypokalemia in patients of these groups enhances the toxic effect of cardiac glycosides). The risk of hypokalemia is also possible in patients with a prolonged QT interval. Hypokalemia predisposes to severe arrhythmias,especially deadly pirouette-type polymorphic ventricular tachycardia. It is necessary to regularly monitor the content of potassium in the blood plasma in all of the above cases.

Thiazide and thiazide-like diuretics can reduce the excretion of calcium ions by the kidneys, which can lead to a moderate and temporary increase in plasma calcium concentration.

It is necessary to regularly monitor the concentration of glucose in the blood plasma in patients with diabetes mellitus, especially in the presence of hypokalemia.

With an increased concentration of uric acid, gout attacks are possible, in such cases it is necessary to adjust the dose of indapamide accordingly.

Hypovolemia caused by the loss of fluid and sodium ions, when treated with diuretics, can cause a decrease in glomerular filtration, which can lead to an increase in the concentration of urea and creatinine in the blood plasma.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, patients who experience dizziness, fatigue, headache, low blood pressure should refrain from driving vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions.

Drug interactions

With the simultaneous use of GCS, tetracosactide for systemic use, the hypotensive effect decreases due to the retention of water and sodium ions under the influence of GCS.

With simultaneous use with ACE inhibitors, the risk of developing hyponatremia increases.

There is a risk of developing sudden arterial hypotension and / or acute renal failure in combination with ACE inhibitors against the background of an already existing reduced concentration of sodium ions in the blood plasma (especially in patients with renal artery stenosis).

With simultaneous use with NSAIDs (for systemic use), it is possible to reduce the hypotensive effect of indapamide. With a significant loss of fluid, acute renal failure can develop (due to a sharp decrease in glomerular filtration).

With simultaneous use with calcium preparations, hypercalcemia may develop due to a decrease in the excretion of calcium ions in the urine.

With simultaneous use with cardiac glycosides, corticosteroids, the risk of hypokalemia increases.

With the simultaneous use of drugs that can cause hypokalemia (amphotericin B, gluco- and mineralocorticoids, tetracosactide, laxatives that stimulate intestinal motility), the risk of hypokalemia increases.

With simultaneous use with tricyclic antidepressants (including imipramine), the hypotensive effect increases and the risk of orthostatic hypotension increases (additive effect).

With simultaneous use with astemizole, bepridil, erythromycin (i / v), pentamidine, sultopride, terfenadine, vincamine, quinidine, disopyramide, amiodarone, bretilium tosylate, sotalol, there is a risk of developing arrhythmias of the 'pirouette' type.

When used simultaneously with baclofen, the hypotensive effect is enhanced.

With simultaneous use with halofantrine, the likelihood of cardiac arrhythmias (including ventricular arrhythmias of the 'pirouette' type) increases.

With simultaneous use with lithium carbonate, the risk of developing the toxic effect of lithium increases against the background of a decrease in its renal clearance.

With simultaneous use with metformin, the appearance of lactic acidosis is possible, which is apparently associated with the development of functional renal failure due to the action of diuretics (mainly 'loop').

With simultaneous use with cyclosporine, an increase in the content of creatinine in the blood plasma is possible, which is observed even with a normal content of water and sodium ions.

Dehydration of the body while taking diuretics increases the risk of developing acute renal failure, especially when using iodine-containing radio-opaque substances in high doses. It is necessary to compensate for the loss of fluid before the introduction of an iodine-containing radio-opaque substance.

Release form / dosage:

Controlled release film-coated tablets 15 mg.

Packaging:

10 tablets in PVC / Al. blister.

3 or 10 blisters with instructions for use are placed in a cardboard box.

Storage conditions:

Store in a dry place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date indicated on the package.

Vacation conditions

On prescription

Manufacturer

Torrent Pharmaceuticals Ltd, India

Marketing Authorization Holder / Organization Receiving Consumer Claims:

Torrent Pharmaceuticals Ltd